MDE Public Information Meeting

The Board conducted a public information meeting on new accessibility standards to be developed for medical diagnostic equipment on July 29. The full-day event enabled interested parties and members of the public to provide input on the approach to this rulemaking. The new standards, which will cover access to examination tables and chairs, weight scales, radiological equipment, mammography equipment, and other types of medical diagnostic equipment, are required by the "Patient Protection and Affordable Care Act" signed into law in March. The law tasks the Board with establishing technical standards in consultation with the Food and Drug Administration within two years.

Board Member Gary Talbot, who is chairing this effort, Board Vice Chair Nancy Starnes, and staff lead David Baquis opened the meeting with an overview of the Board's rulemaking process, the regulatory steps involved, and a proposed timetable for completing the standards. This was followed by presentations and panel discussions on the legislative background, access barriers and solutions to medical diagnostic equipment, legal cases and settlements, industry standards, observations by health care providers and equipment manufacturers, and research and recommendations. The agenda also included a demonstration of an accessible exam table and opportunities for comments and questions from attendees. Presentations were made by experts and researchers in accessible medical diagnostic equipment, industry representatives, advocacy and civil rights specialists, liaisons from Federal agencies, and other invited speakers. Discussions explored the range of equipment to be addressed, access barriers to equipment, design challenges and solutions, reference standards, and other topics relevant to this rulemaking.


 

Transcript

THURSDAY, JULY 29, 2010  
MEDICAL DIAGNOSTIC EQUIPMENT PUBLIC INFORMATION MEETING

Morning Session

>> NANCY STARNES:  GOOD MORNING LADIES AND GENTLEMEN, IF WE COULD HAVE YOU TAKE A SEAT IN THE ROOM, I THINK WE COULD GET STARTED.

GOOD MORNING, I AM NANCY STARNES.  I AM VICE-CHAIRMAN OF THE U.S. ACCESS BOARD.  IT’S MY HONOR TO WELCOME YOU THIS MORNING ON BEHALF OF THE ACCESS BOARD.

AS YOU KNOW, THE NEWLY ENACTED PATIENT CARE ACT DIRECTS THE BOARD TO DEVELOP STANDARDS FOR MEDICAL DIAGNOSTIC EQUIPMENT.  THE NEW AUTHORITY AFFORDS THE BOARD AN EXCITING OPPORTUNITY TO PROMOTE ACCESSIBILITY IN MEDICAL SETTINGS AS MANY PEOPLE WITH DISABILITIES CAN ATTEST, INCLUDING MYSELF.  FOR ME, IT’S A PERSONAL ISSUE.  THIS IS AN AREA WHERE THE LACK OF ACCESSIBILITY HAS PROVEN TO BE DIFFICULT FOR MANY YEARS.

WOMEN HAVEN’T HAD MAMMOGRAMS FOR YEARS BECAUSE OF THE BREAST EXAM MACHINES AREN’T ACCESSIBLE.  THERE WAS ONE GENTLEMAN WHO WROTE TO OUR STAFF A FEW WEEKS AGO EXPLAINING THAT HE IS UNABLE TO STAND, WALK OR LIFT HIMSELF ON TO EXAM TABLE, THEREFORE IT’S DIFFICULT FOR HIM TO EVEN FIND A DOCTOR TO MEET HIS HEALTHCARE NEEDS.

THESE SITUATIONS PLAY OUT EVERY DAY ACROSS OUR COUNTRY, IT’S HIGH TIME SOMETHING WAS DONE ABOUT IT.

THERE WILL BE A FIRM FOUNDATION OF KNOWLEDGE ON WHICH TO BEGIN OUR ACCESSIBILITY STANDARDS.  TODAY WE HAVE INVITED LEADING EXPERTS FROM ACROSS THE COUNTRY TO GIVE US THEIR IDEAS ON HOW WE SHOULD APPROACH THE ACCESSIBILITY STANDARDS.

WE HAVE ALSO INVITED ORGANIZATIONS REPRESENTING PERSONS WITH DISABILITIES, MEDICAL ORGANIZATIONS AND MEDICAL EQUIPMENT TO OPENLY DISCUSS THE MANY ISSUES BEFORE US.

IN CASE YOU MAY HAVE NEVER WORKED WITH THE ACCESS BOARD, WE WANT YOU TO KNOW THAT WE BELIEVE IN ORDER TO PROMOTE ACCESSIBILITY IT’S CRITICAL TO FOSTER AN OPEN DIALOGUE AMONG ALL AFFECTED PARTIES.  WE ARE GOING TO BE ENCOURAGING AUDIENCE PARTICIPATION THROUGHOUT THE DAY.

I WOULD ALSO URGE EACH OF YOU TO STAY IN TOUCH WITH THE ACCESS BOARD STAFF THROUGH OUR WEBSITE.  THIS IS GOING TO ENABLE US TO CONTINUE THE DIALOGUE THAT WE ARE BEGINNING TODAY.

I WANT TO THANK EACH OF YOU FOR COMING TODAY AND PARTICIPATING IN THIS CRITICAL DISCUSSION.  AND I AM NOW GOING TO TURN THE MEETING OVER TO GARY TALBOT.  HE IS CHAIRPERSON OF THE BOARD’S AD HOC COMMITTEE ON ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT.  GARY?

>> GARY TALBOT:  THANK YOU, MADAM CHAIR.  GARY TALBOT, PUBLIC MEMBER.  WELCOME TO THE PUBLIC FORUM ON ACCESSIBLE MEDICAL DIAGNOSTIC EQUIPMENT IN THE NEW MEETING SPACE.  THIS, I BELIEVE, IS OUR FIRST AD HOC MEETING IN THE NEW SPACE.  WELCOME TO THE MANY STAKEHOLDERS HERE TODAY.  WE APPRECIATE YOUR WILLINGNESS TO PARTICIPATE ON THIS TOPIC.  AS I SAID, I AM GARY TALBOT.  I AM A PUBLIC BOARD MEMBER.  WE HAVE A VERY FULL AGENDA TODAY, SO I AM NOT GOING TO TAKE MUCH TIME WITH MY INTRODUCTION.  I THINK NANCY HIT ON A BUNCH OF REALLY GOOD POINTS.  I DO THINK IT’S APPROPRIATE TO SAY A FEW WORDS ABOUT THE IMPORTANCE OF OUR TASK AND THE IMPACT OUR EFFORTS WILL HAVE ON SO MANY AMERICANS.  IMAGINE THE DAY WHEN WE CAN GO TO THE DOCTOR AND BE WEIGHED, EVEN IF THE RESULTS WE SEE MAY NOT BE WHAT WE WANT TO SEE.

(LAUGHTER)

>> GARY TALBOT:  JUST IMAGINE THE DAY, EVEN IF YOU USE A WHEEL MOBILITY DEVICE.  TODAY OFTEN WHEN A DIAGNOSTIC TEST IS ORDERED BY THE DOCTORS THE EQUIPMENT IS NOT ACCESSIBLE, MANY OF US KNOW THAT AND EXPERIENCE IT FIRST HAND.  AN ALTERNATE TEST IS PERFORMED THAT MAY NOT BE ACCURATE OR NO TEST IS RUN AT ALL, ADDITIONAL MEDICATIONS ARE ORDERED IN AN ATTEMPT OF KNOWING WHAT IS GOING ON.  IMAGINE A DAY WHEN THE TEST IS ACCESSIBLE FOR ALL — THE GOALS FOR THE STANDARDS WRITING EFFORT.

WITH THAT, LET ME GIVE YOU A BRIEF EXPLANATION OF THE ACCESS BOARD FOR THOSE THAT DON’T KNOW US.  WE ARE AN INDEPENDENT FEDERAL AGENCY.  WE DON’T FALL UNDER ANY OTHER DEPARTMENT.

THE BOARD IS COMPRISED OF 25 MEMBERS, 13 OF US ARE PUBLIC MEMBERS, LIKE MYSELF, APPOINTED BY THE PRESIDENT.  AND IF I COULD HAVE JUST THE PUBLIC MEMBERS THAT ARE ATTENDANCE, IF YOU COULD RAISE YOUR HANDS, PLEASE.  GREAT.  THANK YOU.

AND THEN THERE ARE ALSO 12 SENIOR OFFICIALS FROM FEDERAL AGENCIES.  AND IF THE FEDERAL AGENCIES — IF THOSE MEMBERS ARE IN ATTENDANCE, IF YOU COULD PLEASE RAISE YOUR HANDS.  OFTENTIMES WE ARE SUPPORTED BY LIAISONS THAT REPRESENT THE POSITION ON THE BOARD FROM THE FEDERAL AGENCIES.  THE TERM “ACCESS BOARD” IS ALSO USED INFORMALLY TO REFER TO STAFF OF THE AGENCY.  IT’S A SMALL AGENCY OF 28 EMPLOYEES.  WE HAVE BEEN IN EXISTENCE FOR OVER 30 YEARS.  I THINK — LET ME ASK STAFF TO RAISE THEIR HAND IF THEY WOULD.  IF ANYBODY HAS QUESTIONS, THESE ARE THE FOLKS THAT REALLY KNOW WHAT IS GOING ON.  AND JUST ASK THEM, I AM SURE THEY WILL HELP.

THE ACCESS BOARD HAS RULE MAKING AUTHORITY UNDER THE ABA, THE ADA, THE TELECOMMUNICATIONS ACT AND THE REHABILITATION ACT.  THE ACCESS BOARD’S PRIMARY RESPONSIBILITY IS TO WRITE ACCESSIBILITY STANDARDS AND GUIDELINES AND PROVIDE TECHNICAL ASSISTANCE AND TRAINING ON THOSE DESIGN REQUIREMENTS, THOSE ADDRESS THE BUILT ENVIRONMENT AS WELL AS INFORMATION AND COMMUNICATION TECHNOLOGY.  WE HAVE AN OFFICE OF COMPLIANCE THAT PROVIDES ENFORCEMENT FOR FEDERAL BUILDINGS UNDER THE ABA ARCHITECTURAL BARRIERS ACT.  AND WE HAVE A SMALL RESEARCH BUDGET.

AS A RESULT OF THE PATENT PROTECTION AND AFFORDABILITY CARE ACT, SECTION 510 WAS ADDED WHICH TASKS THE ACCESS BOARD, IN CONSULTATION WITH THE FDA, TO WRITE ACCESSIBILITY STANDARDS FOR MEDICAL EQUIPMENT WITHIN TWO YEARS.

TO ASSIST STAFF IN DRAFTING THESE STANDARDS, AN AD HOC COMMITTEE WAS FORMED OF 8 ACCESS BOARD MEMBERS.  IF I COULD HAVE A SHOW OF HANDS FOR THE ACCESS BOARD MEMBERS THAT ARE PART OF THE AD HOC COMMITTEE.  AND REPRESENTATIVES OF APPROXIMATELY 8 FEDERAL DEPARTMENTS AND AGENCIES.  AND AGAIN, ANYBODY HERE ON THE AD HOC COMMITTEE, PLEASE RAISE YOUR HANDS.

THEY WILL CAREFULLY CONSIDER THE INFORMATION PROVIDED DURING TODAY’S MEETING AS WE DEVELOP OUR RULEMAKING AND WORK THROUGH THIS PROCESS.

THE DAY CONSISTS LARGELY OF 6 PANELS EACH OF WHICH ENDS WITH A 15-MINUTE PERIOD FOR THE PUBLIC TO ASK QUESTIONS AND PROVIDE VERY BRIEF COMMENTS.  I THINK IT’S IMPORTANT TO NOTE THIS IS NOT THE ONLY BITE OF THE APPLE, THERE ARE MANY OTHER OPPORTUNITIES FOR PEOPLE THAT ARE HERE TODAY TO ASK US QUESTIONS, RECEIVE OUR RESPONSE AND CONTINUE THE DIALOGUE.

BUT CERTAINLY THE FIRST OPPORTUNITY TODAY.

I AM GOING TO TURN THE MEETING OVER TO DAVID BAQUIS FROM OUR STAFF THAT WILL BE LEADING THE MEETING TODAY.  DAVID?

>> DAVID BAQUIS:  THANK YOU GARY.  GOOD MORNING EVERYONE, WE ARE QUITE EXCITED, THANK YOU FOR COMING TODAY.

THIS IS OUR SECOND DAY USING THE MEETING ROOM, SO PLEASE BEAR WITH US AS WE WORK THROUGH A FEW KINKS.  I AM ONLY GOING TO SPEAK WITH YOU FOR A FEW MINUTES.  WE WILL PROCEED QUICKLY THROUGH THE AGENDA.

ONE OF THE ISSUES THAT I WANTED TO TALK ABOUT, WHICH IS ONE OF THE FREQUENTLY MOST ASKED QUESTIONS IS, WHAT IS MEDICAL DIAGNOSTIC EQUIPMENT?  THIS IS SOMETHING THAT WE WILL BE DISCUSSING THROUGHOUT THE DAY.

IN ADDITION TO THIS SLIDE, WE ALSO CREATED A POSTER WITH THE SAME INFORMATION THAT’S ON THE SLIDE, WHICH I WILL READ NOW.  TO PROVIDE SOME PARAMETERS WHICH WE DREW FROM THE STATUTE ITSELF TO HELP YOU UNDERSTAND WHAT THIS — WHAT THESE STANDARDS MAY APPLY TO.

IT’S EQUIPMENT, IT’S PATIENT ACCESS TO MEDICAL DIAGNOSTIC EQUIPMENT THAT IS USED BY HEALTHCARE PROFESSIONALS, THAT’S THE FIRST CRITERION.

THAT IS USED IN MEDICAL SETTINGS.  AND THAT IS USED FOR DIAGNOSTIC PURPOSES.

SO LET’S THINK OF A COUPLE OF EXAMPLES, THEN I WILL TALK A LITTLE BIT ABOUT THE RULEMAKING PROCESS.

LET’S IMAGINE A GLUCOMETER, SOMETHING THAT SOMEBODY USES TO TEST BLOOD SUGAR.  I WANT YOU TO BE ABLE TO KIND OF THINK FOR YOURSELF, TO THINK ANALYTICALLY ABOUT WHY SOMETHING LIKE THAT MIGHT NOT BE COVERED UNDER THIS RULE.

WHICH OF THE THREE CRITERIA DID IT NOT MEET?  IT WAS USED IN A HOME SETTING.

ONE COULD ARGUE MAYBE IT WASN’T REALLY USED FOR DIAGNOSTIC PURPOSES BECAUSE I TEND TO MONITOR MY BLOOD SUGAR AFTER I ALREADY RECEIVED A DIAGNOSIS OF DIABETES OR PRE-DIABETES.  THERE ARE OTHER EXAMPLES WE WILL TALK ABOUT THROUGHOUT THE DAY, SOMETIMES THERE ARE GRAY AREAS.

I ALSO WANTED TO TALK A LITTLE BIT ABOUT THE RULEMAKING PROCESS BECAUSE PEOPLE ARE WONDERING WHAT IS GOING TO BE HAPPENING OVER THE NEXT TWO YEARS.  REALLY, ABOUT A YEAR AND A HALF LEFT NOW.

WE HAVE A COUPLE OF YEARS BY STATUTE TO COMPLETE THE RULE — THE STANDARDS FOR MEDICAL EQUIPMENT.

AT THE VERY LEAST, THIS WILL INVOLVE A NOTICE OF PROPOSED RULE MAKING.  WE WILL PUT OUT A DRAFT BEFORE IT’S FINAL AND RECEIVE COMMENTS ON THAT BEFORE ISSUING THE FINAL RULE.

DURING THIS TIME THERE WOULD BE A COUPLE REGULATORY ASSESSMENTS, SOMETIMES KNOWN AS ECONOMIC IMPACT ANALYSIS OR COST BENEFIT ANALYSIS.  A COUPLE REVIEWS BY THE OFFICE OF MANAGEMENT AND BUDGET — OMB.

AND AT LEAST ONE COMMENT PERIOD.

THERE COULD BE OTHER ELEMENTS INVOLVED, I THINK, THAT WOULD BE THE BARE MINIMUM OF WHAT IS AHEAD.

AND I JUST WANT TO TALK A LITTLE BIT ABOUT TODAY’S MEETING.  AS GARY MENTIONED THERE WILL BE SIX PANELS, THREE IN THE MORNING, THREE IN THE AFTERNOON.  IN ADDITION, A COUPLE INDIVIDUAL SPEAKERS, ONE IN THE MORNING AND AFTERNOON.

A COUPLE BREAKS.  AGAIN, MORNING AND AFTERNOON.  AND LUNCH ON YOUR OWN.

ONE OF THE THINGS THAT I AM PROUD OF IS SOMETIMES PEOPLE COME TO MEETINGS LIKE THIS AND WISH THEY HAD TIME TO TALK INSTEAD OF HAVING TO LISTEN ALL DAY.

SO WE HAVE ADDRESSED THAT CONCERN.  THERE WILL BE ABOUT SEVEN OPPORTUNITIES FOR QUESTIONS, COMMENTS, AND WE HAVE SPRINKLED THEM THROUGH THE DAY.  COLLECTIVELY THAT’S ALMOST TWO HOURS OF TIME FOR INTERACTION.

SO, WE ARE HOPING THAT DURING THAT TIME WE WILL BE ABLE TO DRAW INFORMATION FROM THE AUDIENCE, AS WELL AS FROM OUR INVITED SPEAKERS.  WE ARE HOPING THAT THE COMMENTS WILL STAY FOCUSED TO ISSUES THAT ARE WITHIN THE PURVIEW OF THIS RULEMAKING.  FOR EXAMPLE, IF YOU ARE FRUSTRATED WITH THE STAFF BECAUSE THEY HAVEN’T BEEN SUFFICIENTLY TRAINED IN ADDRESSING THE NEEDS OF PEOPLE WITH DISABILITIES, WE ARE NOT WRITING STANDARDS FOR STAFF SKILLS BUT FOR THE EQUIPMENT ITSELF.

IF YOU HAVE TROUBLE GETTING INTO THE BUILDING WHERE THE PHYSICIAN OR OTHER CLINICIAN IS LOCATED, THESE AREN’T THOSE KIND OF ARCHITECTURAL REQUIREMENTS WE ARE FOCUSED PRIMARILY ON THE EQUIPMENT AND MAYBE A LITTLE BIT ON THE SPACE AROUND THE EQUIPMENT.

AND WE CAN TALK ABOUT SOME OF THOSE THINGS WHEN WE GET INTO STANDARDS.

AND WHEN IT DOES COME TIME TO TALK IT’S IMPORTANT THAT EVERYBODY WAITS FOR A MICROPHONE.  WE ALL NEED TO SPEAK INTO THE MIC FOR MULTIPLE REASONS, ONE OF WHICH IS TO ENSURE ACCESSIBILITY OF THE MEETING BECAUSE WHAT YOU SAY INTO THE MIC IS FED INTO THE ASSISTIVE LISTENING SYSTEM.

OKAY.  SO, CONTACT INFORMATION, WE HAVE A NEW E-MAIL ADDRESS:  MDE @ ACCESS-BOARD.GOV.  I PUT BUSINESS CARDS OUT FRONT IF YOU WANT MY CONTACT INFORMATION.

I AM NOW GOING TO INTRODUCE OUR NEXT SPEAKER, LEE PERSELAY.  WE THOUGHT IT WOULD BE HELPFUL FROM THE START TO HAVE SOMEBODY COME TO SPEAK TO US ABOUT WHAT THE INTENT OF THE STATUTE WAS AND MAYBE THAT WILL HELP US GET SOME CLARIFICATION ON THE TYPES OF EQUIPMENT IT WAS INTENDED TO COVER AND SOME OTHER ISSUES SO LEE FEEL FREE TO COME UP HERE, PLEASE.

>> LEE PERSELAY:  MY NAME IS LEE PERSELAY, I AM DISABILITY COUNSEL TO THE SENATOR TOM HARKIN.  I HAVE BEEN WITH HIM SINCE 2005.

MY POSITION IS ATTACHED TO THE HEALTH PENSION AND LABOR COMMITTEE; IN GENERAL I DO ALL OF HIS DISABILITY POLICY WORK.  AND I FOLLOW IN THE FOOTSTEPS OF A NUMBER OF OTHER INDIVIDUALS WHOSE HELD THE SAME POSITION, INCLUDING BOBBY SILVERSTEIN, WHO WAS THE FIRST DISABILITY COUNSEL, WHO WAS INSTRUMENTAL ALONG WITH THE SENATOR TO GET THE AMERICANS WITH DISABILITIES ACT PASSED 20 YEARS AGO.

WE BASICALLY SPENT THE LAST TWO WEEKS CELEBRATING THE ADA ANNIVERSARY BECAUSE IT’S SUCH A MOMENTOUS EVENT.  I APPRECIATE ALL OF YOU BEING HERE TO LISTEN AND TO PARTICIPATE IN WHAT I CONSIDER TO BE ANOTHER ATTEMPT TO FULFILL THE PROMISE OF THE AMERICANS WITH DISABILITIES ACT.  SENATOR HARKIN’S OFFICE IN TERMS OF OUR POLICY PRIORITIES, WE OFTEN TRY TO FORGE AHEAD OF FULFILLING THE PROMISE OF THE ADA BY LOOKING AT THE GOALS OF THE ADA.  WHICH ARE EQUAL OPPORTUNITY, INDEPENDENT LIVING, FULL PARTICIPATION AND ECONOMIC SELF-SUFFICIENCY.

ALL OF THOSE PRINCIPLES GUIDE THE LEGISLATIVE WORK AND THE LEGISLATIVE INITIATIVES THAT WE DO.

AND THOSE ARE THINGS THAT WE TAKE TO HEART AND WE KEEP IN MIND, PARTICULARLY FULL PARTICIPATION, AND INDEPENDENCE.

AND SO, WITH THAT IN MIND, A COUPLE OF YEARS AGO WE — SENATOR HARKIN IS ACTUALLY A VERY — HE IS VERY DEVOTED TO WELLNESS AND HEALTH PROGRAMS.  IT’S A HUGE PRIORITY FOR HIM IN GENERAL.  IT’S BEEN ONE OF HIS PRIORITIES FOR MANY YEARS IN THE SENATE.  HE HAS DONE A LOT OF WORK WITH INCREASING NUTRITION AND PHYSICAL ACTIVITY, P.E.  , AND THINGS LIKE THAT — PARTICULARLY FOR KIDS.

AND SO, WHAT WE HAVE DONE, WHAT WE DID A COUPLE OF YEARS AGO, WE DECIDED WE WERE GOING IT EXPAND THAT, AND BE SURE TO INCLUDE INDIVIDUALS WITH DISABILITY IN THESE INITIATIVES.  AND THE WAY THAT WE DID IT, WE INTRODUCED A BILL, WHICH HAD A VERY LONG NAME ST — S1050 PROMOTING THE HEALTH AND WELLNESS OF INDIVIDUALS WITH DISABILITIES ACT OR SOMETHING.  NORMALLY WHEN WE INTRODUCE BILLS IN CONGRESS WE TRY TO CREATE SOME ACRONYM THAT PEOPLE CAN REMEMBER, AS OPPOSED TO HAVING TO ACTUALLY REMEMBER THE FULL TITLE OF THE BILL.

HOWEVER, AFTER MANY ATTEMPTS WE WEREN’T ABLE TO CREATE A CUTE ACRONYM FOR THE BILL.  WE ENDED UP WITH A BILL THAT EVEN AT THIS POINT I CAN’T REMEMBER THE TITLE OF.

IN ANY EVENT, THE BILL GAVE US AN OPPORTUNITY TO PUT TOGETHER THREE SEPARATE IMPORTANT HEALTH AND WELLNESS INITIATIVES.  ONE HAD TO DO WITH INCREASING PHYSICAL ACTIVITY AND WELLNESS PROGRAMS IN COMMUNITIES FOR PEOPLE WITH DISABILITIES.  THE SECOND HAD TO DO WITH TRAINING MEDICAL PROFESSIONALS SO THAT THEY COULD LEARN HOW TO COMMUNICATE BETTER; THAT’S THE TERM WE USE COMMUNICATE BETTER WITH INDIVIDUALS WITH DISABILITIES.  PARTICULARLY INDIVIDUALS WITH INTELLECTUAL DISABILITIES.  AND THE THIRD PART OF THE BILL HAD TO DO WITH CREATING OR ACCESSIBLE MEDICAL EQUIPMENT AND MEDICAL DIAGNOSTIC EQUIPMENT FOR INDIVIDUALS WITH DISABILITIES.

AND ALL OF THOSE THREE WERE WE SORT OF SHOE-HORNED INTO THE SAME BILL AS A WAY TO GARNISH SUPPORT.

THE BILL ITSELF DIDN’T HAVE MUCH MOVEMENT, ALTHOUGH THERE WAS A LOT OF SUPPORT IN THE DISABILITY COMMUNITY.

BUT IT DID GIVE US AN OPPORTUNITY WHEN, AS OFTEN HAPPENS IN THE SENATE, TO JUMP INTO TO TAKE AT LEAST SOME OF THE PROVISIONS AND GRAFT THEM ONTO ANOTHER BILL WHICH HAPPENED TO BE THE HEALTHCARE REFORM BILL THAT WE JUST PASSED, THERE ARE ASPECTS OF ALL THREE IN THE HEALTHCARE REFORM BILL.  BUT, CLEARLY, THE PART OF THE ORIGINAL BILL THAT HAS THE MOST PLAY IS THIS REQUIREMENT OF THE — OF ESTABLISHMENT OF STANDARDS FOR ACCESSIBLE MEDICAL EQUIPMENT.

AND THIS IS AN ISSUE THAT I KNOW MANY PEOPLE IN THIS ROOM HAVE WORKED LONG AND HARD ON.  I SEE JUNE IS HERE AND MARILYN IS HERE.  THERE ARE MANY OTHERS I KNOW WILL BE HERE LATER IN THE DAY, AND WHO WILL BE SPEAKING TO YOU AS WELL.

I, TO BE HONEST — IN SENATOR HARKINS OFFICE WE DON’T BELIEVE WE CREATE EACH AND EVERY IDEA OF GOOD INTENT FOR LEGISLATIVE ACTIVITY.

WE ARE HAPPY TO BORROW OR SOME CASE STEAL OTHER PEOPLE’S IDEAS.  IN THIS CASE, OUR PATH DOWN THIS ROAD TOWARDS ACCESSIBLE MEDICAL EQUIPMENT ACTUALLY CAME AS A RESULT OF ANOTHER STAFF PERSON WHO WORKED WITH SENATOR HARKIN INDIVIDUAL WHO IS WHEELCHAIR USER JUST ROLLED IN THE ROOM NOW IN THE BACK.

AND WHO WORKED WITH US IN SENATOR HARKIN’S OFFICE AND WHO ACTUALLY NOTED THE DIFFICULTY OF INDIVIDUALS WITH DISABILITIES AND THE TROUBLES THAT THEY HAD IN TERMS OF ACCESSING MEDICAL EQUIPMENT WHEN THEY GO TO THE DOCTOR.  THE DIFFICULTY FINDING ACCESSIBLE EXAM TABLES, DIFFICULTY IN BEING WEIGHED, THE DIFFICULTY IN USING MAMMOGRAPHY MACHINES THE DIFFICULTY IN GOING TO THE DENTIST.

AND , AS A RESULT, WE BEGAN TO PUT TOGETHER THIS INITIATIVE, A COUPLE OF YEARS AGO IN THIS HEALTH AND WELLNESS BILL.  THESE ISSUES NEAR AND DEAR TO PEOPLE WITH DISABILITIES FOR SENATOR HARKIN ARE OF PRIME IMPORTANCE.  AS I SAID, FULFILLING THE PROMISE OF THE ADA.  WORKING ON THOSE ISSUES, WE COLLECTED SOME STORIES, I FEW I WILL SHARE WITH YOU TODAY.  MOST, IF NOT ALL IN THE ROOM, I KNOW — NANCY AND GARY PROBABLY HAVE STORIES OF THEIR OWN, HAVE SIMILAR EXPERIENCES.

AND IN FACT, YOU KNOW I THINK THIS WAS SORT OF REVEALING TO ME WHEN WE STARTED WORKING ON THIS ISSUE WE FOUND THAT SOME RESEARCH HAD BEEN PERFORMED ON SOME OF THESE ISSUES BACK IN THE EARLY ’90S I THINK BAYLOR UNIVERSITY NIDRR FUNDED SOME OF THOSE INITIATIVES.

FOR ONE REASON OR ANOTHER NOBODY IN CONGRESS PICKED UP ON THEM.  IMAGINE THAT?

AND DECIDED TO RUN WITH IT.

SO, YOU KNOW, AS SENATOR HARKIN LIKES TO SAY, THE ADA HAS FATHER’S AND MOTHER’S AND NOT JUST ONE PERSON.  IT APPLIES TO THIS PIECE OR PORTION OF LEGISLATION AS WELL.

I DON’T CLAIM OWNERSHIP OF IT.  SENATOR HARKIN’S NAME IS ON IT.  BUT IT HAS MANY FATHERS AND MOTHERS.  MANY ARE IN THE ROOM TODAY.  MANY AREN’T WITH US HERE TODAY, BUT HAD AN IMPORTANT ROLE IN MAKING THIS HAPPEN.  I WANTED TO ACKNOWLEDGE THAT AND TELL YOU HOW APPRECIATIVE WE ARE OF PEOPLE’S PARTICIPATION TOWARDS THAT.

AS I SAID, I THINK MOST PEOPLE IN THE ROOM KNOW SOME OF THE STORIES THAT WE HAVE.  I JUST WANTED TO READ A COUPLE OF THEM THEN I WILL TURN TO WHAT WE INTENDED TO DO WITH THE LEGISLATION BEFORE WRAPPING UP.

THE STORIES ARE SHORT IN SOME CASES — WELL, YOU WILL SEE.

FIRST STORY:  I HAD JUST BEGUN TO USE A POWER CHAIR; I HAD AN ARGUMENT WITH AN ELEVATOR DOOR AND TORE MY TOENAIL AT THE DOCTOR’S OFFICE.  THEY PUT ME IN A REGULAR EXAMINING ROOM.  I REMAINED IN THE CHAIR BECAUSE THE TABLE WAS TOO HIGH TO GET ON, THE PA CRAWLED ON THE FLOOR AND LAID ON THE FLOOR TO EXAMINE MY FOOT.

SECOND STORY:  LAST YEAR I GAINED A LOT OF WEIGHT AND MY DOCTOR PUT ME ON HIGH BLOOD PRESSURE MEDICATION, I ASKED TO BE WEIGHED, DUE TO THE FACT NO DOCTOR HAD THE PROPER MEDICAL EQUIPMENT TO WEIGH ME IN 39 YEARS.  THE DOCTOR SAID HIS OFFICE DID NOT HAVE ACCESSIBLE MEDICAL EQUIPMENT TO WEIGH ME ON.  THEREFORE, HE COULD NOT MEET MY MEDICAL NEED, HE SUGGESTED I CALL A WEIGHT REDUCTION CLINIC.  WHEN I DID WHAT THE DOCTOR WAS SUGGESTED, I WAS TOLD TO CALL THE POST OFFICE AND BE WEIGHED AS A PACKAGE WOULD BE WEIGHED.  THIS WAS EXTREMELY DEHUMANIZING HAVING NO OTHER RESOURCE, I CALLED THE POST OFFICE THE PERSON AT THE END OF THE PHONE LAUGHED OUT LOUD SAID, NO, THEY WOULD NOT WEIGH ME AT THE POST OFFICE AND THE SCALES WERE MEANT TO WEIGH PACKAGES AND MAIL, NOT PEOPLE.

THIRD STORY:  MY SON IS 24, IN A WHEELCHAIR DUE TO CEREBRAL PALSY, HE HAS NOT BEEN WEIGHED UNTIL HE GOT TOO HEAVY FOR ME TO HOLD HIM.  IT SHOULD BE POSSIBLE FOR — I’LL LEAVE OUT OF THE NAME OF THE INSURANCE COMPANY — FOR A SCALE TO BE USED BY PEOPLE IN WHEELCHAIRS, THEY DON’T HAVE TO GUESS AT THE DOSAGE FOR THE MEDICINE.  I MENTIONED THIS TO THE NURSES AND DOCTORS SEVERAL TIMES THERE IS NO RESPONSE.  THEY ASK HIM IF HE CAN STAND ON THE SCALE, WHEN HE SAYS NO THEY SAY OKAY, THAT’S THE END OF THAT.

FOURTH STORY:  IN RESPONSE — I HAVE FOUND EXAMINING TABLES ARE TOO HIGH TO ACCESS FROM MY WHEELCHAIR I FOUND THAT MOST TABLES AND DIAGNOSTIC EQUIPMENT IS TOO HIGH AND NARROW.  MAMMOGRAMS ARE TOO HIGH TO ACCESS FOR A PERSON IN A WHEELCHAIR.

LAST STORY:  MY BIGGEST COMPLAINT WHEN ACCESSING MEDICAL SERVICES IS LACK OF MEDICAL EXAMINATION TABLES IN ALL HOSPITALS AND CLINICS, I HAVE BEEN TO OVER THE PAST 17 YEARS.  THIS IS SOMETHING THAT NEEDS TO BE ADDRESSED.  I FIND IT DEGRADING TO HAVE OTHERS LIFT YOU ON TO EXAMINATION TABLES, THE TABLES ARE NARROW.  I HAVE FALLEN ON TWO OCCASIONS.

THESE ARE ONLY A FEW OF THE — I JUST BROUGHT SOME OF THE STORIES HERE TODAY.  THESE ARE STORIES THAT WE GOT FROM PEOPLE WITH DISABILITIES.  NICL HELPED US COLLECT THEM.  AND THEY ARE ONLY THE TIP OF THE ICEBERG.  THIS IS A CRITICAL ISSUE FOR PEOPLE WITH DISABILITIES.  EVERYBODY IN THIS ROOM KNOWS IT’S IMPOSSIBLE, IMPOSSIBLE TO GET FIRST-CLASS HEALTHCARE, IF YOU CANNOT GET ON THE EXAMINATION TABLE, IF THE EXAMINATION TABLE IS NOT ACCESSIBLE TO YOU, IF THE DENTIST CHAIR IS NOT ACCESSIBLE TO YOU, IF THE MAMMOGRAPHY IS NOT ACCESSIBLE OR THE WEIGHT SCALE IS NOT ACCESSIBLE.  WE LIVE IN A WORLD NOW WHERE DOCTORS ARE GUESSING AT WHAT PEOPLE WEIGH WHEN THEY DECIDE HOW MUCH MEDICATION TO GIVE YOU, IT’S A DANGEROUS SITUATION AND IT DOESN’T HAVE TO BE THAT WAY.

NOW, I AM SURE MARILYN CAN TELL US IN CALIFORNIA THERE WAS A LAWSUIT A NUMBER OF YEARS AGAINST KAISER PERMANENTE BECAUSE THEY DIDN’T HAVE ACCESSIBLE MEDICAL EQUIPMENT AND THE DISABILITY ADVOCATES IN CALIFORNIA DECIDED THEY ARE GOING TO DO SOMETHING ABOUT IT.  SO, AFTER SOME PORTION OF LITIGATION SETTLEMENT WAS REACHED WHERE KAISER PERMANENTE AGREED TO PUT ACCESSIBLE EXAMINATION TABLES IN ALL OF THEIR FACILITIES.  PEOPLE SUGGEST THAT THE COST IS SO HIGH FOR THE ADJUSTABLE, RATHER ACCESSIBLE, EXAMINATION TABLES — THAT IT’S A BURDEN ON THE PROVIDERS AND THEREFORE IT SHOULDN’T BE DONE.  IN THE CASE OF KAISER PERMANENTE, BEFORE THE SETTLEMENT AGREEMENT WAS REACHED, THE COST OF EXAMINATION TABLE THAT COULD GO UP AND DOWN WAS ABOUT $11,000.

AFTER THE SETTLEMENT AGREEMENT, AND AFTER KAISER PERMANENTE, THE COST MAGICALLY WENT DOWN TO $3,000 PER TABLE.  AMAZING.  SO, THIS IS THE FUTURE OF HEALTHCARE.

WE HAVE SPENT A LOT OF TIME AND EFFORT, SENATOR HARKIN SPENT A LOT OF TIME AND EFFORT PASSING THE NEW HEALTHCARE REFORM ACT.  WE WANT PEOPLE TO HAVE ACCESS TO HEALTHCARE, BUT THIS CAN’T HAPPEN UNLESS WE HAVE ACCESSIBLE MEDICAL EQUIPMENT FOR ALL PEOPLE AND ALL PEOPLE CAN GET THE APPROPRIATE DIAGNOSTIC TESTS THAT THEY NEED TO HAVE DONE TO HAVE THE EXAMINATION THE SAME WAY AS EVERYBODY ELSE.  WE JOKE, IT’S NOT ACTUALLY A JOKE, I KNOW MANY OF US HAVE BEEN TO LAS VEGAS, PROBABLY MORE FREQUENTLY THAN WE WOULD LIKE TO ADMIT, AND THEN WHEN WE ARE THERE, WHEN WE GO THERE, LET’S SAY YOU DECIDE THAT YOU WANT TO GET A MASSAGE AT THE BELLAGIO OR MONTE CARLO, YOU SIGN UP FOR THE MASSAGE, AND YOU GO IN THERE AND MOST OF THEM THEY HAVE A TABLE THAT GOES UP AND DOWN.

SO, HOW IS IT THAT YOU CAN GET SIGN UP TO GET A MASSAGE, YOU CAN AND YOU CAN HAVE ACCESS TO AN ACCESSIBLE MEDICAL — YOU COULD HAVE ACCESS TO AN ACCESSIBLE TABLE WHEN YOU GO TO THE DOCTOR’S OFFICE, WHICH IS MORE IMPORTANT THAN GETTING A MASSAGE AT ANY PARTICULAR TIME, THEY DON’T HAVE THE EQUIPMENT, THAT’S PRETTY REVEALING.  THE REASON IS IT’S NOT A PRIORITY.  WITH THE NEW LEGISLATION IT’S GOING TO BE A PRIORITY.

AND THAT’S WHY WE HAVE WRITTEN IT THAT WAY AND WE LOOK FORWARD TO THE ACCESS BOARD HELPING US MOVE FORWARD WITH THAT.

LET ME JUST TALK A LITTLE BIT ABOUT WHAT WE HAVE WRITTEN IN THE LANGUAGE.

THE LANGUAGE, AS GARY HAD POINTED OUT EARLIER, IS INTENDED TO SET MINIMAL TECHNICAL CRITERIA FOR MEDICAL DIAGNOSTIC EQUIPMENT USED IN OR IN CONJUNCTION WITH PHYSICIAN’S OFFICES, CLINICS, EMERGENCY ROOMS HOSPITALS OR OTHER MEDICAL SETTINGS.  OKAY?  WE TRIED TO BE AS EXPANSIVE AS POSSIBLE.

IN TERMS OF WHERE WE WANTED IT TO BE.

THE STANDARD SHALL ENSURE, THIS IS IMPORTANT, THAT SUCH EQUIPMENT IS ACCESSIBLE TO AND USABLE BY INDIVIDUALS WITH ACCESSIBLE NEEDS AND SHALL — THIS IS EVEN MORE IMPORTANT — SHALL ALLOW INDEPENDENT ENTRY TO USE OF EXIT FROM THE EQUIPMENT BY SUCH INDIVIDUALS TO THE MAXIMUM EXTENT POSSIBLE.

I THINK OUR POSITION ON ALL OF THIS AND OUR INTENT IN ALL OF THIS WAS WE WANT TO ALLOW PEOPLE TO USE THE EQUIPMENT INDEPENDENTLY IF POSSIBLE.

AND ONLY IF THAT’S NOT POSSIBLE THEN WE WILL — THEN WILL WE FALL BACK ON THE WAYS IN WHICH IT’S CURRENTLY DONE.  WE WANT TO PROMOTE INDEPENDENT USE OF THE EQUIPMENT AND WE WANT THE EQUIPMENT TO BE BUILT IN SUCH A WAY THAT IT CAN ALLOW THE INDEPENDENT USE BY PEOPLE WITH DISABILITIES TO THE MAXIMUM EXTENT POSSIBLE.

IN TERMS OF THE SPECIFIC MEDICAL EQUIPMENT COVERED, WE PUT IN SOME EXAMPLES OF THINGS THAT WE THOUGHT SHOULD BE COVERED AND IT SAYS IN HERE, SHALL APPLY TO EQUIPMENT THAT INCLUDES EXAMINATION TABLES EXAMINATION CHAIRS, INCLUDING CHAIRS USED FOR EYE EXAMINATIONS OR PROCEDURES AND DENTAL EXAMINATIONS FOR PROCEDURES, WEIGHT SCALES, EXTRA MACHINES AND OTHER RADIOLOGIC EQUIPMENT COMMONLY USED FOR DIAGNOSTIC PURPOSES BY HEALTH PROFESSIONALS.  NOW, IN CONGRESS WE DON’T, NONE OF US ARE WISE ENOUGH OR ILL ADVISED ENOUGH TO IMAGINE EVERY TYPE OF MEDICAL EQUIPMENT.  WE HAVE WRITTEN IT IN A BROAD WAY.  THE LIST OF THINGS THAT WE PUT IN HERE IS NOT THE END OF THE LIST.

IT IS EXAMPLES OF THINGS THAT WE WANT COVERED.  IT WOULD BE IMPOSSIBLE TO CREATE AN EXHAUSTIVE LIST OF THINGS THAT WE WANT COVERED AND ANYWAY THINGS CHANGE ON A DAILY, WEEKLY, YEARLY, DECADE BASIS, THIS IS SOMETHING THAT WE WANT TO ENSURE AS TIME GOES ON, THAT WE DO HAVE ACCESSIBLE MEDICAL EQUIPMENT FOR PEOPLE WITH DISABILITIES.

SO THAT NO LONGER DO WE HAVE A SITUATION LIKE GARY AND NANCY AND OTHERS WE WILL TALK ABOUT LATER TODAY, WHERE PEOPLE WITH DISABILITIES ARE NOT ABLE TO GET ON THE EXAM TABLES ARE NOT ABLE TO GET INTO THE DENTIST CHAIRS OR GET MAMMOGRAMS, ARE NOT ABLE TO GET WEIGHED JUST BECAUSE THEY ARE A PERSON WITH A DISABILITY.  IT’S WRONG, AND WE NEED TO END IT THAT’S WHY WE PUT IN THE PROVISION WE LOOK FORWARD TO ALL OF YOUR HELP ESPECIALLY THE ACCESS BOARD’S IN MAKING THIS HAPPEN.  THANK YOU.  DID YOU WANT ME TO TAKE QUESTIONS FOR A MINUTE?

>> DAVID BAQUIS:  YES, THANK YOU LEE.  WE HAVE TIME FOR MAYBE A COUPLE OF QUESTIONS.  LET’S SEE WHO HAS QUESTIONS.  AND I PROBABLY WILL ONLY HAVE TIME FOR A COUPLE BEFORE WE MOVE ON TO THE NEXT PANEL.  PLEASE STATE YOUR NAME AND KEEP IT BRIEF.

>> GOOD MORNING.  TODD ANDERSON SPEAKING FOR MYSELF.  FIRSTLY I WOULD LIKE TO THANK THE COMMITTEE AND SENATOR FOR THIS ACT, BUT I DO HAVE TWO QUESTIONS, I WOULD LIKE TO SEE IF YOU COULD RESPOND TO, DO YOU ACCEPT THE THREE POINTS PUT DOWN AS THE GUIDING PRINCIPLES AS FAIRLY GOOD DESCRIPTION OF THE ACTS INTENT AND DO YOU THINK THERE IS ANYTHING MISSING?  MY NEXT QUESTION IS:  IS THERE ANYTHING IN THE HISTORY OF THE ACT THAT WOULD HELP UNDERSTAND WHAT IS A PROFESSIONAL IN THIS CONTEXT?  BECAUSE OFF TIMES THERE ARE ACTS THERE ARE BITS OF MEDICAL WORLD THAT ARE DONE BY FOLKS I WOULDN’T CONSIDER PROFESSIONALS.

>> LET ME TAKE THE SECOND QUESTION FIRST.

I AM JUST LOOKING OVER THE SPECIFIC LANGUAGE NOW, I AM NOT — I DON’T RECALL THAT THERE IS ANY REQUIREMENT IN THE LANGUAGE THAT WE WROTE, WHICH AS — WAS POINTED OUT EARLIER WAS AN AMENDMENT TO THE REHABILITATION ACT OF 1973, I DON’T RECALL THAT THERE IS ANY LANGUAGE THAT SUGGESTS THAT THIS ONLY APPLIES TO EQUIPMENT THAT’S OPERATED BY CERTAIN INDIVIDUALS.

I MEAN, THE WAY THAT IT’S WRITTEN, IT APPLIES TO EQUIPMENT THAT IS USED BY OR IN CONJUNCTION WITH PHYSICIAN’S OFFICES, CLINICS, EMERGENCY ROOMS, HOSPITALS AND OTHER MEDICAL SETTINGS BUT IT’S NOT RESTRICTED TO EQUIPMENT RUN BY SPECIFIC INDIVIDUALS SUCH AS A PHYSICIAN.  I MEAN, IT’S WHOEVER, WHOEVER IS GOING — FOR EXAMPLE, LET’S TALK ABOUT THE MAMMOGRAPHY EQUIPMENT OR THE OTHER RADIOLOGICAL TESTING EQUIPMENT.  THERE IS NO RESTRICTION IN WHAT WE HAVE WRITTEN THAT SAYS IT ONLY APPLIES TO A LICENSED RADIOLOGIST OR IT ONLY APPLIES TO AN X-RAY TECHNICIAN OR ANYTHING LIKE THAT.  I MEAN OUR UNDERSTANDING IS THAT IT WOULD APPLY TO ANYBODY WHO IS — IT ACTUALLY APPLIES TO THE EQUIPMENT, IT DOESN’T APPLY TO THE INDIVIDUAL.

SO, THE EQUIPMENT ITSELF HAS TO BE ACCESSIBLE.

OKAY?  DOES THAT MAKE SENSE?

>> I WAS HOPING YOU WOULD SAY THAT THE FIRST PRINCIPLE OF THE THREE NEEDS TO BE REDRAFTED.

>> OKAY.  I AM NOT SURE WHAT PRINCIPLE — ARE WE REFERRING TO DAVID, DID YOU WANT TO PUT IT BACK UP?

>> DAVID BAQUIS:  HE WAS REFERRING TO THE CHART HERE DIAGNOSTIC EQUIPMENT USED BY HEALTHCARE PROFESSIONALS WE PULLED THAT FROM THE STATUTE.

>> I ACTUALLY HAVE THE STATUTE IN FRONT OF ME, STUNNINGLY ENOUGH, IT SAYS NOT LATER THAN 24 MONTHS AFTER ENACTMENT OF AFFORDABLE HEALTHCARE, THE ACCESS BOARD SHALL SET FORTH MINIMUM CRITERIA FOR MEDICAL DIAGNOSTIC EQUIPMENT USED IN OR IN CONJUNCTION WITH PHYSICIAN’S OFFICES, CLINICS EMERGENCY ROOMS HOSPITAL OR OTHER MEDICAL SETTINGS.  THE STANDARDS ENSURES SUCH EQUIPMENT IS ACCESSIBLE AND USABLE BY INDIVIDUALS WITH ACCESSIBLE NEEDS.

AND SHALL ALLOW INDEPENDENT ENTRY TO AND USE OF AND EXIT FROM THE EQUIPMENT BY SUCH INDIVIDUALS TO THE MAXIMUM EXTENT POSSIBLE.

MEDICAL DIAGNOSTIC EQUIPMENT COVER THE STANDARDS ISSUED UNDER SUBSECTION A, OR MEDICAL DIAGNOSTIC EQUIPMENT SHALL APPLY TO EQUIPMENT THAT INCLUDES EXAMINATION TABLES, EXAMINATION CHAIRS, WEIGHT SCALES, MAMMOGRAPHY, X-RAY OR OTHER RADIOLOGIC EQUIPMENT USED FOR DIAGNOSTIC PURPOSES.

THEN JUST THE THIRD PROVISION SAYS THE ACCESS BOARD SHALL WORK IN CONJUNCTION WITH THE FDA TO PERIODICALLY REVIEW AND AMEND THE STANDARDS.

SO I DON’T SEE ANY RESTRICTION ABOUT WHO CAN OPERATE THE EQUIPMENT IN TERMS OF THE LEGISLATIVE LANGUAGE.

THE LEGISLATIVE LANGUAGE REALLY GOES TO THE EQUIPMENT ITSELF.  SO —

>> OKAY, OKAY

>> DAVID BAQUIS:  OKAY.  WE WILL TAKE THAT QUESTION UNDER ADVISEMENT.  WE HAVE TIME FOR ONE MORE.  JOHN BOX, DO YOU HAVE A QUESTION?  YOU NEED A MICROPHONE THERE.  THEN THE NEXT FOUR PANELISTS GET READY AND WE NEED TO GET THE POWER POINTS READY.

>> THANK YOU.  JOHN BOX, PUBLIC MEMBER, ACCESS BOARD.  YOU MIGHT HAVE PARTIALLY ANSWERED THIS.  BUT CAN YOU GIVE ME AN EXAMPLE OF OTHER MEDICAL SETTINGS?

>> OF OTHER MEDICAL SETTINGS OR OTHER MEDICAL EQUIPMENT?

>> OTHER MEDICAL SETTINGS.

>> I GUESS THE ONLY WAY I CAN ANSWER THAT IS TO BE HONEST ABOUT IT.  AGAIN, IN CONGRESS WE DON’T EXPECT TO UNDERSTAND EACH AND EVERY POSSIBLE ITERATION OF WHAT A MEDICAL SETTING COULD BE.  AND SO, OFTENTIMES, BECAUSE WE KNOW THAT WE CAN’T POSSIBLY THINK OR LIST EACH OTHER MEDICAL SETTING, WE USUALLY PUT IN A CATCH PHRASE LIKE AND OTHER MEDICAL SETTINGS WE LEAVE IT TO EXPERTS LIKE YOURSELVES AND OTHERS ON THE ACCESS BOARD TO DETERMINE WHAT THE OTHER MEDICAL SETTINGS ARE.  SO, AGAIN, THE LIST ISN’T — THE LIST OF SETTINGS IS NOT INTENDED TO BE RESTRICTIVE.  THE LIST OF SETTINGS IS INTENDED TO BE EXAMPLES OF SOME MEDICAL SETTINGS, IF THERE ARE OTHER MEDICAL SETTINGS THAT THE — THAT THE ACCESS BOARD DETERMINES TO BE APPROPRIATE WE HOPE THAT THEY WOULD BE INCLUDED.

WE DIDN’T WANT TO SAY, AND THIS IS THE LIST.  BECAUSE THE WAY IN WHICH MEDICAL CARE IS DELIVERED IN THE COUNTRY IS CONSTANTLY CHANGING.  AND WE DIDN’T WANT TO, FOR EXAMPLE, IMAGINE THAT WE COVERED SOMETHING BY THE WAY IN WHICH WE DESCRIBED IT, BUT THE USE OF THE SAME EQUIPMENT IN ANOTHER PHYSICAL SETTING WAS NOT COVERED BECAUSE WE NEGLECTED TO DESCRIBE IT IN A PARTICULAR WAY.  OKAY?

>> DAVID BAQUIS:  THANK YOU VERY MUCH, LEE.

>> THANK YOU.  HAVE A GREAT DAY, GUYS.

>> DAVID BAQUIS:  LET’S PROCEED TO THE NEXT PANEL.  ROBERTA AND JANET YOU ARE HERE?  GOOD.  LET’S PUT JUNE’S SLIDE SHOW UP FIRST.  I WILL JUST SAY A FEW INTRODUCTORY REMARKS FOR THE PANEL.

SO, WE ARE GOING TO HEAR FROM FOUR PANELISTS AND WE WILL HAVE TIME FOR QUESTIONS AND COMMENTS AFTERWARDS.  FIRST, WE WILL HEAR FROM JUNE KAILES, WHO WAS A FORMER CHAIR OF THE ACCESS BOARD.  SHE IS WELL-KNOWN IN THE FIELD OF HEALTHCARE ACCESS AND WAS INSTRUMENTAL IN ADVOCACY THAT HELPED TO MAKE TODAY’S MEETING POSSIBLE.

SHE WILL PROVIDE AN OVERVIEW OF DIFFERENT TYPES OF MEDICAL DIAGNOSTIC EQUIPMENT AND THE BARRIERS FACED BY PEOPLE WITH DISABILITIES.

THEN WE WILL HEAR FROM TWO PEOPLE WHO WORK FOR THE AMERICAN ASSOCIATION ON HEALTH AND DISABILITY, ROBERTA CARLIN IS THE EXECUTIVE DIRECTOR WHO WILL SHARE SOME REMARKS ABOUT THE ORGANIZATION AND THEIR PROGRAMS AND JANET KREITMAN WILL TALK ABOUT A SURVEY ABOUT ACCESSIBLE MAMMOGRAPHY EQUIPMENT USED IN ACCESSIBLE SETTINGS AND DIFFERENT INFORMATION.  FINALLY, WE ARE HONORED TO INTRODUCE FLORITA TOVEG FROM BREAST HEALTH ACCESS FOR WOMEN WITH DISABILITIES, SHE IS KNOWLEDGEABLE ABOUT WOMEN’S HEALTH AND BRINGS STAKEHOLDERS TOGETHER TO MAKE RECOMMENDATIONS.  JUNE, PLEASE PROCEED.

>> OKAY.  WELL, WELCOME.  IT’S MORE THAN A PLEASURE TO BE HERE.  AND I WILL EXPLAIN THAT IN A COUPLE MINUTES I AM JUNE, JUNE ISAACSON KAILES, AND MY WORK FOCUSES ON HELPING TO ENSURE THAT THE NEEDS OF PEOPLE WITH DISABILITIES AND ACTIVITY LIMITATIONS ARE INTEGRATED INTO HEALTHCARE AND EMERGENCY PLANNING RESPONSE AND RECOVERY SERVICES AND SYSTEMS.

CAN YOU ALL SEE THE SLIDES?  AND I WILL NARRATE THEM AS WELL FOR PEOPLE WHO CAN’T SEE THEM.  I AM THE ASSOCIATE DIRECTOR OF THE CENTER FOR DISABILITY AND HEALTH POLICY AT WESTERN UNIVERSITY OF HEALTH SCIENCES IN POMONA, CALIFORNIA.  IN GETTING THIS ISSUE IN LEGISLATION WAS REALLY A COMBINED EFFORT OF LEGISLATORS LIKE SENATOR HARKIN AND LEE’S EFFORTS AND RESEARCHERS LIKE JACK WINTERS, WHO YOU WILL HEAR FROM LATER, INDUSTRY REPRESENTATIVES MIDMARK — JOHN WELLS — AND STANDARDS DEVELOPERS GOVERNMENT, FDA, DOJ AND ADVOCACY GROUPS, MANY OF YOU WHO ARE HERE IN THE AUDIENCE TODAY.

A MAJOR EFFORT THAT HELPED DEVELOP OUR KNOWLEDGE BASE WAS THE FINDINGS OF THE RERC, WHICH STANDS FOR REHABILITATION ENGINEERING RESEARCH CENTER, ON ACCESSIBLE MEDICAL INSTRUMENTATION FUNDED BY NIDRR.  NIDRR IS THE NATIONAL INSTITUTE OF DISABILITY AND REHABILITATION RESEARCH.

AND WE WERE PARTNER IN THAT RERC FROM 02 TO 2008.

AS EARLY AS 2004, I DRAFTED A POLICY PAPER WHICH I FIRST PUT IN WRITING AND CONTINUED TO ADVOCATE FOR THE ACCESS BOARD TO DEVELOP THESE STANDARDS.  SO I GUESS PATIENCE NOT SOMETHING I AM USUALLY KNOWN FOR.

(LAUGHTER)

>> AND PERSEVERANCE DOES FINALLY PAYOFF.  SO THAT MAKES IT REALLY A PLEASURE TO BE HERE.

MY COMMENTS ARE ALSO, PROBABLY MOST IMPORTANTLY BASED ON WORKING WITH PEOPLE WITH DISABILITIES FOR DECADES.  AND WORKING WITH AND LEARNING FROM THE MEDICAL CENTERS, COMMUNITY CLINICS THAT HELP PLANS FOR WELL OFFER A DECADE.  WE WERE ALSO THE PEOPLE THAT WORK WITH KAISER AND WASHINGTON HOSPITAL CENTER AND UCSF AND MANY MAJOR MEDICAL CENTERS AS WELL AS IN BOSTON.

SO, I WANT TO COVER REAL BRIEFLY KIND OF THE LAY OF THE LAND, A BROAD OVERVIEW WHICH I SEE IS ALSO INCLUDING THE COMPATIBILITY AND INTERFACE OF ANCILLARY EQUIPMENT.

AS WELL AS COMMUNICATION ISSUES.  AND LOW COST BARRIER REMOVAL STRATEGIES AND JUST A QUICK NOTE RELATED TO OPERATIONS.

WHAT I AM GOING TO USE, I AM GOING TO USE SOME VIDEO CLIPS IN THIS PRESENTATION.  THEY ARE TAKEN FROM A ONLINE WORKSHOP CALLED QUALITY SERVICES FOR PEOPLE WITH DISABILITIES AND ACTIVITY LIMITATIONS IN HEALTHCARE.

I WROTE IT, AND WE ARE ABOUT TO ROLL IT OUT.  AND AFTER WE CAPTION IT AND GET SOME ADDITIONAL PERMISSIONS FROM SOME OF THE CLIPS THAT ARE INCLUDED.

IT REVIEWS WHAT THE “WHAT” IS, AND THE NEED FOR ACCESSIBLE MEDICAL EQUIPMENT.

SO, LEE ALREADY APTLY REVIEWED SOME OF THE “WHY” — WHY WE ARE DOING THIS.  I AM SKIPPING THAT PART.  BUT I DO HAVE THE WHOLE 15-MINUTE SEGMENT WHICH I WANTED TO SHOW ANY OF YOU DURING THE BREAK OR LUNCH OR AFTER THE WORKSHOP.

>> GIVE ME A SECOND I WILL GET YOU THE VIDEO.

>> I WANTED TO GO BACK TO A QUESTION THAT YOU ASKED LEE.  MEDICAL SETTINGS CAN INCLUDE DIVERSE PLACES.

>> DUE TO INSTRUCTIONS THEY WERE GIVEN TO JUST HOP, I HAVE LISTEN “LOOK HERE”, “DON’T BREATHE”, “STAY STILL”.  INSTRUCTIONS LIKE THESE MAY SOUND AMUSING.  FOR SOME PEOPLE WITH FUNCTIONAL ACTIVITY LIMITATIONS, THEY CAN BE DIFFICULT OR IMPOSSIBLE.  IN FACT, SOME HEALTHCARE PROFESSIONALS SEEM TO USE MAGICAL THINKING WHEN THEY ASK PATIENTS TO HOP UP ON TO AN EXAM TABLE MAGICAL THINKING THAT LOOK SOMETHING LIKE THIS (INDICATING).

(LAUGHTER)

A SURVEY OF 400 CALIFORNIANS WITH DISABILITIES FOUND THAT EXAM TABLES ARE INACCESSIBLE TO 69% OF WHEELCHAIR USERS.  AND TO 46% OF PATIENTS WHO USE CANES, CRUTCHES AND WALKERS.

SIMILARLY, EXAM CHAIRS ARE INACCESSIBLE TO 43% OF PEOPLE WHO USE WHEELCHAIRS.  45% FOUND IT DIFFICULT TO USE X-RAY EQUIPMENT INCLUDING MAMMOGRAPHY MACHINES.  60% OF PEOPLE USING WHEELCHAIRS FOUND IT DIFFICULT TO BE WEIGHED.  IN A NATIONWIDE SURVEY OVER 400 PEOPLE WITH A VARIETY OF DISABILITIES WRITE TO THE MEDICAL EQUIPMENT MOST DIFFICULT TO USE.  AGAIN, EXAM TABLES AND CHAIRS WERE AT THE TOP OF THE LIST.  THE LIST IDENTIFIED RADIOLOGY AND MAMMOGRAPHY EQUIPMENT EXERCISE AND REHABILITATION EQUIPMENT AND WEIGHT SCALES AS PARTICULARLY DIFFICULT TO ACCESS.

EXAM CHAIRS WITH EXTRA WIDE CUSHIONS AND HIGHER WEIGHT CAPACITIES ARE HELPFUL FOR LARGER PATIENTS.  EXAM TABLES AND CHAIRS MAY REQUIRE ADDITIONAL EQUIPMENT TO PROVIDE SAFETY, COMFORT, BALANCE, POSITIONING AND STABILITY.

EXAM CHAIRS WITH EXTRA WIDE CUSHIONS ARE HELPFUL FOR LARGER PATIENTS.  EXAM TABLES AND CHAIRS MAY REQUIRE ADDITIONAL EQUIPMENT TO HELP PROVIDE SAFETY, COMFORT, BALANCE, POSITIONING AND STABILITY.

FOR EXAMPLE, ARTICULATING KNEE CRUTCHES ADD SAFETY FOR PATIENT AND PROVIDER BY INCREASING ABILITY AND CONTROL FOR PATIENTS UNABLE TO HOLD THEIR LEGS IN PLACE, FOOT AND LEG SUPPORTS CAN BE ADJUSTED AND LOCKED.  TO PROVIDE ASSISTANCE WITH POSITIONING AND STABILITY ONE CAN USE PROTECTIVE PADDING PILLOWS VELCRO AND ACCESSIBLE HANDRAILS OR SIDE PANELS.

EXAM CHAIRS WITH EXTRA WIDE CUSHIONS.  NEXT SLIDE.

>> JUNE KAILES:  WE HAVE TO REMEMBER MEDICAL CLINICS ARE AT CVS PHARMACIES K-MARTS AND WAL-MARTS AND THEY DO HAVE EXAM TABLES.

SO, I HAVE BEEN ALL OVER WAL-MART, WE COVERED THAT ONE.

(LAUGHTER)

>> JUNE KAILES:  OKAY AND I WANTED TO JUST NARRATE THE VISUAL THAT GOT A LITTLE LEVITY THAT INCLUDED A WHEELCHAIR USER WHO WHEN SHE HOPPED UP MAGICALLY HOP FROM THE WHEELCHAIR TO THE TRAMPOLINE, DID A FLIP AND LANDED ON THE MEDICAL TABLE WITH HER HEAD IN THE STIRRUPS, THAT’S THE NARRATED VERSION.

FOR YEARS I KNOW WE ARE INTERESTED IN TECHNICAL REQUIREMENTS RELATED TO EQUIPMENT I WANTED TO FOCUS ON THAT A BIT.

SO IN TERMS OF CHAIRS AND TABLES WE FEEL IT’S VERY IMPORTANT THAT HEIGHT ADJUSTABILITY MEANS A MINIMUM HEIGHT OF 17 INCHES FROM THE FLOOR TO THE TOP OF THE CUSHION VERSUS THE TOP OF THE PLATFORM.

VERY IMPORTANT.

NEXT SLIDE.

AND STRETCHERS, WHICH ARE VERY OFTEN USED FOR DIAGNOSTIC PROCEDURES.  RIGHT NOW IN THE LATEST RESEARCH SHOWS STRETCHERS CURRENTLY ON THE MARKET HAVE A MINIMUM HEIGHT OF 20.5 INCHES FROM THE FLOOR TO THE PLATFORM.

BUT THAT EXCLUDES THE CUSHION AND MANY CENTERS WE FIND ARE GOING WITH A 5-INCH CUSHION.  WHY?  BECAUSE IT’S MORE COMFORTABLE FOR PEOPLE.  BUT THE 5-INCH CAN MAKE A DIFFERENCE FOR SOME TO DO A SAFE AND EASY TRANSFER.

ANOTHER ISSUE WITH TABLES, WE FOUND, IS THE DIFFERENCE BETWEEN WHAT THE MOTOR CAN ACCOMMODATE IN TERMS OF WEIGHT, AND WHAT THE SPECS SAY THE EQUIPMENT WILL ACCOMMODATE.  IN OTHER WORDS, SOME OF THE SPECS SAY THE EQUIPMENT WILL ACCOMMODATE A 600-POUND INDIVIDUAL WHEN IN REALITY THE MOTOR THE HIGH-LOW MECHANISM SOMETIMES ONLY WILL ACCOMMODATE A 400-POUND OR LESS IN WEIGHT PERSON.

SO, AGAIN, REQUIREMENTS WE SEE ARE IMPORTANT IS A WIDE CUSHION.  AND YOU WILL — THE BOARD IS GOING TO HAVE TO FIGURE OUT WHAT WIDE MEANS.

A HIGHER WEIGHT CAPACITY, AND THAT’S CONTINUING DEBATE IN OUR COUNTRY RIGHT NOW AS TO WHAT THAT SHOULD BE.

AND ADJUSTABLE HANDRAILS AND SIDE PANELS THAT PROVIDE BALANCE AND STABILITY FOR GETTING ON AND OFF.  AND ACHIEVING MAINTAINING POSITIONING.

SO, AGAIN, YOU WILL SEE SOME OF THIS DEMONSTRATED LATER IN THE HANDRAILS AND SIDE RAILS.

FOOT AND LEG SUPPORTS THAT CAN BE ADJUSTED AND LOCKED, WE ALSO SEE IT’S AN IMPORTANT TECHNICAL REQUIREMENT.  AND THESE ARTICULATING KNEE CRUTCHES THAT YOU WILL BE ABLE TO GET UP CLOSE AND SEE, ARE IMPORTANT FOR PEOPLE WITH ISSUES RELATED TO STABILITY AND CONTROL OF LOWER EXTREMITY.

NEXT SLIDE.  BUT — GO BACK.

BUT FOR A LOT OF PEOPLE, THESE KNEE CRUTCHES ARE NOT ENOUGH.

SOME PEOPLE NEED ACTUAL MORE OF A BOOT-LIKE SUPPORT WITH VELCRO STRAPPING TO DEAL WITH, AGAIN, HOLDING POSITIONS AS WELL AS DEALING WITH SPASTICITY ISSUES OR UNCONTROLLABLE MOVEMENTS VERY IMPORTANT.  IF THAT’S AN AFTER-MARKET PRODUCT, IT HAS TO BE ABLE TO STILL FIT INTO THE PRODUCT ITSELF.

BECAUSE THAT MAY BE SOLD BY SOMEBODY WHO IS NOT DEVELOPING THE ACTUAL, FOR EXAMPLE, THE TABLE.

NEXT SLIDE.

IN TERMS OF CHAIRS, MANY GO LOW ENOUGH FOR TRANSFERRING, BUT SOME OTHER PROBLEMS WITH INTERFERING FOOTRESTS OR STATIONARY ARMS.  FOR EXAMPLE, A WHEELCHAIR USER WOULD HAVE TO ROLL-ON TO THE SLIDE FLANGE OF THAT PEDESTAL IN ORDER TO DO A SIDE TRANSFER.

THAT CAN REALLY THROW ONE EASILY OFF BALANCE, AND MAKE THE TRANSFER VERY UNSAFE.

NEXT SLIDE.

DENTAL CHAIRS, OR ARMS ON CHAIRS CAN BE ESPECIALLY PROBLEMATIC.  THAT — THIS SHOWS A DENTAL CHAIR IN WHICH THE ARM ACTUALLY SWINGS BACK BUT YOU WILL SEE THAT THE JOINT COULD EASILY, YOU KNOW RIP SOMEONE’S BUTT APART IN A TRANSFER PROCESS.

SO, WE HAVE MAJOR ISSUES WITH DENTAL CHAIRS.  ONE OF THE CHAIRS YOU WILL NOTICE THE CONTOURS, WHICH ARE VERY MUCH THERE FOR COMFORT ALSO INTERFERE WITH SOME PEOPLE BEING ABLE TO TRANSFER AND MAINTAIN BALANCE.

NEXT SLIDE.

SO WE HAVE SEEN SOME INTERESTING SOLUTIONS ON THE MARKET.  THIS IS A DENTAL CHAIR IN WHICH THE HEADREST ACTUALLY DOES 180-DEGREE TURN, WHEELCHAIR USERS UNABLE TO TRANSFER ARE ABLE TO BACK UP AND USE THE HEADREST, AND ALL OF THE ACTUAL EQUIPMENT SWINGS AROUND.  HAS THE ABILITY TO BE FLEXIBLE AND SWING AROUND SO THAT THERE IS EQUAL ACCESS TO THE PROCEDURES AND EQUIPMENT.  AND THINGS WORK.

STILL RATHER UNUSUAL FIX BUT WE HAVE TO ATTEND TO EVERYTHING COMING ON THE MARKET.  THIS IS REFERRED TO A BUCKET.  THE WHEELCHAIR USER BACKS INTO THE SO-CALLED BUCKET.  THE BUCKET TILTS, IT HAS A HEADREST AND THIS IS AVAILABLE, I BELIEVE IN THE UK, NOT IN OUR COUNTRY.  BUT WE NEED TO BE AWARE OF ALL OF THE DIFFERENT KIND OF FIXES THAT PEOPLE ARE LOOKING AT IN TERMS OF THIS IS FOR PRIMARILY FOR DENTISTS.  SO NEXT SLIDE.

ANOTHER CONCEPT THAT IS USED THERE ARE DENTAL CHAIRS THAT ACTUALLY SWING OUT OF THE WAY EITHER ON A TRACK OR ON AN AIR GLIDE OF RELEASE OF SUCTION.  THIS ALLOWS A WHEELCHAIR USER UNABLE TO TRANSFER TO ACTUALLY POSITION THEMSELVES CORRECTLY, SO THEY COULD STILL ACCESS ALL OF THE NECESSARY DIAGNOSTIC EQUIPMENT TO HAVE THE PROCEDURE PERFORMED.  AND THESE KIND OF PRODUCTS HAVE BEEN ON THE MARKET FOR A WHILE.

SO WE NEED TO BE LOOKING AT THAT IN TERMS OF TECHNICAL REQUIREMENTS AS WELL.

ANOTHER VERSION OF THE SAME THING WITH THE RAMP TO RAISE THE WHEELCHAIR USER TO A POINT WHERE ALL OF THE EQUIPMENT, AGAIN, IS AVAILABLE AND USABLE.

NEXT SLIDE.

AND, AGAIN, IN THE WORLD OF OPHTHALMOLOGY AND OPTOMETRY THERE ARE MANY HEIGHT ADJUSTABLE TABLES THAT ACCOMMODATE ALMOST ALL OF THE OPTOMETRY EQUIPMENT, SO IT BECOMES ACCESSIBLE TO ANY WHEELCHAIR USER OR SOMEBODY UNABLE TO USE THE CHAIR.  THESE ARE OTHER OPTIONS TOO THAT NEED TO BE LOOKED AT.

INFUSION CHAIRS ARE ALSO A PART OF THE DIAGNOSTIC PROCESS.  THIS IS A HIGHLY CONTOURED OLD FASHIONED INFUSION CHAIR.  THAT DOESN’T WORK FOR PEOPLE WHETHER THEY ARE WHEELCHAIR USERS OR OTHERS.  BUT THERE ARE PRODUCTS ON THE MARKET THAT DO WORK BETTER.  NEXT SLIDE.  THIS IS A NEWER INFUSION CHAIR WITH AN ACTUAL SIDE THAT SWINGS AWAY AND MAKES TRANSFER MUCH EASIER FOR MANY PEOPLE WHETHER THEY WALK OR ROLL.

IT COMES IN VERY ACCURATE AS WELL AS TYPICAL MASSAGE CHAIR.  THE PROBLEM WITH THE CHAIR THIS IS WHERE YOU REALLY HAVE TO GO DEEP.  WHEN YOU ARE INVOLVED IN INFUSION PROCESS, AS MANY PEOPLE HAVE TO HYDRATE.  DRINK A LOT OF WATER.  WHAT DOES THAT MEAN?  YOU HAVE TO PEE A LOT.  SO YOU HAVE TO GET UP FAST AND MAKE IT TO THE, YOU KNOW — SO ANYWAY, BUT THE ISSUE WITH THESE CHAIRS IS THE RECLINING MECHANISM IS VERY DIFFICULT TO DO INDEPENDENTLY.

AND WE ARE NOT SURE WHY.

BUT IT’S A REAL PROBLEM.  I THINK I AM FAIRLY STRONG, BUT I COULD NOT DO IT.  IT WAS REALLY HARD.

SO, NEXT SLIDE.  A PICTURE OF SOMEBODY WITH A TRANSFER ASSISTANT USING THE INFUSION CHAIR WITH THE SWING AWAY SIDE PANEL.

THIS IS A REMINDER TO ALL OF YOU WHO CONSUME NEW PRODUCTS COMING ON THE MARKET.  THIS IS A NEW AND IMPROVED CARDIOLOGY DIAGNOSTIC PIECE OF EQUIPMENT DON’T ASK ME WHAT IT DOES.  BUT JUST TO ATTEND TO, WE NEED TO CATCH THE NEW AND EMERGING EQUIPMENT.  NEXT SLIDE.

ANOTHER THING I THINK THE BOARD NEEDS TO ATTEND TO IS PAPER IS USED FOR SAFETY, JOHN MAYBE YOU COULD ADDRESS THIS A BIT LATER.

BUT WE FOUND THAT MOST PEOPLE WITH DISABILITIES IN OUR SURVEYS HATED THE PAPER.  IT SLIPPED IT SLIDED IT WAS DANGEROUS.

BUT THERE WAS ONE PORTION OF THE DISABILITY COMMUNITY WHO LOVED THE PAPER ANY GUESSES WHO THAT IS?

THE DEAF COMMUNITY.  THEY COULD WRITE NOTES ON IT.  (LAUGHTER)

>> JUNE KAILES:  SO THEY THOUGHT WAS QUITE COOL.  ANCILLARY EQUIPMENT.  OKAY LOOKING AT THE ACCESSIBLE OF MEDICAL EQUIPMENT CANNOT BE SEPARATED EVER FROM COMPATIBILITY AND INTERFACE ISSUES REGARDING LIFT EQUIPMENT AS WELL AS STABILITY IN POSITIONING EQUIPMENT.

NO MATTER HOW ACCESSIBLE THE EQUIPMENT IS — THE STATUTE SAYS THE MAXIMUM EXTENT POSSIBLE, THERE ARE THE PORTION OF THE GROUP FOR WHICH IT WILL NEVER EVER BE POSSIBLE WITHOUT TRANSFER AND LIFT ASSISTED.

SO THE EQUIPMENT MUST BE COMPATIBLE WITH THE LIFT EQUIPMENT.  THE GOOD NEWS IS THERE IS A WHOLE LOT MORE LIFT EQUIPMENT NOW ON THE MARKET THAN EVER BEFORE.  WITH MUCH LOWER PROFILES THAN EVER BEFORE.  SO THERE ARE A LOT OF GOOD CHOICES.  SO THIS ILLUSTRATES, I THINK, A VERY IMPORTANT POINT THAT THE BOARDS NEEDS TO ATTEND TO.  WHICH IS THERE IS DIAGNOSTIC EQUIPMENT BECAUSE OF THE NATURE OF WHAT HAS TO HAPPEN, THE DIAGNOSTIC ENGINEERING WHATEVER IT IS THE PARTS UNDERNEATH HAVE TO BE UNDERNEATH.  THIS IS CALLED A STEREOPATHIC TABLE, SOME WOMEN CALL IT A TORTURE TABLE I CAN EXPLAIN WHY LATER.

BUT THIS IS AS LOW AS IT GOES.

THIS HAS TO INVOLVE SOME VERY STABLE AND GOOD LIFT EQUIPMENT.  NEXT SLIDE.  ALSO, THE C-ARM OFTEN USED IN RADIOLOGY AND IMAGING IS HIGHER BECAUSE OF THE — BECAUSE OF THE STUFF UNDERNEATH THAT HAS TO WORK.  SO, AGAIN, LIFT EQUIPMENT IS KEY.

BONE DENSITY EQUIPMENT, ANOTHER PIECE OF EQUIPMENT THAT HAS STUFF UNDERNEITHER IT THAT’S NOT GOING TO GO AWAY ANY TIME SOON.

SO, WHAT ARE THE FIXES HERE?  WELL, THIS IS A SETTING WHERE THEY CREATIVELY USED A LIFT WHICH STRADDLES BONE DENSITY MACHINE, AND IT PERMANENTLY THERE AND MAKES IT ACCESSIBLE TO MANY, MANY USERS.  AND I THINK IT’S THE BEST KEPT SECRET BUT THIS IS ACTUALLY HERE IN THIS CITY.  SO, IT’S QUITE A NICE FIX.

CEILING LIFTS, ANOTHER VERY IMPORTANT WAY TO ACCOMMODATE IMAGING EQUIPMENT.

MRI IS AN INTERESTING PROBLEM, IT OFTEN INVOLVES A DOUBLE TRANSFER, YOU CANNOT GET YOUR WHEELCHAIR — ANY METAL AS YOU KNOW INTO AN MRI ROOM WHICH OFTEN MEANS A DOUBLE TRANSFER FROM THE CHAIR TO STRETCHER FROM THE STRETCHER TO THE MRI TABLE.  BUT THERE ARE PRODUCTS ON THE MARKET — THIS IS A HIGH-LOW STRETCHER WHICH — THIS IS A HIGH-LOW STRETCHER WHICH DOCKS WITH THE MRI MACHINE WHICH MEANS ONE TRANSFER INSTEAD OF TWO.  JUST ISSUES TO BE AWARE OF.  NEXT SLIDE.

>> DAVID BAQUIS:  YOU HAVE GOT A FEW MINUTES TO WRAP UP.

>> JUNE KAILES:  OKAY.  I AM ON IT.

POSITIONING WE HAVE TALKED ABOUT THE IMPORTANCE OF POSITIONING EQUIPMENT THAT IS COMPATIBLE WITH THE — WITH THE MEDICAL EQUIPMENT.  AND THAT MEANS THINGS THAT CAN YOU ATTACH.  WHERE DOES IT ATTACH? WILL IT WORK WITH THE EQUIPMENT?  THAT IS A CRITICAL PIECE THAT I THINK THE BOARD NEEDS TO ATTEND TO.

HOW DOES THIS STRAPPING ATTACH AND STAY SECURE THE WEDGES, ET CETERA.

SO, I AM A MOVING TARGET WHEN IT COMES TO ANY KIND OF X-RAY OR RADIOLOGICAL PROCESS, I FELT VERY SECURE HERE.  THEY WERE DEMONSTRATING.  THIS IS SOMETHING THAT IS ATTACHED TO THE EQUIPMENT, AND YOU REALLY DO FEEL SECURE.  I AM NOT GOING TO BOUNCE OFF THE TABLE, SO THERE ARE A LOT OF THINGS WE NEED TO LOOK AT IN TERMS OF THE POSITIONING EQUIPMENT.

AND THIS IS A PIECE OF EQUIPMENT THAT COMES WITH THE STRAPPING PART OF THE — JOHN YOU WILL PROBABLY TALK ABOUT THIS LATER ON.

NEXT.

THESE ARE TWO TABLES USED FOR A NUMBER OF DIAGNOSTIC ISSUES, POSITIONING HERE STAYING UP RIGHT, IT’S QUITE A CHALLENGE FOR A LOT OF PEOPLE.  AGAIN, POSITIONING CRITICAL, CRITICAL.

WE HAVE ALL KINDS OF NEUROLOGICAL AND GYN EQUIPMENT THAT NEEDS TO ACCOMMODATE POSITIONING DEVICES.  X-RAY EQUIPMENT AND MAMMOGRAPHY MACHINES ARE ANOTHER TYPE OF MEDICAL EQUIPMENT OFTEN HARD TO ACCESS.  DID YOU KNOW THAT WOMEN WITH DISABILITIES HAVE LESS ACCESS TO BREAST HEALTH SERVICES THAN ANY OTHER GROUP OF WOMEN?  EVEN WHEN WOMEN WITH DISABILITIES SCHEDULE MAMMOGRAMS OR CLINICAL BREAST EXAMS SOME CANNOT RECEIVE EITHER SERVICE WHEN THEY ARRIVE BECAUSE OF INACCESSIBLE HEALTHCARE FACILITIES AND MEDICAL EQUIPMENT.

>> JUNE KAILES:  HAND HOLDS ON X-RAY EQUIPMENT ARE CRITICAL FOR A LOT OF US.  SO THAT IS SOMETHING THAT WE REALLY NEED TO ATTEND TO IN THE TECHNICAL REQUIREMENTS.

AND THESE ARE SOME VERY NICE HAND HOLDS ON A MAMMOGRAPHY MACHINE.  I AM SURE ROBERTA AND JANET AND SHE WILL TALK MORE ABOUT THAT.  AND — YES.

AGAIN, THE PEDESTAL BASE ON MAMMOGRAPHY EQUIPMENT GETS IN THE WAY OF SOME WHEELCHAIR USERS WHO FOOT PEDALS DO NOT MOVE, A BIG ISSUE NOT BEING ABLE TO GET CLOSE.

ANOTHER ILLUSTRATION OF NEEDING TO GET CLOSER BUT THE FOOT PEDALS GETTING IN THE WAY.

YOU HAVE TO REMEMBER THE NEW DENTAL PANORAMIC DIGITAL X-RAY STUFF.  USUALLY YOU HAVE TO STAND UP BUT SO YOU GOT TO MAKE SURE THIS GOES LOW ENOUGH.  AND THAT THE AREA ACCOMMODATES WHEELCHAIR USERS.  BIG ISSUE COMING YOUR WAY SOON IF YOU HAVEN’T SEEN IT YET.

MAMMOGRAPHY CHAIR, I THINK YOU COVERED THAT THIS IS AN ANCILLARY PIECE OF PEOPLE CRITICAL FOR PEOPLE WHO TRANSFER OR WALK AND NEED TO SIT DOWN AND BE ABLE TO STAY RIGHT TO GET A GOOD FILM OR DIGITAL IMAGE ON A MAMMOGRAPHY MACHINE.

OKAY.  CRITICAL ISSUE FOR PEOPLE WHO ARE DEAF.  WHEN YOU NEED INSTRUCTIONS IN THIS RADIOLOGICAL PROCESSES, IF YOU CAN’T HEAR HOLD STILL HOLD YOUR BREATH, TURN OVER, DON’T BREATHE, ET CETERA, WHAT DO YOU DO?  THIS IS A FIX COMING WITH THE NEWER MACHINES, THERE ARE ICONS THAT TELL YOU WHEN TO BREATHE OR NOT, SO YOU HAVE THE VISUAL IN ADDITION TO THE AUDITORY AS WELL.  OR YOU HAVE IT IN A DIFFERENT LANGUAGE.  OR BETTER YET, YOU HAVE A HIGH ANXIETY THEY COULD SHOW YOU A VIDEO SO YOU KIND OF FORGET HOW CLAUSTROPHOBIC IT IS.

WEIGHT SCALES ARE ANOTHER TYPE OF HARD TO ACCESS MEDICAL EQUIPMENT.  BELIEVE IT OR NOT, SOME PEOPLE HAVE NEVER BEEN WEIGHED BY THEIR HEALTHCARE PROVIDER.  STANDARDS SCALES REQUIRE A PATIENTS TO STAND TO BE WEIGHED STEP UP TO A NARROW PLATFORM AND MAINTAIN BALANCE BY THE HEALTHCARE PROVIDER READS THE WEIGHT.  BUT THESE ARE OFTEN NOT POSSIBLE FOR WHEELCHAIR USERS OR OTHERS WITH BALANCE OR MOBILITY LIMITATIONS BECAUSE MOST STANDARD SCALES CANNOT ACCURATELY MEASURE WEIGHTS OVER 350 POUNDS, SOME WHEELCHAIR USERS REPORT BEING WEIGHED ON A LOADING DOCK OR IN A HOSPITAL LAUNDRY ROOM OR EVEN A VETERINARY HOSPITAL.  IT’S IRONIC, MORE VETERINARIANS HAVE ACCESSIBLE SCALES THAN PEOPLE DOCTORS.

>> ACCESSIBLE SCALES ARE HELPFUL FOR PEOPLE WHO USE WHEELCHAIRS AND LARGER PEOPLE WHO EXCEED STANDARD WEIGHT MEASUREMENT.  THEY ARE IMPORTANT TO PEOPLE THAT INTERFERE WITH BALANCE MOBILITY CLIMBING OR USING STEPS.  AND PEOPLE WHO USE MOBILITY DEVICES, SUCH AS CANES, CRUTCHES AND WALKERS.  OTHERS WHO BENEFIT FROM ACCESSIBLE SCALES ARE PEOPLE WHO EXPERIENCE JOINT PAIN, FATIGUE, RESPIRATORY OR CARDIAC CONDITIONS, POST SURGICAL CONDITIONS OR ORTHOPEDIC INJURIES OR SHORT PEOPLE OR PREGNANT WOMEN OR PEOPLE WHO HAVE NO MOBILITY LIMITATION AT ALL.  EVERYONE CAN USE AN ACCESSIBLE SCALE.

THERE ARE VARIOUS TYPES OF WEIGHT SCALES.  THE MOST COMMON TYPE IS THE WHEELCHAIR SCALE.  RECOMMENDED FOR PATIENTS WITH LIMITED STABILITY, LARGER PATIENTS AND PATIENTS NEEDING TO SIT ON A CHAIR WHILE BEING WEIGHED.  HOWEVER, THESE SCALES ARE USABLE BY ALL PATIENTS.  OTHER WEIGHING OPTIONS INCLUDE LIFTING DEVICES WITH BUILT IN SCALES USED IN HOSPITALS AND WITH HOSPITAL BESIDES.  STURDY HANDRAILS ARE DESIRABLE ON ANY TYPE OF ACCESSIBLE WEIGHT SCALE AS WELL AS LARGE AND EASY TO READ DIGITAL DISPLAYS AND WIDE PLATFORMS LARGE ENOUGH TO ACCOMMODATE LARGE POWER WHEELCHAIR.

>> JUNE KAILES:  THE BIGGEST POINT IN TERMS OF TECHNICAL REQUIREMENTS FOR SCALES, MANY PLACES ARE STARTING TO PUT IN ACCESSIBLE SCALES, BUT THEY OFTEN DON’T ACCOMMODATE BIGGER POWERED CHAIRS.  SO, YOU HAVE TO ATTEND TO THE SIZE OF THE BASE.

VERY CRITICAL.  SO, OTHER DESIGN ISSUES STRESS TEST, PARTICULARLY FOR PEOPLE WITH LOW VISION, YOU GOT TO HAVE CONTRASTING COLORS ON THE TREADMILLS SO PEOPLE KNOW WHEN THE BELT IS MOVING ON — THERE ARE A NUMBER OF THINGS THAT WILL ACCOMMODATE PEOPLE WITH LOW VISION OR THE STRESS TEST REFLECTIVE COLOR STRIPS TO DISTINGUISH THE MOVING FROM THE SLIP, ANTI SLIP SIDE TRIM.

IF YOU ARE DOING A STRESS TEST ON A BIKE, SOMETHING TO HOLD YOUR FEET IN OR YOUR HANDS ON IF IT’S ERGONOMETER.

TO REMIND YOU THERE ARE STILL THINGS LIKE THIS PULMONARY BOOTHS, BUT THERE ARE OTHER OPTIONS.  I COULD NOT FIGURE OUT ANY WAY TO MAKE THIS THING ACCESSIBLE.

AUDITORY BOOTHS, IT’S JUST A THRESHOLD ISSUE, IF THE BOOTH IS LARGE ENOUGH THERE IS NO PROBLEM WITH ACCESSIBLE BUT IT’S GETTING OVER THE THRESHOLD IT’S A RAMPING ISSUE.

IN LOW COST BARRIER REMOVAL STRATEGIES REAL QUICK, STRATEGIES THAT WILL GO LONG WAY TO HELP SOME PEOPLE IMPROVE THE USABILITY OF EXISTING EQUIPMENT.

STEP STOOLS WITH RAILINGS, PLACEMENT OF GRAB BARS AND WALKERS AROUND SCALES TO HELP PEOPLE STEP UP.

THE SAME KIND OF FIX FOR — GO BACK FOR PEOPLE WHO NEED ASSISTANCE STEPPING UP ON THE AWFUL LITTLE STEP ON THE BOX TABLE, THIS IS ME PERFORMING ACROBATIC THINGS TO GET ME UP THERE.

NEXT.

OR FOLD AWAY PARALLEL BARS NEXT TO TABLES ANOTHER FIX THAT HAS WORKED FOR SOME.

AND LASTLY, I WANT TO JUST END WITH ONE CRITICAL OPERATION REMINDER.

IF POLICIES PROCEDURES PROCESSES AND TRAINING ARE NOT IN PLACE EVEN THE BEST FACILITIES WITH THE BEST ACCOMMODATION AND THE GREATEST EQUIPMENT WILL CONTINUE TO HAVE SIGNIFICANT BARRIERS.  FOR EXAMPLE, IF STAFF DON’T KNOW WHERE THE EQUIPMENT IS OR HOW TO USE IT OR HOW TO RAISE IT OR LOWER IT.  IF THEY DON’T KNOW HOW TO USE THE ACCESSIBLE FEATURES, IF THEY DON’T KNOW HOW TO WEIGH WHEELCHAIR USERS, THEN IT DOESN’T WORK.

SO, THAT’S A VERY SHORT OVERVIEW OF A MUCH LONGER DISCUSSION WHICH I TRUST WILL BE PURSUED IN VIGOR OVER THE UPCOMING MONTHS THANKS.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU JUNE FOR YOUR OVERVIEW.  ROBERTA IF YOU WOULD LIKE TO PROCEED WE CAN PULL UP JANET’S SHOW AT THE SAME TIME.  THANK YOU.

>> ROBERTA CARLIN:  GOOD MORNING.  IT’S ALWAYS A CHALLENGE TO FOLLOW JUNE, THAT WAS A GREAT GREAT PRESENTATION AND I HAVE TO SAY I LEARNED A LOT.  AND I HOPE — I AM SURE EVERYBODY ELSE DID TOO.  MY NAME IS ROBERTA CARLIN, I AM THE EXECUTIVE DIRECTOR OF THE AMERICAN ASSOCIATION ON HEALTH AND DISABILITY WHICH IS LOCATED DOWN THE ROAD HERE, DOWN THE BELTWAY IN ROCKVILLE, MARYLAND.

OUR MISSION, I AM JUST GOING TO GIVE YOU A VERY BRIEF OVERVIEW OF WHO WE ARE JUST FOR FUTURE USE, OUR MISSION IS TO ADVANCE HEALTH PROMOTION AND WELLNESS INTERVENTIONS FOR PEOPLE WITH DISABILITIES, AND WE DO THAT THROUGH RESEARCH, PUBLIC AWARENESS, EDUCATION AND ADVOCACY.

AS MANY OF YOU IN THIS ROOM KNOW, WE LAUNCHED IN 2008 A PEER REVIEW JOURNAL, THE DISABILITY AND HEALTH JOURNAL, WHICH WE ARE VERY PROUD OF, MARILYN AND I WERE TALKING ABOUT IT EARLIER BEFORE THE MEETING BEGAN.

SO, YOU ARE WELCOME TO VISIT OUR WEBSITE AND THEN YOU CAN VISIT THE JOURNAL I HAVE TO SAY, THAT WE BECAME INVOLVED IN THE ISSUE OF ACCESSIBLE BACK IN REALLY IN 2007.

SO, CERTAINLY IT WAS ON OUR RADAR SCREEN AS A HUGE ISSUE BUT WE ARE FORTUNATE ENOUGH TO GET A — RECEIVE A GRANT IN THE SUSAN G.  KOMEN FOUNDATION JUST SPECIFIC TO MONTGOMERY COUNTY, MARYLAND WHERE WE WENT OUT TO MAMMOGRAPHY FACILITIES AND PERFORMED ACCESSIBLE SURVEYS AND SPOKE WITH AND PROVIDED TECHNICAL ASSISTANCE TO THE STAFF.  AND JANET WILL GO INTO MUCH MORE DETAIL ON THAT.  TWO YEARS LATER WE RECEIVED GRANT FROM THE KOMEN FOUNDATION TO BUILD ON WHAT WE HAD DONE IN MONTGOMERY COUNTY IN THE DC AREA AND THE 6 SURROUNDING COUNTIES IN THE METRO AREA.  AND WE ARE COMING TO THE END OF THIS GRANT AT THE END OF THIS YEAR.

AND THEY REALLY HAVE BUILT WHAT WE WOULD LIKE TO SAY A HEALTH PROMOTION INTERVENTION, IT’S PROBABLY A PROMISING PRACTICE AT THIS POINT.  THERE IS A NUMBER OF SURVEY INSTRUMENTS AND TOOLS THAT ARE ACCESSIBLE, AND AGAIN THEY ARE ALL ON OUR WEBSITE.  AND WE ENCOURAGE YOU ALL TO LOOK AT THAT AND THINK ABOUT SOME OF THE ISSUES THAT WE HAVE FOUND NOT ONLY RELATED TO PHYSICAL ACCESSIBLE AND ACCESSIBLE OF — AND ACCESSIBILITY OF MACHINES BUT CULTURAL ATTITUDINAL AND ENVIRONMENTAL BARRIERS.

SO I WILL NOW TURN OUR PORTION, OUR 15-MINUTE PORTION, OVER TO JANET.  SHE IS GOING TO GO INTO MORE DETAIL ABOUT THE KOMEN GRANT AND SOME OF THE RECOMMENDATIONS FOR MACHINES AND POSITIONING CHAIRS AND THANK YOU, AND I FAILED TO THANK THE ACCESS BOARD FOR INVITING US AND INCLUDING US IN REALLY WHAT’S A VERY IMPORTANT MOVE IN TERMS OF REALLY REFINING THE REGS FOR DIAGNOSTIC MEDICAL EQUIPMENT.  THANK YOU.

>> JANET KREITMAN:  AS ROBERTA MENTIONED, I AM JANET, THE PROGRAM COORDINATOR FOR TWO SUSAN G.  KOMEN FOR THE CURE GRANTS THAT AAHD RECEIVED IN 2007 AND 2009 AND ’10.

THE 2007 GRANT WAS CALLED INCREASING BREAST CANCER SCREENING FOR WOMEN WITH DISABILITIES IN MONTGOMERY COUNTY, MARYLAND BY IMPROVING ACCESS EDUCATION AND TRAINING AT MAMMOGRAPHY SITES.  THE 2009 AND ’10 GRANT WAS CALLED PROJECT ACCESSIBLE:  REMOVING BARRIERS FOR WOMEN WITH DISABILITIES.

BOTH GRANTS INCLUDED AN ONLINE BREAST CANCER SCREENING SURVEY FOR WOMEN WITH DISABILITIES AS WELL AS FACILITY SITE VISITS.  THE WOMEN’S SURVEY IN 2009 AND ’10 SHOWED THAT 13 OUT OF 41 WOMEN HAD SOME TYPE OF PROBLEM ACCESSING MAMMOGRAPHY EQUIPMENT, ALTHOUGH THEY GAVE NO DETAILS IN TERMS OF THE ACCESSIBILITY ISSUES THEY ENCOUNTERED SO WE HAVE SOME INDICATIONS THAT PROBLEMS DO EXIST.

55 MAMMOGRAPHY SITE VISITS WERE CONDUCTED IN THE GREATER DC AREA DURING 2007 AND THEN IN 2009 AND ’10 WE LOOKED AT SEVERAL AREAS OF PHYSICAL ACCESSIBILITY INCLUDING MAMMOGRAPHY EQUIPMENT THE FOLLOWING RECOMMENDATIONS ARE BASED ON THE WOMEN’S SURVEY, MY CONVERSATIONS WITH MAMMOGRAPHY STAFF AT THE SITES, AND THE STUDIES THAT ARE MENTIONED BELOW, THE 2009 STUDY WAS BASED ON RECOMMENDATIONS OF TECHNOLOGISTS AS WELL AS ACCESS FOR WOMEN WITH DISABILITY OR BHAWD, THE DIRECTOR IS FLORITA TOVEG, WHO WILL SPEAK AFTER ME.

IN DESIGNING A PERFECT MAMMOGRAPHY MACHINE IF SUCH A THING IS POSSIBLE.  ACCORDING TO A 2006 ARTICLE, MANY WITH DISABILITIES REPORTED AVOIDING MAMMOGRAMS BECAUSE OF AN INABILITY TO ASSUME THE POSITION REQUIRED TO GET A MAMMOGRAM.

THIS MIGHT EXPLAIN, IN PART, THE AUTHOR’S FINDING THAT OLDER WOMEN WITH SEVERE FUNCTIONAL LIMITATIONS WERE SIGNIFICANTLY LESS LIKELY THAN WOMEN WITHOUT FUNCTIONAL LIMITATIONS TO RECEIVE REGULAR MAMMOGRAMS, SO IT’S IMPORTANT FOR US TO LOOK AT THE SPECIFICATIONS FOR MAMMOGRAPHY EQUIPMENT AND DETERMINE POSSIBLE BARRIERS TO ACCESSIBILITY.

ONE POSSIBLE BARRIER MIGHT BE THE BUCKY HEIGHT OR HOW LONG THE BUCKY ON THE MAMMOGRAPHY MACHINE CAN GO.  THERE ARE CURRENTLY NO STANDARDS ON THIS.  ACCESS TO MEDICAL CARE FOR INDIVIDUALS WITH MOBILITY DISABILITIES BY THE U.S. DEPARTMENT OF JUSTICE IN MAY 2010 STATES INDIVIDUALS WITH WHEELCHAIRS WILL NEED TO HAVE AN EXAM WHILE STAYING IN THEIR WHEELCHAIR.  THE MAMMOGRAPHY MACHINE WILL NEED TO ADJUST TO THEIR HEIGHT, AND ACCOMMODATE THE SPACE OF THE WHEELCHAIR.

WHEN I CALLED THE AMERICAN CANCER SOCIETY AND THE NEW JERSEY HOSPITAL ASSOCIATION WHICH HAD DONE AN ACCESSIBILITY SURVEY, AND ASKED THEM IF THERE WERE ANY RECOMMENDATIONS ON HOW LOW THE BUCKY HEIGHT — HOW LONG THE BUCKY SHOULD GO, BOTH ORGANIZATIONS SAID THEY HAD NO RECOMMENDATIONS AND THEY SUGGESTED CHECKING WITH LOCAL MAMMOGRAPHY FACILITIES TO SEE WHAT THEIR STANDARDS ARE.

THERE HAS BEEN SOME THOUGHT GIVEN ON THIS SUBJECT, AND RECOMMENDATIONS MADE ON ACCEPTABLE HEIGHTS FOR THE LOWERED BUCKY.  A MONTANA STUDY FOUND THAT ALL MAMMOGRAPHY CENTERS IN THE STATE HAVE AT LEAST ONE MACHINE THAT CAN BE LOWERED TO SOMEONE SEATED DOWN TO 31 INCHES.

SEVERAL YEARS AGO, BHAWD DEVELOPED A PROTOCOL BASED ON OBSERVATIONS OF ITS TECHNOLOGISTS OF AN ACCEPTABLE BUCKY HEIGHT OF 24 INCHES FROM THE FLOOR WHICH WAS USED AS A BASIS FOR A MASSACHUSETTS STUDY AS WELL AS SURVEY DONE BY THE NORTH CAROLINA OFFICE OF DISABILITY AND HEALTH AND THE 2007 AND 2009 AND ’10 AAHD SURVEYS.

IN GENERAL, THE PRESENT AAHD SURVEY FOUND THAT FROM OUR SMALL SAMPLE SIZE THAT MOST MACHINES IN THE DC AREA SEEM TO LOWER 25 INCHES FROM THE MACHINE TO THE FLOOR IN THE FRONT, AND 23 INCHES FROM THE MACHINE TO THE FLOOR IN THE BACK.

IT’S POSSIBLE, HOWEVER, THAT OUTSIDE THE DC METRO AREA PARTICULARLY MORE IN RURAL OR POOR AREAS, THAT OLDER MACHINES MAY BE USED THAT ARE NOT AS ACCESSIBLE.

AND THIS SLIDE SHOWS ONE TYPE OF MAMMOGRAPHY MACHINE THAT TYPICALLY SEEMED TO BE FOUND IN THE SURVEY MAMMOGRAPHY SITES THAT LOWERS TO AROUND 24 INCHES.

THE QUESTION REMAINS, HOWEVER, WOULD 24 INCHES BE LOW ENOUGH?  WE RECOMMEND FURTHER RESEARCH BE DONE TO INCLUDE CONSULTATION WITH TECHNOLOGISTS AND WITH WOMEN WITH DISABILITIES TO LEARN THE LOWEST ACCEPTABLE BUCKY HEIGHT ESPECIALLY FOR SHORT WOMEN WHO NEED TO SIT IN THEIR WHEELCHAIRS AS WELL AS SHORT WOMEN WHO ARE ABLE TO STAND TO GET THEIR MAMMOGRAMS.

OTHER RECOMMENDATIONS MADE IN THE KAILES AND LEE STUDY INCLUDES ISSUES SUCH AS PLATE DISTANCE.  THE END OF THE BUCKY PLATE SHOULDN’T BE TOO CLOSE TO THE POWER OF THE MAMMOGRAPHY MACHINE.  WOMEN SITTING IN WHEELCHAIRS BUMP THEIR NEEDS ON THE TOWER ON ONE PARTICULAR MODEL OF A MAMMOGRAPHY MACHINE BECAUSE THE BUCKY PLATE WAS TOO CLOSE TO THE TOWER.

SO WHEN DESIGNING EQUIPMENT THERE SHOULD BE ENOUGH DISTANCE FROM THE PLATE TO THE TOWER TO ACCOMMODATE A WHEELCHAIR.

ALSO, WOMEN SOMETIMES HAVE TO SIT FORWARD, TO PUT THEIR BREASTS IN PROPER POSITION, WHICH MIGHT BE HARD FOR SOME WOMEN TO DO.

DESIGNERS SHOULD MAKE SURE THAT THE ANGLE OF THE BUCKY PLATE IS GOOD FOR SOMEONE WHO IS SEATED.

AND AS JUNE MENTIONED, AS FAR AS THE FLOOR PLATFORM, SOME MACHINES HAVE A FLAT FORM ON THE FLOOR PROTRUDING FROM THE TOWER WHICH CAN INTERFERE WITH WHEELCHAIR POSITIONING, SO MANUFACTURERS SHOULD MAKE SURE THAT THERE IS NO PLATFORM THAT INTERFERES.  IT’S KIND OF HARD TO SEE ON THE PICTURE AS YOU CAN SEE FROM THE BOTTOM, THIS IS ONE TYPE OF MAMMOGRAPHY MACHINE WHERE THE FLOOR PLATFORM PROTRUDES SOMEWHAT AND MIGHT INTERFERE WITH THE FUNCTIONING OF THE WHEELCHAIR.

A LARGER TUBE HEAD CAN GET IN THE WAY OF A WHEELCHAIR, SO TUBE HEADS SHOULD BE MADE SMALL ENOUGH SO THEY DON’T INTERFERE.

IF THE RECEPTOR IS TOO THICK IT CAN INTERFERE WITH THE BODY OF A WOMAN SITTING IN A WHEELCHAIR AND PRESS ON HER STOMACH, SO IT’S IMPORTANT TO MAKE IT AS THIN AS POSSIBLE.  THE PART THAT ALLOWS THE PLATFORM TO TILT UP AND DOWN NO LONGER EXISTS IN CERTAIN MODELS OF MAMMOGRAPHY MACHINES.  BECAUSE THAT HELPED PATIENTS WITH POOR POSTURAL STABILITY IT WOULD BE GOOD TO REINSTITUTE THE TILT FEATURE.

COMPANIES SOMETIMES TEND TO CONSULT WITH JUST SERVICE PROVIDERS WHEN MAKING CHANGES TO EQUIPMENT.

BOTH TECHNOLOGISTS AND WOMEN WITH DISABILITIES SHOULD BE INVOLVED IN THE DESIGN STAGES OF NEW EQUIPMENT TO OFFER SUGGESTIONS WHICH WOULD INCREASE ACCESSIBLE.  AND AS WELL AS JUNE HAD MENTIONED TRAINING TECHNOLOGIST ON HOW TO USE NEWLY DEVELOPED ACCESSIBLE MACHINES PROPERLY IS ALSO CRUCIAL.

IN TERMS OF POSITIONING CHAIRS, THE U.S. DEPARTMENT OF JUSTICE’S 2010 ACCESS DOCUMENT STATES THAT:  PEOPLE WHO WALK WITH MOBILITY DEVICE OR WHO CANNOT STAND FOR PROLONGED PERIODS OF TIME MAY NEED TO SIT IN A CHAIR WITH ADEQUATE SUPPORT, LOCKING WHEELS AND AN ADJUSTABLE BACK AND LIKE PEOPLE WHO USE WHEELCHAIRS NEED THE MACHINE TO ADJUST TO THEIR HEIGHT ONCE SEATED.

ACCORDING TO THIS DOCUMENT, THERE SHOULD BE SOME AUXILIARY CHAIR AVAILABLE TO PROVIDE SUPPORT AND STABILITY FOR PATIENTS.  THIS CHAIR SHOULD BE AVAILABLE FOR USE BY PATIENTS WHO USE WHEELCHAIRS THAT DO NOT HAVE DETACHABLE ARMS AS WELL AS FOR PATIENTS WHO DO NOT USE WHEELCHAIRS BUT ARE UNABLE TO STAND.

THE MASSACHUSETTS FACILITY ASSESSMENT TOOL ASKED FACILITIES IF THEY HAVE A POSITIONING CHAIR WITH THE BRAKING DEVICE AND ADJUSTABLE ARMS AVAILABLE FOR READY ACCESS.  WHICH INDICATES THE IMPORTANCE OF HAVING THIS TYPE OF EQUIPMENT.  ALTHOUGH THERE WERE NO QUESTIONS ASKED ABOUT POSITIONING CHAIRS IN AAHD’S SURVEY, THE QUESTIONS CAME UP IN QUESTIONS I HAD WITH MAMMOGRAPHY STAFF WHO MENTIONED THAT INSTEAD OF USING A SUPPORTIVE AND SECURE POSITIONING CHAIR, SOMETIMES THEY USED A CHAIR OR STOOL WITH WHEELS AND NO BREAKS WHICH COULD POTENTIALLY BE QUITE DANGEROUS.  THAT SHOWED ME THE IMPORTANCE OF THE NEED FOR MANDATORY POSITIONING CHAIRS ALTHOUGH SOME FACILITIES MAY CONSIDER THE COST OF SUCH EQUIPMENT TO BE PROHIBITIVE.

ACCORDING TO A 2009 STUDY, THE USE OF MAMMOGRAPHY EQUIPMENT WAS DIFFICULT FOR PARTICIPANTS WHO HAD DIFFICULTY STANDING.

ONE PARTICIPANT IN PARTICULAR WAS PRONE TO DIZZY SPELLS AND NEEDED TO HAVE THE MAMMOGRAM DONE IN A SEATED POSITION.

SO, SINCE IT MIGHT BE HARD FOR A MAMMOGRAM TO BE DONE IN A WHEELCHAIR WITHOUT DETACHABLE ARMS IT’S IMPORTANT TO HAVE ANOTHER OPTION AVAILABLE.  SUCH AS AN ACCESSIBLE POSITIONING CHAIR.

ALTHOUGH, THERE ARE NO SPECIFICATIONS FOR MAMMOGRAPHY POSITIONING CHAIRS THERE HAVE BEEN SOME RECOMMENDATIONS MADE IN THE STUDIES IN THE DOCUMENTS PREVIOUSLY MENTIONED.

THEY INCLUDE POSITIONING CHAIRS NEED TO BE MADE ADJUSTABLE ENOUGH DOWN TO THE FLOOR SO A WOMAN DOESN’T HAVE TO JUMP UP OR DO ANY, YOU KNOW GYMNASTICS GETTING INTO THE CHAIR.  AND POSITIONING CHAIRS SHOULD INCLUDE REMOVABLE FOOTRESTS AND ARMRESTS TO FACILITATE TRANSFER TO AND FROM A WHEELCHAIR AND ACCESSIBILITY TO THE MAMMOGRAPHY MACHINE.

ADJUSTABLE SEAT LENGTH FROM KNEES TO HIPS SO PILLOWS MIGHT NOT HAVE TO BE USED TO PUSH THE WOMAN FORWARD.

A SEATBELT TO ENSURE STABILITY AND ADJUSTABLE BACK TO SUPPORT A PATIENT TO LEAN FORWARD AND RECLINE FEATURE SO THE PATIENT CAN BE ON HER BACK IF NEEDED.  AND THE NEXT SLIDE SHOWS A POSITIONING CHAIR THAT IS ADJUSTABLE AND RECLINABLE.

A MOTORIZED SEAT HEIGHT ADJUSTER INSTEAD OF A PEDAL OPERATED ADJUSTER AND DUAL LOCKING BRAKES ACCORDING TO ONE MAMMOGRAPHY TECHNOLOGIST WHO SHOWED ME THE POSITIONING CHAIR THAT SHE USED THEE SAID ALTHOUGH THE CHAIR WAS VERY HELPFUL, IT HAS A BRAKE ONLY ON ONE SIDE WHICH IS INCONVENIENT IF THE MAMMOGRAM IS BEING DONE ON THE BREAST ON THE OTHER SIDE.

AS WITH MAMMOGRAPHY EQUIPMENT, BOTH TECHNOLOGIST AND WOMEN WITH DISABILITIES SHOULD BE INVOLVED IN THE DESIGN STAGES OF NEW POSITIONING CHAIRS TO OFFER SUGGESTIONS WHICH WOULD INCREASE ACCESSIBILITY AND FOLLOW-UP STRANGE OF THE TECHNOLOGISTS IS VERY NECESSARY.

SO, HERE IS MY CONTACT INFORMATION, IF YOU HAVE ANY FURTHER QUESTIONS ABOUT OUR STUDIES PLEASE FEEL FREE TO CONTACT ME AND WE APPRECIATE THE OPPORTUNITY TO SPEAK TODAY.

>> DAVID BAQUIS:  THANK YOU JANET, THAT’S JUST WHAT THE DOCTOR ORDERED.

(APPLAUSE)

>> DAVID BAQUIS:  IT WAS HELPFUL THAT YOU GAVE AN OVERVIEW OF THE RESEARCH THAT WENT WAY BEYOND YOUR OWN STUDIES.  NOW WE ARE GOING TO HEAR FROM FLORITA TOVEG.  I HAVE LEARNED A LOT SPEAKING TO YOU ON THE TELEPHONE.

>> THIS IS FLORA —

>> THANK YOU FOR INVITING US, AND I CERTAINLY REPRESENT ALL OF US IN BACK IN BERKELEY, CALIFORNIA, AND ESPECIALLY IN NORTHERN CALIFORNIA.

I AM THE MANAGER FOR BREAST HEALTH ACCESS FOR WOMEN WITH DISABILITIES, AND WE ARE LOCATED AT ALTA BATES SUMMIT MEDICAL CENTER IN BERKELEY, CALIFORNIA.  BHAWD WAS ESTABLISHED IN 1995 AND IT WAS THE FIRST BREAST ACCESSIBLE, COMPLETELY ACCESSIBLE BREAST SCREENING CLINIC FOR WOMEN WITH DISABILITIES AND WE OPENED THE CLINICAL SERVICES IN 1997.

>> BHAWD IS NATIONALLY RECOGNIZED MODEL FOR INCREASING HEALTH SERVICES AND ACCESSIBILITY FOR WOMEN WITH DISABILITIES.  WE ARE A PARTNERSHIP OF WOMEN WITH DISABILITIES BREAST CANCER SERVICES FOLKS AND THE DISABILITY ORGANIZATIONS AND ADVOCACY.  AND A BREAST CENTER IN THE MEDICAL CENTER.

THESE PEOPLE USUALLY AT LEAST IN THE PAST 10, 15 YEARS WERE NOT PEOPLE THAT SAT AROUND THE TABLE AND LOOKED FOR POINTS OF AGREEMENT, IT BECAME A VERY COLLABORATIVE GRASS-ROOTS APPROACH AND THAT SPIRIT INFUSES BHAWD AND HOW WE MAKE DECISIONS AND THE INITIATIVES THAT WE DEVELOP.

WOMEN WITH DISABILITIES CONTINUE TO BE INVOLVED IN EVERY ASPECT OF OUR PLANNING IMPLEMENTATION AND EVALUATION OF ALL OF OUR INITIATIVES AS WELL AS COMMUNITY PROVIDERS.

SO, AS — AS WE MENTIONED BEFORE, WE HAVE PROTOCOLS FOR MAMMOGRAPHY AND CLINICAL BREAST EXAMS AND SELF BREAST EXAMS.

WE INCLUDE THE PROVIDERS THAT ARE INVOLVED IN THAT, IT’S NOT JUST OUR COMMITTEE MEMBERS, WE GO TO THE BREAST CENTERS AND TO THE PROVIDERS WE HAVE THEM SIT AROUND THE TABLE FOR PEOPLE WITH DISABILITIES AND WE DEVELOP PROTOCOLS WITH PROVIDERS AND COMMUNITY MEMBERS.

WE HAVE FOUR PRIORITY AREAS:  CLINICAL SERVICES, EDUCATION, PROVIDER AND CLIENT.  OUR PROVIDER EDUCATION INCLUDES ADAPTATION TO SERVICES DELIVERY AND ONGOING EDUCATION AND OUTREACH TO PEOPLE WITH DISABILITIES AND WOMEN WITH DISABILITIES IN DIVERSE POPULATIONS.  WE ENSURE THAT ALL OF OUR PROVIDER EDUCATION INCLUDES CULTURAL COMPETENT LANGUAGES, AS WELL AS CULTURAL COMPETENT SERVICES.

WE ALSO HAVE PUBLIC POLICY AND RESEARCH.

THE BHAWD MODEL, I AM HERE REALLY TO TALK ABOUT SPECIFIC ASPECTS OF THE MODEL.  AND ONE IS OUR PUBLICATIONS WHICH INCLUDE A LOT OF PROVIDER EDUCATION WHICH ALSO INCLUDED EQUIPMENT ISSUES IN TERMS OF EXAM TABLES, RECOMMENDATIONS FOR MAMMOGRAPHY, ACCESSIBILITY MACHINES, PROCEDURE CHAIRS, AS WELL AS WEIGHT SCALES.

WE ALSO, AS I SAID EARLIER, HAVE ADVISORY COMMITTEES THAT INCLUDE BROAD DIVERSE STAKEHOLDERS THAT INCLUDES MAMMOGRAPHY TECHNOLOGIST RADIOLOGISTS NURSE PRACTITIONERS AND PHYSICIANS.  THE BHAWD MODEL INCLUDED THE FIRST MAMMOGRAPHY ACCESSIBILITY INITIATIVE WE THINK IN THE COUNTRY CERTAINLY FIRST IN CALIFORNIA.

INCLUDED HEALTHCARE PROVIDER TRAININGS AND TECHNICAL ASSISTANCE, WHICH WE INCLUDED CULTURAL COMPETENCY IN TERMS OF QUALITY IMPROVEMENT AND IN TERMS OF INCREASED PATIENT SATISFACTION.  SO WE CONNECTED THE DOTS TO INCREASE PATIENT SATISFACTION TO ACCESSIBILITY FOR PEOPLE WITH DISABILITIES.

THE NEED FOR SERVICES WHAT WE FELT WAS BEYOND THE FACT THAT WOMEN WITH DISABILITIES WERE NOT RECEIVING SUBSEQUENT ONGOING MAMMOGRAMS, AND EVEN THOUGH THEY HAD A LIFETIME RISK, AS FOR ALL WOMEN ONE IN EIGHT LIFETIME RISKS FOR BREAST CANCER THEY WERE 1/3 MORE LIKELY TO DIE FROM BREAST CANCER.  THE ISSUE BECAME IN TERMS OF ACCESS AND IN TERMS OF INACCESSIBLE EQUIPMENT IS ABOUT AVOIDING DELAYED DIAGNOSIS, WHICH NOT ONLY ARE WE CONCERNED ABOUT BUT OBVIOUSLY PROVIDERS ARE CONCERNED ABOUT.  BREAST CANCER IS THE MOST COMMON CONDITION IN MALPRACTICE CLAIMS.  AND A DELAY IN DIAGNOSIS OF BREAST CANCER IS THE LEADING CAUSE OF LAWSUITS.  IN A STUDY PRODUCED IN 1995 AND SUBSEQUENT 2002 STUDY BY THE NATIONAL CONSORTIUM OF PHYSICIAN AND LIABILITY INSURANCE CARRIERS, THEY CITED THE RADIOLOGIST AS NUMBER 2 IN 2002 AS A DEFENDANT IN LAWSUITS.  SO THAT IS NOT JUST A CONCERN FOR ALL OF US SITTING IN THE ROOM, BUT IT IS A CONCERN ALSO FOR THE MEDICAL PROVIDERS AND THE HEALTHCARE COMMUNITY.  AND SPECIFICALLY ANYONE WHO IS CONDUCTING AND PROVIDING MAMMOGRAPHY SERVICES.

I INCLUDED THIS, BECAUSE I THOUGHT IT WAS VERY IMPORTANT AND WE CAN NEVER REALLY FORGET WHY WE ARE ALL DOING THIS WE ARE DISABLED MORE BY BARRIERS OF ACCESSIBLE THAN FROM SPECIFIC LIMITATIONS OF OUR BODIES.  I CONSISTENTLY HEAR IN MANY, MANY MEETINGS THAT I GO TO THROUGHOUT CALIFORNIA AND OTHER PARTS OF THE COUNTRY, USUALLY BY PEOPLE THAT ARE NOT NORMALLY IN THE DISABILITY WORLD THAT HER LIMITATION OR HER DISABILITY — HERS OR HIS — MADE THE EXAMINATION INACCESSIBLE.  IT WAS NOT REALLY SOMETHING THEY UNDERSTOOD.  IT WAS REALLY THE DISABILITY NOT THE PIECE OF THE EQUIPMENT OR NOT THE PROVIDERS OR THE SYSTEMS IN PLACE.  I THINK IT’S VERY IMPORTANT TO REMEMBER THAT.

WE HAVE A LOT TO EDUCATE OTHER PROVIDERS.  AGAIN, I KNOW WE HEARD SOME CASE STORIES, SOME CASE STUDIES, BUT I THINK IT’S IMPORTANT, AGAIN, TO JUST REMIND PEOPLE IN THE ROOM ABOUT THIS.  THESE ARE ALL OF OUR CLIENTS THAT ARE ACTIVE IN OUR PROGRAM.  51 YEAR OLD WOMAN WITH CEREBRAL PALSY HAD UPPER BODY SPASMS, SHE HAD REGULAR MAMMOGRAMS THAT WERE ALL NEGATIVE AND SHE WAS LATER DIAGNOSED WITH TWO LARGE TUMORS OF THE LEFT BREAST REQUIRES MODIFIED RADICAL MASTECTOMY.  SHE WONDERS IF OUTCOME WOULD HAVE BEEN DIFFERENT IF THE BREAST EXAM WOULD HAVE BEEN PERFORMED ON THE EXAM TABLE INSTEAD OF ON THE WHEELCHAIR AND IF ADAPTIVE MAMMOGRAPHY EXAMS WERE DONE.

A 69-YEAR-OLD WOMAN IS RECOVERING FROM A STROKE, WHICH HAS HER PARALYZED IN THE RIGHT ARM AND LEG.  SHE HAS ALWAYS HAD REGULAR CHECKUPS IN THE PAST BUT NOW WONDERS HOW SHE IS GOING TO CLIMB ON TO AN EXAM TABLE FOR AN ANNUAL EXAM OR STAND FOR A MAMMOGRAM.

SO THESE ARE ALSO NEWLY DIAGNOSED MEN AND WOMEN NOT NECESSARILY IDENTIFY THEMSELVES AS PEOPLE WITH DISABILITIES BUT PERHAPS SEE THEIR LIMITATIONS AS ONSET OF AGING.

SO WE NEED TO MAKE SURE THAT THE EQUIPMENT ALSO CAN ACCOMMODATE THEIR NEEDS.

A 55-YEAR-OLD WOMEN WITH CONGENITAL FEMORAL DEFICIENCY CANNOT REACH MAMMOGRAPHY MACHINE IN A STANDING POSITION.  AFTER SEVERAL ATTEMPTS TO POSITION HER, IT IS SUGGESTED SHE HAS HER TEENAGE SON HOLD HER IN HIS ARMS WITH HER NAKED FROM THE WAIST UP SHE FEELS SO HUMILIATED BY THE EXPERIENCE, SHE DOES NOT HAVE ANOTHER MAMMOGRAM FOR ANOTHER 7 YEARS.

SO I AM GOING TO TALK A LITTLE BIT ABOUT OUR INITIATIVES.  ONE I MENTIONED EARLIER, WHICH WAS OUR QUALITY CULTURAL COMPETENCY TRAININGS IN WHICH WE WORK WITH PROVIDERS, WE TALKED ABOUT WHO ARE PROVIDERS, AND WHAT ARE CLINICS.  I THINK WE NEED TO REMIND OURSELVES THAT IT’S THE CLINICS; IT’S THE PROVIDERS OFFICE.  IT’S THE PHARMACY.  IN TERMS OF SITES WE ALSO NEED TO REMEMBER ABOUT ALL OF THE MOBILE VANS THAT ARE ALSO OUT THERE THAT ARE USUALLY INACCESSIBLE, COMPLETELY INACCESSIBLE MAYBE OR MAYBE NOT HAVE A VAN.

WE ALSO NEED TO TALK ABOUT THINK ABOUT ALL OF THE MOBILE DEVICES THERE IS A LOT OF MOBILE MAMMOGRAPHY DEVICES UNITS THAT ARE OUT THERE THAT GO OUT TO THE COMMUNITIES, WE ALSO HAVE TO BE VERY THOUGHTFUL IN SOME CASES BECAUSE MANY OF THESE DEVICES ACCOMMODATE NEIGHBORHOOD AND COMMUNITIES IN WHICH THEY DO NOT HAVE CLINICS.  OR THAT THEIR COUNTY HOSPITALS ARE SO BACKED UP IN RECEIVING SCREENING SERVICES FOR INSTANCE I WON’T MENTION A MEDICAL CENTER BUT EVEN IN SAN FRANCISCO, ONE OF THE HOSPITALS IS BACKED UP FOR SCREENING MAMMOGRAPHY FOR 8 MONTHS.

DIAGNOSTIC FOR 10 MONTHS.  THIS MAMMOGRAPHY MOBILE UNIT DOES HELP THE SMALLER CLINICS GO INTO THE NEIGHBORHOODS AND ACTUALLY GET THE MAMMOGRAPHY SCREENING FOR THE UNDERSERVED POPULATIONS IN THOSE COMMUNITIES SO WE NEED TO THINK ABOUT HOW THAT IS GOING TO AFFECT THE DISPARITIES OR PROVIDING SERVICES TO UNDERSERVED COMMUNITIES.

OUR MAMMOGRAPHY ACCESSIBILITY INITIATIVE.  AGAIN WE TALKED A LITTLE BIT ABOUT OUR ADAPTIVE PROTOCOLS HOW WE PROVIDED PROVIDERS IN HELPING US WITH THE MEETINGS WOMEN WITH DISABILITIES AND PROVIDERS ARE SITTING NEXT TO ONE ANOTHER, AND PRODUCING THESE PROTOCOLS.  WE PROVIDE TRAINING FOR THE TECHNOLOGIST WHICH IS THE ASRT AMERICAN SOCIETY OF RADIOLOGIC TECHNOLOGIST APPROVED.  THEY ARE A PROFESSIONAL ORGANIZATION THAT PROVIDES CONTINUING EDUCATION TO ALL RADIOLOGIC TECHNOLOGISTS IN OUR COUNTRY.

THEY ARE ONE OF SEVERAL.  WE CHOSE THE ASRT.

WE ALSO PROVIDE SERVICES TO TRAININGS TO SCHOOLS TRAINING SCHOOLS SPECIFICALLY AROUND MAMMOGRAPHY.

WE HAVE AN ADVISORY COMMITTEE AS I MENTIONED EARLIER.  WE ALSO PRODUCED A DVD AND BOOKLET WHICH I THINK JUDY PUT A LITTLE PIECE OF IN HER TALK WHICH IS ASRT APPROVED.  WE PROVIDED AN ACCESSIBILITY ASSESSMENT IN 20 OF OUR MAMMOGRAPHY FACILITIES IN OUR HEALTH SYSTEM.

WE DID FIND OUT A LOT ABOUT PHYSICAL ARCHITECTURAL INACCESSIBILITY OR ACCESSIBILITY FEATURES.  WE TALKED A LOT ABOUT MACHINES, AT THE TIME WHICH WAS 2005, IN CALIFORNIA MANY OTHER PARTS OF THE COUNTRY DEPENDING ON WHERE WE ARE AT, ANALOG MACHINES WERE GIVING WAY TO MORE OF THE DIGITAL MAMMOGRAPHY MACHINES.  SO THAT’S ANOTHER CONSIDERATION I THINK FOR THE BOARD TO LOOK AT HOW NEW TECHNOLOGY AND WHAT THAT MEANS FOR PEOPLE WITH DISABILITIES.

THE PEDESTAL ISSUE, WHICH I THINK ALL OF MY COLLEAGUES TALKED ABOUT, WHICH IS A REALLY ISSUE OF INACCESSIBILITY, WHEN A WOMAN WITH — ESPECIALLY IN A WHEELCHAIR, COMES IN YOU HAVE A HUGE PEDESTAL ON THE FLOOR, IT REALLY DOES INTERRUPT HER ABILITY TO GET AS CLOSE TO THE MACHINE AS POSSIBLE.

THAT DID NOT HAPPEN WITH THE ANALOG THAT WAS A KNEW FEATURED THAT OCCURRED WITH DIGITAL.  THOSE ARE ISSUES WE NEED TO THINK ABOUT AS WE ARE LOOKING AT EQUIPMENT, WHAT ARE THE NEW TECHNOLOGIES ARE THEY GOING TO ASSIST OUR ACCESSIBILITY OR TAKE US BACK.  AND CONSIDERING ALSO IN TERMS OF — WE NEED TO MAKE SURE THAT THEY INCREASE ACCESSIBILITY, BUT THEY ALSO MAINTAIN THE SAME SAFETY STANDARDS AS THE NEWER FEATURES FOR INSTANCE WE TALKED A LITTLE BIT ABOUT THE MACHINE THE TILTING C-ARM MACHINE THAT A LOT OF TECHNOLOGISTS LOVED BECAUSE IT REALLY MOLDED THE MACHINE TO THE PERSON’S BODY ESPECIALLY IF THE WOMAN HAD DISABILITY — WAS UNABLE, BECAUSE OF HER ABILITIES, WAS UNABLE TO MOVE HERSELF FORWARD, THE MACHINE BECAUSE OF THE TILTING C-ARM KIND OF CURVED ITS ANGLE INTO THE PERSON’S UPPER BODY PERSON’S BREAST.  THAT MACHINE WAS GREAT FOR THE TILTING C-ARM BUT WAS NOT GREAT FOR THE RADIATION EXPOSURE THAT’S WHY IT WAS TAKEN OUT OF THE MARKET.  WHEN WE RECOMMEND PIECE OF EQUIPMENT OR FEATURES IN EQUIPMENT WE NEED TO MAKE SURE THAT WE ALSO KEEP THAT SAME SAFETY ISSUES AND THE SAME SCREENING HIGH STANDARDS FOR OUR POPULATION AS WELL.

WE TALKED A LOT ABOUT IN OUR RADIOLOGIC TRAINING WE PROVIDE 6 HOURS OF TRAINING TO MAMMOGRAPHY TECHNOLOGISTS TALK A LOT ABOUT CULTURAL COMPETENCY AND SETTING THE TONE EXAM PREPARATION THAT SYSTEMS NEED TO BE IN PLACE IN A FACILITY PRIOR TO THAT WOMAN, IN THIS CASE WE ARE TALKING FEMALES, EVEN THOUGH MEN DO HAVE 1% OF DIAGNOSIS OF BREAST CANCER IN THIS COUNTRY.  THAT PROCEDURES AND POLICIES NEED TO BE IN PLACE.  THAT PREPARATION NEEDS TO OCCUR WAY BEFORE THAT WOMAN PRESENTS HERSELF TO THAT WAITING ROOM.  WE TALK A LOT ABOUT POSITION AND TROUBLESHOOTING THE ROUTINE EXAM.

MOSTLY BECAUSE OF THE INACCESSIBILITY OF THE MAMMOGRAPHY MACHINE.

WE TALK A LOT ABOUT EXAM COMPLETION THE SAFETY ISSUES NOT ONLY FOR THAT PERSON THAT WOMAN WITH A DISABILITY ABILITY COMING IN BUT ALSO FOR THE TECHNOLOGIST.  THE TECHNOLOGIST, ESPECIALLY IF SHE HAS TO ADAPT THE MAMMOGRAPHY THE EXAM NEEDS TO DO A LOT OF UP AND DOWN SWAYING HER BODY.  WE NEED TO MAKE SURE THAT SHE IS SAFE.

THAT SHE IS NOT GOING TO HURT HERSELF.

AND THEN WE TALK A LOT ABOUT FACTORS FOR SUCCESS AND DISCUSSION.  WE HAVE DISCUSSIONS IN Q AND A.  IT IS USUALLY SIX HOURS WE HAVE REACHED OVER 1,000 TECHNOLOGISTS IN CALIFORNIA WE HAVE BEEN INVITED IN OREGON TO PROVIDE A DAY-LONG STATE-WIDE TRAINING TO IN OREGON AS WELL AS IN ARKANSAS.

WE TALK A LOT ABOUT SUPPORTS I THINK AS BOTH OF — BOTH PAST THREE PRESENTATIONS TALKED ABOUT, FOAM SPONGES, WEDGES, PILLOWS, LINENS, PADDED VELCRO LET’S TALK WITH PERMISSION NONLATEX AND MAKE SURE THE STICKY SIDE IS NOT ON THE SKIN.  WE NEED TO THINK ABOUT PEOPLE WHO ARE ALLERGIC AND PEOPLE WHO DON’T HAVE FEELING ON THEIR SKIN.

A LOT OF THE MATERIAL OUT THERE, PEOPLE ARE SENSITIVE TO THAT.

SO, I DON’T KNOW IF THE BOARD IS GOING TO BE LOOKING AT THOSE SUPPORTS, THOSE TECHNICAL SUPPORTS BUT THAT IS SOMETHING TO BE — TO THINK ABOUT.

WE TALK ABOUT OTHER TECHNOLOGISTS AND AGAIN GOING BACK TO CULTURAL COMPETENCY PART OF THAT IS HAVING A GOOD ATTITUDE, PREPARATION, GOOD HUMOR SETTING THE TONE FOR ANYTHING FOR ANY EXAM AND I WILL TALK ABOUT IT FOR A MAMMOGRAPHY IS REALLY — WE NEED — WHEN WE LOOK AT EQUIPMENT AND WE ARE LOOKING AT EQUIPMENT FOR A SPECIFIC EXAM, FOR A CLINICAL EXAM I AM SURE THE PROVIDERS ARE GOING TO TALK ABOUT THIS IN THE NEXT HOUR OR — HOUR OR SO.  IS THAT WE NEED TO LOOK AT WHAT THAT EXAM NEEDS TO DO WHAT IS THE ROLE OF THAT EXAM.  WHAT IS IT THAT YOU WANT TO THAT PERSON EQUALLY AND EQUITABLY TO GET OUT OF THAT EXAM.

SO MAMMOGRAPHY, THE GOAL IS TO OBTAIN THE BEST IMAGE BY MAXIMIZING TISSUE VISUALIZATION.  IF YOU DON’T DO THAT, THAT WOMAN IS GOING TO HAVE TO COME BACK OR THAT WOMAN MAYBE — PERHAPS THERE MIGHT BE OTHER OPTIONS IN TERMS OF THE MRI ULTRASOUND OR MRI.

SO, WE NEED TO THINK ABOUT HOW TO DO THAT.

HOW TECHNOLOGISTS WILL DO THAT.

AND WE ALSO WITH ALL OF THAT WE NEED TO PROMOTE SERIAL MAMMOGRAPHY.

WHICH PEOPLE WITH DISABILITIES ARE NOT RECEIVING.

IN MANY OF THE STUDIES, AT LEAST IN CALIFORNIA, MANY PARTS AROUND THE COUNTRY, I BELIEVE WITH THE BEHAVIORAL RISK SURVEILLANCE STUDIES WE ARE FINDING WOMEN WITH DISABILITIES ARE COMING IN FOR THEIR BUSINESS LINE MAMMOGRAPHY SCREENING BUT THEY ARE NOT RETURNING GOING BACK TO DELAYED DIAGNOSIS THEY ARE COMING BACK FOR A BREAST PROBLEM OR BREAST CANCER DIAGNOSIS.

WHEN WE LOOK AT WHAT NEEDS TO BE DONE FOR MAMMOGRAPHY, THESE ARE THE THINGS THAT WE GO THROUGH.  SOME OF THE REASONS FOR ALTERNATIVE VIEWS, ALTERNATE VIEWS FOR MAMMOGRAPHY AT LEAST WITH EXISTING UNITS IS THAT BECAUSE SOMETIMES THE WHEELCHAIR ARMS ARE NOT REMOVABLE, BECAUSE THE MACHINE ITSELF IS NOT ADAPTABLE TO A WOMAN’S BODY, OR TO HER ABILITIES.

AND THAT CAUSES A STRAIN ON TIME TECHNOLOGIST’S TIME, THE PATIENT’S TIME AND POSSIBLE PHYSICAL INJURY.

WHEN WE DO POSITIONS FOR CC VIEW, THE TECHNOLOGIST ALWAYS TELLS US TO CONSIDER USING A MAMMOGRAPHY POSITIONING CHAIR IF THEY HAVE THAT AVAILABLE.  OFTEN THEY DON’T.  OFTEN WHAT WE HEAR WHAT JANET HAS SAID IS THAT THEY USE AN OFFICE CHAIR THAT HAS NO ARMS AND THAT CAN ACTUALLY GET US CLOSE AND CAN GET AS CLOSE AS POSSIBLE TO THE PERSON TO THE MACHINE.

>> WE DO TALK A LOT IN OUR TRAINING ABOUT BEFORE A PERSON GIVES UP.  BEFORE TECHNOLOGIST GIVES UP TO CONSIDER DECUBITUS POSITION WITH A GURNEY WE HAVE TO TRANSFER THE PATIENT INTO A GURNEY AND TAKING FOR GRANTED THE EXAM ROOM NOW WITH THE DIGITAL MACHINE NOT ONLY HAS THE MACHINE BUT HAS A COUPLE OF OTHER STANDS IS BIG ENOUGH TO HOLD THE GURNEY.

WE ALSO SAY PERHAPS THE CLIENT TRANSFER TO A MAMMOGRAPHY CHAIR IF THE MAMMOGRAPHY CHAIR IS AVAILABLE TO RESCHEDULE TO A LONGER APPOINTMENT TIME, AND TO MAKE SURE THAT EVERYTHING THE NEXT TIME IS AVAILABLE.  WHICH MAY MEAN A LIFT OR LARGER EXAM ROOM.

WE DO HAVE A CLIENT QUESTIONNAIRE, IF ANYONE IS INTERESTED, IT IS IN OUR WEBSITE.

WE HAVE OUR MAMMOGRAPHY PROTOCOL AS I HAVE BEEN REFERRING TO AGAIN IN OUR WEBSITE.

THIS IS THE — I THINK THIS IS A GOOD PICTURE OF A DIGITAL MACHINE.  A PERSON IN A WHEELCHAIR ONE OF OUR CLIENTS IN A WHEELCHAIR YOU SEE THE PEDAL PIECE WHICH CAN BE CUMBERSOME FOR A PERSON TO GET AS CLOSE AS POSSIBLE TO THE MACHINE.

THIS MACHINE ACTUALLY LOWERS TO 24 INCHES.  AND SOME MACHINES OBVIOUSLY FROM THIS PIECE DO NOT.

THIS IS MY CONTACT INFORMATION.  THANK YOU AGAIN, FEEL FREE TO CONTACT ME OR TO CONTACT BHAWD AND THANK YOU.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU VERY MUCH FOR COMING ALL THIS WAY.

AND I AM GLAD THAT BHAWD WAS REPRESENTED HERE TODAY.  DO ACCESSIBLE MAMMOGRAPHY VANS EXIST ANYWHERE?

>> DAVID BAQUIS:  JUST THE FIRST PART, YOU CAN GET IN, BUT THE EQUIPMENT IS NOT ACCESSIBLE.

>> I THINK THERE IS AN ISSUE IN WOMEN WITH SCOOTERS THERE IS A PLATFORM, YOU KNOW, YOU ROLL UP AND THERE IS A FLAT FORM THAT GOES UP AND DOWN THEY CAN PUT A WHEELCHAIR ON IT BUT THERE WAS AN ISSUE AS FAR AS SCOOTER YOU HAVE TO LEAVE THE SCOOTER DOWN BELOW AND YOU KNOW IF YOU CAN STAND BY YOURSELF THAT’S GREAT.  BUT IF YOU CAN’T, THAT’S A PROBLEM.  BUT THEY HAVE PUT WHEELCHAIRS ON IT.

AND THEY SAID THAT THEY HAVE DONE WOMEN IN WHEELCHAIRS IN IT.

>> JUST ONE.

>> DOWN AT GW, GEORGE WASHINGTON UNIVERSITY HOSPITAL.

>> NANCY STARNES:  NANCY STARNES, PUBLIC MEMBER.  A COUPLE OF REALLY QUICK COMMENTS.  I WAS PLEASED TO HEAR THE INCLUSION OF MEN WITH BREAST CANCER, EVEN THOUGH IT IS RARE, THERE IS LESS BREAST TISSUE, THERE IS MORE DISTANCE BETWEEN HIP AND KNEE THAT REQUIRES ADDITIONAL CONSIDERATIONS, AND I GUESS IT’S PROBABLY TOO MUCH TO HOPE FOR BUT I WOULD LOVE THEM WARM THE PLATE A LITTLE BIT BEFORE THEY DO THE BREAST THING, YOU KNOW.

AND ALSO, WHAT I DIDN’T HEAR, IT’S A SAFETY ISSUE, NOT SO MUCH AS ACCESSIBLE ISSUE, BUT I HOPE WE CAN LOOK AT THAT, I CAN’T FIND ANY OR — ANY DOCTORS WHO ARE SURGEONS, WHO ARE EVEN FAMILIAR WITH A QUAD PAD, FOR SOMEBODY WHO HAS TO BE ON AN OPERATING TABLE FOR A LONG TIME WITH LITTLE TISSUE COVERING SOME OF THE BONY AREAS.  THEY CAN REALLY EXPERIENCE TISSUE BREAKDOWN DURING ON OPERATION.  THANK YOU.

>> DAVID BAQUIS:  THANK YOU.  LET’S TAKE ONE MORE ON THE SIDE OF THE ROOM PLEASE,

>> MARILYN GOLDMAN WITH THE DISABILITIES RIGHT EDUCATION AND DEFENSE FUND.  IT’S WONDERFUL TO BE AROUND THE ACCESS BOARD AGAIN.  WHEN CREATING STANDARDS FOR THE MEDICAL DIAGNOSTIC EQUIPMENT THERE SHOULD BE CONSIDERATION OF LIFT EQUIPMENT AT THE SAME TIME.  NOW THERE IS VIRTUALLY NOTHING TO ENSURE THAT THE LIFT EQUIPMENT WORK FOR THE USER, ONLY FOR THE MEDICAL PERSONNEL.

TWO QUICK POINTS ON THAT:  INCLUDING LIFTS AND THE RANGE OF EQUIPMENT TO BE EVALUATED, AND LOOKING AT THEM FOR COMFORT, SAFETY AND PATIENT PREFERENCE.

THE OTHER POINT IS THAT WHEN DEVELOPING STANDARDS FOR MEDICAL AND DIAGNOSTIC EQUIPMENT, CONSIDER THE COMPATIBILITY WITH THE LIFT EQUIPMENT SUCH AS HIGHER TYPE LIFT INTENDED TO BE USED FROM ROOM TO ROOM.  WE WANT TO REFERENCE SENATOR FRANKLIN’S BILL F1788, IT’S PARTICULARLY IMPORTANT BECAUSE IF THAT BILL GOES FORWARD THERE WILL BE A REQUIREMENT FOR LIFT EQUIPMENT IN VIRTUALLY EVERY MEDICAL FACILITY.  AND SENATOR FRANKLIN’S STAFF IS OPTIMISTIC ABOUT THE BILL, THEY’RE LOOKING TO ATTACH IT TO THE MINING SAFETY BILL.  THIS IS REALLY A PERFECT OPPORTUNITY TO TAKE INTO CONSIDERATION THIS LIFT COMPATIBILITY ISSUE.  TO CLOSE, WITHOUT TAKING AWAY FROM THE EXTREMELY SERIOUS AND IMPORTANT NATURE OF THE SUBJECT, I HAVE TO SMILE TO MYSELF BECAUSE AS A WOMAN WHO HAD TO PUBLICLY REPRESENT THE EXACT TECHNICAL SPECIFIC NEEDS OF MEN USING URINALS, AND I MEAN SPECIFIC, I ENCOURAGE EVERYONE, INCLUDING THE MEN DEALING WITH THIS ROUND OF STANDARDS SETTING TO ABANDON ALL HESITATION AS YOU DISCUSS THIS SPECIFIC DETAILS OF WHAT IT REALLY MEANS FOR WOMEN WITH DISABILITIES TO GET A MAMMOGRAM.  THANK YOU.

>> DAVID BAQUIS:  OKAY.  AND PERHAPS GO AHEAD ON THAT SIDE OF THE ROOM AND WE WILL BREAK.

>> IT IS ALSO A PLEASURE TO BE AROUND WITH SUCH DEVOTED ADVOCATES AND PEOPLE WITH SUCH TECHNICAL KNOWLEDGE.

I WANTED TO —

>> DAVID BAQUIS:  WHAT IS YOUR NAME?

>> ROSEMARY COITTI, ACCESSIBLE LIVING, INCORPORATED.

WHEN WE TALK ABOUT WOMEN WITH DISABILITIES, AND WHERE THEY ARE ON THE RISK FACTOR, WE STILL NEED WITHOUT GO DATA AND GOOD RESEARCH WE DON’T REALLY KNOW HOW TO COME UP WITH GOOD RECOMMENDATIONS.

AND WOMEN WITH DISABILITIES, DEPENDING ON THEIR DISABILITIES, MOST LIKELY HAVE HAD MULTIPLE CT SCANS.  AND WE KNOW THAT THIS IS INCREASING THE INCIDENCE OF BREAST CANCER.  WHAT WE NEED TO DO IS TEASE OUT THE WOMEN WITH DISABILITIES AND CT SCANS AND TRY AND FIND IT SO WE HAVE BETTER RECOMMENDATIONS FOR SCREENING WHEN TO START, HOW OFTEN TO DO IT.

WE ARE — WE ARE HAVING UNNECESSARY MORTALITY WITHOUT BETTER DATA AND BETTER RESEARCH.

WITH SPECIFIC HEALTH RELATED ISSUES FOR WOMEN.  AND MEN BUT WE ARE TALKING ABOUT MAMMOGRAMS HERE.

AND THE BREAST ISSUE SEEMS TO BE PARTICULARLY VULNERABLE TO CT SCANS.

THE OTHER THING THAT NOW WE HAVE ACCESS TO MRI’S.  BREAST MRI’S AND THEY ARE NOT A SUBSTITUTE FOR DIGITAL MAMMOGRAPHY BUT THEY ARE BECOMING A MORE AND MORE IMPORTANT ADJUNCT WAY OF SCREENING PARTICULARLY FOR WOMEN WITH VERY DENSE BREAST WITH YOUNGER WOMEN AND WHEN WE HAVE YOUNG WOMEN WITH SPINAL CORD INJURIES WITH MULTIPLE CT SCANS I BELIEVE EMPIRICALLY WE ARE SEEING YOUNGER WOMEN WITH BREAST CANCER BECAUSE OF THEIR EXPOSURE OVER THEIR LIFETIME AT YOUNG AGE TO CAT SCAN PARTICULARLY WHEN WE HAVE MULTIPLE CELL DEVELOPMENT AS A YOUNG MANY WOULD.  AND WE ARE SEEING INCREASED INCIDENTS IT HAS TO BE STUDIED THE MRI MACHINE IS NOT ACCESSIBLE, THE BREAST MRI MACHINE IS NOT ACCESSIBLE FOR WOMEN WITH STOMAS, THEY MAY BE TRACHED, YOU HAVE TO BE ABLE TO LAY ON YOUR STOMACH, SOME COMPRESSION ON THE NECK AND THEY HAVE CUT OUTS FOR THE BREAST TO LAY IN THEM.

I THINK THERE IS GOING TO BE A LOT OF PEOPLE, PEOPLE WITH RHEUMATOID ARTHRITIS, PEOPLE WITH CEREBRAL PALSY, THERE ARE MANY CONDITIONS THAT PREVENT WOMEN FROM BEING ABLE TO AVAIL THIS LEVEL OF DIAGNOSTIC EQUIPMENT THAT HAS THE CAPACITY TO SAVE LIVES BUT WE REALLY HAVE TO LOOK AT THIS.  THIS IS VERY SERIOUS.  THANK YOU VERY MUCH FOR ALL OF YOU FOR DOING THIS.

>> I WOULD LIKE TO COMMENT AND AGREE WITH EVERYTHING THAT YOU SAID AND I THINK THAT THERE IS SOME RESEARCH OUT THERE THAT EVEN INDICATES MRI’S ARE JUST EVEN A BETTER DIAGNOSTIC PIECE THAN THE MAMMOGRAPHY ITSELF.

AND THEN GET DOWN TO THE WHOLE ISSUE OF WHO IS GOING TO PAY FOR IT.

BUT —

>> WE KNOW IN JAPAN WITH THEIR SYSTEM THEY USE IT WIDELY AND THEY COST $25.

>> I AGREE WITH YOU BELIEVE ME.

>> SO, WE REALLY NEED TO — THIS COST CURVE DEPENDS HOW WE LOOK AT IT, WHEN WE DON’T HAVE ADEQUATE SCREENING AND WE CAN’T GIVE ACCESSIBLE HEALTHCARE THE DOLLARS ON THE BACK END OF HUGE.

>> THERE IS WAY TOO MUCH BREAST CANCER IN THE COUNTRY AND WAY TOO MANY CASES DUE TO IMPROPER MAMMOGRAMS, THE PROCESS OF TECHNOLOGY THE READING OF THE MAMMOGRAM.  IT’S JUST —

>> OF COURSE WE ARE TALKING ABOUT EQUIPMENT HERE IT TENDS TO REMOVE US FROM THE PERSONAL THINGS BUT THESE ARE PEOPLE THAT WE LOVE THESE ARE OUR SISTERS, OUR MOTHERS, THESE ARE OUR WIVES, THESE ARE REAL PEOPLE THAT GO WITH THESE STORIES.

>> WE ARE SURVIVORS AROUND THE TABLE.

>> DAVID BAQUIS:  I HATE TO CUT YOU OFF, THERE ARE PEOPLE ANXIOUS TO USE THE RESTROOM.  WE WILL BE ABLE TO CONTINUE THIS ALSO IN THE HEALTHCARE PROVIDERS PANEL.  WE HAVE RESTROOMS ON UP ON THE 9TH FLOOR, AS WELL AS 8TH FLOOR.  ON THE 8TH FLOOR THAT’S WHERE YOU GET THE BUTTON TO PRESS THE DOOR OPEN.  LET’S COME BACK IF WE CAN IN ABOUT FIVE MINUTES

(SHORT RECESS TAKEN.)

>> DAVID BAQUIS:  OUR NEXT PANEL IS GOING TO ADDRESS LEGAL ISSUES.  WE WILL HEAR FROM TWO SPEAKERS.  AND THEN WE WILL AGAIN HAVE SOME TIME FOR QUESTIONS.  WE ARE GOING IT HEAR FROM LAINEY FEINGOLD WHO IS A WELL-KNOWN DISABILITY RIGHTS ATTORNEY.  WHO CAN HELP US UNDERSTAND WHAT A NEGOTIATED SETTLEMENT IS AND WHAT SHE HAS LEARNED FROM HER WORK IN BARRIER FREE HEALTHCARE.

WE WILL ALSO HEAR FROM RENEE WOHLENHAUS WHO IS DEPUTY CHIEF OF THE DISABILITY RIGHTS SECTION IN THE CIVIL RIGHTS DIVISION AT THE U.S. DEPARTMENT OF JUSTICE.  AND SHE WILL COVER INFORMATION ABOUT LEGAL SETTLEMENTS, MENTION SOME TECHNICAL ASSISTANCE THAT DOJ HAS RECENTLY POSTED AND A RECENT ADVANCED NOTICE OF PROPOSED RULEMAKING THAT COULD BE OF RELEVANCE.  YOUR TIMING WAS GREAT.

SO, LET US PROCEED.  GO AHEAD PLEASE.

>> OKAY.  I AM LAINEY FEINGOLD, I AM A DISABILITY RIGHTS LAWYER IN BERKELEY CALIFORNIA.  I REALLY APPRECIATE THE OPPORTUNITY TO BE HERE AND THANK DAVID AND THE BOARD AND THE COMMITTEE FOR INVITING ME TO MAKE A FEW REMARKS.

I KNOW EVERYONE IS INTERESTED IN THE TECHNICAL STUFF SO RENEE AND I ARE GOING TO TRY TO BUZZ THROUGH SO THERE WILL BE A LOT OF QUESTION TIME SO WE CAN GO BACK TO THE EARLIER PANELISTS BEFORE THE FIRST SLIDE, I WANTED TO SAY I HAVE BEEN IN DC SINCE SUNDAY I HARDLY EVER COME I CAME FOR THE 20TH ANNIVERSARY EVENTS.  I THINK BECAUSE OF THAT I AM JUST FEELING THE SORT OF HISTORIC RELEVANCE THE WHOLE WEEK AND ALSO OF THIS — OF THIS GATHERING AND THIS MEETING AND THERE IS TWO PARTS OF HISTORY THAT ARE REALLY STRIKING ME.  ONE IS THE WHOLE ADA AND REG HISTORY THAT WE HAVE ALL EXPERIENCE IN THE PAST WEEK, AND THAT YOU KNOW I FEEL SO HONORED TO HAVE BEEN A PART OF.  AND YOU KNOW, BURIED IN ALL OF THE ADA ANNIVERSARY STUFF AND THE INCREDIBLE NOW APRM’S THE DEPARTMENT PUT OUT THE DEPARTMENT OF JUSTICE ON MONDAY FINALLY FINALIZE THE ACCESS BOARD’S WORK THAT WAS FINALIZED BY THE ACCESS BOARD IN 2004.

SO, IT REMINDS ME THAT THIS — THESE PROCESSES TAKE A LONG TIME.  AND IT’S GREAT THAT THERE IS A TWO-YEAR DEADLINE IN THE HEALTHCARE BILL, BUT THAT WILL ONLY BE THE BEGINNING OF THE PROCESS WHERE THESE STANDARDS BECOME REQUIRED BY DIFFERENT AGENCIES AND DOJ STARTS LOOKING AT THEM, SO I REALLY URGE THE COMMITTEE TO THINK IN THE FUTURE BECAUSE LIKE EARLIER PANELISTS HAD SAID, THE LANDSCAPE IS RAPIDLY CHANGING AND ESPECIALLY IN THE TECHNOLOGY ASPECTS OF DIAGNOSTIC MEDICAL EQUIPMENT, THINGS ARE CHANGING EVERY DAY MORE AND MORE ADVANCES ARE MADE.  SO WHAT WE ARE DOING HERE TODAY WHAT YOUR TASK IS JUST FEELS VERY SORT OF REAL AND IMPORTANT AND THE NEED TO REMEMBER THAT WHAT MIGHT BE ON THE MARKET TODAY SOMETHING MORE ADVANCED IS GOING TO BE ON THE MARKET TOMORROW.  SO IT’S REALLY IMPORTANT AS SOMEONE WHO WORKS LEGALLY AND LOOKS AT WHAT THE STANDARDS ARE, YOU KNOW, WE NEED STANDARDS THAT ARE GOING TO WORK TWO YEARS FROM NOW FOUR YEARS FROM NOW TEN YEARS FROM NOW.

SO, WITH THAT I WILL GO TO THE FIRST SLIDE.

WHICH IS CALLED ADA:  A STRONG FOUNDATION.

WITHIN OF THE IMPORTANT THINGS THAT I WANTED TO SAY HERE TODAY AND I THINK IT’S CLEAR FROM THE EARLIER PANELISTS IS THAT THE ADA ALREADY PREVENTS DISCRIMINATION AGAINST PEOPLE WITH DISABILITIES IN THE HEALTHCARE SETTINGS.

AND IF YOU ARE A PERSON WITH A DISABILITY AND YOU GO TO A DOCTOR AND YOU CAN’T GET THE SAME EXAM THE SAME DIAGNOSIS AS A PERSON WITHOUT A DISABILITY THAT HEALTHCARE ENTITY IS IN VIOLATION OF THE ADA.

SO, INCREDIBLE WORK ON A CASE BY CASE BASIS HAS BEEN GOING ON IN THE LEGAL FIELD I WILL TALK ABOUT SOME OF THE WORK THAT I KNOW ABOUT AND RENEE IS GOING TO TALK ABOUT SOME OF THE GREAT WORK THE DEPARTMENT OF JUSTICE HAS DONE.  AND THEN WHAT WE HEARD THIS MORNING IS PEOPLE ARE INSTALLING THIS EQUIPMENT, YOU KNOW, WITHOUT LAWSUITS JUST BECAUSE THEY KNOW IT’S THE RIGHT THING TO DO AND THESE INCREDIBLE PROJECTS IN BERKELEY DC AND AROUND THE COUNTRY.  AS YOU GO THROUGH THE RULEMAKING PROCESS I REALLY NEED TO STRESS THAT WE NEED THESE STANDARDS, IT’S CRITICAL THAT WE HAVE THESE STANDARDS, BUT ONE OF THE THINGS THAT I ALWAYS HEAR IN MY WORK IS OH, THE ACCESS BOARD IS WORKING ON STANDARDS WE CAN’T DO ANYTHING UNTIL WE SEE WHAT THEY SAY.  I DON’T KNOW HOW YOU GUYS CAN HELP THAT, IF NOT MAYBE IN GUIDANCE OR WHAT’S ON YOUR BOARD, BUT THE ADA ALREADY PROVIDES A VERY STRONG FOUNDATION FOR PEOPLE WITH DISABILITIES WHO NEED ACCESS TO MEDICAL CARE.

IT’S NOT JUST NONDISCRIMINATION PROVISIONS, THE EQUAL ACCESS TO SERVICES AND BENEFITS.  AND ALSO AUXILIARY AIDS AND SERVICES THE ABILITY OF BLIND PEOPLE, THE ABILITY OF DEAF PEOPLE, TO GET QUALITY HEALTHCARE AND ACCESS TO SERVICES IN DIAGNOSTIC MEDICAL EQUIPMENT.  I AM GOING TO TALK IN A BIT ABOUT DIAGNOSTIC MEDICAL EQUIPMENT AS IT APPLIES TO THE BLIND COMMUNITY, WHICH IS THE GROUP WITH WHOM I DO MOST OF MY WORK.

AND I WILL SAVE THAT FOR THE NEXT THE NEXT SLIDE BUT I THINK IT’S VERY IMPORTANT TO REMEMBER WE ARE IN A FRAMEWORK WHERE THE ADA AS WELL AS LAWS OF MANY STATES INDIVIDUAL STATE LAWS CALIFORNIA IN PARTICULAR ARE ALREADY REQUIRING A QUALITY OF SERVICES.  NOW WE JUST NEED REALLY STRONG STANDARDS TO CLARIFY WHAT THAT MEANS.

OKAY.  THE LEGAL — I SEE MY ROLE UP HERE I AM FROM BERKELEY, CALIFORNIA, LIKE I SAID, I AM A LAWYER IN PRIVATE PRACTICE.  SEVERAL OF US, I AM REALLY HERE I FEEL ON BEHALF OF ALL OF THE LEGAL ADVOCATES THAT HAVE BEEN DOING WORK IN THE FIELD WITHOUT THE REGULATIONS WANTING REGULATIONS BUT COBBLING THINGS TOGETHER, THERE HAS BEEN LITIGATION ON THESE ISSUES SOMEONE MENTIONED THE KAISER CASE WHICH WAS FIRST KIND OF FIRST OUT OF THE BOX LANDMARK LITIGATION LANDMARK SETTLEMENT REALLY CHANGED THE ENTIRE LANDSCAPE FOR ESPECIALLY BEDS THAT GO UP AND DOWN.

BECAUSE IF PROVIDERS ARE REQUIRED TO DO THESE THINGS, HOPEFULLY VOLUNTARILY BUT ALSO OFTEN BY LAWSUITS AND SETTLEMENTS, IT’S GOING TO CHANGE THE MARKET.

AND YOU ARE GOING TO BE CHANGING THE MARKET WITH THE WORK THAT YOU DO IN THIS PROCESS OVER THE NEXT TWO YEARS.  AND SO, IT JUST ADDS TO THE CRITICAL NATURE OF IT.

IN ADDITION TO LITIGATION THERE IS A PROCESS CALLED STRUCTURED NEGOTIATIONS, I AM A LAWYER BUT I HAVE NOT FILED A LAWSUIT IN THE PAST 15 YEARS OF THE

BECAUSE I HAVE WORKED IN A COLLABORATIVE WAY MOSTLY WITH THE BLIND COMMUNITY BUT ALSO PEOPLE WITH DID DISABILITIES APPROACHING INSTITUTIONS WHO ARE IN VIOLATION OF THE ADA WITH THE IDEA IT IS BETTER, IF POSSIBLE, TO WORK IN COLLABORATION AND WORK ON SOLUTIONS RATHER THAN SUE, I AM HAPPY TO SAY THAT THE IN THE HEALTHCARE FIELD, THE STRUCTURED NEGOTIATIONS HAS REALLY BROUGHT ACCESSIBILITY TO A LOT OF INSTITUTIONS.

I WAS INVOLVED IN UCSF MEDICAL IT STARTED WITH MAN WHO USED A WHEELCHAIR HE HAD AS AN INPATIENT — HE WAS INPATIENT IN THE HOSPITAL.  AND THEY DID NOT HAVE A SINGLE ACCESSIBLE RESTROOM FOR A PATIENTS — THIS IS A HOSPITAL.  WHEN HE CAME TO ME BECAUSE HE KNEW WE DID STRUCTURED NEGOTIATIONS, HE DIDN’T WANT TO SUE THE PLACE.  HE WANTED TO, YOU KNOW, GET AN ACCESSIBLE ROOM AND WORK WITH THEM AND, YOU KNOW, I WROTE — WE STARTED OUT WITH A LETTER LAYING OUT WHAT THE ISSUES ARE.  WHEN WE WROTE THE LETTER I FIGURED THEY ARE GOING TO WRITE BACK SAY, YOU MISREAD THE LAW, WE DON’T NEED ONE, WE ARE TOO OLD.  WELL, THEY JUST HAD GOTTEN TO IT, THEY AGREED TO BE IN STRUCTURED NEGOTIATIONS THIS PERSONS NAME AUGUST LONGO, HE PASSED AWAY 6 MONTHS AGO, HE WAS SINGLE HANDEDLY, BEING INVOLVED IN THE STRUCTURED NEGOTIATIONS WITH ME AND MY PARTNER LINDA, WE DID STRUCTURED NEGOTIATIONS WITH UCSF BECAUSE HE WAS A PERSON WITH MEDICAL NEEDS, HE WAS BACK THERE, IT WAS ONE THING OR THE NEXT.  HE COULDN’T GET WEIGHED, HE COULDN’T GET THE BLOOD PRESSURE TAKEN IN PRIVACY.  THEREFORE WE DID STRUCTURED NEGOTIATION SETTLEMENT WITH UCSF USING JUNE AS OUR EXPERT.  IF IT HASN’T BEEN KNOWN, JUNE IS THE EXPERT IN ALL OF THESE CASES THAT YOU WILL HEAR ABOUT.  JUNE AND HER PARTNER BRENDA PRIMO.  WE DID A COMPREHENSIVE AGREEMENT WHERE THEY DID A SURVEY AND OTHER ISSUES, I WILL TALK ABOUT IN A MINUTE.  IN ADDITION TO THAT WORK, SEVERAL LAWYERS WHO HAVE DONE STRUCTURED NEGOTIATIONS, THE GROUP IS — YOU ARE GOING TO HEAR THIS AFTERNOON FROM CHERYL BRADLEY FROM SUTTER WHO HAS DONE A WONDERFUL JOB IN COLLABORATION WITH THE DISABILITY COMMUNITY AS A RESULT OF THE STRUCTURED NEGOTIATIONS TWO BIG HOSPITALS IN BOSTON DID STRUCTURED NEGOTIATIONS.  SO THE COMBINATION OF LITIGATION AND STRUCTURED NEGOTIATIONS HAS REALLY RESULTED IN AN ON-THE-GROUND, YOU KNOW, EFFORT TO IMPROVE ACCESS TO DIAGNOSTIC MEDICAL EQUIPMENT.

OBVIOUSLY WE DON’T HAVE TIME TO GO THROUGH THE WHOLE DETAILS OF THE SETTLEMENTS HERE I URGE YOU TO LOOK AT THOSE HOSPITALS AS LEADERSHIP HOSPITALS AND GET THEIR LEARNINGS GET THEIR LEARNINGS FROM THEM.

THOSE OF US WHO ARE INVOLVED IN THIS WORK HAVE PUT TOGETHER WEBSITE CALLED THE BARRIER FREE HEALTHCARE INITIATIVE, WHICH THANK YOU DAVID FOR PUTTING IT ON THE ACCESS BOARD’S WEBSITE.

THE GROUPS INVOLVED IN THAT FIRST AND FOREMOST DISABILITY RIGHTS EDUCATION AND DEFENSE FUND WHO HAS BEEN IN THE TRENCHES ON THESE SUCCESSFUL MEDICAL EQUIPMENT ISSUES AND ACCESS TO MEDICAL CARE GENERALLY IN A BROADER WAY THAN JUST EQUIPMENT.

AND THEY ARE MAIN TAPING THE WEBSITE MARY LOU IS PART OF THE BRAINS AND HEART BEHIND THE EFFORT.  MYSELF AND LINDA, DAN MANNING OF THE GREATER BOSTON LEGAL SERVICES IN BOSTON, WHO HAS DONE A LOT OF GREAT WORK.  I URGE YOU TO TURN TO HIM AS A GOOD PERSON WITH INFORMATION ON LEGAL ISSUES DISABILITY ABILITY RIGHTS ADVOCATES.  AND I THINK THAT’S IT.  WE ARE TRYING TO BE A BEST PRACTICES KIND OF WEBSITE FOR THE LEGAL CASES.  YOU CAN FIND LINKS TO ALL THE SETTLEMENTS THERE AS HOSPITALS WE ARE WORKING WITH ARE DEVELOPING THE POLICIES WE ARE HOPING TO PUT THOSE UP AS WELL.

THE HOSPITALS THAT HAVE DONE THE STRUCTURED SETTLEMENT I TITLED THE SLIDE 4079S TO LEARN FROM KAISER SUTTER UCSF MEDICAL BRIGHAM AND WOMEN’S IN BOSTON AND MASSACHUSETTS GENERAL HOSPITAL.

THEY HAVE ALL SIGNED BINDING LEGAL AGREEMENTS WITH THE DISABILITY COMMUNITY TO IMPROVE ACCESS TO HEALTHCARE THEY ARE IN VARIOUS STAGES OF IMPLEMENTING THE AGREEMENTS AND I THINK THEY HAVE A LOT OF GOOD INFORMATION FOR YOU A AS YOU GO FORWARD IN THIS PROCESS.  THE SETTLEMENT TERMS AGAIN, I DON’T HAVE A LOT OF TIME HERE, BUT IN THE SETTLEMENTS WE HAVE AGREED UPON EXPERTS USUALLY JUNE, I PUT PARENTHESES, BUT IT’S USUALLY JUNE.

TO DO THE ACCESSIBLE MEDICAL EQUIPMENT DESIGN THE SURVEY AND PERFORM THE SURVEY.  THERE IS ALSO A NEED I DON’T KNOW HUH TIME THERE IS GOING TO BE TO GET INTO THIS ON THIS DAY’S SESSION THE ARCHITECTURAL BARRIERS AND THE STRAIGHT UP TYPICAL ADAAG ISSUES FOR THE ROOMS IN WHICH THE ACCESSIBLE MEDICAL EQUIPMENT IS PLACED, JIM TERRY FROM EVAN TERRY ASSOCIATES HAVE DONE A LOT OF THAT WORK SOMEONE FROM HIS OFFICE IS HERE AND THE OTHER ARCHITECTS WHO HAVE DONE THAT AS WELL.  FACILITY SURVEYS EQUIPMENT SURVEYS INTERNAL WORKING GROUPS WITHIN THE HOSPITAL AND ALSO IN CONJUNCTION WITH THE PEOPLE WITH DISABILITIES I REALLY AGREE WITH THE WOMAN FROM SUTTER ON THE BREAST HEALTH PROJECT THAT YOU KNOW TO QUOTE ADAAG, NOTHING ABOUT US WITHOUT US, THIS WORK CAN’T BE DONE WITHOUT SIGNIFICANT INPUT FROM THE DISABILITY COMMUNITY.  WE TRY TO BUILD THAT INTO THE SETTLEMENTS.

THERE IS ALSO IMPLEMENTATION PLAN TRAINING AND POLICY, I AGREE WITH JUNE, CRITICAL ON ALL WORK IN TECHNOLOGY WITH THE BLIND COMMUNITY, MONEY IS SPENT ON EQUIPMENT IF PEOPLE DON’T KNOW HOW TO USE IT, IT MAY HAVE NOT BEEN SPENT.  THAT’S NOT THE ACCESS BOARD’S CHARGE MAYBE IN THE INTRODUCTION OR, YOU KNOW, YOU GUYS HAVE SUCH AUTHORITY ON THIS ISSUE WHEN THE PROCESS IS DONE ANY WAY YOU CAN WORK IN EVEN A LINE OR TWO ABOUT THE IMPORTANCE OF TRAINING AND POLICIES TO GO WITH THE EQUIPMENT IS REALLY IMPORTANT.

THE MONITORING REPORTING AND ENFORCEMENT.  THE AGREEMENTS THAT ARE DONE WITHOUT LITIGATION HAVE THE SAME EXACT MONITORING REPORTING AND ENFORCEMENT THAT WE HAVE IN AGREEMENTS WITH LITIGATION.

SO, I WANT TO JUST, SINCE I AM A LAWYER I FELT LIKE I NEEDED TO SAY A FEW WORDS ABOUT WHAT IS DIAGNOSTIC MEDICAL EQUIPMENT.  AND I HATE TO DISAGREE WITH DAVID BECAUSE HE HAS JUST DONE A PHENOMENAL JOB OF PUTTING THIS THING TOGETHER, BUT I DID PRINT OUT THE LANGUAGE THAT THE PERSON FROM HARKIN’S OFFICE READ THIS MORNING, AND I THINK THAT THE BOARD REALLY NEEDS THE COMMITTEE REALLY NEEDS TO LOOK AT THE FACT THAT THE HEALTHCARE BILL SAYS MEDICAL DIAGNOSTIC EQUIPMENT USED IN OR IN CONJUNCTION WITH PHYSICIAN’S OFFICE.

AND I THINK THOSE THREE WORDS FOUR WORDS OR IN CONJUNCTION WITH PHYSICIAN’S OFFICE, REALLY NEEDS TO INFORM YOUR DECISION ABOUT THE SCOPE OF THE RULE MAKING.

AND AS IF A LITTLE LIKE ANGEL WAS YOU KNOW PAYING ATTENTION THIS WEEK IN THE WASHINGTON POST ON THE 27TH, THERE WAS AN ARTICLE I AM GOING TO LEAVE IT OR DAVID HE CAN PROVIDE COPIES, CALLED “THE DO IT YOURSELF HOUSE CALL.”

TECHNOLOGY THAT AIMS TO KEEP CONGESTIVE HEART FAILURE PATIENTS OUT OF THE HOSPITAL IS GAINING TRACTION.

AND A GUY SAYS THE SYSTEM HE USES TO MONITOR HIS WEIGHT AND BLOOD PRESSURE HAS A ELIMINATED TRIPS TO THE DOCTOR’S OFFICE.

THIS IS WIRELESS TRANSMITTAL OF INFORMATION FROM A PATIENT’S HOME RIGHT TO THE DOCTOR’S OFFICE SO WHAT IS THE DOCTOR’S OFFICE?  AND I THINK — ANOTHER THING THAT HAPPENED ON MONDAY, I MEAN I GOT TO COME TO WASHINGTON MORE OFTEN.  I FEEL LIKE OH, MY GOD SO MUCH HAPPENS HERE.  I KNOW THIS PROCESS IS IN CONJUNCTION WITH THE FDA, FCC ANNOUNCED ON MONDAY I THINK A KNEW INITIATIVE TO ADVANCE WIRELESS MEDICAL TECHNOLOGY, WHICH IS ALL ABOUT IN CONJUNCTION WITH.

SO, YOU KNOW, LIKE THE HARKIN’S PERSON SAID THE LANGUAGE OF THE BILL IS REALLY EXPANSIVE, IT’S NOT JUST THE IN CONJUNCTION WITH, BUT IT’S THE FACT THAT THEY DIDN’T SPECIFY WHAT EQUIPMENT IS COVERED.  THEY JUST SAID INCLUDES EQUIPMENT.

SO, FOR THE BLIND COMMUNITY, IF THERE IS EQUIPMENT THAT THE INFORMATION IS PROVIDED VISUALLY ON A FLAT SCREEN WITHOUT AN AUDITORY COMPONENT, THAT IS JUST AS INACCESSIBLE AS EQUIPMENT THAT A PERSON IN A WHEELCHAIR CANNOT GET TO.

SO I KNOW THAT THIS DAY IS DESIGNED MORE TOWARDS WHEELCHAIR ACCESS MOBILITY ACCESS ISSUES, BUT I REALLY URGE THE COMMITTEE TO LOOK AT THE MANDATE FOR “IN CONJUNCTION WITH”.  THERE IS A LOT OF PEOPLE IN THE BLIND COMMUNITY WITH EXPERTISE ON HOW TO MAKE EQUIPMENT ACCESSIBLE.  PEOPLE ARE SENT HOME FROM THE HOSPITAL WHEN THEY ARE BLIND WITH EQUIPMENT TO DIAGNOSE.  A LINE BETWEEN “DIAGNOSE” AND “MONITOR” IS NOT BRIGHT.

AND THIS IS A HISTORIC OPPORTUNITY FOR THIS BOARD WHO IS GOING TO BE MAKING RULES THAT ARE GOING TO BE WITH US YOU KNOW 10 YEARS FROM NOW, I REALLY URGE YOU TO CONVENE ANOTHER SESSION WITH THE MANUFACTURER — THERE ARE JUST LIKE IN THIS MAMMOGRAPHY ISSUE THERE IS ACCESSIBLE GLUCOSE METERS, THERE IS ACCESSIBLE BLOOD MONITOR METERS NOT COVERED BY INSURANCE.  PEOPLE HAVE TO STAY IN LONGER IN THE HOSPITAL BECAUSE THE STUFF AT HOME IS NOT ACCESSIBLE.  YOU CAN OPEN A GREETING START AND GET AUDIBLE INFORMATION.  YOU KNOW.  THERE IS JUST — (LAUGHTER)

>> THERE IS NO I AM NOT KIDDING.  THERE IS THAT BUT — YOU KNOW THE IDEA OF DIAGNOSTIC MEDICAL EQUIPMENT REALLY, I WOULD SAY NEEDS TO — YOU NEED TO LOOK AT ALL DISABILITIES AND LOOK AT THAT IN CONJUNCTION LANGUAGE AND SEE THE HOME AS REALLY IN CONJUNCTION WITH A MEDICAL, A MEDICAL FACILITY.

I DON’T KNOW IF THIS — I JUST WANT TO SAY ONE WORD ABOUT THE NEEDS OF THE WORKERS WITH DISABILITIES WHO ARE USING THIS EQUIPMENT, I DON’T KNOW IF BECAUSE OF THE STATUTE THIS IS LIMITED TO JUST THE PATIENTS, BUT YOU KNOW THERE ARE AND THERE NEED TO BE MORE PEOPLE WITH DISABILITIES IN THE MEDICAL FIELD DOING THE TESTING, DO THE READING DO, THE DIAGNOSIS.  IF THE EQUIPMENT IS NOT ACCESSIBLE TO THEM THEN THAT’S AN EMPLOYMENT BARRIER THAT NEEDS TO BE ADDRESSED.

OKAY.  MY LAST SIDE IS — LET’S AVOID, I THINK I HAVE SAID THAT, I NEED TO SAY IT AGAIN, LET’S AVOID PENDING REGULATIONS AS EXCUSE FOR CURRENT ACTION.  IT’S NOT FAIR TO THE LEADERSHIP, MEDICAL ENTITIES THAT ARE ALREADY DOING THINGS, AND IT’S NOT FAIR FOR THE PEOPLE WITH DISABILITIES TO HAVE TO WAIT ONE MORE DAY FOR THESE THINGS THANK YOU VERY MUCH.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU, LAINEY.  YOU ARE TRULY AN ADVOCATE.  YOU ARE WELCOME TO DISAGREE WITH US.  I SHOULD HAVE FRAMED OUR POSTER TENTATIVELY IT’S OUR PROPOSED THINKING AND WE WELCOME DISCUSSION ABOUT THAT.

AND JR I WAS THINKING OF TAKING QUESTIONS AFTER RENEE SPEAKS, WHAT DO YOU THINK?

>> J.R.  HARDING:  WELL I THINK MY QUESTION — IT WILL SEGUE INTO JUSTICE.

>> J.R.  HARDING:  THANK YOU J.R.  HARING PUBLIC MEMBER.  APPRECIATE YOUR COMMENTS AND AS JUSTICE BEGINS, WOULD THE TWO OF YOU AGREE THAT MEDICAL RECORDS AS A PART OF THE PROFESSIONAL EQUIPMENT AND DIAGNOSTIC AND IF SO, PLEASE ELABORATE ON THAT DURING YOUR PRESENTATION THANK YOU.

>> GOOD MORNING EVERYBODY, I AM RENEE WOHLENHAUS.  I AM ONE OF THE DEPUTY CHIEFS IN THE DISABILITY RIGHTS SECTION.  BEFORE I START I WANT TO RECOGNIZE LAINEY, WHO I STARTED WORKING WITH 15 YEARS AGO WHEN I STARTED DOING THIS WORK WE WORKED TOGETHER TO HELP MAKE CANDLESTICK PARK IN THE BAY AREA ACCESSIBLE TO PEOPLE WITH DISABILITIES.  AND LIKEWISE, THERE IS SOMEONE ELSE IN THE ROOM I HAVE TO HONOR TODAY I AM GOING TO GET CHOKED UP WHEN I DO THIS I AM AFRAID JANET I THINK IS STILL HERE SHE IS ONE OF OUR DEPUTY CHIEFS WHO KNOWS MORE ABOUT THE ADA STANDARDS AND WHAT THE JUSTICE DEPARTMENT HAS DONE TO IMPLEMENT THE LAW THAN ANYONE ELSE IN YOUR SECTION I WANT TO TAKE MY HAT OFF TO HER —

(APPLAUSE)

>> AMAZING TALENT AND LEADERSHIP IN THE AREA.  MOVING ON TO THE SUBSTANTIVE PART OF THE MEETING TODAY I APPRECIATE THE OPPORTUNITY TO COME TALK TO YOU I FOCUS PRIMARILY ON ENFORCEMENT AT THE JUSTICE DEPARTMENT.  SO, I DEFER TO JANET AND HER TEAM ON REGULATORY ISSUES BUT I WILL BE HAPPY TO TALK IN THE CONTENTION OF OUR LITIGATION AND SETTLEMENTS HOW WE HAVE TRIED TO IMPLEMENT THE GOOD WORK OF THE REGULATORY UNIT IN OUR OFFICE THE GOOD NEWS IS LAINEY ALREADY POINTED OUT WE NOW HAVE A NEW REGULATION ON ITS WAY TO THE FED REGISTER FOR THE TITLE II AND III STANDARDS WE ARE VERY EXCITED ABOUT THAT.  LIKEWISE WE ARE EQUALLY EXCITED BY FOUR NEW ADVANCE NOTICES OF PROPOSED RULE MAKING PUBLISHED ON THE ANNIVERSARY WE NOW HAVE UNTIL JANUARY 26 TO GET THE PUBLIC’S COMMENTS ON FOUR MAJOR TOPICS THE FIRST IS EQUIPMENT AND FURNITURE WHICH WILL OVERLAP WITH WHAT WE ARE TALKING ABOUT HERE TODAY.

AND THE SECOND IS INTERNET ACCESS.  THE THIRD TOPIC IS 911 EMERGENCY SERVICES.  AND CAPTIONS IN MOVIE THEATERS.

WE ARE TREMENDOUSLY EXCITED TO BE ACCEPTING COMMENTS AND LOOK FORWARD TO A LOT OF PUBLIC INTEREST IN ALL FOR OF THOSE AREAS.  LIKEWISE WE FEEL PLEASE AND PROUD TO HAVE IN MAY PUBLISHED A NEW TECHNICAL ASSISTANCE DOCUMENT ENTITLED ACCESS TO MEDICAL CARE FOR PERSONS WITH MOBILITY DISABILITIES IF YOU HAVEN’T SEEN IT YOU CAN FIND AT ANY WEBSITE WWW.ADA.GOV EVERYONE IN THE ROOM PROBABLY KNOWS THAT WEBSITE AND HAS PROBABLY ALREADY PERHAPS SEEN THE DOCUMENT I AM SPEAKING ABOUT.

A LOT OF MY COMMENTS WILL REFER BACK TO THAT DOCUMENT.

AND LAST, BUT NOT LEAST, OUR ENFORCEMENT RESOURCES HAVE GONE UP WE ARE EAGER TO GO OUT AND DO MORE THAN WE HAVE IN THE PAST.  THERE IS HUGE ENTHUSIASM IN THE CIVIL RIGHTS DIVISION, PRESIDENT OBAMA HAS ENERGIZED US, TOM PEREZ OUR ASSISTANT ATTORNEY GENERAL IS GETTING STAFFING AND WE ARE ABLE IT GET OUT AND DO MORE WORK FOR THRILLED ABOUT THAT AS WELL.

I WILL TURN I GUESS FIRST TO THE TA DOCUMENT THE GUIDE FOR ACCESS TO MEDICAL CARE AND INDIVIDUALS WITH MOBILITY DISABILITIES AND I WILL JUST QUICKLY HIT THE HIGHLIGHTS BECAUSE HOPEFULLY OTHER SPEAKERS HAVE ADDRESSED IT.  IT’S WRITTEN IN FOUR PARTS.  THE FIRST JUST PUTS OUT GENERAL REQUIREMENTS.  THE SECOND COMMONLY ASKED QUESTIONS AND ACCESSIBLE EXAM ROOM FINALLY ACCESSIBLE MEDICAL EQUIPMENT IT’S THE FOURTH POINT I ADDRESS A LITTLE BIT MORE DETAIL.

THE ACCESSIBLE MEDICAL EQUIPMENT GUIDANCE TALKS FIRST ABOUT EXAM TABLES AND CHAIRS, IT TALKS SPECIFICALLY ABOUT FEATURES FOR EXAM TABLES THE EARLIER PANEL TALKED ABOUT COMPATIBILITY OF LIFTS AND BEDS WE TALKED ABOUT THIS IN PART OF THE TECHNICAL ASSISTANCE DOCUMENT.  WE OBVIOUSLY TALKED ABOUT GETTING EXAM SURFACES DOWN TO 17 TO 19 INCHES FROM THE FLOOR.  WE TALK ABOUT ANCILLARY EQUIPMENT USED TO HELP MAKE THE EXAM TABLES AND BEDS ACCESSIBLE ALL OF THOSE TOPICS ARE ADDRESSED IN THE GUIDANCE.  THERE IS A SEPARATE SECTION ON LIFTS.  MAKING THEM COMPATIBLE WITH OTHER EQUIPMENT.  MAKING — I WILL FEEL FREE TO LOOK AT THE DOCUMENT IT’S VERY SELF EXPLANATORY IT HAS SOME GREAT PICTURES WE OUR ARCHITECTS WORKED LONG AND HARD ON I ENCOURAGE YOU TO LOOK AT THAT AS WELL.  IT TALKS ABOUT RADIOLOGY EQUIPMENT AND SCALES AND TO REINFORCE WHAT LAINEY SAID, STAFF TRAINING WHICH WE I AGREE IS FUNDAMENTAL.  TURNING TO THE ENFORCEMENT PIECE AND THE REAL REASON WHY I GOT THE INVITATION TODAY.  WE HAVE TWO PRIMARY AGREEMENTS THAT WE HAVE USED AS EXAMPLES OF AT LEAST OUR START IN THIS AREA THE FIRST IS AN AGREEMENT IN 2005 WITH THE WASHINGTON HOSPITAL CENTER, WHICH IS ONE OF THE LARGEST MEDICAL CENTERS IN THE WASHINGTON METROPOLITAN YEAR.  THEY ARE HOSPITAL THAT WE NEGOTIATED WITH FOR QUITE SOMETIME BUT CAME AROUND WITH WHAT I THINK IS A VERY STRONG AGREEMENT.

WE HAVE KIND OF A TOP 10 LIST ON THE ITEMS THAT THE AGREEMENT ADDRESSES AND AGAIN I WILL TRY TO FOCUS PRIMARILY ON THE ACCESSIBLE EQUIPMENT PIECE OF THE HE AGREEMENT BUT I CAN’T GO WITHOUT GIVING YOU THE HIGHLIGHTS I GUESS OF THE AGREEMENT IN GENERAL 10% NON-ICU ROOMS WILL BE ACCESSIBLE UNDER THE AGREEMENT.  ALL OF THE ACCESSIBLE PATIENT ROOMS WILL INCLUDE ACCESSIBLE TOILET ROOMS.  OVERALL 35 OF 600 ROOMS WILL BE ACCESSIBLE WITH ADDITIONAL ACCESSIBLE ROOMS ONCE THE FUTURE FUNDING IS APPROVED.  AS WE ALL KNOW BUDGET CONSTRAINTS ARE MAKING THE WORK A LITTLE MORE CHALLENGING THESE DAYS THAT AGREEMENT CONTEMPLATES ADDITIONAL ACCESSIBILITY IF WASHINGTON HOSPITAL GETS MORE MONEY.

IN THE TERMS OF ACCESSIBLE MEDICAL EQUIPMENT, THE AGREEMENT ENSURES EACH DEPARTMENT HAS AT LEAST ONE EXAM TABLE THAT LOWERS TO 17 TO 19 INCHES AND IT REQUIRES THE HOSPITAL CENTER TO SURVEY ALL EQUIPMENT AND PURCHASE NEW EQUIPMENT IN WAYS TO GUARANTEE THE PERSONS WITH DISABILITIES GET EQUAL ACCESS.  AGAIN, TO REINFORCE WHAT LAINEY SAYS, THAT’S ADA CONCEPT, CIVIL RIGHTS CONCEPT, IT UNDERLIES EVERYTHING WE DO IN OUR OFFICE IN TERMS OF ENFORCEMENT WORK.  IT’S THE GROUNDING FOR NEARLY ALL OF THE AGREEMENTS THAT WE NEGOTIATE.  AND LIKEWISE HERE.  WHAT THAT MEANS IN TRANSLATION, AND HAS ALREADY, I COULD HAVE BROUGHT SEVERAL NOTEBOOKS OF EVALUATION SURVEYS THAT THE CONSULTANTS AT WASHINGTON HOSPITAL CENTER BROUGHT TO DEMONSTRATE THEIR KNOWLEDGE OF RESOURCES THEY HAVE AND NEW ACQUISITIONS THEY ARE MAKING THAT COMPLY WITH THE ADA THE AGREEMENT GOES ON TO BARRIER REMOVAL HOSPITAL WISE, ADA OFFICER AND COMPLAINT PROCESS, REVIEW OF ALL OF THE POLICIES WITH AN OPPORTUNITY FOR US TO CONSULT WITH THEM TO MAKE SURE THE POLICIES GUARANTEE ACCESSIBLE.

THEY ARE, IN TURN, HIRING THEIR OWN CONSULTANTS PERMANENT ON ACCESSIBLITY AND THEY HAVE CREATED AN ADVISORY GROUP OF PERSONS WITH DISABILITIES TO GIVE THEM FEEDBACK AND COMMENTS ON THE WORK AND THE COMPLIANCE AND IMPLEMENTATION OF THIS AGREEMENT.  THEY’RE MAKING ACCESSIBILITY A FEATURE IN ALL OF THE PUBLICATIONS BOTH ONLINE AND ON PAPER.  AND LAST BUT NOT LEAST, THE TOP 10 LIST IS TRAINING.  TRAINING TRAINING TRAINING.  YOU CAN’T DO THESE AGREEMENTS WITHOUT IT TURNING QUICKLY TO BETH ISRAEL IN BOSTON.  SO WE HAVE TIME FOR QUESTIONS THE AGREEMENT HAS SIMILAR TERMS IN MANY WAYS TO THE WASHINGTON HOSPITAL AGREEMENT, 10% OF THE ACCESSIBLE PATIENT ROOMS IN BETH ISRAEL HAVE TO BE FULLY ACCESSIBLE AND DISBURSED THROUGHOUT ALL OF THE CLINICAL SERVICES.  THE REALITY IN A LOT OF LARGE HOSPITALS, AS EVERYONE KNOWS, I AM SURE THEY ARE STRUCTURED, SOME ARE LARGE HOSPITALS ON ONE SIDE MANY AND MORE ALL THE TIME ARE BECOMING LARGE HOSPITALS WITH SATELLITE CLINICS AND SERVICES OUTLYING FROM THE MAIN HOSPITAL BUILDING.  THIS AGREEMENT ASSURES ACCESSIBLE FEATURES WILL BE DISTRIBUTED AND ALL OF THE REQUIREMENTS THE PRO RATA REQUIREMENTS WILL APPLY TO EVERY SATELLITE LOCATION THAT THE HOSPITAL IS RESPONSIBLE FOR.

THAT’S — THAT’S THE FIRST ITEM ON THAT IN THAT AGREEMENT.

THE SECOND ITEM IN THE BETH ISRAEL LIST IS THAT THE DEPARTMENTS AND CLINICAL PRACTICES ALL HAVE TO HAVE AT LEAST ONE ACCESSIBLE EXAM TABLE, AGAIN 17 TO 19 INCHES FROM THE FLOOR.  NEXT THEY EVALUATE AND SURVEY ALL OF THE EQUIPMENT AND MAKE NEW PURCHASES TO ENSURE PEOPLE WITH DISABILITIES GET AN EQUAL OPPORTUNITY FOR ACCESSIBLE MEDICAL TREATMENT.

AND THEY WILL MAINTAIN A DATABASE FOR THAT EQUIPMENT.

WHAT WE HAVE ALREADY LEARNED TO REITERATE WHAT LAINEY SAID THIS DRIVES THE INDUSTRY.  THESE AGREEMENTS DRIVE THE INDUSTRY THE BETH ISRAEL FOLKS TOLD US OVER AND OVER AGAIN THE SUPPLIES WERE TALKING TO THEM ABOUT WHEN WE NEEDED TO BUY IN ORDER TO COMPLY WITH OR AGREEMENT.  I THINK THAT IS AN INDICATION OF HOW IMPORTANT THESE NEW GUIDELINES ARE GOING TO BE.  IT DEFINITELY WILL DRIVE THE INDUSTRY.  AS WE KNOW THE HEALTHCARE INDUSTRY IS WHERE A LOT OF DOLLARS ARE GOING THESE DAYS PROBABLY AS THE GENERATIONS AGE MORE WILL GO TO HEALTHCARE ALL THE TIME.  IT’S ESSENTIAL THAT THIS NEW EQUIPMENT GETS ACQUIRED IS ACCESSIBLE.

BETH ISRAEL DEALS WITH BARRIER REMOVAL THEY HIRE A COMPLIANCE OFFICER ASSIGNED TO WORK WITH ACQUISITIONS AND PROCUREMENT DEPARTMENT.  THE WAY THE HOSPITAL IS SET UP BECAUSE THEY ARE SO LARGE WITH SO MANY DIFFERENT BUILDINGS THEY CENTRALIZED THE PROCUREMENT.  A LOT OF HOSPITALS DO, BUT NOT ALL.  WE HAVE MADE IT A FUNDAMENTAL ELEMENT AT THE GET-GO, THEY WILL DEAL WITH ACCESSIBILITY AS A PROCUREMENT ISSUE.  THE WEBSITE WILL INCLUDE THE ACCESSIBLE EQUIPMENT.  AND IN GENERAL, I HAVE TO SAY BETH ISRAEL HAS DONE AN EXCELLENT JOB MEETING WITHS AT THE TABLE AND WORKING WITH US COOPERATIVELY, LIKEWISE WASHINGTON HOSPITAL CENTER, THEY ARE ABOUT TO EXTEND THEIR AGREEMENT TO CONTINUE TO IMPROVE ON QUALITIES AND CHARACTERISTICS IN THAT HOSPITAL.

THE ECONOMY IS JUST AN IRREFUTABLE REALITY AND WE ARE DOING EVERYTHING WE CAN TO MAKE SURE ACCESSIBILITY IS AT THE TOP OF THE LIST BUT WE HAVE TO GO COGNIZANT OF THE FACT THAT WE HAVE GOT TO GET THE THINGS DONE IN A WAY THAT’S AFFORDABLE SO WE DO GET THEM DONE.

AND I WILL AT MY CLOSE HERE BEFORE WE TAKE QUESTIONS.  MENTION ONE TOPIC THAT LAINEY AND I TALKED ABOUT I WASN’T QUITE SURE WHETHER IT WAS NECESSARY TO BRING IT UP I WILL MENTION THAT LAINEY’S GROUP AND MANY OF THE ADVOCATES DRA ALL OF THE GROUPS WE WORKED WITH SO SUCCESSFULLY FOR SO MANY YEARS ARE DOING GREAT WORK THERE ARE SETTLEMENT AGREEMENTS WITH HOSPITALS THAT ADDRESS MEDICAL EQUIPMENT THAT ARE PERHAPS NOT AS GOOD AS WE WOULD LIKE.

AND THERE WAS ANOTHER ONE ENTERED ABOUT A YEAR AGO NOW IN CALIFORNIA WITH CATHOLIC HEALTHCARE WEST, THAT IS ONE OF THESE LARGE AGREEMENTS IN WHICH THERE ARE TOLERANCES MUTUALLY AGREED TO BY THE PARTIES ENTERING THE AGREEMENTS THAT DO NOT COMPLY WITH THE EXISTING STANDARDS.  ON BASIC ELEMENTS LIKE ACCESSIBLE PATHS AND DOORS, AND THINGS LIKE THAT.

AND WHILE WE ENCOURAGE, STRONGLY ENCOURAGE ADVOCATE ENFORCEMENT OF THE ADA BECAUSE IT’S, YOU KNOW, WE SIMPLY DON’T HAVE THE RESOURCES TO DO EVERYTHING THAT NEEDS TO BE DONE.  WE ARE CONTINUALLY MONITORING AND CONCERNED ABOUT AGREEMENTS THAT COMPROMISE ON ACCESSIBILITY AND DON’T DELIVER WHAT THE ADA PROMISES.

AND I AM — I WANT TO HIGHLIGHT THAT ISSUE AND JUST LET YOU KNOW WE ARE CONCERNED ABOUT IT, WE ARE WATCHING IT, AND FOR PEOPLE WHO ARE ALSO CONCERNED ABOUT IT LET US KNOW.  OUR BOSSES LOVE TO TELL US WHAT THE BEST THING THAT FOLKS WHO WANT TO ADVOCATE CAN DO RIGHT NOW IS TO COME TELL US THINGS.  YOU KNOW YELL AT US.  TELL US WHAT TO DO.

I MEAN, THAT IS THE VERY BEST PRESSURE TO BRING ABOUT CHANGE, AND YOU HAVE ADMINISTRATION NOW THAT WANTS TO MAKE CHANGE HAPPEN.

YOU KNOW THE BEST WAY TO DO THAT IS HOLD OUR FEET TO THE FIRE AND TELL US EXACTLY WHAT IT IS WE NEED TO BE DOING.  BELIEVE ME WE HAVE A NEW SHERIFF IN TOWN.  IT’S GOING TO BE A NEW DAY AND WE ARE THRILLED ABOUT THAT.

BUT WE NEED TO HEAR FROM YOU ABOUT WHAT NEEDS TO BE DONE.

SO I WOULD JUST HIGHLIGHT THAT WE ARE OPEN FOR BUSINESS, YOU CAN ALWAYS CALL US.  I AM EAGER TO HEAR FROM ANYBODY WHO WANTS TO GIVE A CALL.  IF YOU WANT TO RENEE.WOHLENHAUS @ USDOJ.GOV, 202-514-5527.  AND GIVE US A CALL I WILL BE GLAD TO OPEN UP FOR QUESTIONS.

>> DAVID BAQUIS:  THANK YOU FOR ALL OF THE WONDERFUL THINGS DOJ IS DOING FOR ACCESSIBILITY.  ONE OF THE CHALLENGES NOW IS GOING TO BE TO THINK ABOUT WHAT ISSUES FALL WITHIN THE SCOPE OF THIS MEETING.  SO, YOU ASKED ABOUT WHETHER WE WOULD HAVE TIME TO GET INTO ARCHITECTURAL ISSUES, IF WE STAY FOCUSED ON EQUIPMENT WE DON’T HAVE ENOUGH TIME FOR THAT.

SO I WOULD LIKE TO BE RESPECTFUL TO EVERYBODY’S CONCERNS.

SO ANYWAY THE POINT WAS WE HAVE AN EMAIL ADDRESS TO SEND QUESTIONS THAT MIGHT FALL OUT OF THE PURVIEW.  I WOULD SAY NO I DON’T BELIEVE HEALTH INFORMATION TECHNOLOGY, LIKE MEDICAL RECORDS, WOULD FALL WITHIN THE PURVIEW OF MEDICAL DIAGNOSTIC EQUIPMENT, BUT PEOPLE WHO HAVE THOUGHTS ABOUT IT MAY WANT TO SUBMIT THOSE, ESPECIALLY AS THEY RELATE TO WEBSITE INTERFACES TO GETTING TO IT; TO THE DOJ IN RELATION TO THE AMPRM ON WEB ACCESSIBILITY; AND ALSO TO HHS TO THE OFFICE OF THE NATIONAL COORDINATOR WHOSE WRITING STANDARDS FOR HEALTH INFORMATION TECHNOLOGY.

SO, LET’S LOOK AT THE TIME.  WE HAVE TIME FOR ABOUT 5 MINUTES WORTH OF QUESTIONS.  AT THE END OF THOSE QUESTIONS I WANT TO GIVE THE MIC BACK TO FLORA AND WE WILL GET BACK TO THE NEXT PANEL PEOPLE.  WHO HASN’T ASKED A QUESTION ALREADY?  I SEE ONE.  I DON’T SEE THAT WELL.  I AM GOING TO BE FAIR I WILL HIT BOTH SIDES OF THE ROOM — THE GENTLEMAN WITH THE TIE DYE SHIRT.  IF YOU COULD STATE YOUR NAME, PLEASE?

>> JOE P.  FROM CALIFORNIA, AND THE BARRIER FREE INITIATIVE WEBSITE, DOES IT INCLUDE ANY OF THE CASES BROUGHT AGAINST THE CALIFORNIA DEPARTMENT OF CORRECTIONS AND DO YOU THINK FROM THE STANDPOINT OF THE DEPARTMENT OF JUSTICE SHOULD THERE NOT BE A LOOK AT THE 2 MILLION PEOPLE INCARCERATED IN JAILS AND PRISON IN THE UNITED STATES AND 3 MILLION ON PAROLE AS RELEVANT GROUP FOR THE RIGHTS FOR INSTITUTIONAL PERSONS.  THAT’S TWO QUESTIONS.

>> THAT’S A REALLY GOOD QUESTION.  I MEAN, THAT’S A REALLY GOOD POINT, THE BARRIER FREE HEALTHCARE INITIATIVE WEBSITE DOES NOT HAVE THE ACCESSIBILITY CASES AGAINST CALIFORNIA STATE PRISON SYSTEM ONE OF WHICH I WORKED ON.  DEALING WITH HEALTHCARE AND ACCESSIBLE SERVICES WE WILL TAKE A LOOK AND SEE WHETHER WE PUT UP REFERENCES AND LINKS BACK TO THE PRISON LAW OFFICE THAT DID THE LABORING JOB ON THAT SO THANK YOU FOR THAT.

>> I CAN SAY THE DISABILITY RIGHTS SECTION WE HAVE A SUBUNIT WITHIN THE INVESTIGATIONS UNIT FOCUSING ON PRISON ISSUES, I WILL TAKE IT BACK TO THAT GROUP.  WE HAVE GOT SEVERAL EXPERIENCED ADVOCATES WHO HAVE BEEN NEGOTIATING INDIVIDUAL RESOLUTIONS IN PARTICULAR CASES.

>> DAVID BAQUIS:  THANK YOU.  NEXT QUESTION FROM RON GARDNER FROM THE ACCESS BOARD.

>> RONALD GARDNER:  THANK YOU DAVID.  MY NAME IS RON GARDNER, PUBLIC MEMBER OF THE ACCESS BOARD.  I GUESS MY QUESTION REALLY GOES TO LAINEY’S QUESTION ABOUT “IN CONJUNCTION WITH”.  BUT I AM WONDERING WE HAVE SOMEBODY HERE THAT WAS ON HARKIN’S STAFF EARLIER, I AM WONDERING IF YOU RECEIVED DAVID, OR IF AT THE ACCESS BOARD, WE HAVE RECEIVED LEGISLATIVE HISTORY DEALING WITH THAT PHRASE?  AND WHAT WENT INTO THE LEGISLATORS’ THE CONGRESS’ MIND COLLECTIVELY WHEN THEY PUT INTO THE LEGISLATION “IN CONJUNCTION WITH.”  I THINK SHE MAKES AN EXTREMELY VALUABLE POINT WHEN SHE TALKS ABOUT THE IN CONJUNCTION WITH LANGUAGE AS IT DEALS WITH CONTINUING THAT TREATMENT THAT YOU ARE RECEIVING FROM THE MEDICAL PROFESSION.  I AM WONDERING IF YOU HAVE ANYTHING, DAVID, IF THERE IS ANY OTHER COMMENTS ON WHAT THE LEGISLATIVE HISTORY MIGHT HAVE BEEN?

>> DAVID BAQUIS:  THANK YOU, RON.  I THINK OUR SIMPLE ANSWER WAS NO, COULDN’T FIND A LEGISLATIVE HISTORY.  THAT ISSUE WE COULD TAKE UP IN OUR MEDICAL DIAGNOSTIC AD HOC COMMITTEE AS SOMETHING FOR US TO DISCUSS FURTHER.

>> LET ME SAY REAL QUICK AS SORT OF A — NOT SORT OF — AS A LAWYER, WHO, YOU KNOW, DOWN THE ROAD 10 YEARS FROM NOW WHEN THE REGS ARE OUT, SOMETHING ISN’T COVERED, SOMEONE DOES A LAWSUIT, IT SHOULD HAVE BEEN COVERED, IT SAID “IN CONJUNCTION WITH,” THAT’S WHY I BROUGHT THE WASHINGTON POST THING.  WE HAVE NO IDEA WHAT IS GOING TO BE GOING ON FIVE YEARS FROM NOW.  I MEAN, IT’S CLEAR TO ME THAT THE HOME IS NOW IN CONJUNCTION WITH.  GIVEN THE WIRELESS PROTOCOL BETWEEN, YOU KNOW, THAT FDA, FCC THING.  THE LEGISLATIVE HISTORY IS THAT’S REALLY SMART OF YOU TO LOOK AT IT, BUT I THINK IF YOU WANT TO PICTURE HOW THESE REGS ARE GOING TO BE HANDLED IF THEY HAVE TO GO TO COURT FIVE YEARS FROM NEW THE WORDS ARE GOING TO STAND THERE AND THEY SAY “IN CONJUNCTION WITH.”

>> DAVID BAQUIS:  THANK YOU.  LOOKING FOR A QUESTION ON THIS SIDE OF THE ROOM.  I WILL GIVE IT TO YOU, FLORITA, LAST.  STATE YOUR NAME, PLEASE.

>> MARY HARTLY FROM ACHIEVA IN WESTERN PENNSYLVANIA.  MY QUESTION GOES TO THE INAPPROPRIATE USE OF SOME OF THIS EQUIPMENT AND HOW IT WILL BE USED.

PARTICULARLY, AS IT BECOMES MORE UNIVERSAL, AND HOPEFULLY IT WILL.

WE TALKED EARLIER ABOUT USE OF RESTRAINT STRAPS OR MEDICAL IMMOBILIZATION DEVICES TO SUPPORT PEOPLE WHO AGREE TO BE SUPPORTED IN THAT WAY.  MY CONCERN GOES TO PEOPLE IN THE INTELLECTUAL AND DEVELOPMENTAL DISABILITY COMMUNITY WHO MIGHT BE NEEDLESSLY AND UNCOMFORTABLY AND DISREGARDED IN THEIR CARE AND USED AND THE STRAPS ARE USED IN A WAY FOR USE OF BEHAVIOR MANAGEMENT LET’S SAY.

AND THIS SPEAKS TO THE MEDICAL EQUIPMENT IN THAT PERHAPS IN SOME OF THIS INSTRUCTIONAL INFORMATION WE TALKED ABOUT TRAINING, PERHAPS THESE PIECES OF EQUIPMENT COULD ACTUALLY HAVE PRINTED MATERIALS ON THEM SO THAT AS THEY ARE USED PERIODICALLY THEY SAY THINGS LIKE ON THE STRAP NOT FOR USE FOR BEHAVIORAL MANAGEMENT OR LIFT HERE OR PULL HERE.  JUST BECAUSE THEY ARE USED PERIODICALLY AND NOT CONSISTENTLY ALL THE TIME IN THE SAME MANNER, I JUST WONDER IF THAT COULD BE ADDRESSED BY THE ACCESS BOARD.

>> DAVID BAQUIS:  THANK YOU.

WE WILL DISCUSS THAT IT BRINGS UP A LABELING ISSUE, SOMETHING THAT FDA KNOWS A LITTLE SOMETHING ABOUT.  LET’S DO TWO THINGS AT ONCE, THANK YOU FOR SPEAKING.  LET’S TRANSITION THE NEXT TWO PANELISTS UP FRONT AND AT THE SAME TIME LISTEN TO FLORA’S COMMENTS.

>> DAVID BAQUIS:  WE HAVE A LOT OF QUESTIONS BUT WE HAVE TO TRANSITION WE ENCROACHED INTO THE NEXT PANEL’S TIME.  WE HAVE TIME TO CATCH UP.

>> DAVID, I JUST HAD A QUESTION.  I DON’T KNOW IF YOU CAN ANSWER IT NOW, BUT YOUR POWERPOINT SAID IN TERMS OF YOUR CONSENT WITH THE TWO HOSPITALS THAT THEY REQUIRED TO HAVE AT LEAST WITHIN ACCESSIBLE TABLE IN A SERVICE OR DEPARTMENT.

DID THAT TAKE INTO CONSIDERATION SOME SERVICES THAT NORMALLY OR HISTORICALLY SEE MORE PEOPLE WITH PHYSICAL DISABILITIES LIKE REHAB, OR EVEN BREAST CANCER OR ANY OTHER?  SKILLED NURSING FACILITIES.

>> IT DID, AND THOSE FACILITIES AT BETH ISRAEL IN GENERAL ALREADY HAD MORE THAN THE NUMBERS THAT WERE REQUIRED BY THE AGREEMENT, SO THAT WHAT THE AGREEMENT ESSENTIALLY GO WAS SPREAD THAT TO OTHER PARTS OF THE HOSPITAL THAT DIDN’T TRADITIONALLY SEE AS MANY PATIENTS WITH DISABILITIES OR DIDN’T HAVE THOSE KINDS OF EXAMS TYPICALLY GOING ON.

>> YOU DID HAVE LIKE A RATIO IN TERMS OF —

>> NO.

>> YOU DIDN’T DEAL WITH THAT, WILL THE BOARD DEAL WITH RATIOS IN TERMS OF EQUIPMENT FOR SPECIFIC SERVICES OR FOR SPECIFIC DEPARTMENTS?

>> DAVID BAQUIS:  WE ARE GOING TO FOCUS ON THE DESIGN OF THE EQUIPMENT ITSELF, AND THE STATUTE WAS SILENT ON WHAT THE NEXT STEPS WOULD BE BUT THAT’S SOMETHING ELSE THAT I THINK WE WILL HAVE TIME TO TALK ABOUT TODAY.  BUT IT LOOKS LIKE THERE MAYBE OTHER OPTIONS FOR HOW SCOPING MAY BE WRITTEN AND IMPLEMENTED.  SO SHALL WE MOVE ON TO THE NEXT PANEL?  THIS IS GOING TO FOCUS ON MDE, WHICH IS THE ABBREVIATION FOR MEDICAL DIAGNOSTIC EQUIPMENT, FROM THE PERSPECTIVE OF HEALTHCARE PROVIDERS.  AGAIN, WE WILL HEAR FROM TWO SPEAKERS FOLLOWED BY QUESTIONS.  ROSEMARY COITTI IS A CLINICAL SPECIALIST AND NURSE PRACTITIONER IN THE FIELD OF COMMUNITY HEALTHCARE FOR WOMEN.

SO YOU CAN’T SAY WE OVERLOOKED WOMEN’S HEALTHCARE TODAY.  SHE IS PRESIDENT OF ACCESSIBLE LIVING AND A BOARD MEMBER OF THE NATIONAL ORGANIZATION OF NURSES WITH DISABILITIES.

AND THEN WE WILL HEAR FROM CAROL BRADLEY, WHO IS THE DISABILITY ACCESS OFFICER WITH SUTTER HEALTH.  AND SHE BRINGS YEARS OF EXPERIENCE IN IMPLEMENTING THE ADA.  AND WILL SPEAK FROM THE PERSPECTIVE OF A LARGE HEALTHCARE ORGANIZATION.  GO AHEAD, AND PROCEED PLEASE.

>> THIS IS AN EXTREME PLEASURE TO BE HERE AND FEEL LIKE WITH OTHER PEOPLE WHO REALLY ARE COMMITTED TO MAKING A DIFFERENCE.

AS I SAID, I AM A NURSE PRACTITIONER, AND I HAVE A MASTER’S DEGREE IN HEALTHCARE AND TOOK CARE OF UNDERSERVED POPULATIONS.

HOWEVER, FOR AS POOR AS MY PATIENTS ALWAYS WERE, I HAD NO IDEA ABOUT PEOPLE WITH DISABILITIES.

WHEN I BECAME DISABLED I MOVED TO THIS AREA.  THIS WAS THE FIRST TIME I MET YOUNG NONELDERLY PEOPLE WITH DISABILITIES.  MY CLINICS WERE NEVER ACCESSIBLE.  I HAD NO IDEA.  WHAT I STILL HEAR MANY YEARS LATER IS “WELL WE DON’T HAVE THAT MANY PEOPLE WHO WOULD NEED A WEIGHT SCALES”.  AS FAR AS I AM CONCERNED, NO SCALES SHOULD BE MADE AND SOLD TO A HEALTHCARE PRACTITIONER THAT YOU HAVE TO STEP ON.

THE REASON THAT THEY DON’T HAVE PATIENTS WITH DISABILITIES IS BECAUSE THEY PEOPLE DON’T COME.  AND THAT’S THE TRUTH — WHY SHOULD THEY?  THEY CAN’T GET ON THE TABLE.  IT’S HUMILIATING, FRUSTRATING, AGGRAVATING.  IT COSTS MONEY IT GET TRANSPORTATION TO GET THERE — JUST TO BE AGGRAVATED.  PEOPLE ARE NOT PRESENTING FOR CARE.  THIS IS WHAT I SEE ALL THE TIME IN THE COMMUNITY.

THE BEHAVIOR OF NOT COMING FOR SCREENING AND CARE IS REINFORCED BY THE SYSTEM.  BY THE VERY PEOPLE WHO ARE TASKED WITH PROMOTING HEALTH AND WELLNESS.

SO, I SEE GOING FORWARD THAT THIS IS A GREAT OPPORTUNITY TO ACHIEVE WELLNESS AND IMPROVE HEALTH OUTCOMES IN AN INACCESSIBLE HEALTHCARE ENVIRONMENT.  AND THE SOLUTIONS ARE GOING TO BE LARGELY THROUGH BETTER MEDICAL ENGINEERING.

AND I TRY TO THINK OF EVERY DAY THINGS THAT MY PATIENTS STRUGGLE WITH THAT ACTUALLY HAVE PROVEN TO BE LIFE AND DEATH.

AND I DON’T — AND I DON’T SAY THAT LIKELY.  WE DON’T HAVE STATISTICS.  I CAN TELL YOU ANECDOTALLY, WE ARE LOSING MEMBERS OF OUR SOCIETY, OUR COMMUNITY NEEDLESSLY ALL THE TIME AND PREMATURELY.

AND A LOT OF IT IS BECAUSE OF THE WAY HEALTHCARE IS NOT BEING DELIVERED.  AND I HAVE TO TELL YOU THAT HOSPITALS ARE TERRIBLY UNSAFE PLACE FOR PEOPLE WITH DISABILITIES.

FROM THE TIME THEY COME INTO THE EMERGENCY ROOM UNTIL THE TIME IF THEY ARE LUCKY TO GET DISCHARGED IT’S A VERY, VERY UNSAFE PLACE.

IT’S NOT MADE FOR PEOPLE WITH DISABILITIES.

IT’S MADE FOR ABLE BODIED PROVIDERS OF CARE.

AND I DO NOT SEE WANT TO SEEM EXTREME.  THIS IS THE REALITY.  I DON’T LET ONE OF MY PATIENTS GO TO THE HOSPITAL IF THEY HAVE TO.  MY WHOLE LIFE IS TO KEEP PEOPLE OUT OF THE HOSPITAL AND IN THE COMMUNITY.  BUT SOMETIMES THEY DO HAVE TO GO.

AND I NEVER LEAVE THEM ALONE.  IT’S THE ONLY WAY I CAN GUARANTEE THAT I HAVE ANY CHANCE OF GETTING THEM OUT WITHOUT UNTOWARD OUTCOME AND WITHOUT MORE MORBIDITY THAN WHEN THEY ENTERED.

AND IT’S GOING TO COME DOWN TO EQUIPMENT AND TRAINING.  WE NEED RESEARCH, WE NEED THE DATA, WE NEED TO BE ABLE TO PROVE THAT WE CAN IMPROVE THE OUTCOMES.  FIRST OF ALL, I GOT INTO MY SECOND CAREER BECAUSE NO ONE WOULD HIRE ME AFTER I WAS IN A WHEELCHAIR, I WAS ADJUNCT PROFESSOR.  I RAN LARGE CLINICS AT UNIVERSITY OF PENNSYLVANIA.

STARTED HIV IN PREGNANCY, CANCER SCREENING FOR BREAST AND CERVICAL IN TRENTON.

ONCE I WAS IN A WHEELCHAIR NO ONE WOULD HIRE ME BECAUSE THEY FEEL THAT NURSES IN WHEELCHAIRS AREN’T SAFE.

LUCKILY MY PATIENTS WITH SPINAL CORD INJURIES DON’T FEEL THAT WAY AND INSURANCE COMPANIES WHO PAY ME DON’T KNOW I AM IN A WHEELCHAIR BECAUSE THEN THEY WOULDN’T HIRE ME TO TAKE CARE OF THE PATIENTS THEY NEVER SEE.  GOING ON TO THE NEXT SLIDE, I TRIED TO PICK THINGS WE DIDN’T COVER YET OR I WOULDN’T THINK WOULD BE COMMONLY COVERED TODAY.

>> REALLY, IT’S BEEN VERY SAD.  WE ALL HAVE COVERED EXAM TABLES.  THIS IS THE LEADING CAUSE OF PEOPLE NOT GOING AND GETTING DECENT CARE.  PEOPLE HAVE ABDOMINAL PAIN YOU CAN’T PALPATE SOMEBODY’S ABDOMEN IN A WHEELCHAIR.  YOU CAN’T DO A PAP SMEAR ON A WOMAN IN A WHEELCHAIR.  WHEN I BECAME DISABLED AND I CAME HERE, MET YOUNG WOMEN WITH DISABILITIES, I REALIZED I HAVE DONE THOUSANDS OF PELVIC EXAMS HUNDREDS OF THOUSANDS OF PAP SMEARS, HOW IN THE WORLD DO YOU DO ONE ON A WOMAN WITH A SIGNIFICANT DISABILITY?

WHEN I WENT BACK TO PENN, I TALKED TO THE PHYSICIANS THERE, ROSEMARY, WE ARE GLAD YOU MOVED WE DON’T KNOW HOW TO TAKE CARE OF YOU, THESE ARE SUPER SUBSPECIALISTS IN ONCOLOGY, IN WOMEN’S CANCERS.

WHAT I WAS FINDING IS WOMEN ARE TELLING ME THEY ARE GETTING THE PAP SMEARS IN A WHEELCHAIR.  FIRST OF ALL, IF YOU CAN’T VISUALIZE A CERVIX, YOU AREN’T GETTING CERVICAL SCRAPINGS.  I HAVE COME TO MEET PEOPLE NOW WHO HAVE CANCER OF THE CERVIX AND, YES, THEY HAD PAP SMEARS ALWAYS IN THE WHEELCHAIR.  THERE IS NO WAY YOU CAN GET GOOD CYTOLOGY.  THESE ARE GOOD DOCTORS, THESE ARE WELL-TRAINED DOCTORS.

I DON’T KNOW WHAT TO DO WITH THIS PROBLEM.

BUT WE WILL GET SOME RELIEF WITH BARRIERS WITH GETTING MANDATES FOR ACCESSIBLE EQUIPMENT.  BUT GOING BACK TO DOJ, I WAS A PLAINTIFF IN THE WASHINGTON HOSPITAL CENTER, THAT’S A MED STAR HOSPITAL.

BUT WE HAVE OTHER MAJOR HOSPITALS IN THIS CITY THAT I HAVE PATIENTS WHO COME TO ME AFTERWARDS THAT WERE ADMITTED THERE.  WHEELCHAIR USERS.  WHICH STILL HAVE WHOLE UNITS WITHOUT ACCESSIBLE BATHROOMS THAT MEANS THAT YOU HAVE TO USE A BED PAN.  NOW, SOMEBODY WITH A SPINAL CORD INJURY WITH A BED PAN, THIS IS HUMILIATING BEYOND BELIEF.  THERE IS NO WAY TO DO IT WITHOUT WEARING THE PRODUCTS OF YOUR EXCREMENT, YOU HAVE TO WAIT FOR SOMEBODY TO COME CHANGE YOU.  IT COMES TO THE NEXT ONE, HOW DO YOU GET SOMEONE TO HELP YOU WHEN YOU HAVE VERY LIMITED ABILITY TO USE YOUR HANDS.

THIS IS YOUR TYPICAL BED CONTROL IN THE HOSPITAL.

HELP NURSE, PRESS HERE.  THAT’S WHAT IT SAYS, IT’S A PICTURE OF BUTTONS, TYPICAL BUTTON THINK THAT YOU GET IN THE HOSPITAL TO CALL THE NURSE AND MOVE YOUR HEAD UP AND DOWN.

WE — THIS IS VERY SERIOUS.

THIS IS LIFE AND DEATH.

THERE ARE PEOPLE IN THE DISABILITY COMMUNITY WHO HAVE BEEN FOUND DEAD WHEN THE NURSES HAVE ROUNDED.  PEOPLE WITH QUADRIPLEGIA CANNOT CALL.  THEY DON’T HAVE THE LUNG CAPACITY FOR PEOPLE TO HEAR THEM — THE CLAMORING IN THE HALLWAY ALL OF THE OTHER NOISES.

I ALWAYS TELL PEOPLE DON’T EVER LET YOUR FAMILY LEAVE UNTIL YOU HAVE AN ACCESSIBLE CALL BELL.  BUT THE PROBLEM IS, THAT PEOPLE DON’T KNOW WHERE THEY ARE.  PEOPLE DON’T KNOW HOW TO SET THEM UP.  IT’S MEDICAL ENGINEERS.  IT’S THE MIDDLE OF THE NIGHT.  THEY WANT PEOPLE TO GO HOME.

PEOPLE ARE DYING BECAUSE THEY CAN’T — THEY ASPIRATE — THEY ASPIRATE, CHOKE, THEY CAN’T GET HELP.  WE NEED TO COME UP WITH A UNIVERSAL DESIGN FOR A CALL BELL IN THE HOSPITAL THAT WILL MEET EVERYBODY’S CRITERIA.

WHETHER IT’S THE BUTTON — BUT I CAN’T TELL YOU, THE PEOPLE WHO WOUND UP IN THE ICU ON VENTILATORS BECAUSE THEY CHOKED.  THEY ARE QUADS, THEY CHOKED, THEY COULDN’T CALL FOR HELP.  OR WORSE, I HAVE PERSONAL EXPERIENCE WITH — EXPERIENCE WITH INDIVIDUALS WHO ARE FOUND DEAD WHO ASPIRATED AND COULDN’T GET HELP BECAUSE THEY ARE FLAT ON THEIR BACK.  IT’S A VERY SERIOUS PROBLEM.  I THROW THE GAUNTLET DOWN TO COME UP WITH UNIVERSALLY ACCESSIBLE CALL BELLS FOR ALL HOSPITAL BEDS.  WHEN SOMEBODY COMES IN THEY ARE NOT LEFT TO THEIR OWN DEVICES UNTIL ENGINEERING COME IN 9 O’CLOCK MONDAY MORNING TO GET THEM A CALL BELL THEY CAN USE.  IT WILL SAVE LIVES.

THESE YOU CAN SEE THERE IS NO BRAILLE.  PEOPLE HAVE YOU KNOW THIS IS NOT FOR PEOPLE WHO ARE VISUALLY IMPAIRED.

THIS IS NOT A GOOD BUTTON.  AND THIS IS TYPICAL.  OR IT’S THE RED BUTTON PUSH THE RED BUTTON FOR THE NURSE, THAT’S GREAT.  FIRST, IF YOU CAN’T USE YOUR FINGERS OR COLORBLIND OR IF YOU HAVE LOW VISION, OR NO VISION.

THE NEXT ONE THAT I WOULD LIKE TO TALK ABOUT ON THE NEXT SLIDE IS SOMETHING YOU ARE HEARING MORE ABOUT WITH THIS ADMINISTRATION IS NUTRITION AND INCIDENCE OF DIABETES WHAT IS UP HERE IS A TYPICAL GLUCOMETER SOMEBODY MENTIONED THEM EARLIER THIS IS DIAGNOSTIC EQUIPMENT ESSENTIAL TO MANAGE DIABETES.

RIGHT NOW, DEPENDING ON THE STATISTICS THAT YOU READ, WE KNOW THAT AT LEAST 8% OF THE POPULATION OF THE ADULT POPULATION IS TYPE II, BUT WE SUSPECT IT’S ACTUALLY ONE IN FOUR.

THEY ARE CHANGING AND TIGHTENING THE CRITERIA.

FROM THE TIME WE SUSPECT SOMEBODY HAS DIABETES TYPE II AND ARE DIAGNOSED IT CAN BE 10 YEARS THERE IS A GREAT DEAL OF MICROVASCULAR DAMAGE IN THE EYES, BRAIN AND KIDNEYS — KIDNEYS AND THE HEART.  BY THE TIME THEY RECEIVE A GLUCOMETER, THEY ARE HAVING CHANGES NOT ENOUGH TO BE REFERRED TO THE BLIND SOCIETY, BUT CERTAINLY THIS IS WHAT I AM SEEING ALL THE TIME IN CLINICAL PRACTICE.

FIRST OF ALL, QUADS CAN’T USE IT.

SO, IT MAY HAVE BIG NUMBERS AND IT MAY TALK IF YOU CAN SEE — ON THE SLIDE, YOU HAVE RE-AGENT STRIP STICKING OUT OF THE TOP OF THE GLUCOMETER, FIRST OF ALL, THE SLOT IS VERY TINY.  THE TRIP IS VERY TINY.  IT’S PAPER THIN.  IT’S GOT A LITTLE MORE STRUCTURE THAN PAPER.  BUT THE RE-AGENT AREA IN THIS VERY TINY QUARTER-INCH-WIDE THIN STRIP, THERE IS LESS THAN AN 8TH OF AN INCH IN THE CENTER OF THAT THAT YOU HAVE TO GET THE DROP OF BLOOD ON.

YOU HAVE TO BE ABLE TO LINE THAT UP WITH THE DROP OF BLOOD ON YOUR FINGER.

THESE RE-AGENT STRIPS THE LITTLE STRIP STICKING OUT COST A DOLLAR A PIECE, NOT COVERED BY INSURANCE.  YOU ARE SUPPOSED TO CHECK BLOOD SUGAR 3, 4, 5 TIMES A DAY.  MINIMUM IS 3, IT’S OFTEN 4 OR 5.

IF YOU DON’T GET THE BLOOD RIGHT ON RIGHT SPOT YOU GET ERROR, YOU HAVE TO START OVER.

IT’S NOT — IT’S NOT AFFORDABLE.

WE ARE HAVING UNDUE COMPLICATIONS VISION LOSS KIDNEY FAILURE AMPUTATIONS AND DISABILITIES FROM VASCULAR INSUFFICIENCY.  A LOT OF IT IS LACK OF CONTROL.

PEOPLE DON’T HAVE THE TOOLS TO HAVE CONTROL.

THEY CAN’T GET THE BLOOD ON THE STRIP.

AND THEY GET DISGUSTED BECAUSE EACH ONE IS A DOLLAR.

BUT YOU CAN’T LINE IT UP.  THE FIRST THING THAT GOES IS YOUR — IS VASCULAR CHANGES IN THE EYES.  AND YOU PUNCTURE YOUR FINGER ON ONE HAND THEN YOU HAVE TO LIFT THIS YOU HAVE TO GET THAT ONE TINY DROP BEFORE IT DRYS OR FALLS OFF ON TO THIS LITTLE TINY SPOT IT’S IMPOSSIBLE.

WE CAN’T EVEN BEGIN TO HOPE TO ADDRESS THE MASSIVE NUMBERS OF PEOPLE WITH TYPE II DIABETES IN THIS COUNTRY, WHILE WE CAN’T MONITOR THEIR BLOOD SUGARS, AND THEY NEED TO BE ABLE TO DO IT FAIRLY INDEPENDENTLY THE WHOLE MONITOR NEEDS TO BE RE-ENGINEERED.

WE WILL PREVENT UNTOLD DISABILITIES AND PREMATURE DEATH DISABILITY BY THIS SINGLE RE-ENGINEERING OF SOMETHING THAT IS UBIQUITOUS IN OUR SOCIETY.  NOW THE GLUCOSE MONITORS THEY ARE GETTING SMALLER AND SMALLER.  WHICH IS ONE THING.

BUT WE NEED TO FIGURE OUT HOW WE CAN DO AN ASSAY THAT’S CHEAPER AND CAN BE DONE WITH PEOPLE WITH VISUAL — THESE ARE MILD VISUAL IMPAIRMENTS AND PREVENTS PEOPLE FROM LINING IT UP IT’S TOO COMPLICATED FOR MOST PEOPLE WITH ARTHRITIS, CEREBRAL PALSY, WITH VISION LOSS AND MANY OF THE DISABILITIES.  THIS IS A CHALLENGE OF OUR TIME, IT’S IMPERATIVE THAT WE MOVE ON THIS, AND AGAIN, THEN IT COMES TO EDUCATION EDUCATION EDUCATION, AND I DO BELIEVE BEING INSIDE THE PROFESSION DEALING WITH DOCTORS EVERY DAY, AND OTHER CLINICIANS IS THAT UNLESS WE MAKE THIS MANDATORY EVERY YEAR AT THE NATIONAL CONFERENCES, WE DON’T REALLY HAVE A HOPE OF MAKING INROADS INTO THE PROFESSION BECAUSE THEY ALL TELL ME I DON’T HAVE DISABLED PATIENTS.

AND THIS WON’T CHANGE UNTIL WE ARE ABLE TO GET TO THE TABLE WITH THE CLINICIANS.  AND MAKE IT REAL.

THANK YOU.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU ROSEMARY.  AS I WAS LISTENING TO YOU I GOT RESEARCH IDEAS.  THE OTHER HAT WE WEAR IN ACCESS BOARD IS PARTICIPATING IN THE ICDR, INTERAGENCY COMMITTEE ON DISABILITY RESEARCH.  AND THEIR ANNUAL REPORT GOES TO THE PRESIDENT AND TO CONGRESS.  SO I WILL PASS THAT ON.

>> HELLO.  AND I GUESS I AM WAITING FOR MY POWERPOINT TO COME UP.  GREAT.

JUST WHILE WE ARE WAITING, THE ONLY VISUAL ELEMENTS THAT ARE ON MY POWERPOINT ARE THERE IS AN ACCESSIBILITY SYMBOL ON THE LEFT BOTTOM OF EACH SLIDE AND ON THE RIGHT EXCEPT FOR THE TITLE SLIDE AN THE RIGHT SUTTER HEALTH LOGO, WHICH SAYS, WITH YOU FOR LIFE.  THE REST I WILL COVER IN MY PRESENTATION.

>> WE CAN SKIP OVER MY BACKGROUND AND GO INTO THE NEXT.  BASICALLY WHAT I THINK IS IMPORTANT IS THAT I DO HAVE A DISABILITY 29 YEAR’S WORTH.  I HAVE SPENT A NUMBER OF MY YEARS ADVISING PEOPLE ON HOW TO MAKE THEIR PROGRAMS AND SERVICES ACCESSIBLE.  AND YOU KNOW, I WANT TO DITTO, YOU KNOW, EVERYONE UP HERE TODAY HAS MADE GREAT POINTS ABOUT HOW IMPORTANT IT IS TO HAVE A DIALOGUE AROUND THESE ISSUES.  BECAUSE IT’S REALLY IMPORTANT TO BE TALKING TO PROVIDERS FROM THE INSIDE, AND THAT’S AN EXCITING OPPORTUNITY FOR THE ACCESS BOARD.  AND IT GOES TO PART OF WHAT I WANTED TO BRING FORWARD TODAY AS WE GO THROUGH THIS I REALLY THOUGHT ABOUT WHAT DO I HAVE TO SAY THAT’S UNIQUE THAT OTHER FOLKS HAVEN’T COVERED.  AND I THINK ONE OF THE THINGS THAT I REALLY WANT TO EMPHASIZE IS AN APPROACH.  I THINK ONE OF THE THINGS THAT WE HAVE TRIED TO BRING INTO OUR SYSTEM THE SUTTER HEALTH SYSTEM IS OUR APPROACH.  MORE SPECIFICALLY, YOU KNOW, WE ARE — JUST ABOUT US WE ARE A NETWORK OF — WE ARE REALLY UNUSUAL I THINK HEALTH PROVIDER SYSTEM BECAUSE WE ARE A NETWORK OF DOCTORS NOT FOR PROFIT HOSPITALS, AND OTHER PROVIDERS WHICH INCLUDE VISITING NURSES ASSOCIATIONS AND WE ALSO, I JUST RECENTLY RECOGNIZED THAT WE HAVE A COMPREHENSIVE SENIOR CARE PROGRAM THAT’S BASICALLY IN ESSENCE AN INSURANCE PROGRAM FOR SENIORS.  WHERE THEY GET ALL OF THEIR WELLNESS CARE ALL OF THEIR HEALTHCARE THROUGH THIS PROGRAM.

SO, YOU KNOW, WE HAVE A WIDE VARIETY IN OUR SYSTEM.  WE SERVE OVER 100 NORTHERN CALIFORNIA COMMUNITIES.  AND YOU KNOW, WHAT I AM GOING TO FOCUS ON TODAY IS BASICALLY ALL OF OUR PATIENT CARE PROVIDERS ARE FOCUSED ON ASSESSING THEIR ACCESSIBLE MEDICAL EQUIPMENT.  THAT’S WHAT WE REFER TO, THAT’S ALSO MDE, IT’S THE SAME THING.

SO, THE SUTTER PHILOSOPHY THERE IS A COMMITMENT TO CREATING A PROGRAM TO SUPPORT ONGOING ACCESSIBILITY.  AND I GUESS AS I REALLY LOOKED AT WHAT WE DO AND I THINK THAT’S ONE OF THE THINGS THAT WE MAY BE SOMEWHAT UNIQUE ON, IT CERTAINLY IS NOT UNIQUE TO HAVE AN ADA COMPLIANCE OFFICER BECAUSE MANY SYSTEMS DO, BUT I THINK ONE OF THE THINGS THAT WE HAVE REALLY FOCUSED ON IS THE VALUE OF BRINGING THE KNOWLEDGE INSIDE THE SYSTEM.

RATHER THAN JUST HAVING OUTSIDE CONSULTANTS COME IN THAT’S ALWAYS VALUABLE AND PEOPLE BRING GOOD STUFF, BUT YOU HAVE TO MAKE SURE THAT YOUR INSIDE PEOPLE UNDERSTAND THE IMPORTANCE OF THIS.

AND THAT IS THERE ARE SOME BENEFITS TO THAT, THE OUTCOME IS GOING TO BE QUALITY ACCESSIBLE CARE FOR ALL OF OUR PATIENTS.

THE OTHER UNIQUE ASPECTS ARE YOU KNOW WE PUT A PRIORITY ON IMPLEMENTING — I THINK WHAT IS ESPECIALLY IMPORTANT IS TO BEGIN TO ADDRESS THE CULTURE CHANGE THAT’S NECESSARY FOR SUCCESS.

BECAUSE WITHOUT REALLY CHANGING THE CULTURE IN OUR SYSTEM, WE SEE THAT IT’S GOING TO BE REALLY IMPORTANT FOR PEOPLE TO UNDERSTAND HOW TO USE EQUIPMENT, WHAT THE BENEFITS ARE, WHY IT’S SO CRITICAL.  AND I — YOU KNOW HOPEFULLY I WILL MAKE THIS COMMENT THROUGHOUT, BUT AS WE TALK ABOUT UNIVERSAL DESIGN PRINCIPLES, YOU KNOW THAT’S ESPECIALLY IMPORTANT IN THIS SETTING.

AND I WILL TOUCH ON THAT A LITTLE LATER, BUT YOU KNOW WE DON’T WANT TO HAVE TWO KINDS OF EQUIPMENT UNLESS THERE IS NO OTHER WAY TO DO THAT.

BECAUSE WHAT YOU WANT TO MAKE SURE IS HEALTH PROVIDERS KNOW HOW TO QUICKLY ASSESS THINGS.  KNOW HOW TO USE IT, THAT THEY DON’T HAVE TO READ SOMETHING, AND STANDARDIZATION IS ONE OF THE KEY COMPONENTS OF THAT.

I THINK THE OTHER BENEFIT IS THAT WE SEE THAT IT’S GOING TO REDUCE COST.  AND I WILL SAY WE ARE REALLY EXCITED ABOUT THIS DIALOGUE.  BECAUSE SOME OF THE GAPS THAT WE HAVE SEEN IS THAT WE ARE RUNNING INTO MANY SITUATIONS WHERE YOU BRING IN ACCESSIBILITY PRINCIPLES AND YOU FIND THAT THERE JUST ISN’T MUCH OUT THERE, AND SO CERTAINLY WE ARE ALL AN ADVOCATE OF CREATIVE SOLUTIONS WHERE THAT’S THE ONLY OPTION BUT I AM EXCITED OUR SYSTEM IS REALLY EXCITED TO SEE MORE STANDARDIZED EQUIPMENT OUT THERE SO THAT EVERYONE HAS ACCESS TO IT.  THAT’S GOING TO BE REALLY IMPORTANT.

IT’S GOING TO IMPROVE ACCESS TO MEDICAL CARE FOR EVERY ONE.

YOU KNOW NOT JUST FOLKS WITH DISABILITIES IN MY OPINION.  BECAUSE I THINK THE MORE STANDARDIZED SYSTEM THAT YOU CAN COME UP WITH — SO I GUESS MY CHARGE TO THE BOARD ON SOME LEVEL IS REALLY TO SAY, THAT WE WANT TO TAKE THOSE PRINCIPLES INTO ACCOUNT, AS YOU GO THROUGH DEVELOPING THE STANDARDS.

WITHIN THE OTHER THINGS THAT WE HAVE DONE, WE HAVE PUT TOGETHER AN ACCESSIBLE MEDICAL EQUIPMENT WORKING GROUP.  I GUESS THIS IS ONE OF THE KEY COMPONENTS I KNOW YOU ALL HAVE STARTED THIS PROCESS AS WE ARE HAVING THIS DIALOGUE TODAY, BUT I REALLY WANT TO EMPHASIZE THE IMPORTANCE OF HAVING ALL OF THE RIGHT PLAYERS IN THE ROOM.  BECAUSE YOU KNOW IT’S REALLY IMPORTANT TO HAVE DISABILITY ACCESS KNOWLEDGE, IT’S OBVIOUSLY REALLY IMPORTANT TO UNDERSTAND THE HEALTHCARE CLINICAL PRACTICES, SO CLINICIANS WHO ARE KNOWLEDGEABLE NEED TO BE IN THE ROOM.

EQUIPMENT EXPERTS NEED TO BE IN THE ROOM AND OF COURSE, COMMUNITY MEMBERS NEED TO BE IN THE ROOM.  WE TRIED TO REPLICATE THAT IN THE ACCESSIBLE MEDICAL EQUIPMENT WORKING GROUP IN OUR SYSTEM.

SO FOCUSING ON CLINICAL PRACTICES.

AND YOU KNOW, THE FIRST POINT THAT I WANTED TO MAKE IS WE WANT TO ASSURE THAT APPROPRIATE CLINICAL PROCESSES ARE ALWAYS CONSIDERED.

AND I THINK THAT’S REALLY IMPORTANT.  BECAUSE I KNOW, YOU KNOW, MY BACKGROUND BEFORE I CAME INTO A HEALTHCARE SETTING CERTAINLY WAS ACCESS.  SOMETIMES YOU KNOW IT’S TEMPTING TO GO, WELL, COULD JUST WE MAKE THAT MATTRESS SIZE LESS BECAUSE THEN THE PERSON WILL BE ABLE TO TRANSFER.  WELL TRANSFER IS REALLY IMPORTANT, BUT EVEN MORE IMPORTANTLY WE NEED TO MAKE SURE THAT THE BED FRAMES THAT GO LOW ENOUGH SO THAT WE CAN HAVE A CLINICALLY APPROPRIATE MATTRESS ON THAT BED ARE THERE.  BECAUSE IN — YOU KNOW, MAYBE I WILL JUMP INTO IT AND SKIP IT LATER.  ONE OF MY POINTS AROUND WHAT WE HAVE RUN INTO WITH BEDS IS THE TWO MAIN BED MANUFACTURERS THAT ARE OUT THERE SELLING THEIR WARES DO NOT MAKE BED FRAMES THAT GO LOW ENOUGH FOR WHAT OUR SYSTEM USES SO — THEY ARE CALLED PRESSURE ULCER PREVENTION.  THEY EQUALIZE PRESSURE.  WELL, THEY ARE 7 INCHES WHEN YOU PUT THAT MATTRESS ON A BED FRAME THE BED FRAME NEEDS TO BE APPROXIMATELY 12 INCHES OR LOWER IN ORDER TO ACCOMMODATE A 19 INCH SURFACE AND WHAT WE FOUND — AND OF COURSE THE INITIAL REACTION IS TO SAY, HEY, LET’S JUST PUT A LESSER MATTRESS ON THAT BED

BUT I CAN TELL YOU THAT OUR — OUR SYSTEM HAS SPENT A LOT OF TIME LOOKING AT THE IMPORTANCE OF USING THAT KIND OF MATTRESS IN THE CLINICAL SETTINGS.

AND IF YOU — IF YOU COMPROMISE CARE IF YOU TAKE — IF WE DECIDED, OKAY, WE ARE GOING TO ALLOW FOLKS NOT TO USE THAT MATTRESS, AND TO USE A LESSER MATTRESS, WHAT YOU ARE GOING TO END UP WITH IS PRESSURE ULCERS IN A COMMUNITY WHO OBVIOUSLY IS VERY VULNERABLE TO THAT.

AND SO THAT’S AN EXAMPLE OF SOMETHING WHERE WE FOUND SOME CHALLENGES IN WHAT IS ON THE MARKET.

AND YOU KNOW, WE ARE OBVIOUSLY TRYING TO COME UP WITH SOME CREATIVE SOLUTIONS TO ADDRESS THAT AS WE GO THROUGH THIS.

THE OTHER POINT HEALTH PROVIDERS ARE FOCUSED ON PRO — IT GOES WITHOUT SAYING THAT OFTENTIMES THERE IS CONFUSION BETWEEN DISABILITY AND A HEALTH CONDITION.

OBVIOUSLY THE HEALTH CONDITION MAY BE RELATED TO THE DISABILITY OR IT MAY NOT BE AS A PERSON WITH A VISUAL IMPAIRMENT I CAN TELL YOU THAT MOST OF THE TIME THAT I GO TO THE DOCTOR IT’S NO LONGER ABOUT MY EYES.

SO IT’S IMPORTANT TO — ONE OF THE PIECES THAT AS WE GO THROUGH THIS PROCESS IS IT’S IMPORTANT TO DISTINGUISH THOSE THINGS.

AND I JUST THINK IT’S SOMETHING THAT THE BOARD NEEDS TO TAKE INTO ACCOUNT.  AS THEY ARE THINKING ABOUT THE STANDARDS.

OTHER ISSUES ON CLINICAL PRACTICE ONE OF THE GAPS THAT I HAVE SEEN IS UNDERSTANDING THE EQUIPMENT FUNCTION IN THE MEDICAL SERVICE PROCESS.

AND YOU KNOW, I DON’T KNOW THAT I HAVE TALKED MUCH ABOUT HOW WE ARE DOING IT BUT I BASICALLY HAVE — WE HAVE A NUMBER OF ENTITIES AS I HAVE TALKED ABOUT I HAVE ADA COORDINATORS AND EACH OF THE SITES AND WHAT I AM WORKING TO DO IS TO TRAIN EACH OF THEM TO GO OUT AND ASSESS THEIR EQUIPMENT.

AND ONE OF THE CHALLENGES IS THEN WE ASK THEM, OKAY, IF YOU DON’T HAVE ACCESSIBLE EQUIPMENT HOW ARE YOU DOING THIS.  HOW ARE YOU APPROACHING THE MEDICAL PROCESS AND PART OF WHAT IS REALLY IMPORTANT IN THAT PROCESS IS TO MAKE SURE THAT YOU ARE TAKING INTO ACCOUNT — AND WE HAVE TRIED TO COME UP WITH THE STANDARD OF CARE AS — SO WE WILL TALK TO CLINICIANS WHO CAN TELL US, OKAY, WHAT IS THE STANDARD OF CARE THAT’S NEEDED IN THAT PARTICULAR SETTING.  BECAUSE IT’S HARD SOMETIMES TO DETERMINE WHAT IS THE EQUIPMENT’S FUNCTION IN THAT MEDICAL PROCEDURE.

SO, AND WE TEND — YOU KNOW FROM OUR PERSPECTIVE, WE ARE LOOKING AT PROCEDURES EXAMS AND TREATMENTS, WE LOOK AT THE WHOLE GAMUT.  SO WE HAVEN’T LIMITED IT JUST TO DIAGNOSTIC EQUIPMENT ALTHOUGH THERE IS PROBABLY A LOT OF OVERLAP IN HOW THAT IS APPROACHED.  I THINK I COVERED IT SOME EXAMPLES I THINK I TALKED ABOUT THE MED SEARCH BEDS AND THE PRESSURE ULCER MATTRESSES THAT WE RAN INTO THE HEIGHT ISSUE.  THERE IS ALWAYS ISSUES WHEN YOU LOOK AT WHEN THE PRIMARY TWO VENDORS THAT ARE OUT THERE SELLING ACROSS THE COUNTRY DON’T MAKE A FRAME THAT GOES LOW ENOUGH.

THOSE ARE GENERALLY THE VENDORS THAT FOLKS ARE GOING TO LOOK AT BECAUSE YOU KNOW THEY HAVE LONGEVITY AND YOU ARE LIKELY — SO I GUESS THAT’S SOMETHING TO TAKE INTO ACCOUNT THE WAY MEDICAL PROFESSIONALS LOOK AT EQUIPMENT IS THAT THEY ARE INTERESTED IN MAKING SURE THAT THE COMPANY IS GOING TO BACK WHAT THEY DO BECAUSE THEY WANT TO BE ABLE TO USE THAT EQUIPMENT SUCCESSFULLY OVER THE LONG HALL.

HOPEFULLY WHAT I AM EXCITED ABOUT AS WELL IS THIS PROCESS WILL HELP VENDORS UNDERSTAND THE IMPORTANCE OF MAKING SURE THAT THEIR EQUIPMENT ADDRESSES THE FULL RANGE OF THINGS.  THE OTHER EXAMPLE WAS INFUSION CHAIRS.  I HAVE TO SAY IN TERMS OF MEDICAL CHAIRS WE REALLY SEE THAT AS A HUGE FRONTIER.  THERE IS A LOT OF — THERE IS BIG GAPS IN TERMS OF WHAT IS ON THE MARKET.  INFUSION WAS ONE OF THE AREAS WHERE WE ARE REALLY TAKING A LOOK AT WHAT — WHAT’S THE VALUE OF THE INFUSION CHAIR.

AND SORT OF WORKING YOUR WAY BACK.  BECAUSE OBVIOUSLY ONE OF THE KEY PIECES OF THAT INFUSION CHAIR IS IT PROVIDES COMFORT FOR THE PATIENT.  YOU HAVE TO FIGURE OUT A WAY THAT IS APPROPRIATE TO PROVIDE COMFORT.  HOPEFULLY BECAUSE THE INFUSION CHAIRS THAT ARE CURRENTLY ON THE MARKET AS JUNE COVERED THIS MORNING ARE DIFFICULT TO TRANSFER INTO, AND THEY ALSO DON’T GO LOW ENOUGH.  FROM OUR RESEARCH.

SO THEY DON’T REALLY ALLOW AN EFFECTIVE TRANSFER IN OUR EXPERIENCE.

MRI IMAGING I THINK AGAIN JUNE COVERED SOME OF THAT BECAUSE YOU KNOW THERE ARE ISSUES WHEN YOU GO INTO AN MRI ROOM WITH THE KINDS OF EQUIPMENT THAT CAN BE IN THAT ROOM.  SO, WHAT YOU NEED IS A SEAMLESS ABILITY TO TRANSFER SO SOMEONE DOESN’T HAVE TO TRANSFER MORE THAN ONCE YOU CAN HAVE AN ACCESSIBLE SPACE.  THE OTHER COMMENT THAT I DID WANT TO MAKE IS THAT ONE OF THE THINGS IS WE HAVE GONE THROUGH THIS IN OUR SYSTEM, AND I ADMIT THIS WAS A SURPRISE TO ME THAT PROBABLY ONE OF THE MOST COMMON PIECES OF EQUIPMENT THAT IS USED IN AN ACUTE CARE SETTING ARE STRETCHERS OR GURNEYS.  AT THIS POINT THERE ARE NONE THAT GO LOW ENOUGH.  I THINK JUNE TOUCHED ON THAT.  AND AGAIN IF YOU — THE PADDING MAY BE IMPORTANT IF SOMEBODY IS ON THAT FOR A PERIOD OF TIME.  WE NEED TO MAKE SURE THAT THERE ARE GURNEYS OR STRETCHERS THAT GO LOW ENOUGH.  THOSE ARE ACTUALLY DIFFERENT THAN EXAM TABLES.  SO THAT GETS ME TO ONE OF THE POINTS THAT I WANT TO MAKE SURE THAT IT EMPHASIZES THE IMPORTANCE OF MEDICAL CARE FOLKS UNDERSTANDING THE CLINICAL PROCESSES AND BEING A PART OF THIS.  IT’S TEMPTING AS A NONCLINICIAN TO SAY, GEE, WHY CAN’T YOU USE AN EXAM TABLE.  WELL, THE DIFFERENCE BETWEEN GURNEYS AND STRETCHERS AND EXAM TABLES ARE THAT GURNEYS AND STRETCHERS ARE MOBILE THEY MADE TO MOVE FOLKS AROUND

FOR EXAMPLE, IN THE — IN MANY OF THE EMERGENCY ROOM SETTINGS GURNEYS AND STRETCHERS ARE WHAT YOU ARE SEEN ON.

AND SO THOSE ARE IMPORTANT PIECES TO BRING IN TO THE EQUIPMENT PROCESS.

OKAY.

WELL, KEY TO SUCCESSFUL INTEGRATION PROVIDERS NEED TRAINING AND I KNOW WE HAVE COVERED THAT IT IS REALLY IMPORTANT.  I GUESS PART OF WHERE I AM GOING WITH THIS, AND AGAIN, I SEE THE ACCESS BOARD AS A LEADER IN THIS AREA.  AND THAT IS THAT WE NEED TO CHARGE VENDORS WITH PUTTING OUT APPROPRIATE TRAINING MATERIAL.  SO I CAN TELL YOU, FOR EXAMPLE, THAT WHERE VENDORS WE ARE USED TO GETTING TRAINING OR WHERE OUR SOME OF OUR MEDICAL FOUNDATION SITES WERE USED TO GETTING TRAINING FROM THE VENDORS WHAT THEY FOUND SOME VENDORS WERE NOT WILLING TO COME AND TRAIN ON ACCESSIBLE TABLES, WHERE IT WAS A SMALL, YOU KNOW, OF COURSE A MEDICAL FOUNDATION IS A GROUP OF DOCTOR’S OFFICES BASICALLY.  IN SOME CASES CLINICS.  SO, YOU KNOW, THE VENDORS SOMETIMES DON’T WANT TO TRAIN.  I JUST THINK IT’S REALLY IMPORTANT TO MAKE SURE THAT APPROPRIATE TRAINING GETS DEVELOPED IN A FORMAT THAT IS PROVIDED WITH THE EQUIPMENT.

BECAUSE, AGAIN, WE ALL KNOW IT’S GOING TO GO BY THE WAYSIDE IF YOU ARE NOT DOING THE TRAINING AND IF YOU CAN’T PROVIDE THAT ALONG WITH THE EQUIPMENT THAT COMES IN.

SO, OFTEN TIMES PEOPLE THINK IT’S SELF-EXPLANATORY, BUT IN THE CLINICAL SETTING IT’S REALLY IMPORTANT THAT YOU HAVE THE TRAINING AHEAD OF TIME BECAUSE IT’S NOT GOING TO BE USED IF THE PATIENT COMES IN AND DOESN’T HAVE ACCESS TO THAT EQUIPMENT AND THE PROVIDER DOESN’T KNOW HOW TO USE IT.

SO — I JUST WANTED TO ALSO SAY AS YOU GO THROUGH THIS PROCESS, IN TERMS OF — I KNOW YOU KNOW IT’S PROBABLY NOT GOING TO BE INCORPORATED IN THE TECHNICAL STANDARDS, BUT THERE PROBABLY DOES NEED TO BE AN AWARENESS OF THE DIFFERENCES BETWEEN ACUTE CARE SITES AND WHAT IN OUR TATE ARE MEDICAL FOUNDATION SITES OR DOCTOR’S OFFICES.

BECAUSE THEY DO OPERATE VERY DIFFERENTLY.  AND OBVIOUSLY THEY ALL NEED TO HAVE ACCESSIBLE EQUIPMENT.

BUT HOW YOU GET THAT IN TO THOSE PROCESSES MAY BE SLIGHTLY DIFFERENT.  AND AGAIN I AM CHARGING THE ACCESSIBLE AS AN EXPERT IN THE FIELD TO HELP SET SOME TONES ON THESE KINDS OF ISSUES.  OKAY.

STANDARDIZATION I THINK I TOUCHED ON THE STANDARDIZATION ISSUE.  I KNOW THAT IN OUR RISK DEPARTMENTS, THAT’S BEEN A BIG ISSUE BECAUSE YOU KNOW MEDICAL CARE PROVIDERS NEED TO KNOW HOW TO USE THE EQUIPMENT AND ANY TIME THEY HAVE TO FIGURE OUT WHERE THE BUTTONS ARE ON THE BED, FOR EXAMPLE, IF THE NURSE HAS DIFFERENT BUTTONS FOR FOLKS WITH DISABILITIES THAT THEY ARE GOING TO HAVE WITH OTHER FOLKS, IN TERMS OF HOW TO WORK THAT BED IT’S GOING TO MEAN A DELAY.

SO THAT, I KNOW THAT IS ONE OF THE THINGS THAT WE FOUND THAT CAN BE AN ISSUE.

SO I REALLY, AGAIN, URGING FOR STANDARDIZATION IS BEING ABLE TO MAKE SURE THAT THEY ARE STANDARDIZED BUTTONS AND THAT WE GO TO A UNIVERSAL DESIGN APPROACH.  WE ALL KNOW IT MAKES A HUGE DIFFERENCE.

WELL, I JUST BASICALLY WANTED TO TALK ABOUT THE FACT THAT — AND I THINK I HAVE MADE THIS POINT AND I THINK OTHERS HAVE.  THERE IS A LOT OF THINGS THAT ARE NOT ON THE MARKET.

SO, AGAIN, WHEN YOU BRING ACCESSIBILITY INFORMATION INTO THE MIX, WHAT YOU SOMETIMES FIND IS IT’S REALLY DIFFICULT TO FIGURE OUT HOW TO FIND ACCESSIBLE EQUIPMENT.

AND THAT WAS — THOSE ARE SOME OF THE ISSUE OTHER YOUS THAT I SEE WITH — HAPPENING THROUGH THIS.

AND YOU KNOW WE WANT TO CONSIDER, YOU KNOW IT’S IMPORTANT TO CONSIDER PHASING IN THOSE KIND OF THINGS.  AND AGAIN I GUESS THAT’S NOT A TECHNICAL SPEC BUT I DO SEE IT AS AN IMPORTANT THING FOR THE ACCESS BOARD AS A LEADER.

AND THEN IN TERMS OF KEY IMPLEMENTATION, IT REALLY IS IMPORTANT, ALSO, TO SEE MEDICAL EQUIPMENT AS A PART OF A BIGGER COMPLIANCE PROGRAM.

AND THANK YOU.  I APPRECIATE YOUR ATTENTION.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU, CAROL.

IN FOLLOW-UP TO ONE OF YOUR POINTS, I WANTED TO EXPLAIN THAT THE ACCESS BOARD DOES WRITE TECHNICAL ASSISTANCE AFTER WE ISSUE STANDARDS AND GUIDELINES TO HELP PEOPLE BETTER UNDERSTAND THEM OR HOW TO IMPLEMENT THEM AND WE PROVIDE TRAINING SO WE CAN TRAVEL, DO IT THROUGH WEBINARS AND SO ON.  AT THAT TIME WE WILL BE WORKING CLOSELY WITH SOME OF THE PEOPLE IN THE ROOM TO HELP US TO DO THAT WE ARE GETTING CLOSE TO OUR LUNCH HOUR, I THINK WE WILL MAKE TIME FOR A FEW QUESTIONS.  IT LOOKS LIKE JOE CIRILLO HAS A QUESTION.

>> JOSEPH CIRILLO:  CAROL, YOU MENTIONED SEVERAL TIMES ABOUT THE MOVING BEDS AND THE LIGHT AND EVERYTHING, AND THE 9-INCH MATTRESS THE DIMENSION.  I HAPPEN TO BE AN ARCHITECT, DIMENSIONS BOTHERS ME, THEY COULD BE CHANGED.  AND IF WE TAKE THE ATTITUDE THAT EVERYTHING HAS TO BE DONE DIFFERENTLY, AND NOBODY IS EVER GOING TO COME UP WITH A FOUR-INCH MATTRESS THAT WILL NOT CAUSE ULCERS AND EVERYTHING ELSE, THEN WHAT WAS THE DIFFERENCE BETWEEN A SEALY AND TEMPERPEDIC, I SLEEP ON THAT, IT HELPS MY BACK PROBLEM.  THEY COULD CREATE A BETTER MATTRESS.  BY THROWING OUT THE BED WITH THE BATH WATER WE ARE STOPPING SOMEBODY FROM CREATING SOMETHING THAT MIGHT WORK WITH EXISTING EQUIPMENT.

IF WE TAKE THE ATTITUDE, THE MATTRESS IS TOO HIGH.  I WANT A FOUR-INCH THAT DOES THE SAME THING MAYBE THE MANUFACTURERS OF THE BEDS WILL GO OUT OF THEIR WAY TO KEEP THE BUSINESS THEY HAVE GOT AND CREATE A BETTER MATTRESS.

SO SOMETIMES IT’S THAT ATTITUDE HAS TO BE TAKEN I THINK A LITTLE BIT IN THIS RATHER THAN JUST THROW IT ALL OUT AND DESIGN US A NEW FOUR-INCH HIGH TABLE OR WHATEVER, YOU KNOW?

>> WELL, I JUST AGREE WITH YOU, PART OF WHAT I WANT TO MAKE SURE WASN’T LOST IS WHAT I AM TRYING TO GET AT IS THE COMPLEXITY OF THIS PROCESS YOU TRY TO SOLVE ONE PROBLEM YOU FIND THERE IS ANOTHER ONE.

IT’S REALLY IMPORTANT TO BRING THESE THINGS TOGETHER SO THAT FOLKS ARE WORKING TOGETHER.

>> DAVID BAQUIS:  THANK YOU JOE.  EVEN THOUGH THERE IS A QUESTION ABOUT WHETHER BEDS WOULD BE COVERED UNDER MEDICAL DIAGNOSTIC EQUIPMENT, LET’S TAKE THAT ISSUE AND MOVE IT TO THE MANUFACTURER PANEL AND SEE WHAT THEY HAVE TO SAY ALSO.  SO, LET’S SEE WHO I HAVEN’T CALLED ON YET.  A WOMAN IN THE MIDDLE OF THE ROOM WITH A BROWN SHIRT ON WITH A HEADSET.  PLEASE STATE YOUR NAME.

>> THANK YOU, MY NAME IS DORIS RAY, WITH THE CENTER FOR INDEPENDENT LIVING IN NORTHERN VIRGINIA, ENDEPENDENCE CENTER OF NORTHERN VIRGINIA.

AND I WANT TO ECHO WHAT THE SPEAKERS HAVE SAID BEFORE ABOUT TABLES EXAM EQUIPMENT AND CALL BUTTONS AND ALL OF IT, I ESPECIALLY APPRECIATED MISS COITTI’S PRESENTATION.  I WANTED TO ASK WHETHER THE — THE GUIDELINES AND RULES THAT YOU ARE GOING TO CREATE ARE ALSO GOING TO COVER EXAM EQUIPMENT AND DIAGNOSTIC EQUIPMENT USED IN CLINICS ALSO IN DOCTOR’S OFFICES INCLUDING OPHTHALMOLOGISTS OFFICES, OTOLOGISTS OFFICES, MY BACKGROUND IS SPEECH PATH AND AUDIOLOGY AND FOR EXAMPLE GOING TO AN ORTHOPEDIST AND GOING TO THEIR — GOING TO PT THERE ARE BEDS AND SUCH IN THE OPHTHALMOLOGIST OFFICES THERE IS EQUIPMENT FOR SCREENING AND DIAGNOSING GLAUCOMA AND ALL KINDS OF CONDITIONS IN YOUR EYES AND MOST OF THE CHAIRS ARE FIXED TO THE GROUND, SO YOU KNOW ARE GOING TO HAVE TO TRANSFER OR ARE GOING TO HAVE TO DO SOMETHING.

AND FOR OTOLOGY EXAMS SOME OF THOSE EXAMS REQUIRE YOU TO GET UP ON A EXAM TABLE THAT’S EVEN HIGHER THAN MOST THAN I HAVE SEEN, AND THEY USE EQUIPMENT THAT’S FIXED SO THAT’S WHY I BRING THAT UP.

AND AUDIOLOGY AUDIO METRIC EXAMS DONE AS THEY ARE SUPPOSED TO BE DONE ARE DONE IN SOUNDPROOF BOOTHS THAT ARE NOT ACCESSIBLE SO THOSE ARE SOME OF THE THINGS THAT I WANTED TO BRING UP TO YOU THAT I HADN’T HEARD TODAY

I ALSO WANTED TO MENTION THAT WHEN PEOPLE ARE COMING FROM HOSPITAL AND IN REHAB, I HOPE THAT WILL BE COVERED, IT IS APPALLING TO ME THAT, FOR EXAMPLE, THERE AREN’T ACCESSIBLE RESTROOMS IN EVERY SINGLE ROOM IN — IN NURSING FACILITIES AND SUCH AND WHY IN MEDICAL FACILITIES THERE AREN’T ROLL IN SHOWERS AND WALK IN NO THRESHOLD SHOWERS RATHER THAN HAVING TUBS IT JUST DOESN’T MAKE ANY SENSE.

>> DAVID BAQUIS:  THANK YOU DORIS FOR YOUR QUESTION.  THE SIMPLE ANSWER TO THE FIRST PART OF THE QUESTION WAS YES.  YES, WE WILL CONSIDER THE VARIOUS MEDICAL SETTINGS.

AND SOME OF THE OTHER THINGS MIGHT NEED TO BE DIRECTED TO DOJ FOR HANDLING UNDER ADA.

>> WHY IS THERE DIAGNOSTIC EQUIPMENT AND THE OTHER THING THAT I DIDN’T MENTION IF I GO — IF I GO INTO — IF I GO INTO MY DOCTOR’S OFFICE, OKAY, AS A BLIND WOMAN IF I GO — MOST OF THE DOCTOR’S OFFICES NOW ARE BECOMING VERY COMPUTERIZED I HAVE TO WALK IN THE DOOR I AM SUPPOSED TO USE A COMPUTER I FIXED COMPUTER I MIGHT ADD TO GET INFORMATION ABOUT — ABOUT TESTING THAT THEY HAVE DONE AND SUCH.  AND NONE OF THEM ARE ACCESSIBLE EITHER PHYSICALLY ACCESSIBLE OR ACCESSIBLE TO BLIND PEOPLE.

>> DAVID BAQUIS:  I RESPECT ALL OF THE BARRIERS YOU BROUGHT UP THE QUESTION WAS WHICH BARRIERS TO DIRECT TO OUR RULE MAKING OR TO OTHER AGENCIES FOR HANDLING.  WHY DON’T WE TALK LATER AND PARSE THOSE OUT, ALL OF THOSE ARE WORTHY OF BEING ADDRESSED.  I WANT TO BE RESPECTFUL FOR EVERYTHING THAT YOU HAVE POINTED OUT THE FIRST PART IS EASY, YES, WE WANT TO LOOK AT THE DIFFERENT KINDS OF CLINICIANS PULMONARY AUDIOLOGY AND SO ON.  THE FIRST SPEAKER MADE IT CLEAR THEY WERE CALLING OUT A FEW EXAMPLES IN THE STATUTE.  WE HAVE TIME FOR ONE MORE.  WE ARE EATING INTO OUR LUNCH PERIOD AND THEN WE WILL HAVE A 55-MINUTE LUNCH INSTEAD OF 60 MINUTES HOW ABOUT THE FRONT OF THE ROOM HERE.  THANK YOU.  HERE COMES THE MIC.

>> AS LONG AS WE ARE TALKING ABOUT HOSPITALS, I THINK IT ALSO INVOLVES ARCHITECTURE TO A CERTAIN DEGREE THERE IS A LOT OF OLDER BUILDINGS THAT ARE HOSPITALS THAT ARE PITIFUL.

MORE PITIFUL THAN NEWER BUILDINGS AND AS I HAVE HAD PERSONAL EXPERIENCE IN SEEING RECENTLY THE ELEVATORS, I MEAN YOU CAN CHANGE THE BEDS AND YOU CAN CHANGE THE GURNEYS YOU CAN MAKE THEM BIGGER, BUT MY HUSBAND RECENTLY PASSED AWAY IN ONE OF THE HOSPITALS IN NORTHERN VIRGINIA, AND HIS LAST MONTH WAS HELL BECAUSE HE WAS WITHOUT LEGS, AND RELATIVELY LARGE.

AND MOVING HIM AROUND THE HOSPITAL AN OLD HOSPITAL THE ELEVATOR COULD NOT TAKE THE BED.  AND IT WAS JUST IMPOSSIBLE TO GET INTO THE ELEVATOR.

AND I MEAN THOSE ARE THE KIND OF THINGS THAT WE ARE GOING TO RUN INTO.

I KNOW INITIALLY THE ADA MADE ALLOWANCES FOR BUSINESSES FOR RESTAURANTS FOR ALL SORTS OF FACILITIES THAT WERE OLDER.  IS THAT GOING TO BE THE SAME THING HERE.

>> DAVID BAQUIS:  THANK YOU.  I SHOULD TELL YOU IT’S NOT MY AREA OF EXPERTISE, IT’S NOT SOMETHING THAT FALLS WITHIN THE RULE MAKING, BUT I CAN GIVE YOU AN ANSWER BY PROVIDING A REFERRAL TO DISCUSS IT LATER WITH PEOPLE WHO ARE MORE FAMILIAR WITH THE ARCHITECTURE ISSUES.

>> I’M SORRY, MY NAME IS RHODA BAKER, I AM WITH THE FAIRFAX COUNTY DISABILITY SERVICES BOARD.

>> DAVID BAQUIS:  THANK YOU VERY MUCH.  SO, ACCORDING TO OUR SCHEDULE, WE ARE LISTED TO BE BACK FROM LUNCH AT 1:45.  THE LUNCH IS ON YOUR OWN, THERE ARE PLENTY OF PLACES OUTSIDE OF THIS BUILDING, WE ARE IN THE NICE AREA OF THE CITY.

(SHORT RECESS TAKEN.)

Afternoon Session

>> NANCY STARNES:  IF I COULD REMIND EVERYONE LIMIT YOUR QUESTIONS OR COMMENTS TO THE MEDICAL DIAGNOSTIC EQUIPMENT, AND THEN PLEASE IF YOU COULD JUST TRY TO LIMIT MAKE YOUR COMMENTS AS BRIEF AS POSSIBLE ON TWO MINUTES OR LESS TO BE HELPFUL AND THEN WE CAN GET THE MAXIMUM NUMBER OF PEOPLE TO BE ABLE TO MAKE A COMMENT OR ASK A QUESTION.  THANK YOU VERY MUCH.  WITH THAT I AM GOING TO TURN IT OVER TO DAVID.

>> DAVID BAQUIS:  THANK YOU.  OKAY.  SO, FOR OUR NEXT SPEAKER WE ARE GOING TO HERE FROM JON WELLS FROM MIDMARK CORPORATION, HE WILL SPEAK WITH US ABOUT THE ACCESSIBILITY FEATURES OF THEIR EXAM TABLE AS WELL AS A LITTLE BACKGROUND IN HOW THEY ARRIVED AT THAT CRITERIA AND SOME OTHER RELATED ISSUES OF INTEREST INCLUDING HOW THIS HAS BEEN ACCEPTED BY MEDICAL CARE PROVIDERS.

JON, PLEASE TAKE IT AWAY THANK YOU.

>> JON WELLS:  HELLO EVERYONE.  BECAUSE I AM GOING TO BE REFERENCING THE TABLE HERE AND THERE, I AM GOING TO BE STANDING, IF THAT’S ALL RIGHT.  ALL RIGHT, IS ANYONE FAMILIAR WITH MIDMARK?  EXAM TABLES OR EXAM PRODUCTS?

WE HAVE BEEN AROUND SINCE 1915.  AND WE ARE A PRIVATE COMPANY IN OHIO.  OUR CEO IS FOURTH GENERATION IS A FAMILY PHYSICIAN, AND HER HUSBAND IS A FAMILY PHYSICIAN PRACTICING IN OHIO.  MAKING THE EXAM ROOM EFFICIENT AND ACCESSIBILITY IS DEAR TO IT IT’S MORE THAN JUST A SLOGAN BECAUSE WE CARE.  WE HAVE BEEN INVOLVED WITH ACCESSIBLE SOLUTIONS SINCE 2000.  I WILL TALK ABOUT HOW THE ACCESS BOARD WAS INVOLVED WITH THAT, EVEN BACK THEN I WORKED WITH JUNE IN THE PAST AND OTHERS, AND THAT’S BEEN HELPFUL FOR US TO LEARN AND HELP IMPROVE OUR PRODUCTS FOR ACCESSIBILITY.

EXISTING CONDITION, WHAT IS HAPPENING OUT THERE WE WENT THROUGH THIS.  THE BOX TABLE.  UNFORTUNATELY THAT’S ONE OF OUR BOX TABLES.  AND BUT THIS TABLE IS PROBABLY 20, 25 YEARS OLD.  THAT’S ONE OF THE THINGS.  THERE ARE A LOT OF BOX TABLES AND THEY LIVE FOREVER.  THAT’S ONE OF THE — IF A BOX TABLE LOOKS GOOD, THEY PUT NEW UPHOLSTERY ON IT, EVEN THOUGH THERE IS ADVANCES IN ACCESS, THAT TABLE IS GOOD ENOUGH.  AND I WILL TALK ABOUT A LITTLE MORE ABOUT THAT.  THIS IS A NEW VERSION IT’S A BOX TABLE.  ANOTHER THING IS, THERE IS A SOLUTION WHERE JUST PUTTING A BIGGER FOOT STEP IS THE SOLUTION.

WELL, FOR SOME THEY CAN BE, BUT WE WANT ACCESS FOR ALL.  JUST POP UP ON THE TABLE, WE HEARD THIS, THIS IS FROM AN ARTICLE FROM QUEST MAGAZINE.  AND WE HAVE THIS A NUMBER OF TIMES THIS MORNING WE HEAR IT ALL THE TIME.

WE HEAR IT ALL THE TIME.  WHY IS THIS?  WITH REGARD TO INACCESSIBLE ROOMS BOX TABLE OR MANUAL TABLES MEDICAL PROCESSES HAVE BEEN SLOW TO CHANGE WITH THE HEALTHCARE BILL THAT’S PUSHING MAKING A LOT OF PRESSURE OUT THERE.  THIS CATALYST THE HEALTHCARE BILL MAKING ROOMS FOR ACCESSIBLE AND ALSO THE PC, THE I.T. INSIDE THE EXAM ROOM IS A HUGE CATALYST DESIGN ROOM WILL CHANGE SIGNIFICANTLY WHERE IT IS TODAY AND WHERE IT’S GOING IN THE NEXT FIVE YEARS.  WE ARE EXCITED ABOUT THAT.  PHYSICIAN AWARENESS, THEY JUST DON’T KNOW THE LAW, THEY JUST DON’T KNOW ABOUT THESE THINGS.

AND A COMMON RESPONSE, I DIDN’T KNOW, AND WHO IS GOING TO PAY FOR THIS IS ANOTHER PIECE.

WELL, IF YOU ARE A SMALL BUSINESSMAN, YOU HAVE TO BUY YOUR OWN EQUIPMENT.  YOU HAVE A PRIVATE PRACTICE, YOU STILL HAVE TO FOLLOW THE LAW, EVEN THOUGH YOU HAVE TO BUY EQUIPMENT, RIGHT?  THAT’S THE REALITY OF IT.  SOMETIMES IT’S HARD FOR — TO ACCEPT AS A PHYSICIAN.

AND WHAT IS REALLY BASING THIS ON IS THE UNCLEAR REQUIREMENTS, WHICH IS THE REASON FOR THIS COMMITTEE TO COME TOGETHER.

THEY ARE REALLY DIFFICULT TO INTERPRET.

THE MANAGERS THAT WE WORK WITH, THE DOC WE WORK WITH SAYING YOU HAVE TO CONSIDER HAVING YOUR FACILITY ACCESSIBLE OR A PORTION OF IT ACCESSIBLE DEPENDENT UPON YOUR PATIENT POPULATION THEY ASK FOR REFERENCE POINTS.  THEY ASK FOR, WHAT — SHOW ME IN THE LAW WHERE IT SAYS THAT SPECIFICALLY ABOUT EXAM ROOMS AND EXAM TABLES.

AND WE WORK VERY HARD TO ALIGN ALL OF THE DOTS THE SPIRIT OF THE LAW IS LIKE, THIS HERE IS THIS.

AND THIS COMMITTEE OBVIOUSLY WILL CLARIFY THIS.  NOW, WITH REGARD TO COMPARATIVE EXAMPLE.

BACK IN 2000, WE ACTUALLY WERE INVOLVED WITH KAISER THROUGH THAT LAWSUIT AND WE HELPED THEM WITH THEIR SETTLEMENT.  BUT WE WERE ACTUALLY WORKING ON THAT TABLE BEFORE THAT LAWSUIT OCCURRED.

THE BEAUTY OF THAT IS WHEN THEY CALLED US, HEY TALK TO US, BECAUSE WE HAVE THIS THING IN THE WORKS.

WHEN WE STARTED THE RESEARCH, I ACTUALLY MADE SOME CALLS TO DC, HAD TO BE TO THE ACCESS BOARD, IT WAS TO AN 800 NUMBER, IT HELPED INTERPRET THE ADA FOR ANYONE WHO WOULD CALL IN.  I CALLED IN, SAY WE ARE WORKING ON EXAM TABLES WE WANT THEM TO BE ACCESSIBLE WHAT DIMENSIONS DO YOU HAVE.  THERE WERE NO DIMENSIONS.  WE WORKED BACK AND FORTH AND GOT TO RESIDENCE — THE WATER CLOSETS IN THE 17 TO 19 INCH, IT ISN’T TOO OFTEN A PERSON IN A PUBLIC SPACE HAVE TO COME OFF THE WHEELCHAIR, WATER CLOSET IS THE CLASSIC EXAMPLE SO WOULD BE AN EXAM TABLE.  THEREFORE, HERE IS A GREAT REQUIREMENT THAT YOU CAN USE.  WITH THAT, ACTUALLY THIS IS THE RECENT DOJ DOCUMENT THAT’S POSTED.  AND THEY HAVE REFERENCE 17 TO 19 INCHES AS WELL WHICH IS INTEGRAL.

NICE TO SEE THESE BEING ALIGNED.  WHAT WE DID IS WE SAID, OKAY, HOW COULD WE DESIGN A PRODUCT IN THAT 17 TO 19.  THE CHALLENGE IS YOU NEED TO HAVE AS A MANUFACTURER, YOU WANT TO HAVE THAT LOW ACCESS HEIGHT, BUT YOU ALSO NEED HIGH ACCESS HEIGHT.  WHAT DO YOU MEAN BY THAT?  WELL, THE CAREGIVER’S BACK, IF IT’S OB, YOU KNOW THERE ARE A LOT OF BACK STRAIN.  WE NEED TO HAVE AT LEAST 37 WORKING INCH HEIGHT.  BUT EVERY TIME THAT YOU LOWER THAT PRODUCT, THAT STROKE GETS LONGER AND LONGER, RIGHT.  IT’S SAFETY ISSUES WEIGHT BEARING, ALL OF THESE THINGS COME INTO EFFECT.  THOSE ARE THE CHALLENGES WE WORK WITH THE 18 TO 37 WERE THE SPECS THAT WE CREATED.  VISUALLY THIS IS A CLASSIC EXAM TABLE, 34 AND A HALF AND THEN YOU SEE OUR ACCESSIBLE TABLE AT 18.  AND THIS KIND OF IMAGE YOU SEE THE DIFFERENCE AND HOW ACCESSIBLE THAT IS, IT’S 34 AND A HALF, YOU ACTUALLY GOES UP THREE INCHES HIGHER THAN THIS PARTICULAR PRODUCT.

I DO WANT TO ADD BACK IN 2002, WE HAD HIGH-LOW, WE CALLED THEM HIGH-LOW EXAM TABLES.  THEY ONLY WENT DOWN TO 25 INCHES, NOT EXACTLY ACCESSIBLE.  WE HAD THEM HIGH-LOW BACK THEN.  IT WAS 8% OF WHAT WE SOLD INSIDE OF EXAM ROOMS.  WE ARE THE LEADER.  WE HAVE PRETTY LARGE MARKET SHARE.  ABOUT 8% OF WHAT WE SOLD INTO EXAM ROOMS WERE HIGH-LOW TABLES TODAY IT’S 25%.

WE HAVE MADE QUITE A HEADWAY.  IT’S INTERESTING BECAUSE IT’S GEOGRAPHICAL IN THE NORTHWEST 15% OF EXAM ROOMS BUY HIGH-LOW TABLES; IN THE SOUTHEAST, IT’S MUCH LESS THAN THAT.  IT’S JUST DIFFERENT, IT’S THE DEMOGRAPHICS AND THE CULTURE AND HOW THINGS ARE MOVING ACROSS THE U.S.

WE KEEP AN EYE ON IT AND WORK TO BRING AWARENESS TO IT WHICH YOU WILL SEE IN A SECOND.

WE ALSO STUDIED WHEELCHAIR TRANSFERS, THE DIAGONAL AND SIDE APPROACH RIGHT FROM THE GUIDELINES.

HERE IS THE SHOWING THE HEIGHT AND STROKES.  WE WORKED ON ACCESSORIES, THEY HAVE TO BE UBIQUITOUS FOR ALL THE TYPES OF EXAMS.  WE WERE ASKED TO HAVE SOME SIDE, YOU KNOW, SIDE RAILS SO TO SPEAK, BUT ALSO THE ABILITY TO DRAW BLOOD, THE ABILITY TO BE THERE WHEN YOU NEED THESE LITTLE LOOPS THAT YOU SEE HERE.  THEY ARE ACTUALLY DESIGNED FOR A NUMBER OF REASONS, ONE IS MORE THE PATIENT TO PULL THEMSELVES ON TO THE TABLE FROM A SIDE ACCESS, BUT ALSO IF YOU HAVE AN OB PATIENT AND IN A PHLEBOTOMY POSITION, THEY HAVE TO SCOOT DOWN, IF THEY DON’T HAVE ANYTHING TO HOLD ON TO YOU CAN IMAGINE, THE MEN IN THE ROOM CAN IMAGINE SWIMMING DOWN THE EXAM TABLE.  THAT’S WHAT THOSE ARE FOR.  THESE ARE USED FOR A NUMBER OF DIFFERENT THINGS.  THEY LOCK INTO SPACE, LIKE THIS, JUST THIS LEVER DOWN HERE.  THEY DO HANDLE HALF THE WEIGHT OF THE TABLE.  MEANING THIS PARTICULAR TABLE HANDLES 650 POUNDS.  THIS TABLE IS ACTUALLY HITTING THE MARKET ON MONDAY, I WOULD LIKE TO SAY FOR THE 20TH ANNIVERSARY OF THE ADA, BUT IT’S COINCIDENCE.  BUT THIS IS A NEW PRODUCT, WHICH IS A MUCH HIGHER WEIGHT CAPACITY THAN IN THE PAST.  THESE ARE THE ACCESSORIES.  THERE IS ACTUAL SHRINES, FEMALE SPLINES HERE AND HERE.  THOSE ACT AS PLATFORMS FOR FUTURE SIDE RAILS, WHATEVER THE NEEDS ARE.

WE LOOK FORWARD TO THE BOARD GIVING US GUIDANCE AND RECOMMENDATIONS ON HOW TO DEVELOP THESE SIDE RAILS MOVING FORWARD, BECAUSE WE HAVE A PLATFORM TO BUILD IT ON.  THIRD-PARTY MANUFACTURERS HAVE THE ABILITY TO USE THOSE SPLINES.  A FEW IMAGES HERE.  WHEN YOU SPEAK OF EXAM TABLES, I MEAN EXAMINATION ROOMS.  WE HAVE PROCEDURE TABLES.

TYPICALLY IN A PHYSICIAN’S OFFICE IT’S A FOUR-TO-ONE RATIO, YOU HAVE FOUR EXAM TABLES AND YOU HAVE ONE PROCEDURAL TABLE.

A PROCEDURAL TABLE GOES DOWN TO 19 INCHES AND NOT JUST BECAUSE OF THE ACCESSIBILITY, IT’S A SMALLER BUILD BECAUSE OF THE TYPE OF PROCEDURES, IT HAS NOT QUITE 18 BUT IT’S 19 IT JUST FIT INSIDE THAT RANGE.

THE DIFFERENT RAILS IN THE SYSTEM THEY HAVE THE SAME SPLINE ACCESS THAT CAN BE USED.  IT’S VERY DURABLE HANDLES 325 POUNDS.  POSITIONING AIDS.  I MEAN, THERE IS A NUMBER OF DIFFERENT THINGS YOU COULD USE AND LEVER OFF OF THOSE.  WE ALSO HAVE THE SAFETY ARMS, WHICH ARE ACTUALLY PRETTY BASIC, AND THEY ARE JUST TO CREATE COMFORT THEY ARE LESS EXPENSIVE YOU COULD GRAB AHOLD OF THEM, GET ON THE TABLE AND YOU CAN USE THEM FOR THE OB PROCEDURE.  BUT A LOT OF THESE TYPES OF PRODUCTS CAN BE USED.  A LOT OF TIMES THE PHYSICIAN WILL WANT THEM.  I NEED THEM THEN I WANT THEM OFF.  I WANT THEM OFF I NEED TO PUT THEM.  NOW I NEED THEM.  THEY HAVE TO HANDLE A LOT OF WEIGHT YOU ARE PUTTING A LOT OF STRESS ON THEM WHEN PATIENTS ARE TRANSFERRING ON.  AT THE SAME TIME THEY HAVE TO BE BOOM, I WANT THEM GONE BECAUSE I WANT PATIENT ACCESS.

WE ALSO WORK WITH EXAM ROOM DESIGN, ONE OF THE THINGS THAT WE FOUND WAS WHEN A WHEELCHAIR OR SCOOTER COMES INSIDE THE EXAM ROOM SPACE, WHERE DOES A WHEELCHAIR GO DURING THE EXAM.  WELL THE PATIENT WANTS IT TO STAY IN THE ROOM.

BECAUSE THEY FEEL LIKE THEY ARE ON AN ISLAND THEY DON’T WANT THEIR DEVICE TO BE OUTSIDE.  THERE ARE DIFFERENT WAYS TO DO THAT ONE CAN BE YOU ARE STACKING THESE SIDE CHAIRS TO MOVE THEM OUT OF THE WAY THEY COULD HAVE THE DEVICE STAY IN THE ROOM WHERE YOU LOOK AT IT FROM A TRAINING ISSUE IT’S NOT NECESSARILY EXPENSIVE PRODUCT DESIGN THIS IS A PAPER RECORD ROOM, AND THEN WE HAVE THE PC, ENTERING THE SPACE AS WELL.

HOW DOES THAT CHANGE THE DYNAMICS?  DO YOU HAVE FLAT PANELS, THEY ARE BECOMING MUCH LESS EXPENSIVE.  HOW DO YOU GET THAT CONNECTION WITH THE PATIENT WE ALSO HAD IN THE PREVIOUS ROOM THERE WAS INTERVIEW ZONE AND THE CARE ZONE THE INTERVIEW ZONE WAS ON THE SIDE CHAIR WITH A LITTLE DESK.  IF YOU HAVE AN ACCESSIBLE TABLE, YOU DON’T NEED TO HAVE TWO ZONES JUST HAVE ONE THEN YOU DON’T HAVE TO TRANSFER THE PATIENT BACK AND FORTH YOU JUST POINT THEM ONCE AND YOU CAN DO BOTH OF THOSE.  IT FITS THE LEAN PROCESSES, THE WORK FLOW AND ALL OF THE STEPS THAT OCCURS INSIDE THESE SPACES.  EXAM ROOM DESIGN IS FLUID, NOW IT’S AN EXCITING TIME, THE — ACCESSING THE TABLE AND TREATMENTS ARE REALLY BEING STUDIED.

THIS IS ONE OF THE ROOMS WE HAVE A WEBSITE WITH A LOT OF THE DATA, THE 16 INCH RADIO WE ARE LOOKING AT IT AS AN ORGANIZATION TO LOOK AT THE SIZE IS THAT THE RIGHT SIZE.  WE ARE COGNIZANT OF THAT, WE CALL IT BARRIER FREE ACCESS.  WE ARE TRYING TO BRING AWARE THIS TO THESE CAREGIVERS, IT’S BEEN DIFFICULT FOR THEM TO ACCEPT.

>> 32-INCH-WIDE UPHOLSTERY.  WE DO BUY-OUTS, TRADE IN OLD EXAM TABLES TO GET MOVEMENT, AND TO UNDERSTAND THAT IT’S THERE.

WE PARTNER WITH THE DISTRIBUTORS TO TALK ABOUT THESE THINGS.

AND LASTLY, WE DO HAVE PATIENT, NATIONAL PATIENT ACCESSIBILITY WEEK THE FIRST WEEK OF NOVEMBER.  WE HAVE DONE IT THE LAST THREE YEARS, THE VA IS INVOLVED, IT’S JUST TO BRING AWARENESS AROUND THESE THINGS.  THERE ARE VIDEOS ONLINE THAT WE CAN SHARE WITH YOU.  NEEDLESS TO SAY, IF YOU HAVE ANY QUESTIONS ON THE TABLE WE ARE GOING TO STICK AROUND AFTER WE CAN SHOW YOU THE ACCESSORIES WHAT THE DESIGN, BY ALL MEANS WE ARE OPEN TO YOUR FEEDBACK.  THIS ORGANIZATION IS REALLY GOING TO DRIVE THE STANDARDS I AM SURE THERE IS PLENTY OF THINGS WE DIDN’T CONSIDER WITH THE PROFESSIONALS IN THE ROOM THAT YOU WILL HELP US, WITH SO FEEL FREE TO E-MAIL ME IF YOU HAVE ANY QUESTIONS OR COMMENTS.  THANK YOU.

>> DAVID BAQUIS:  THANK YOU, JON.  NOW WE ARE GOING TO DO TWO THINGS AT ONCE, CAROL AND JACK IF YOU WOULD LIKE TO GET PREPARED FOR THE NEXT PANEL WE COULD LOAD JACK’S SLIDE SHOW, AT THE SAME TIME, JON, IS THERE ANY FEATURE OF THE TABLE THAT YOU WANTED TO DEMONSTRATE WHILE WE ARE SETTING UP?

>> I CAN DO THAT.  YOU CAN SEE THE SPLINES THERE IS A NUMBER OF THINGS THAT THIS PARTICULAR TABLE HAS.

IT ACTUALLY HAS, IT’S A VERY FAST MOVING TABLE, SO IT ACTUALLY MOVES TWICE AS FAST AS A TYPICAL EXAM TABLE.  AS IN THE PAST EFFICIENCY BECAME APPARENT WHEN YOU HAVE A LONG STROKE.  IF YOU ARE LOWERING THE TABLE VERY LOW AND YOU HAVE A LONGER STROKE, THE CAREGIVER, THE USER, IS ACTUALLY THINKING THIS THING TAKES FOREVER, IT’S A LONGER STROKE, IT’S THAT DEAL.  IF YOU HAVE A 6-5 DOC, YOU CAN HANDLE THE HIKE, NO BACK ISSUES.  THERE IS A NUMBER OF FEATURES IF YOU ARE YOU HAVE EVERYTHING THAT YOU NEED YOU CAN LOAD THIS WITH THE PAP SMEAR INSTRUMENTS, WHAT HAVE YOU.  HAS A HEATED TOP FOR, YOU KNOW, A NUMBER OF DIFFERENT REASONS.

THAT BEING SAID, THE PRODUCT IS VERY FLUID IN REGARD TO JUST MAKING IT ACCESSIBLE AND MAKING IT EASY AND TRYING TO GET THE ACCESSORIES ON IF YOU NEED AND BACK OFF IF YOU DON’T.  THERE IS A BALANCE THERE WHEN YOU GO TO 650 POUNDS, ALL OF THE ACCESSORIES HAVE TO BE RATED, THEY ARE PRETTY HEAVY AND PRETTY DURABLE SO —

>> DAVID BAQUIS:  JON, THANK YOU FOR BRINGING THE TABLE OUT.  WE WILL TAKE A QUESTION.  I THOUGHT IT WAS IMPORTANT THAT THIS MEETING HAVE A DEMONSTRATION OF EQUIPMENT, AND NOT JUST TALK AND LOOK AT SLIDES.  WE APPRECIATE THAT.  I GUESS WE WILL TAKE ONE QUESTION FROM WHOM?

>> YOUR TABLE, THE ONE — IS IT FORMALDEHYDE FREE AND FOR PEOPLE WITH CHEMICAL SENSITIVITIES ARE DESIGNING BUILDING THINGS WITH ANY ECOLOGY POST CONSUMER —

>> YEAH, THESE ARE ACTUALLY CARD COMPLIANT AND KNOW THE CASH II AS WELL.  THE EMISSIONS CODE, AND WHAT HAVE YOU.  WE ARE VERY SENSITIVE TO THAT.  WE DO — THIS IS ACTUALLY A VINYL TYPE OF UPHOLSTERY, WE HAVE POLYURETHANE, WHICH IS VINYL, DOES NOT HAVE IT IN THE BENEFITS OF THE VINYL, THEY ARE WICKED EXPENSIVE AND DURABLE.  IF YOU NEED VINYL-FREE, WE HAVE THOSE SOLUTIONS AS WELL.  WE ARE LEAD CERTIFIED IN ALL OF OUR CABINETRY, AND WE CAN GET LEAD CREDITS FOR BUILDING.  WE ARE LOOKING AT THOSE DIFFERENT THINGS.  WE ARE A SUPPLIER TO A LOT OF THE MAJOR HEALTHCARE INSTITUTIONS SO WE WORK WITH THAT EVERY DAY, SO APPRECIATE IT.

>> DAVID BAQUIS:  THANK YOU.  ROSEMARY, I RECEIVED A FLURRY OF E-MAILS FROM THE CHEMICAL SENSITIVITY COMMUNITY ALREADY, THEY WILL BE HAPPY THAT YOU PUT THE ISSUE ON THE RADAR.  THERE WILL BE TIME FOR QUESTIONS AT THE END OF THE DAY AS WELL AS FOLLOWING THE NEXT FEW PANELS.  BUT NOW I WOULD LIKE TO INTRODUCE OUR NEXT PANELISTS.  OKAY.  WE ARE GOING TO HEAR FROM THE PERSPECTIVE OF STANDARDS NOW.

AND FIRST WE WILL HEAR FROM CAROL HERMAN, WHO IS THE DIRECTOR OF THE STANDARDS PROGRAM AT THE FDA CENTER FOR DEVICES AND RADIOLOGICAL HEALTH.  AS YOU MAY RECALL THE STATUTE REQUIRES THE ACCESS BOARD TO DEVELOP OUR STANDARDS QUOTE, UNQUOTE, IN CONSULTATION WITH THE FDA.

SO, IT’S BEEN A PLEASURE TO WORK WITH THE FDA SO FAR.  THERE IS A LOT OF EXCITEMENT FROM MANY MEMBERS OF THEIR STAFF AND THEY OFFERED SOME RESOURCES TO HELP ANALYZE STANDARDS.  WE WILL LEARN A LITTLE BIT MORE ABOUT MEDICAL STANDARDS FROM CAROL.  AND THEN WE ARE GOING TO HEAR FROM JACK WINTERS, I HAVE KNOWN PROFESSOR WINTERS FOR A WHILE IN THE AREA OF HEALTH INFORMATION TECHNOLOGY.  AND HIS WORK AT THE CENTER FOR ACCESSIBLE MEDICAL INSTRUMENTATION WAS FUNDAMENTAL IN THE STANDARD THAT HE IS GOING TO TALK ABOUT THAT THE ACCESS BOARD WILL LOOK TOWARDS LEANING ON FOR DEVELOPING OUR STANDARDS.

SO, I THINK WE WILL JUST START WITH YOU CAROL.  PROCEED PLEASE.

>> THANK YOU, DAVID.  >> SO,WE HAVE JUST RECENTLY STARTED WORKING WITH THE ACCESS BOARD AND WE THINK WE HAVE A LOT TO LEARN ABOUT HOW THE ACCESS BOARD OPERATES.  FDA, THIS IS A NEW EXPERIENCE FOR US.  I THINK IT’S NEW EXPERIENCE FOR THE ACCESS BOARD WORKING WITH FDA.  I AM GOING TO TAKE A FEW MINUTES TO GIVE YOU A LITTLE OVERVIEW OF WHAT WE ARE AND HOW WE REGULATE AND WHAT WE DO.

>> HERE IS A BRIEF OVERVIEW OF FDA SIMPLY STATED PROMOTE AND PROTECT PUBLIC HEALTH.  THAT’S FIRST AND FOREMOST GOAL BY KEEPING SAFE EFFECTIVE PRODUCTS, MAKE SURE THEY REACH THE MARKET IN A TIMELY WAY.  WE MONITOR PRODUCTS FOR CONTINUED SAFETY AFTER THEY ARE IN USE AND WE HELP THE PUBLIC GET THE ACCURATE SCIENCE BASED INFORMS NEEDED TO IMPROVE HEALTH.  THIS IS TRUE, WHETHER IT’S A DRUG, WHETHER IT’S A MEDICAL DEVICE, WHETHER IT’S SPINACH, IT ALL COMES DOWN TO US.  WE HAVE A WIDE RANGE OF PRODUCTS THAT WE ARE RESPONSIBLE FOR.  THESE PRODUCTS FROM FOOD INGREDIENTS TO COMPLEX MEDICAL DEVICES LIFE SAVING DRUGS AND RADIATION EMITTING CONSUMER AND MEDICAL PRODUCTS IT’S A TRILLION DOLLAR A YEAR INDUSTRY THAT TRANSLATES TO ABOUT 25 CENTS PER EVERY DOLLAR IS REGULATED BY FDA.

AND THAT IS SIGNIFICANT OBVIOUSLY.

VARIETY OF APPROACHES.  NEW DRUGS AND COMPLEX MEDICAL DEVICES MUST BE PROVEN SAFE AND EFFECTIVE BEFORE COMPANIES MARKET THEM X-RAY MACHINES AND MICROWAVE OVENS MEASURE UP TO PERFORMANCE STANDARDS AND COSMETICS AND DIETARY CAN BE MARKETED WITH NO PRIOR APPROVAL.  TO CLARIFY A BIT OF SOME THINGS THAT WERE SAID EARLIER TODAY ABOUT WHAT DEFINES A DIAGNOSTIC PIECE OF EQUIPMENT.  THERE IS A DISTINCTION BETWEEN DIAGNOSTIC EQUIPMENT AND MONITORING EQUIPMENT.

AND HOW WE REGULATE IS BY THE MANUFACTURER’S DEFINITION OF THE INTENDED USE OF THE DEVICE.  SO THEY TELL US WHAT THAT INTENDED USE IS.  AND IN THAT INTENDED USE, THEY DEFINE IT AS A DIAGNOSTIC DEVICE.  IF THEY DEFINE IT AS A MONITORING DEVICE IT’S A MONITORING DEVICE AND NOT A DIAGNOSTIC DEVICE.  IT’S VERY MUCH DEPENDENT ON HOW INDUSTRY DESIGNS, MANUFACTURERS AND PROMOTES THEIR PRODUCT.

CONTINUING WITH THE BRIEF OVERVIEW OF FDA, FDA USES REGULATIONS AND PRODUCT STANDARDS AS YARDSTICKS THAT’S WHAT WE ARE GOING TO TALK ABOUT TODAY.  BECAUSE WE HAVE A NEW RELATIONSHIP WITH THE ACCESS BOARD AND HOW CAN THE WORK THAT WE DO IN STANDARDS DEVELOPMENT TO ENSURE SAFETY AND EFFICACY WITH MEDICAL DEVICES HOW CAN THAT HELP THE ACCESS BOARD ACHIEVE THE GOALS OF THIS NEW ACT.

AND SO, WE HAVE, BACK IN 1995, THERE WAS A LAW THAT WAS PUBLIC LAW 104-113 THE NATIONAL TECHNOLOGY TRANSFER AND ADVANCEMENT ACT OF 1995.  BASICALLY WHAT THE LAW SAYS GOVERNMENT AGENCIES MUST NOT WRITE MANDATORY PERFORMANCE STANDARDS IN LIEU OF VOLUNTARY CONSENSUS STANDARDS UNLESS THAT’S THE ONLY WAY TO GET THE JOB DONE.

AND SO, FDA HAS TAKEN THAT TO HEART.  AND IN A NEW ACT, THE FOOD AND DRUG MODERNIZATION ACT, WE TOOK IT TO HEART.  AND WE ACTUALLY CHANGED OUR BUSINESS MODEL AND HAD YOU WE ACTUALLY REGULATE — HOW WE USE STANDARDS IN REGULATING MEDICAL DEVICES IF YOU GO TO WWW.STANDARDS.GOV YOU CAN LEARN ABOUT THE NTTAA AND LEARN ABOUT HOW FEDERAL AGENCIES NOT JUST FDA BUT HOW ALL FEDERAL AGENCIES ARE UTILIZING THE NTTAA, AND HOW THEY ARE USING DEVICES IN THEIR REGULATORY PROCESSES.

SO, AGAIN, WITH THE FOOD AND DRUG MODERNIZATION ACT, WE INTRODUCED A PROGRAM IN 1997.  IN THAT PROGRAM, WE REQUIRED THE RECOGNITION OF VOLUNTARY CONSENSUS STANDARDS TO THE PREMARKET REVIEW PROCESS.  WHAT IT MEANS, IT ALLOWS INDUSTRY TO CITE STANDARDS WE HELP TO DEVELOP, WE HELPED TO DEVELOP THE STANDARDS WE RECOGNIZE THEM AND INDUSTRY KNOWS WHAT YOU ARE EXPECTATIONS ARE WITH RESPECT TO THE USE OF THOSE STANDARDS.

AND THAT THEORETICALLY THEN IS HELPS THE REVIEWERS TO REVIEW THE PREMARKET SUBMISSIONS MORE RAPIDLY.  IT REQUIRES ALLOWANCE OF A DECLARATION OF CONFORMITY OF STANDARDS TO EXPEDITE REVIEW PROCESSES, IF THEY FOLLOW TO THE LETTER OF THE STANDARD.  IF THEY FOLLOW IT THEY ARE NOT REQUIRED TO SUBMIT DATA TO US REQUIRING A LENGTHIER REVIEW PROCESS.  SO, THAT’S ONE OF THE GREAT BENEFITS OF THE WAY WE USE STANDARDS IN THE PREMARKET PROCESS.  SINCE THE IMPLEMENTATION OF THE PROGRAM, WE HAVE RECOGNIZED 867 VOLUNTARY CONSENSUS STANDARDS AND IN ORDER TO BE ABLE TO DO THAT, WE PARTICIPATE JUST THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH NOT ALL OF FDA BUT JUST CDRH PARTICIPATES IN 535 COMMITTEES CURRENTLY AND A QUARTER OF OUR STAFF ARE LIAISONS THAT SIT ON THE COMMITTEES TO MAKE SURE THE STANDARDS NOT ONLY GET WRITTEN BUT THEY HELP TO MEET THE REGULATORY NEEDS AND REQUIREMENTS.  TO FIGURE OUT WHAT — WHICH COMMITTEES WE ARE GOING TO SIT ON, WE ASK OURSELVES THE QUESTIONS IS THIS THE RIGHT STANDARD DOES IT WORK IN THE RIGHT AREA AND DOES IT HELP MEET YOUR PROGRAM NEEDS.

SO STANDARDS UTILIZATION — IT’S A VERY IMPORTANT TOOL FOR US, OBVIOUSLY THEY CAN GET PRODUCTS TO MARKET FASTER.  AND STANDARDS ARE A MAJOR CONTRIBUTOR TO SAFE PRODUCTS.  HORIZONTAL STANDARDS ARE VERY, VERY IMPORTANT BECAUSE THEY CAN COVER A BROAD RANGE OF MEDICAL PRODUCTS.

STERILITY AS AN EXAMPLE WHETHER IT’S FOR CARDIOLOGY OR WHETHER IT’S ORTHOPEDIC, STERILITY IS STILL ON IMPORTANT PROCESS THAT’S INVOLVED IN THE MANUFACTURER OF THOSE MEDICAL DEVICES.  SO THAT’S CONSIDERED A HORIZONTAL STANDARD.  VERTICAL ARE VERY SILOED AND ARE VERY PRODUCT SPECIFIC.

THE ANESTHESIA RELATED EQUIPMENT IS GOING TO BE A VERTICAL STANDARD BECAUSE IT’S A VERY SPECIFIC PRODUCT LINE.

WE OPERATE WITH BOTH NATIONAL AND INTERNATIONAL STANDARDS COMMITTEES BUT OBVIOUSLY WITH THE GLOBAL MARKETPLACE SUCH AS IT IS WITH EACH AND EVERY YEAR WE FOCUS MORE AND MORE ON INTERNATIONAL STANDARDS.

STANDARDIZATION IS BASED ON SOLID DATED RESULTS OF SCIENCE TECHNIQUE AND EXPERIENCE, IN SOME PARTICULAR APPLICATIONS ARE UNITS OF MEASURE TERMINOLOGY AND SYMBOLS PRODUCTS AND PROCESSES AND SAFETY OF PERSONS AND GOODS.

I THINK WHAT WE ARE TALKING ABOUT HERE TODAY FIT VERY NICELY UNDER THOSE — WE HAVE TALKED A LITTLE BIT ABOUT STANDARDIZATION IF WE HAVE NEW EQUIPMENT AND POSSIBLY DIFFERENT KINDS OF EQUIPMENTS WITHIN MEDICAL FACILITIES, WE ARE GOING TO NEED THE STANDARDIZATION TO ENSURE THAT THE HEALTHCARE USERS CAN MOVE — MOVE EFFECTIVELY BETWEEN ONE PRODUCT AND ANOTHER.

SO WHY DO WE LIKE VOLUNTARY CONSENSUS STANDARDS OTHER THAN THAT’S THE LAW?  AND I THINK THIS CRITERIA IS REALLY IMPORTANT.  THAT IT’S WHERE I THINK ALL OF YOU MATTER AND FIT IN VERY NICELY.  CRITERIA INCLUDE OPENNESS, AND BALANCE OF INTEREST DUE PROCESS APPEALS PROCESS AND CONSENSUS IT’S THE BALANCE OF INTEREST I THINK PROBABLY HAS THE MOST SIGNIFICANCE HERE.  IF YOU HAVE A NEED AND YOU HAVE A DOG IN THE FIGHT, YOU NEED TO BE AT THE TABLE.  THAT’S WHERE YOUR INTERESTS GET MET.

AND THAT’S WHY FDA IS AT THE TABLE IN EACH AND EVERY AREA WHERE WE THINK THAT WE HAVE VESTED INTEREST.  BECAUSE IF WE ARE NOT THERE OUR REGULATORY NEEDS ARE NOT GOING TO BE MET.  OTHER REGULATORY NEEDS ARE GOING TO BE MET, THE EU’S REGULATORY NEEDS WILL BE MET WITH THEIR DIRECTIVES OR JAPAN’S OR SOMEONE ELSE’S.  IF WE ARE NOT AT THE TABLE OUR REGULATORY NEEDS ARE NOT GOING TO BE MET.  I AM GOING TO HIGHLY RECOMMEND TODAY HERE THAT TO THE EXTENT POSSIBLE THAT THIS COMMUNITY ALSO NEEDS TO TRY TO GET A SEAT AT THE TABLE.  FDA WILL DO WHAT WE CAN OBVIOUSLY, AS WE BETTER UNDERSTAND THE NEEDS OF THIS COMMUNITY AND AS WE ARE WORKING WITH THIS COMMUNITY TO MAKE SURE THAT WE HAVE BETTER PRODUCTS OUT THERE AND YOU ARE GOING TO HEAR MORE ABOUT SOME HUMAN FACTORS STANDARDS THAT ARE GOING TO HELP ENSURE THAT WE GET BETTER PRODUCTS OUT THERE.  WE WILL — WE WILL DO WHAT WE CAN, BUT IT CAN’T TAKE THE PLACE OF THIS COMMUNITY ALSO BEING WHERE THEY THINK, YOU KNOW WHERE WE IDENTIFY GREAT NEEDS FOR YOU TO BE AT THOSE TABLES.  WE PRIORITIZE ACTIVITIES BECAUSE WE CAN’T, THE 535 COMMITTEES, WE DON’T HAVE UNLIMITED RESOURCES WE CAN’T BE — WE CAN’T PUT THE SAME LEVEL OF EFFORT INTO EACH AND EVERY ONE OF THOSE.  SO WE HAVE TO ASK OURSELVES THESE QUESTIONS IF WE ARE GOING TO TRY TO MAKE SURE THAT WE ARE AT THE RIGHT TABLES AT THE RIGHT TIME AND SO TO WHAT EXTENT WOULD THE SAFETY AND EFFECTIVENESS THAT’S FIRST AND FOREMOST IS PUBLIC HEALTH THAT’S IN EVERYTHING THAT WE DO.  OF THE REGULATED PRODUCTS BE IMPROVED TO WHAT EXTENT WOULD THE RESULTING STANDARDS BE USEFUL IN REDUCING OUR OWN WORK LOADS, SO WE COULD GET THROUGH PRODUCT REVIEWS FASTER AND IS THE STANDARD INTENDED TO BE INTERNATIONAL OR PART OF JUST NATIONAL OR PART OF AN INTERNATIONAL PROGRAM.  AND OBVIOUSLY WE ALSO MEET BETTER NEEDS IF WE CAN BE INTERNATIONAL TO THE EXTENT POSSIBLE.

SO, HERE WE ARE TODAY AND SO HOW ARE WE GOING TO IMPLEMENT THIS OR HELP US — HOW DOES THIS HELP US WITH THE PROCESS THAT WE HAVE BEFORE US OR WITH THE TASK BEFORE US.

SO THERE IS SECTION 4203 OF THE PATIENT PROTECTION AND AFFORDABLE CARE ACT.  ACCESSIBLE STANDARDS ARE NEEDED TO ENSURE THAT SUCH EQUIPMENT ARE ACCESSIBLE AND USABLE BY INDIVIDUALS WITH DISABILITIES TO THE MAXIMUM EXTENT POSSIBLE.  WE ALL KNOW THAT NOT EVERY MEDICAL DEVICE WE ARE GOING TO MEET EVERY SINGLE NEED BUT TO THE MAXIMUM EXTENT POSSIBLE I THINK THAT’S A GOAL FOR ALL OF US TO WORK FOR.

SO, THE STANDARDS.  THE STANDARDS REQUIREMENTS OF THE ACT ARE THAT THE STANDARDS WILL ADDRESS EQUIPMENT USED BY HEALTHCARE PROFESSIONALS IN CONJUNCTION WITH PHYSICIAN’S OFFICES CLINICS EMERGENCY ROOMS HOSPITALS AND OTHER MEDICAL SETTINGS FOR DIAGNOSTIC PURPOSES.

AND YOU HAVE TO REMEMBER THAT ANOTHER LITTLE CAVEAT THAT MAYBE I CAN THROW OUT HERE FDA DOES NOT REGULATE THE PRACTICE OF MEDICINE.  A LOT OF WHAT IS BEING DISCUSSED HERE TODAY ARE THINGS THAT YOU WOULD LIKE TO SEE HEALTHCARE FACILITIES TAKE UNDER CONSIDERATION.  AND I THINK ALL OF THAT IS WELL AND GOOD.

AND I THINK YOUR PROFESSIONAL ASSOCIATIONS WRITE VERY GOOD PRACTICE GUIDELINES THAT WILL HELP ENSURE THAT THOSE KINDS OF — THOSE NEEDS GET MET.

BUT WHEN YOU ARE TALKING ABOUT STANDARDS FOR MEDICAL PRODUCTS, WE ARE TALKING ABOUT VOLUNTARY CONSENSUS STANDARDS, WE ARE TALKING ABOUT SAFETY AND PERFORMANCE STANDARDS AND NOT USE PRACTICES FOR USE.  THOSE COME — THEY COME DIFFERENTLY AND ACTUALLY I THINK JACK MIGHT TALK ABOUT THAT A LITTLE BIT AS WELL.

SO EXAMINATION TABLES AND CHAIRS MAMMOGRAPHY EQUIPMENT, X-RAY MACHINES AND OTHER RADIOLOGICAL EQUIPMENT AND WEIGHT SCALES ARE EXAMPLES, THE TYPES OF EQUIPMENT THAT THE STANDARDS WILL ADDRESS.  HOW CAN FDA AND ACCESS BOARD WORK TOGETHER TO MEET THESE REQUIREMENTS.  MANY STANDARDS ALREADY EXIST.  I TOLD YOU THAT WE HAVE RECOGNIZED CURRENTLY 867 STANDARDS.  SO ONE OF THE FIRST THINGS THAT CDRH IS UNDERTAKING IS A GAP ANALYSIS, HOW MANY OF THE STANDARDS ALREADY EXIST THAT COULD JUST BE TWEAKED — MAYBE THEY ALREADY MEET OUR NEEDS, BUT WE HAVEN’T IDENTIFIED THAT THEY ACTUALLY MEET ACCESSIBILITY NEEDS.  HOW MANY OF THEM ALREADY EXIST.  THERE IS A SAFETY OR PERFORMANCE STANDARD OUT THERE THAT JUST NEEDS A NEW SECTION TO MEET — TO BE WRITTEN TO ADD TO IT TO HAVE IT REVISED SO THAT IT COULD MEET THE ACCESSIBILITY NEEDS.  AND THEN TO THE EXTENT POSSIBLE WE WILL LEVERAGE THE STANDARDS CITING THEM IN THE NEW REGULATIONS.  INSTEAD OF THE ACCESS BOARD HAVING TO WRITE STANDARDS FROM A BLANK PIECE OF PAPER, THE IDEA THAT WE ARE COLLABORATING WITH AND MEETING WITH AND DISCUSSING IS ACTUALLY WRITING UMBRELLA STANDARD WHERE WE CAN CITE THE EXISTING VOLUNTARY CONSENSUS STANDARDS AND HAVE THOSE ACTUALLY WORK FOR US AND WE CAN GET TO — WE CAN GET THESE REQUIREMENTS AND THESE GOALS ACCOMPLISHED MUCH FASTER.  AN EXAMPLE OF THAT.  WE HAD A REQUIREMENT, WE HAD A MANDATORY LASER STANDARD THAT WE HAD THE REGULATIONS FOR MANY, MANY YEARS WE FOUND THAT THROUGH THE REGULATORY THE WRITING REGULATIONS PROCESS, WHICH IS VERY CUMBERSOME, WAS TAKING FAR LONGER THAN WE COULD KEEP UP WITH IT.

SO ACTUALLY, THAT MANDATORY STANDARD WAS GETTING FURTHER AND FURTHER BEHIND THE SCIENCE.

SO STANDARDS HAVE TO BE — THEY ARE REQUIRED TO BE REVISED ON A REGULAR SCHEDULE.  YOU CAN’T SAY WE WILL GET AROUND TO IT WHEN WE GET AROUND TO IT.  THERE IS A SCHEDULE.

AND THEY HAVE — IT STARTS IN FIVE YEARS IF IT’S NOT — IF IT’S NOT DONE WITHIN 10 YEARS IT DISAPPEARS.

SO YOU HAVE VERY RIGID REQUIREMENTS FOR GETTING THESE THINGS DONE.  SO THIS IS A MUCH FASTER WAY TO STAY CURRENT WITH — WITH SCIENCE AND SO IN THE — IN THE REGULATION IN THE LASER REGULATION, WE WORKED WITH IEC, WHICH IS THE INTERNATIONAL ELECTROTECHNICAL COMMISSION TO BE ABLE TO CITE A SECTION — SECTIONS A PARTICULAR SECTION OF THE LASER — THE VOLUNTARY CONSENSUS STANDARDS FOR LASERS THAT MET OUR REGULATORY REQUIREMENTS.  WE STILL HAVE IN THE REGULATIONS WE HAVE A MANDATORY LASER REQUIREMENT, REGULATION BUT IT CITES AND PEOPLE GO THEN TO THE VOLUNTARY CONSENSUS STANDARD TO FOLLOW THAT.  AND THAT’S THE SCENARIO THAT I AM SUGGESTING THAT WE MIGHT WANT TO UTILIZE HERE TO MEET THE REQUIREMENTS OF THIS ACT.

SO, WHERE STANDARDS, WHERE NEW STANDARDS MIGHT BE NEEDED BECAUSE THEY DON’T ALREADY EXACTLY, CDRH WILL PROVIDE LEADERSHIP TO ASSURE NECESSARY STANDARDS EITHER GET REVISED OR DEVELOPED.  BECAUSE THEY ARE ON A RIGOROUS SCHEDULE, THEY WILL BE MUCH MORE CURRENT THAN IF WE HAD TO WRITE MANDATORY PERFORMANCE STANDARDS THROUGH THIS.

SO, SOME PRODUCTS — HOW ARE WE GOING — HOW ARE WE GOING TO DEAL WITH SOME OF THESE PRODUCTS THAT ARE WRITTEN INTO THIS ACT, IN FACT ARE EXEMPT FROM THE CLASS I EXEMPT DEVICES, THEY ARE EXEMPT FROM REGULATION.  WE ARE GOING TO USE, I HAVE GOT HERE HOSPITAL BEDS AS A GREAT EXAMPLE.  BECAUSE HOSPITAL BEDS IN FACT ARE CLASS I EXEMPT DEVICES.  ALTHOUGH THEY CAN POSE SOME — THEY CAN POSE SOME RISK.  THEY HAVE THE LEGACY DEVICES, THEY HAVE BEEN ON THE MARKET FOR A VERY LONG TIME.  AND THE WAY THAT WE IDENTIFY AND WORK THROUGH THOSE RISKS ARE BY WRITING GOOD GUIDANCES FOR INDUSTRY AND GOOD STANDARDS TO HELP IMPROVE CONSTANTLY IMPROVE THE SAFETY AND EFFECTIVENESS OF THOSE DEVICES.

AND EVEN THOSE THEY ARE CLASS I EXEMPT, WE ARE STILL AT THE TABLE.  WE STILL HAVE A HIGH PRIORITY ON THOSE, WE THINK IT’S IMPORTANT FOR US TO BE AT THE TABLE AND TO CONTINUE TO IMPROVE THE SAFETY OF THOSE DEVICES.

I ENCOURAGE YOU IF YOU KNOW OF ANY — IF ANY VOLUNTARY CONSENSUS STANDARDS OUT THERE THAT MIGHT MEET ANY OF OUR NEEDS TO CONTACT ME AND MY CONTACT INFORMATION IS GOING TO BE AT THE END AND WE WILL LOOK AT ANYTHING THAT CAN BE IDENTIFIED BY ANYONE IN THIS ROOM AS A GOOD BASE STANDARD TO FOR INCLUSION.  SO, TO SORT OF WRAP THIS UP, SO WE CAN MOVE TO A VERY SPECIFIC AND VERY IMPORTANT STANDARD WHY STANDARDS BESIDES THE LAW?  FOR US IT’S BECAUSE IT IMPROVES TIME FROM TO MARKET IT IMPROVES THE SAFETY AND EFFECTIVENESS OF THE DEVICES ON A CONTINUING BASIS.  IT — THE PRODUCT IT FACILITATES PRODUCT DESIGN AND PERFORMANCE.  WE ARE GOING TO TALK ABOUT THAT AGAIN WITH DR. WINTERS.  WE ARE GOING TO CONTINUE TO RAISE THE BAR ON SAFETY AND EFFECTIVENESS.  IT FACILITATES COMMUNICATION — COMMUNICATION ALSO BETWEEN REGULATORS AND INDUSTRY YOU CAN PUT A PRICE ON THAT IT’S VERY IMPORTANT.  IT SERVES AND EDUCATION FOR US INTERNALLY HERE IS MY CONTACT INFORMATION IF YOU WANT TO E-MAIL ME ABOUT ANYTHING — I THINK WE WILL TAKE QUESTIONS AT THE VERY END INSTEAD OF RIGHT NOW I OTHER WOULD LIKE TO TURN IT OVER TO JACK TO TALK ABOUT AAMI HE75.

>> I WILL TRY TO PRETTY MUCH SAY ALL OF THE WORDS THAT WAS ON HERE I WENT TEXT HEAVY FOR ACCESSIBILITY REASON THE TITLE IS AAMI HE75-HUMAN FACTORS ENGINEERING DESIGN OF MEDICAL DEVICES.  THIS IS TARGETED TO DESIGNERS.  WE WILL BE SPECIFICALLY TALKING ABOUT SECTION — WHAT ENDED UP BEING SECTION 16 ACCESSIBILITY CONSIDERATIONS, WHICH WERE AUTHORED BY MYSELF, MOLLY STORY AND ANOTHER COLLEAGUE MELISSA HELPED US OUT.  I AM HERE ON BEHALF OF AAMI HUMAN FACTORS ENGINEERING, I AM PROFESSOR OF BIOMEDICAL AT MARQUETTE UNIVERSITY AND BEEN A PROFESSOR 25 YEARS.  I WAS ALSO THIS IS IMPORTANT AS WELL, I WAS THE PRINCIPAL INVESTIGATOR AND CO-DIRECTOR OF THE REHABILITATION RESEARCH CENTER ON MEDICAL INSTRUMENTATION WHICH JUNE MENTIONED EARLIER.  I AM WEARING A COUPLE OF HATS MY MAIN HAT IS THAT AS A CONCERNED CITIZEN AND MEMBER OF THE HUMAN FACTORS COMMITTEE.  THE TITLE IS OVERVIEW THERE ARE THREE PARTS:  FIRST IS A BRIEF BACKGROUND ON THE REHAB ENGINEERING RESEARCH CENTER AND MEDICAL INSTRUMENTATION PARTLY TO PROVIDE FRAMEWORK.  ONE IS THE CONCEPT OF ACCESS THE OTHER IS CONCEPT OF DEVICES AND NEXT IS CONCEPT OF INDIVIDUALS IN TECHNOLOGY AND ROLES.  OKAY?  THEN WE WILL TALK ABOUT WHAT IS IN AAMI HE75 SPECIFICALLY THE ACCESSIBILITY CONSIDERATION SECTION I WILL GIVE YOU A BRIEF OVERVIEW OF THE ENTIRE SCOPE THAT’S IMPORTANT.

AND I WILL ALSO MENTION ITS RELATION TO THE RECENT DEPARTMENT OF JUSTICE AND HHS DOCUMENT WHICH IS I THINK A WONDERFUL DOCUMENT.

AND THEN THERE WILL BE BRIEF SUGGESTIONS AND FUTURE DIRECTIONS.

THE TITLE OF THIS REHABILITATION RESEARCH CENTER ON ACCESSIBILITY MEDICAL INSTRUMENTATION 2002-2009 THIS WAS ON BEHALF OF NIDRR THEY HAVE EACH CENTERS GETS 4 AND A HALF MILLION WE COMPETED WERE FORTUNATE TO GET AN AWARD IN 2002 THE VISION WAS ALL PERSONS SHOULD HAVE ACCESS TO HEALTHCARE PRODUCTS FACILITIES AND SERVICES AND TO EMPLOYMENT IN THE HEALTHCARE PROFESSIONS REGARDLESS OF DISABILITY.  THAT’S A HIGH VISION BUT THAT’S A VISION OF THE TEAM CONSISTED OF FIVE INSTITUTIONS:  MARQUETTE IN THE LEAD, WESTERN UNIVERSITY WHICH JUNE REPRESENTS AND BRENDA PLAYED A CRITICAL ROLE THERE AS WELL.  UNIVERSITY OF CALIFORNIA AT SAN FRANCISCO AND BERKELEY THE CRITICAL — THE PRINCIPAL INVESTIGATOR FOR THE SUBCONTRACT WAS DR. DAVID WHO RUNS THE LAB THERE.  MOLLY STORY WAS WORKING THROUGH THERE.  UNIVERSITY OF CONNECTICUT AND THE DOCTOR WHO RAN NATIONAL STUDENT DESIGN COMPETITION ABOUT 15 OR 20 UNIVERSITIES PARTICIPATE EVERY YEAR TO DESIGN ACCESSIBLE PRODUCTS.  AND THEN THE UNIVERSITY OF WISCONSIN AND MILWAUKEE DR. ROGER SMITH WHO YOU HEARD OF IN ONE TARGETED PROJECT.  THAT’S OUR TEAM.

AND ON THIS SLIDE IT’S ENTITLED RERC RESEARCH AND DEVELOPMENT PROGRAMS VERY BRIEFLY TO GIVE YOU A BROAD SWEEP AND MOVE ON ON RESEARCH SIDE MOLLY STORY COORDINATED WE HAD R1 NEEDS ANALYSIS JUNE WAS IN THIS.  NATIONAL SURVEYS OVER 400 INDIVIDUALS WITH DISABILITIES WE DISSEMINATED THAT IT’S IN A BOOK AT THE BACK OF THE ROOM.  JUNE HAS A COUPLE OF CHAPTERS IF YOU READ CHAPTER 4 FROM JUNE AND YOU REALIZE IT WAS WRITTEN FOUR, FIVE YEARS AGO HERE IS THE BOOK.  IT’S SHOWS SOME OF THE INSIGHTS THAT SHE HAD.  THERE WAS R2 USABILITY ANALYSIS INVOLVING HUMAN SUBJECT STUDIES WITH VARIOUS PRODUCT LINES DEVICES.  WITH INDIVIDUALS WITH DIVERSE ABILITIES WE WILL COME BACK TO THAT.  WE HAD PROJECT R3 WITH ACCESSIBLE MEASURES THIS LED BY DR. ROGER SMITH THAT TARGETED TECHNOLOGY WE CALLED MED AUDIT LOOKING AT WAYS OF PROVIDING METRICS FOR THE ACCESSIBILITY OF DEVICES.  WE ALSO HAD POLICY ANALYSIS RUN THROUGH WESTERN UNIVERSITY ON THE DEVELOPMENT SIDE WE HAD TOOLS FOR ANALYSIS, WHICH I AM GOING TO SAY A COUPLE OF WORDS ABOUT.  THEN WE HAD NEW INSTRUMENTATION EMERGING TECHNOLOGIES AND GUIDELINES AND POLICIES.

I AM GOING TO SKIP OVER NOW AND TALK ABOUT PROJECT D1 TOOLS FOR ONE OR TWO TARGETED REASONS ONLY.

FIRST, THIS IS WHAT WE DEVELOPED WHAT WE CALLED MOBILE USABILITY AND ACCESSIBILITY LAB, MUA LAB.  THE JOINT TEAM WAS MARQUETTE UNIVERSITY AND UNIVERSITY OF CALIFORNIA.  THE CORE TEAM WE HAD A NUMBER OF STUDENTS INVOLVED OVER THE YEARS BUT THE CORE TEAM WAS MYSELF AND MELISSA LEMKE AND THE OTHER DOCTORS AT UNIVERSITY OF CALIFORNIA.  THE TOOL WAS USED FOR A NUMBER OF PROJECTS IT COULD GO IN A SUITCASE GO ON SITE IT HAD MODULAR EQUIPMENT.  IT INTEGRATED CONCEPTS FROM ACCESSIBILITY ERGONOMICS UNIVERSAL DESIGN.  ONE COMMENT IS ACCESSIBILITY DOES NOT EQUAL USABILITY IF YOU MAXIMIZE USABILITY USING USABILITY TESTING YOU WON’T NECESSARILY MAXIMIZE ACCESSIBILITY THEY ARE DIFFERENT METRICS WE WILL TALK MORE ABOUT THAT AS WE PROCEED.  THAT’S IMPORTANT TO RECOGNIZE.

OKAY.  SOME UNIQUE FEATURES OF THE MOBILE USABILITY AND ACCESSIBILITY LAB VERSUS USABILITY TESTING PROTOCOLS WHICH ARE USED IN THE MEDICAL DEVICE INDUSTRY AND THROUGHOUT ALL HUMAN FACTORS THIS IS IMPORTANT.

WE DID THINGS LIGHTLY DIFFERENTLY.  WE HAD A PROTOCOL MANAGER WEB-BASED SOFTWARE HELPED COORDINATE THE RESEARCH PROCESS INCLUDING CRITERIA FOR SUBJECT SELECTION.

IN OTHER WORDS, SUBJECTS WITH DIVERSE ABILITIES, THAT’S NOT THE NORMAL USABILITY TESTING AS DOCUMENTED IN MANY, MANY BOOKS AND TEXTBOOKS AND THE LIKE INVOLVES 12, 8 TO 12 INDIVIDUALS AT BEST ONE WILL HAVE A DISABILITY, OKAY?  DIFFERENT MODEL.  I WANT TO POINT IT OUT WE WERE PURPOSELY GOING FROM DIVERSABILITY FROM THE GET-GO.  WE HAD PRE AND POST ACTIVITY INTERVIEW FORMS, PRE BECAUSE WE WANTED TO UNDERSTAND WHAT THEY THOUGHT OF THE EQUIPMENT THEY WERE GOING TO BE USING WHILE WE VIDEOED THEM POST BECAUSE WE WANTED TO UNDERSTAND WHAT WE THOUGHT.

SO WE HAD A VERY, VERY STRUCTURED PROCESS THIS IS FREELY AVAILABLE IF OTHERS WANT TO PICK UP ON IT IT’S AVAILABLE IN CALIFORNIA WISCONSIN, FDA HAS ONE AS WELL.

AND WE ALSO FOCUSED IN OUR VIDEO-BASED ANALYSIS ON THE DIFFICULTY TO ACCESS OF THE THIS IS A METRIC USED IN AROUND THE WORLD NOW WHERE YOU HAVE DIFFICULTY METRIC WHERE YOU HAVE DEGREES OF DIFFICULTY THAT END WITH IMPOSSIBLE.

DEGREES OF DIFFICULTY.  OKAY?

MOVING ON, NOW HERE IS SOMETHING ELSE I WANT TO MENTION BEFORE WE GET INTO THE STANDARD.  THERE ARE OVER 10,000 MEDICAL DEVICES.  THE TITLE IS EVALUATE WHAT PRODUCTS FROM OVER 10,000 CATEGORIES OF MEDICAL INSTRUMENTATION/DEVICES/EQUIPMENT.

ONE CATEGORY IS DIAGNOSTIC DEVICES AND EQUIPMENT.  THAT CAN INCLUDE HEALTH DIAGNOSIS IMAGING AND THE LIKE.  BUT THERE ARE OTHERS.  PROCEDURAL DEVICES THIS IS BIG.  MUCH OF HEALTHCARE IS PROCEDURAL IN NATURE RIGHT?  A SEQUENCE OF TASKS.  AND FOR INSTANCE MANUAL TOOLS IN DENTISTRY WOULD BE AN EXAMPLE OF PROCEDURAL DEVICES.

THERAPEUTIC DEVICES WHETHER FOR PHYSICAL THERAPY OR DRUG THERAPY OR RADIATION THERAPY.  THERE ARE ALSO THERAPEUTIC DEVICES, THESE ARE CLASSIFIED IN THE FDA.  IN OUR CLASSIFICATION SYSTEM THERE ARE ALSO ASSISTIVE TECHNOLOGIES WHETHER POSTURE MANIPULATION SENSORY COMMUNICATION COGNITION.  I THINK YOU GET THE IDEA.  YOU HAVE TO SOMEHOW SLIM IT DOWN.

NOW, IN THIS THE TITLE OF THIS SLIDE IS SIMPLIFIED CLASS STRUCTURE FOR MEDICAL DEVICES/EQUIPMENT/INSTRUMENTATION.  THERE ARE FIVE CIRCLES EACH WITH A COUPLE OF WORDS.  AT THE TOP LEFT IS SURGICAL SLASH PROCEDURAL INSTRUMENTATION.  THERE IS DIAGNOSTIC IMAGES MEDICAL DEVICES ON THE LEVEL LEFT CLINICAL HOME MONITORING AND THERAPY DEVICES.  THESE THREE ARE THE FOCUS.  AND THEN BEHIND THEM IS PATIENT SUPPORT SURFACE OPERATE.  IT’S A LITTLE BIT BEHIND BUT IT’S A PILLAR BECAUSE IT’S NEEDED FOR SURGERY, IT’S NEEDED FOR DIAGNOSTIC IMAGING.  IT’S NEEDED FOR MONITORING THERAPY.  YOU NEED TO HAVE PATIENT SUPPORT SURFACE APPARATUS, BUT IT’S EASY FOR IT TO BE IN THE BACKGROUND.

ALSO, OFF IN THE BACKGROUND IS HEALTHCARE RECORDS ESPECIALLY ELECTRONIC HEALTHCARE RECORDS.  WE ARE TRYING TO PARTITION A VERY BIG WORLD INTO FIVE AREAS.  RECOGNIZING IT MAKES SOME SENSE IN SOME CASES PEOPLE ARE SERIOUSLY LOOKING AT DIAGNOSTIC IMAGING, THEY MAY NOT PUT AS MUCH FOCUS ON PATIENTS SUPPORT SURFACE APPARATUS.  AS AN EXAMPLE OF THAT, FDA HAS CLASSES ONE THROUGH THREE, THE VAST MAJORITY OF EXAM TABLES CHAIRS BEDS, YOU NAME IT, ARE CLASS I OR CLASS II.

MOST ARE CLASS I EXEMPT OR CLASS II EXEMPT.

OKAY.  NOW IF I WAS RUNNING THE FDA AND I HAVE TO WORRY ABOUT RISK MANAGEMENT I WOULD PUT THE MAJORITY OF MY FUNDS IN MY CLASS II AND CLASS III PRODUCTS — THOSE ARE THE ONES PERCEIVED TO BE THE HIGHEST RISK, THEY ARE ON THE RADAR SCREEN, BUT THEY ARE NOT QUITE AS HIGH IF THEY ARE CLASS I EXEMPT.  MAKE SENSE?

I JUST MENTION THAT IN PASSING.  AND IT’S NOT ANYTHING WRONG OR RIGHT ABOUT IT IT’S JUST REALITY.

OKAY.  I JUST WANT TO MENTION RELEVANT RERC AMI DELIVERABLES BECAUSE THEY ARE OF IMPORTANCE HERE.  AND THEN WE GO RIGHT INTO THE STANDARD ONE IS WE DECIDE TO HAVE THE STATE OF THE SCIENCE CONFERENCE WHICH NIDRR REQUIRES, AT THE FDA.

IT WAS JOINT WITH THE FDA, THIS WAS A WONDERFUL EXPERIENCE, THE TITLE OF THE WORKSHOP, ACCESSIBLE INTERFACES FOR MEDICAL INSTRUMENTATION DRAFT GUIDELINES AND FUTURE DIRECTIONS, INTERESTING, HUH?  THIS HAPPENED IN OCTOBER OF 2005.  AT THE THEN FDA HEADQUARTERS IN ROCKVILLE.  THERE WERE OVER 60 ATTENDEES FROM THE MEDICAL DEVICE, HUMAN FACTORS, FROM THE REHAB DISABILITY COMMITTEE.  I WANT TO MAKE A POINT THESE ARE PROFESSIONALS AND THEY WERE NOT TALKING THE SAME LANGUAGE.

THE MAJORITY OF INDIVIDUALS FROM THE MEDICAL DEVICE HUMAN FACTORS COMMITTEE HAD NEVER HEARD OF SECTION 508 OF THE REHAB ACT.  NEVER HEARD — I AM NOT SAYING THIS IN A CRITICAL WAY AT ALL.  AND THE FUNNY THING THEY ARE LOOKING AT HUMAN TECHNOLOGY INTERFACE, AND THEY CARE A LOT, RIGHT?  I WILL GET TO THAT A LITTLE BIT MORE IN TERMS OF THE EDUCATION THAT WENT INTO THIS PROCESS.

OKAY.  THESE RECOMMENDATIONS ARE ACTUALLY CHAPTER 31 IN A BOOK ENTITLED MEDICAL INSTRUMENTATION:  ACCESSIBILITY AND USABILITY CONSIDERATIONS, WHICH IS SITTING RIGHT BY ME CHAPTER 31 EDITED BY MYSELF AND MOLLY STORY CAME OUT IN CRC PRESS IN 2007 IT’S SUDDENLY SELLING BETTER I WONDER WHY.  11 OF THE 31 CHAPTERS OF DUE TO RERC STAFF AND THE LIKE.  WE ALSO HAVE A SERIES OF TECHNICAL REPORTS WOMAN COMING FROM WESTERN UNIVERSITY JUNE WAS AN AUTHOR ON APPEARED HER COLLEAGUES.  SOME COMING FROM STUDENTS PROJECTS ON DIFFERENT PRODUCTS LINES LIKE INFUSION AND THINGS LIKE THAT.

AND THOSE WE CAN MAKE AVAILABLE IF YOU WANT.  WE HAVE A NUMBER OF JOURNAL PAPERS AND THE LIKE IN TERMS OF STANDARD ACTIVITIES WE WERE INVOLVED IN A LOT WE HAVE A PORTFOLIO THAT WE WERE PARTICIPATING IN.  ONE OF THEM WAS THE AAMI HUMAN FACTORS ENGINEERING COMMITTEE OF WHICH HE75 WAS A BIG TARGET.

OKAY?

NOW, I AM GOING TO MENTION THE FACT THAT I HATE TO DO THIS IN A WAY THE FACT WE WERE NOT RENEWED IT WAS NOT CONSIDERED A PRIORITY BY NIDRR TO RENEW US IN 2007 WE WROTE A PROPOSAL.  THE INTERESTING THING WE INVOLVED FDA BIG TIME IN OUR PROPOSAL.  THE PROJECT R4 I THINK THE TITLE IS IMPORTANT SAFETY EFFICACY AND ACCESSIBILITY STUDIES WITH THE FDA, WINTERS AND JOEL MYKLEBUST, HE IS HERE.  WE ARE INTERESTED IN UNDERSTANDING BETTER IN R AND D RELATIONS BETWEEN ACTUAL DEVICES USERS IN DIVERSE ABILITIES WITH DIVERSE ENVIRONMENTS.  EVERYBODY CAN BE TEMPORARILY DISABLED IN A CHALLENGING ENVIRONMENT RIGHT?

HE WANTED TO TARGET ONE NEW TARGET CLASS PER YEAR FOCUS ON EACH FOR TWO YEARS.  WE HAVE TWO GOING OUT AT ONCE, THE FIRST WAS GOING TO BE INFUSION WE HAD DONE PILOT WORK.  WE WANTED TO HAVE A VIRTUAL INTERFACE.  I DON’T WANT TO SAY TOO MUCH ABOUT IT EXCEPT IT ALLOWS YOU TO DO MORE CONTROLLED STUDIES YOUR RESULTS CAN BE EXTENDIBLE TO MORE PRODUCT LINES, WHICH IS NICE.  THAT IS MOBILE USABILITY HUMAN MOTION CONTACT FORCES, AND EMG’S.  ANOTHER PROJECT WAS D4 DESIGN GUIDELINES AND POLICY DEVELOPMENT.  LEMKE, KAILES AND JUNE PLAYED A ROLE JUNE PLAYED A ROLE ON THAT I THINK THAT’S PART OF THE REASON WE ARE HERE SHE DESERVES SOME OF THAT CREDIT.

HERE IS WHAT WE HAVE.  I THINK WE HAVE HAD THIS READ BEFORE.  SECTION 510 ESTABLISHMENT OF STANDARDS FOR ACCESSIBILITY MEDICAL DIAGNOSTIC EQUIPMENT.  STANDARDS SHALL ENSURE THAT SUCH EQUIPMENT IS ACCESSIBLE TO USABLE BY INDIVIDUALS WITH ACCESSIBILITY NEEDS AND ALLOW INDEPENDENT ENTRY TO USE OF AND EXIT FROM THE EQUIPMENT BY SUCH INDIVIDUALS TO THE MAXIMUM EXTENT POSSIBLE.

ENGINEERING LIKE TO SEE WORDS LIKE THAT.

AND THEN IT INCLUDES VARIOUS CATEGORIES WE MENTIONED BEFORE.  THE MAIN POINT — I WANTED TO MAKE SURE THIS WILL APPLY TO EQUIPMENT THAT INCLUDES EXAM TABLES, EXAM CHAIRS, EYE, DENTAL, WEIGHT SCALES, MAMMOGRAPHY, X-RAY AND THE LIKE.  IT DOESN’T MEAN THAT IT CAN’T INCLUDE MORE, JUST INCLUDES.

OKAY.  NOW, IN TERMS OF LOOKING AT THAT, ONE OF THE THINGS — WHEN I TEACH REHAB ENGINEERING WE TALK ABOUT THE ING’S:  POSITIONING, TOUCHING, MANIPULATING, COMMUNICATING, HEARING, SEEING.  IF YOU LOOK AT WHAT WAS WRITTEN ON THE PREVIOUS PAGE, THE BIG FOCUS IN TERMS OF ACTIVITY CATEGORIES RELATED TO ACCESS DIFFICULTIES IS POSITIONING.

NOW, THERE IS A HEALTHCARE COMMUNICATION STANDARD THAT IS USED IN THE U.S. AND NATIONALLY AND THEY ALWAYS LOOK AT ENTITIES AND ROLES PARTICIPATING IN ACTS.  A PERSON AN ENTITY IS A PERSON PLACE THING OR NOUN.  A PERSON DOES NOT EXIST UNTIL THEY ARE IN A ROLE, THAT ROLE TO BE PATIENT PROVIDER WHATEVER.  I AM A TEACHER I AM A SCIENTIST I AM A DAD THOSE ARE ALL ROLES; I CAN FLIP BETWEEN THEM QUICK.  ONCE YOU ARE IN A ROLE YOU CAN PARTICIPATE IN ACTS.  MAIN MEDICAL PROCEDURES HAVE A SEQUENCE OF ACTIONS THAT WE CONSIDER.  THIS IS HOW REIMBURSEMENT IS DONE BETWEEN MEDICAL ELECTRONIC PACKAGES AND THE LIKE.  I JUST WANT TO MENTION THAT ENTITIES AND ROLES PARTICIPATING IN ACTS MOST OF THE PARTICIPATION HERE ARE THAT WE ARE TALKING ABOUT ARE PERSON IN THE ROLE OF PATIENT BEING POSITIONED.  TO SOME EXTENT REACHING IS IN A SLIGHTLY SMALLER FONT BUT REACHING MATTERS BECAUSE YOU HAVE TO REACH GRAB BARS AND THE LIKE.  JUST TO PROVIDE YOU A CONTEXT FOR WHERE THIS FITS IN.  OUR ROLE WAS IN THE SECTION ON ACCESSIBILITY CONSIDERATIONS WAS PRETTY FUNDAMENTAL IT WAS NOT PART OF THE PLAN.  THERE WAS NO PART OF THE COMMITTEE’S ORIGINAL SCOPE OR PLAN THAT INVOLVED ACCESSIBILITY CONSIDERATIONS; WE PUSHED OUR WAY IN.  THIS WAS A DIRECT OUTPUT OF NIDRR.  THE TIME LINE WAS WE STARTED GOING TO THE MEETING IN 2005 WE BECAME A MEMBER.  AND THEN IN 2006 WE WROTE A PROPOSAL FOR SECTION HE — WITHIN HE-75 ON ACCESSIBILITY CONSIDERATIONS FOR MEDICAL DEVICES.  THE AUTHORS WERE MYSELF, MOLLY AND MELISSA, AND AFTER A LOT OF ITERATIONS REMEMBER ALL OF THE STAKEHOLDERS ARE GATHERED HERE VERY IMPORTANT IS THE FACT THAT THE STAKEHOLDERS WERE THERE.  ALL OF THE MAJOR MEDICAL DEVICE COMPANIES WERE AT THE TABLE ALL OF THEM.  ABBOTT, GE.  METRONIC GO DOWN THE LIST THEY WERE THERE.  THAT’S REALLY IMPORTANT.

AND WE HAD TO DO A LITTLE BIT OF GIVE AND TAKE IT WAS A VERY LONG ITERATIVE PROCESS I GOT THE MOST FRUSTRATED PROBABLY OF THE THREE OF US.  THE CO-CHAIRS MATT AND ED ARE WORTH POINTING OUT THEY WERE WONDERFUL IN THIS WHOLE PROCESS THEY WERE INCLUSIVE OF US.  WE WERE TWO OF 40 FORMAL MEMBERS 3 OF THE 23 AUTHORS IN THIS PROCESS.

AND IT WENT OUT FOR PUBLIC COMMENTARY IN 2008.  WHAT IS IN IT?  REAL QUICKLY, I WANT TO GIVE YOU A BROAD SWEEP THEN SECTION 16.  THE BROAD SWEEP THERE ARE DEFINITIONS YOU HAVE TO MENTION DEFINITIONS.  THEN THERE WAS A SECTION ON GENERAL CONSIDERATIONS AND PRINCIPLES SECTIONS 4 THROUGH 16.  THE GENERAL PRINCIPLE SECTION CHAPTER 4 IS WELL WRITTEN.  WORTH READING.

THE NUMBER 5 IS MANAGING THE RISK OF USE ERROR.  IF YOU WANT TO UNDERSTAND WHAT THE FDA HAS TO DO, READ CHAPTER 5.  GIVES YOU A GOOD SENSE OF THE CHALLENGES.

6 IS BASIC HUMAN SKILLS AND ABILITIES.  7 IS ANTHROPOMETRY AND BIOMECHANICS.  8 IS ENVIRONMENTAL CONSIDERATIONS.  NOT BAD.

9 IS USABILITY TESTING IT’S VERY WELL WRITTEN BUT USABILITY TESTING IN THE PROTOCOLS ESTABLISHED DO NOT REQUIRE IN ANY WAY THAT YOU HAVE PERSONS WITH DISABILITIES AS PART OF THE INDIVIDUALS YOU ARE TESTING.

OKAY?

16 WE ARE 10 FOR A LONG TIME IN THE FINAL EDITING WE BECAME 16 IT’S ACCESSIBILITY CONSIDERATIONS.  WE ARE PAGES 230 YOU CAN SEE HIGH UP THIS IS A LONG STANDARD.  A LOT OF WORDS.  I WANT TO POINT OUT DESIGN ELEMENTS.  SECTION 18 THROUGH 21 ARE ALSO RELEVANT.  18 IS CONTROLS, WHICH IS INPUT DEVICES 19 IS VISUAL DISPLAYS WHICH IS OUTPUT GETTING TO A PERSON.  THOSE ARE IMPORTANT SECTIONS I WILL SAY SOME WORDS ABOUT OUR PARTICIPATION IN SOME OF THE SUBTLETIES OF THE LANGUAGE OF SOME OF THE SECTIONS.

ALSO WITHIN INTEGRATED SOLUTIONS THE VERY LAST CHAPTER IS SECTION 25 ON HOME HEALTHCARE AND THAT’S A VERY GOOD SECTION AUTHORED PRIMARILY BY DARYL GARDNER WHO IS WONDERFUL THROUGH THE WHO PROCESS FOR US.

FROM THE INTRODUCTION HUMAN FACTORS ENGINEERING IS THE APPLICATION OF HUMAN CAPABILITIES PHYSICAL SENSORY EMOTIONAL AND INTELLECTUAL AND LIMITATIONS TO DESIGN AND DEVELOPMENT OF TOOLS DEVICES SYSTEMS ENVIRONMENTS AND ORGANIZATIONS.

GREAT DEFINITION.  THE PERSPECTIVE USERS OF THIS.  THIS IS REALLY IMPORTANT, THE PROSPECTIVE USES.  MEDICAL DEVICE MANUFACTURERS WHO ARE DESIGNING PRODUCTS PERSONS IN THE ROLE OF DESIGNER ANALYST.  ALSO HEALTHCARE FACILITIES EVALUATING DEVICES FOR PURCHASE.  REGULATORS AND OTHER ORGANIZATIONAL ENTITIES.  AND STUDENTS IMPORTANT TO ME A GOOD PRACTICE IN MEDICAL DEVICE DESIGN.  WE ARE TRYING TO TRAIN THE DESIGNERS OF THE FUTURE AFTER ALL.

THIS IS ONE I ADDED IN YOU DON’T HAVE ON THE WEB IF YOU LOOK AT SECTION 16 I THINK IT’S REALLY IMPORTANT HOW WE DEFINE USER.

USES ARE A PERSON WHO INTERACTS WITH THE PRODUCT.  PERIOD.

USE ERROR.  NO LONGER IS IT USER ERROR, IT’S USE ERROR PATTERN OF USE FAILURE THAT INDICATES A FAILURE MODE THAT IS LIKELY TO OCCUR WITH USE, THUS HAS A REASONABLE POSSIBILITY OF PREDICTABILITY OF OCCURRENCE.

IT CAN BE ADDRESSED BY A USABILITY TESTING.  THAT’S WHAT IT SAYS.  HERE IS THE MOST IMPORTANT OF ALL INTENDED USER.  A LOT OF YOU HAVE NEVER HEARD THAT TERM GET TO KNOW IT.  THIS IS THE BREAD AND BUTTER OF WHAT THE FDA HAS TO DEAL WITH.  INTENDED USERS POPULATION SEGMENT FOR WHICH A MANUFACTURER HAS DEVELOPED A PARTICULAR DEVICE, EXPLICITLY RECOGNIZING THE GROUP’S SPECIFIC REQUIREMENTS AND CHARACTERISTICS.  THE FDA RECEIVES PROPOSALS.  THEIR MISSION IS SAFETY AND EFFECTIVENESS OR EFFICACY.  THE OTHER MISSION IS EFFECTIVENESS AND SAFETY.

IT’S UP TO THE MANUFACTURER TO SAY WHO THE INTENDED USERS ARE.  A LOT OF DEVICES, THE INTENDED USERS DO NOT INCLUDE GUESS WHAT?  OKAY.  SO THERE CAN BE A BIG DIFFERENCE BETWEEN THE INTENDED USERS THAT THE MANUFACTURER DEFINES TO GET THROUGH THE SYSTEM, AND THE ACTUAL USERS.  OKAY?

BUT THIS IS THE ROLE THAT THE — WORLD THAT THE FDA LIVES IN ANOTHER IMPORTANT TERM USER GROUP SOMEBODY SET OF INTENDED USERS WHO ARE DIFFERENTIATED FROM OTHER INTENDED USERS BY FACTORS THAT ARE LIKELY TO YOU IN — TO INFLUENCE USABILITY SUCH AS AGE CULTURE OR EXPERTISE.  MOST OF YOU KNOW WHAT DIRECT ACCESS AND INDIRECT ACCESS IS, I DON’T NEED TO SAY DIRECT ACCESS IS ACCESS TO DEVICE CAPABILITIES FOR PEOPLE WITH DISABILITIES THAT DEPENDS ONLY ON THE DEVICE ITSELF.  INDIRECT ACCESS YOU HAVE ACCESS TO THE DEVICE CAPABILITIES BY SUPPORTING CONNECTION TO OR USE WITH ASSISTIVE TECHNOLOGIES SUCH AS SCREEN READERS SPEECH CONTROL TECHNOLOGIES CAPTIONING TECHNOLOGIES WHEELCHAIRS AND THE LIKE.

I MENTIONED THAT BECAUSE WE GOT THAT IN AND APPROVED.

IN TERMS OF WHAT WE ORIGINALLY PLANNED TO HAVE FOUR SECTIONS FUNCTIONAL MODE FOR ACCESS, WHICH WAS VERY MUCH BASED ON SECTION 508 OF THE REHAB ACT THE ADA ACCESSIBILITY GUIDELINES THE TELECOMMUNICATIONS ACT ACCESSIBILITY GUIDELINES, THE WIDE WORLD WEB GUIDELINES FOR WEB ACCESSIBILITY AND OTHERS.  NOW, A LOT OF THESE FOR SECTION 508 ARE OF THOSE FORM PROVIDE ONE MODE OPERATION/INFO RETRIEVAL THAT DOES NOT REQUIRE OR SUPPORT AN INTERFACE FOR ASSISTIVE TECHNOLOGY.  THIS CONCEPT IS NEW TO MOST PEOPLE IN THE ROOM DURING THESE MEETINGS.  WE HAD DESIGN FOR ALL OR UNIVERSAL DESIGN THAT DIDN’T MAKE IT.  THE NUMBER ONE MADE IT SECTION 16.3, WHICH I AM ABOUT TO TALK ABOUT.  UNIVERSAL DESIGN WAS INTEGRATED AROUND NO PART OF THE DOCUMENT.  PATIENT SUPPORT SURFACES IS CUT ROUGHLY IN HALF.  16.4 MOST RELEVANT TO TODAY.  TELECOM GOT CUT.  IT’S MOTIVATED BY MAINSTREAM ADVANCES IN TELECOM.  IT’S THREE TO FIVE YEARS BEHIND YOU KNOW SOCIETY IN MANY WAYS IN TERMS OF INNOVATION IN AREAS SUCH AS INFORMATION TECHNOLOGY AND THE LIKE THAT’S JUST TO BE EXPECTED.  THEY HAVE TO DESIGN TO BE VERY SAFE.

NOW, THERE IS A GENERAL CONSIDERATIONS PART TO THIS.  THIS WAS INTENDED TO BE EDUCATIONAL TO THE HUMAN FACTORS COMMUNITY.

I AM SAYING THIS BECAUSE THIS IS WHAT YOU HAVE ON THE ACCESS BOARD WEB PAGE.  YOU CAN LOOK AT THINK ABOUT WHAT YOU PERSONALLY THINK SHOULD BE INCLUDED AND NOT INCLUDED.  I WANT TO QUICKLY SWEEP THROUGH IT ALL SO YOU ARE AWARE OF IT ALL.

THEY WON’T ALL BE USED I KNOW THAT.

SO THIS WAS INTENDED IN PART TO EDUCATE READERS.  WE HAVE A TABLE ABOUT DISABILITY.  WE ADDED A COLUMN ABOUT FUNCTIONAL LIMITATIONS TO HELP PROVIDE GUIDANCE TO DESIGNERS.

THERE IS ALSO A TABLE 2.  THIS IS AN IMPORTANT TABLE.  MOST OF THE INDIVIDUALS IN THE ROOM DIDN’T HAVE A GOOD SENSE OF WHAT WERE ASSISTIVE TECHNOLOGIES.  WE DEFINE THEM IN 13 ROWS AND THEN WE HAD COLUMNS AND THESE INCLUDE CANES, CRUTCHES, WALKERS, GUIDE CANES, WHEELCHAIRS, SCOOTERS, STEPPING TOOL, SPEECH RECOGNITION, HEADSTICK, MOUTHSTICK, AMERICAN SIGN LANGUAGE, TEXT, PHONE, SCREEN READER, BRAILLE, YOU GET THE IDEA.  IN COLUMNS WE DEFINED THE FUNCTION OF THESE AND INTERFACE CONSIDERATIONS FOR THEM.

I THINK THAT WAS IMPORTANT FOR THE MEDICAL DEVICE COMMUNITY.

NOW, IN THE FIRST SECTION THESE DESIGN GUIDELINES ARE BASED ON EXISTING LEGISLATIVE GUIDANCE DOCUMENTS, TO BE HONEST THAT’S HOW WE GOT THEM IN.  AS I SAID BEFORE, THESE ARE BASED WITH THE AMERICANS WITH DISABILITIES ACT DISABILITY GUIDELINES, SECTION 508 OF THE REHAB ACT AND SPECIFICALLY SUBPART C ON FUNCTIONAL PERFORMANCE CRITERIA.

AND THEY ARE ALSO BASED ON THE TELECOMMUNICATIONS ACT ACCESSIBILITY GUIDELINES.  IN MANY CASES, WE POINT IT FORWARD AND PEOPLE IMMEDIATELY SAID NO.  WE POINTED OUT AND WE GOT GOOD AT MAPPING THEM.

THESE WERE ALREADY FEDERAL LAW.  THESE WERE ALREADY FEDERAL REGULATIONS THAT EXISTED AND WE WENT THROUGH GIVE AND TAKE AND IT WAS A GREAT PROCESS ACTUALLY AND WONDERFUL BECAUSE OF THE CROSS — THERE WERE LONG COMMITTEE MEETINGS THREE OR FOUR TIMES A YEAR DIFFERENT CITIES.  OKAY IN THIS DOCUMENT, THERE IS TITLE USER WITH LOWER EXTREMITY DISABILITIES.  I HAVE A QUOTE HERE THE DEVICE SHOULD HAVE AT LEAST ONE MODE OF USE THAT DOES NOT REQUIRE THE USER TO STAND OR MAINTAIN UNSUPPORTED POSTURES SUCH AS SPECIFIC HEAD, TORSO, ARM AND LEG POSITIONS.

THE TITLE OF THIS ENDED UP BEING CLUMPED IN USERS WITH DISABILITY EXTREMITIES WE ARE TALKING ABOUT POSTURE.  BUT THE FINAL EDITING THAT HAPPENED TO CREEP IN AND I DIDN’T CATCH IT.

THERE IS A SECTION THERE TOTALLY RELATED TO ADAAG FIGURES IN THERE RELATED TO REACH.  FORWARD AND SIDE REACH WE YOU CAN LOOK AT THAT.  THERE IS SECTION ON SIGHT LINES.  FOR BOTH SEATED AND STANDING USERS.  THERE IS A SMALL SECTION ON NEUTRAL BODY POSITION MAINTENANCE OF POSTURE IS BIG.  THERE IS A SECTION ON ACCESSIBLE SPACE ROOM FOR ASSISTIVE TECHNOLOGIES AND ASSISTANCE.  MY SUGGESTION IS INCLUDE THIS AND MAYBE CHANGE THE TITLE AND CONTEXTS TO USE FORCE.  OTHER PHYSICAL DISABILITIES POSITIONING FOR ACCESS.  THIS IS TO ASSIST WITH FEDERAL GUIDANCE.

THERE IS ALSO WHAT ENDED BEING CALLED UPPER EXTREMITY DISABILITIES I WANTED TO POINT THIS OUT I THINK THERE IS GOING TO BE A STRONG MOVE NOT TO INCLUDE A LOT OF THIS I WANT TO POINT OUT THE DEVICE SHOULD HAVE AT LEAST ONE MODE OF USE THAT DOES NOT REQUIRE FINE MOTOR CONTROL OR PERFORMANCE OF SIMULTANEOUS ACTIONS AND GOES ON FROM THERE BASED ON SECTION 508.

AND THEN ADHERENCE TO THIS, FOLLOWING GUIDANCE CAN INCREASE THE ACCESSIBILITY OF MECHANICAL CONTROLS THAT USERS WITH DISABILITIES MUST REACH AND MANIPULATE.

NOW, THERE IS AN A THROUGH I HERE.  I JUST WANT TO POINT OUT B IS OPERABLE WITH ONE HAND WHEN POSSIBLE; C IS EITHER HAND; AND F IS THE FORCE REQUIRED TO ACTIVATE CONTROLS AND KEYS SHOULD BE AT MOST FIVE POUNDS TO GIVE YOU A SAMPLE OF WHAT SOME OF THESE ARE.  THEY WON’T BE USED — YOU MIGHT WANT TO LOOK THEM OVER.

THIS COULD BE CHANGED TITLEWISE TO, USERS WITH DISABILITIES, ACCESS TO OPERATING DEVICES.

NOW, THE NEXT SECTION WON’T BE INCLUDED.  I WANT TO MAKE YOU AWARE USERS WHO ARE DEAF OR HARD OF HEARING THE DEVICE SHOULD HAVE AT LEAST ONE MODE OF OPERATION AND GOES ON FROM THERE.  ANOTHER IS USERS WHO ARE BLIND AND HAVE VISUAL IMPAIRMENTS OR LOW VISION.  THERE IS A WHOLE BUNCH OF VISUAL ACUITY COLOR.  THIS IS COMING FROM EXISTING FEDERAL GUIDANCE PROBABLY NOT TO BE USED I WANT TO MAKE YOU AWARE IT’S THERE.  MAYBE THERE ARE ADVOCATES.

ALSO INCLUDING ON SECTION 16.3.6 WE ARE UP TO 6.  THIS USERS WITH LIMITED TACTILE SENSITIVITY SOME OF THAT WE MIGHT WANT TO CONSIDER.  IT MENTIONED MODE OF USE THAT DOES NOT DENY ON USER’S TACTILE — YOU GET THE IDEA.  USERS WITH COGNITIVE OR MEMORY IMPAIRMENTS.  MINIMIZING THE DEMANDS OF THE USER’S COGNITIVE AND MEMORY ABILITIES.  AND THEN 16.3.8 USERS WHO COULD BENEFIT FROM HAVING MORE TIME FOR DEVICE OPERATION.  I WANT TO POINT OUT USUALLY WHEN YOU THINK ABOUT TIME CRITICAL OPERATION YOU THINK ABOUT SOMETHING ELECTRONIC RIGHT?

BUT THAT ALSO COULD WORK IT’S WAY INTO THE TIME IT TAKES TO GET ON TO A TABLE.

RIGHT?

AND I AM TRYING TO MINIMIZE USE ERRORS.

OKAY.  SECTION 16.4 IS PROBABLY THE BREAD AND BUTTER OF WHAT WILL BE USED:  RESEARCH-BASED DESIGN GUIDELINES FOR PATIENT-SUPPORT SURFACES.  IN THE OVERVIEW, WE TALKED ABOUT THE RERC.  I DON’T NEED TO SAY TEACH.  WE USE MOBILE USABILITY AND ACCESSIBILITY LAB FOR 9 STUDIES.  IN EVERY CASE WE HAD SUBJECTS WITH DIVERSE ABILITIES.  WHATEVER PRODUCT LINE, WE LOOKED AT TWO PRONGS ESPECIALLY RELEVANT MELISSA LEMKE, HER MASTER THESIS SHE BECAME A FULL-TIME ENGINEER ON OUR PROJECT.  SHE LOOKED AT EXAM TABLES, DENTAL CHAIRS, HOSPITAL BEDS, AND WEIGHT SCALES FOR A DOZEN INDIVIDUALS WITH DIVERSE ABILITIES.  A VERY THOROUGH PROCESS HERE.  THE HUMAN FACTORS ENGINEERING COMMITTEE GAVE A PAPER OF THE YEAR TO A PAPER MELISSA AND MYSELF WROTE IN 2008.  WHAT WE DID; WE USED METRICS DEGREE OF DIFFICULTY TO ACCESS.  ONE OF THE THINGS THAT I WANT TO POINT OUT ONE OF THE THINGS WE EVALUATED IS QUOTE ACCESSIBLE WEIGHT SCALE.  ACCESSIBILITY HAS DEGREES.  WHAT MATTERS IS WHERE YOU WANT TO DRAW THE LINE IN THE SAND RIGHT?  WHAT BARS YOU WANT TO HAVE AND TECHNICAL SPECIFICATIONS WHERE YOU DRAW THE LINE.

IT’S ALWAYS A PROCESS OF COMPROMISE.  THE OTHER ONE I WANTED TO MENTION IS MOLLY STORY HER R AND D.  SHE WAS FULL-TIME, OF COURSE, AND HER PH.D. DISSERTATION IN 2008 FOCUSED ON IMAGING PLATFORMS.

AND SHE ALSO IN CALIFORNIA WORKED ON EXAM TABLES, GLUCOMETERS, AND A LOT OF PRODUCTS.  WE HAVE A LOT OF KNOWLEDGE.

THIS WAS PARTITIONED.  THIS IS WHAT MADE IT IN.  THIS IS NOT WHAT WE STARTED WITH, BUT MADE IT IN THROUGH CONSENSUS PROCESS.  16.4.2 IS WIDTH OF DEVICE BASE.  THE BASE SHOULD NOT GO BEYOND THE SURFACE OF SUPPORT.  THAT IS SOMETHING JUNE MENTIONED AS WELL.  WE MENTIONED CLEARANCE FOR LIFT EQUIPMENT.  WE COULDN’T GET REAL SPECIFIC HERE THEY DIDN’T — IT DIDN’T MAKE SENSE TO GET OVERLY EXPLICIT BUT IT’S IN THERE.  ADJUSTABILITY FOR SURFACE HEIGHT WE MENTIONED 19 AS LOW SOME PEOPLE WOULD LIKE IT TO BE 17 BUT WHAT WE HAVE IN THERE IS 19.  WE MENTIONED THE TRANSFER PATH.  AND MODULAR SIDE RAILS AND ARM RESTS AND THE LIKE.  WE HAVE EXPLICIT DISCUSSION ABOUT THAT.  WE MENTIONED HAND-HOLDS AND THEY SHOULD BE INTEGRATED IN WITH THE DEVICE AND WE HAVE GUIDANCE THERE.

WE MENTION CONTACT SURFACES FOR EXAMPLE FOR TRANSFER SAFETY AND MAINTENANCE OF POSTURES.  I WANT TO MENTION MAINTENANCE OF POSTURE AS BEING SUPER IMPORTANT IT’S SUPPORTING THEM WHILE THEY MAINTAIN A POSTURE WHICH IS NEED NEEDED FOR A SIGNIFICANT PERIOD OF TIME.  CONTROL FOR SUPPORT SURFACES MAKING THEM EASY TO USE.  I WANT TO SAY A COUPLE OF WORDS.

>> THE DEPARTMENT OF JUSTICE AND HHS CAME OUT WITH A DOCUMENT MENTIONED ACCESS TO MEDICAL CARE FOR PERSONS WITH MOBILITY DISABILITIES.  IT’S A WONDERFUL DOCUMENT.

IT’S JOINTLY DONE WITH DEPARTMENT OF JUSTICE AND HHS IT’S A TECHNICAL ASSISTANCE DOCUMENT.  BUT I WANT TO MENTION IT TARGETS PROVIDERS AND FACILITIES.  LOOK AT HOW COMPLIMENTARY THIS IS HE-75 TARGETS WHO?  MANUFACTURERS DESIGNERS.

LET ME GIVE YOU AN EXAMPLE ONE OF THE THINGS THAT WE LOST WAS THE IDEA OF WEDGES AND CUSHIONS AND THE LIKE I REMEMBER TALKING RECENTLY TO AN X-RAY PROFESSOR, AND WHO WAS VERY FRUSTRATED BECAUSE THEY TALK ABOUT HOW TO POSITION PEOPLE WITH WEDGES 15 DEGREE, 30 DEGREE 45 DEGREE AND THAT KIND OF THING.

THEN THE STUDENTS WOULD GO OFF TO THE HOSPITALS AND SOME OF THEM WOULD BE MISSING.  TRAIN THEM AND THEN YOU KNOW — THAT’S NOT SOMETHING WE CAN ASK THE DESIGNER TO DO THAT IS SOMETHING WE CAN ASK THE FACILITY TO DO.  WHY SHOULD WE BE WORRYING ABOUT WEDGES THEY ARE RIGHT THEY ARE DEVELOPING IMAGING TECHNOLOGY THEY SHOULDN’T WORRY ABOUT THE WEDGES AND CUSHIONS THAT’S UP TO THE FACILITY TO DO.  DEPARTMENT OF JUSTICE DOCUMENT DOES A WONDERFUL JOB COMPLIMENTING HE-75 IT’S A DIFFERENT TARGET BOTH ARE NEEDED, OKAY?  THE FOCUS IS, AGAIN, ON PERSONS WITH IN THE ROLE OF PROVIDERS STAFF AND ADMINISTRATIVE.  IT’S ALSO A FOCUS ON PERSONS WHO ARE DISABLED IN THE ROLE OF PATIENT.  AND FOCUS ON TRANSFERRING AND POSITIONING AND MAINTENANCE.  I WANT TO MENTION MAINTENANCE YOU NEED TO MAINTAIN A POSTURE.  PAGES 8 THROUGH 19 OF PART 4 OF THE 19-PAGE DOCUMENT IS ON ACCESSIBILITY MEDICAL EQUIPMENT.  WHICH IS WONDERFUL.  I WANT TO POINT OUT IT’S FULLY COMPLIMENTARY WITH SECTION 16.4.  THAT WE WROTE.

OKAY.  TARGETED EQUIPMENT FEATURES INCLUDE EXAM TABLES AND CHAIRS.  I HAVE A COUPLE OF THINGS I WANT TO POINT OUT.  TRADITIONAL FIX HEIGHT EXAM TABLES OR TREATMENT TABLES OR PROCEDURE STABILITY, DEPARTMENT OF JUSTICE IS ASSUMING AN EXAM TABLE A TREATMENT TABLE AND PROCEDURE TABLE ARE THE SAME THING.

OKAY?

SO, I JUST WANTED TO POINT THAT OUT.

OKAY.  ARE TOO HIGH FOR MANY PEOPLE WITH MOBILITY DISABILITY TO USE.  I WANT TO POINT OUT THEY ARE EXPLICIT ABOUT STRETCHERS AND GURNEYS.

SO THOSE WORDS ARE UNDERLINED, I WANT TO POINT OUT POSITIONING AND SUPPORT SIDES SUCH AS WEDGES OR ROLLED UP BLANKETS SHOULD BE AVAILABLE I WANT TO POINT THAT OUT AS IMPORTANT.  PATIENTS LIFTS MORE THAN WE COULD PUT INTO HE-75 RADIOLOGIC EQUIPMENT INCLUDING MAMMOGRAPHY AND THEY HAVE TREATMENT OF WEIGHT SCALES AS WELL.

MY SUGGESTION IS IMPLEMENT ALL OF SECTION 16.4 AND COMPLIMENT IT WITH THIS AS A START.  BECAUSE THEY ARE DIFFERENT TARGETS DESIGNERS VERSUS PROVIDERS.

NOW, THE LAST ONE IN HERE IS ONE CLOSE TO MY LOVE, DESIGN GUIDELINES FOR WEB-BASED MOBILE AND HOME-USE HEALTH CARE PRODUCTS BASED ON INDUSTRY GUIDANCE.  IT HAS GONE UP EVERY SINGLE YEAR.  IT’S NOT THE TARGET HERE I WANTED TO POINT OUT THERE ARE ASPECTS YOU MIGHT WANT TO CONSIDER.  SECTION 16.5.2 EXISTING GUIDELINES AND STANDARDS MENTIONED ACCESSIBILITY GUIDELINES EXPLICITLY.  THERE IS BUILT IN MULTI-MODAL CAPABILITIES AND DEVICES THAT USE HOME BASED TECHNOLOGIES EXISTING GUIDELINES, IT TALKS ABOUT VIDEO CONFERENCING AND TELEHEALTH.  AND THEN THE LAST ONE IS TRAINING AND INFORMATIONAL MATERIALS.

AND I WILL HAVE A QUOTE HERE “TAKE ADVANTAGE OF MODERN INFRASTRUCTURE WITH ACCESSIBILITY CAPABILITIES FOR DIRECT ACCESS OR FOR INDIRECT ACCESS” SECTION 508 (A-C) THIS IS EXPLICITLY LEFT IN THERE IN HE-75.  I WANT TO POINT THAT OUT BECAUSE HERE IS MY SUGGESTION IS SINCE THE OUTPUT SINCE THE OUTPUT OF A DIAGNOSIS IS INFORMATION TO BE USED, CONSIDER INCLUDING PART OF THE TRAINING AND INFORMATIONAL MATERIALS AS PART OF THIS.

HERE IS MY POINT.  MY POINT IS DIAGNOSTIC EQUIPMENT IS USED BY AN INDIVIDUAL WITH DISABILITY IN THE ROLE OF PATIENT.  BUT IF YOU ARE MAKING A DIAGNOSIS YOU ARE PRODUCING INFORMATION IF YOU HAVE INFORMATION YOU HAVE TO HAVE ACCESS TO THAT INFORMATION.

AND SO, THEN YOU HAVE AN INDIVIDUAL WITH DISABILITY IN THE ROLE OF CONSUMER.

NOT JUST PATIENT BUT ALSO CONSUMER BECAUSE THEY NEED ACCESS TO THE INFORMATION I SUGGEST TRAINING MATERIALS AND LIKE BE INCLUDED, I AM JUST WRAPPING UP.  WE STARTED OUT WITH THE FIVE CIRCLES AND IN THESE FIVE CIRCLES.

>> IN THE ORIGINAL FIVE CIRCLES, SURGICAL PROCEDURAL INSTRUMENTATION DIAGNOSTIC IMAGING AND MEDICAL DEVICES AND MONITORING DEVICES WERE THE ONES THAT REALLY SHOWED IN OUR CASE WHAT REALLY SHOWS IS PATIENT SUPPORT SURFACE APPARATUS.  AND THAT INCLUDES IMAGING PLATFORMS THE OTHER ONE I POINT OUT IS ELECTRONIC HEALTH RECORDS.  THE VA IS 100% AND OTHER PLACES ARE 100% ELECTRONIC.  CONSUMERS SHOULD HAVE ACCESS TO THE INFORMATION WHICH IS CONSEQUENCE OF A DIAGNOSIS.  SYNTHESIS WHAT WITHIN HE-75 SHOULD BE INCLUDED.  ACCESSIBILITY TO DIAGNOSTIC EQUIPMENT IN ROLE AS PATIENT SHOULD BE INCLUDED.  MINIMALIST APPROACH SHOULD BE INCLUDED AND PARTS OF 16.5 AND 16.5.

BUT PERSONS WITH DISABILITIES ARE ALSO CONSUMERS.  AND THEY SHOULD HAVE ACCESS TO ALL OF THE INFORMATION AND SO MAYBE THE INFORMATION ITSELF SHOULD BE ACCESSIBLE THAT WOULD BE A BIG STEP COULD THAT TECHNOLOGICALLY BE DONE ABSOLUTELY SECTION 508 EXISTS.  THERE ARE LOTS OF PEOPLE WITH THE TECHNICAL WHEREWITHAL TO IMPLEMENT THAT.  WHAT IF WE WERE TO DO THAT IN THE HEALTHCARE PROVISION.

OKAY.  AN EXAMPLE OF POTENTIAL IMPACT I BECAME A MEMBER OF THE VA BECAUSE OF THIS INITIATIVE I WAS GOING TO REPRESENT THEM THAT DOESN’T MATTER.  THE REALITY IS, I AM NOW JUST GOING TO WORK WITH THEM.

BUT LOOK AT VETERANS AS AN EXAMPLE THEY HAVE SYSTEM-WIDE PROCUREMENT THEY ARE THE LARGEST PROCURER OF MEDICAL TECHNOLOGY, THEY GO THROUGH THE PRODUCTS LINES EVERY FEW YEARS, THEY DO IT SYSTEM-WIDE DIFFERENT PLACES HAVE DIFFERENT RESPONSIBILITIES.  THEY HAVE SYSTEM WIDE 100% ELECTRONIC HEALTHCARE RECORDS OLDER TO YOUNGER ADULTS COMING BACK TO THE BATTLEFIELD.  GREW UP WITH COMPUTERS AND CELL PHONES AND THE LIKE THEY SHOULD HAVE ACCESS TO INFORMATION NOT JUST ACCESS TO GETTING ON AN EXAM TABLE.  THAT’S WHAT I SUGGEST.

HERE IS THE OTHER ONE.  SECTION 508 IS AN EXISTING PROFESSIONAL NORM OF PRACTICE PERIOD.  SUGGESTION:  SIMPLY ADD A SENTENCE SAYING IT APPLIES TO MEDICAL DIAGNOSTIC EQUIPMENT AND ITS INFORMATION WOULD, IN MY EYES, EXPAND THE SCOPE BUT DO IT IN A WAY THAT I THINK MAKES SOME LOGICAL SENSE.  WHAT ABOUT PROPRIETARY INFORMATION?  I THINK THE ONUS IS ON THE DEVICE COMPANY.  AND EXCEPTIONS WELL THERE ARE CERTAINLY TIME CRITICAL INTERACTIVE OPERATIONS IN WHICH ACCESSIBILITY IS LESS IMPORTANT, FOR INSTANCE IF SOMEBODY NEEDS TIME CRITICAL INFORMATION IN THE MIDDLE OF SURGERY, THAT’S DIFFERENT.

NOW, I JUST WANT TO CLOSE SAYING A COUPLE OF WORDS ON RESEARCH I HAD THIS UP BEFORE.  THIS SAYS SELECTED R AND D ACTIVITIES IN THE OLD PROPOSAL SAFETY EFFICACY ACCESSIBILITY STUDIES WITH THE FDA.  WINTERS AND MYKLEBUST RELATIONS WITH ACTUAL DEVICES.  WHAT IF IN THE FUTURE R AND D WE WERE TO SAY WE WANTED TO HAVE USERS WITH DIVERSE ABILITIES OPERATING IN DIVERSE ENVIRONMENTS? WE HAVE A LOT OF USE ERRORS YOU IDENTIFY.  YOU WOULDN’T HAVE SO MANY RARE EVENTS.  IT WOULD BE A GREAT WAY FOR THE FDA TO BE MORE EFFECTIVE IDENTIFYING USE ERRORS WITH THEIR R AND D.  SO JUST THROW THAT OUT AS A PARADIGM SHIFT OF THINKING.

AND LET ME JUST GO ON.

I THINK I PROBABLY HAVE GONE OVER I JUST WANT TO WRAP UP WITH, ONE EXAMPLE OF WHY WE NEED R AND D.

IF YOU LOOK AT THE EXISTING ACCESSIBILITY STANDARDS, THERE IS SOMETHING IN THE SECTION 508 AND ALSO IN ADAAG THAT SAYS 5 POUNDS FOR HAND FORCE.  IT’S LISTED IN VARIOUS STANDARDS.  WHY FIVE POUNDS?  WE DID A STUDY JOEL MYSELF AND GRAD STUDENT WHERE WE HAD INDIVIDUALS WHO WERE WRONG WHO WERE OLD AND WHO HAD STROKES GO TO 19 LOCATIONS IN THEIR PHYSICAL WORK SPACE EVERYONE OF THE 19 LOCATIONS THEY WENT LEFT RIGHT UP DOWN FORWARD BACK WE WANTED TO SEE WHAT WE COULD DO.  FOR CERTAIN PARTS OF THE REACH SPACE EVEN ABLE BODIED OLDER PERSON CANNOT GO 5 POUNDS.  ESPECIALLY IF I AM USING MY RIGHT HAND IF THEY HAVE TO GO TO THE RIGHT OR UP THOSE ARE THE WEAKEST MODES.  IF YOU THINK ABOUT OUR EXISTING REGULATIONS ON REACH THAT EXIST IN OUR LAWS AND IN THE 5 POUNDS FOR CONTACT FORCE IT SHOWS YOU WE STILL NEED TO DO R AND D BECAUSE WE CAN IMPROVE THINGS IT SHOWS YOU THE ROLE THAT IS MY PITCH FOR FUTURE R AND D.  THIS IS SOMETHING THAT JOEL AND I WROTE.  INTERNAL DOCUMENT FOR THE FDA AND FOR NIDRR CALLED SAFE AND EFFECTIVE ACCESS FOR MEDICAL DEVICES FOR ALL AMERICANS IN 2007 (READS.)  REQUIRES EVOLUTIONARY PROCESS ON THREE LEVELS.  GOOD SCIENCE AIMED AT UNDERSTANDING HOW MANY TECHNOLOGY INTERFACES HOW THEY AFFECT PERFORMANCE AND SAFE USE FOR DIVERSITY OF BOTH DEVICES AND PEOPLE.

GENERATION OF DESIGN GUIDELINES THAT CAN HELP TRAIN CURRENT AND FUTURE PRODUCT DESIGNERS AND ENGINEERS IN INTEGRATING RISK ANALYSIS WITH ACCESSIBLE DESIGN CONSIDERATIONS AND CAN LEAD TO ADVANCES SUCH AS CERTIFICATION PROGRAMS.

I MENTIONED THAT BECAUSE THERE IS A COLLECTION OF FACULTY, A COUPLE OF UNIVERSITIES MYSELF INCLUDED, WHO PUBLISHED A LITTLE BIT I AM TRYING TO GET ACCESSIBLE DESIGN INTO THE ENGINEERING DESIGN CURRICULUM AROUND THE COUNTRY.  THAT’S AN ASIDE.

THE THIRD ONE IS THE VISION OF SOCIETAL POLICY CHANGE THAT MAKES ACCESS TO MEDICAL TECHNOLOGY A PRIORITY.  THERE IS SYNERGY.  IT REQUIRES COORDINATED EFFORT.  THIS IS A SUMMARY OF SUGGESTIONS.  TECHNICAL STANDARDS NEED TO OCCUR.  IT DEPENDS ON WHERE YOU WANT TO DRAW THE LINE ON THE SAND, YOU WANT TO DO IT IS BASED ON INFORMATION, R AND D AND EXPERIENCE AND EVERYTHING ELSE.

WHAT ARE THE RELEVANT ACCESS BARRIERS ADDRESSED IN SECTION 16?  WELL, PHYSICAL SUPPORT SERVICES SECTION 16.4 AND PART OF 16.3, I THINK YOU WILL WANT TO INCLUDE IT.  THERE IS ALSO THE MEDICAL DEVICE DIAGNOSTIC PART 16.3 AND 16.5.  AND WHAT ABOUT THE IDEA OF DISTANCE.  AN ENTITY IS A PERSON PLACE OR THING.  THE PLACE STARTS TO GET FUZZY WHEN — WHEN AN OFFICE HAS A TELEACCESS TO SOMEBODY IN THEIR HOME.  A MEDICAL OFFICE.

I JUST THROW THAT OUT.  I DON’T WANT TO GO ANYWHERE FURTHER I WANT TO MENTION TELEINTERFACES AS WELL.  I WOULD SAY THE TWO PRODUCT READY AREAS PRETTY MUCH ARE PATIENT TRANSFERRING POSITIONS AND POSTURAL MAIN INNOCENCE TECHNOLOGIES FOR THE PRODUCTS LINES WE TALKED ABOUT.  PRODUCTS ON THE MARKET OR THEY ARE CLOSE ENOUGH THAT WE CAN GO FAR THERE.  I THINK CONSUMER ACCESS TO ELECTRONIC HEALTHCARE REPORTS AND MANUALS IS SOMETHING TO ARCAINE.  THE OTHER AREAS INFUSION PUMPS, YOU NAME IT, THEY PROBABLY NEED MORE SYSTEMATIC R AND D PROGRESS.  SO QUESTIONS COMMENTS?

>> JACK, THANK YOU SO MUCH.  THAT FLOWED SO WELL.  THAT WAS A FANTASTIC PANEL.

(APPLAUSE)

>> DAVID BAQUIS:  YOU COVERED CONCEPTUAL INFORMATION, YOU COVERED THE STANDARD AND MADE YOUR POINTS.  CAROL, YOU PROVIDED A RECOMMENDATION FOR HOW THE FEDERAL GOVERNMENT CAN WORK MORE EFFICIENTLY, THANK YOU FOR THAT SUGGESTION FOR AN APPROACH.

THIS IS WHAT WE ARE GOING TO DO WITH THE AGENDA, FOLKS.  WE ARE GOING TO MOVE EVERYTHING AHEAD 15 MINUTES, THAT GIVES US 15 MINUTES NOW FOR QUESTIONS.  AND THEN WE WILL ACTUALLY BEGIN THE BREAK AT 3:15, INSTEAD OF 3.  HAVING SAID THAT, LET’S SEE WHO HAS QUESTIONS.  LET ME WALK AROUND.

>> HI, MARIO DAMIANI MEMBER OF AD HOC COMMITTEE.  MY QUESTION IS ABOUT INTENDED USE.  HOW CAREFUL OR WORRIED, OR WHATEVER ADJECTIVE DO YOU WANT TO USE, DO WE HAVE TO BE THAT ONCE OUR STANDARDS COME OUT THAT WE ARE NOT GOING TO SEE A SEA CHANGE IN THE MANUFACTURER’S OWN DEFINITIONS EVER INTENDED USE SO THAT SUDDENLY WE SEE YOU KNOW THESE DEFINITIONS THAT COME OUT FROM THE MANUFACTURERS THAT TOTALLY SHIFT REALLY TO ESCAPE THE STANDARDS THAT WE ARE LOOKING TO PROMULGATE.  THAT’S JUST A GENERAL QUESTION THERE.  IS THAT SOMETHING THAT WE REALLY — NOT ALL MANUFACTURERS ARE GOING TO DO THAT OBVIOUSLY BUT HOW IMPORTANT IT SEEMS LIKE IT’S SUCH A CENTRAL PIECE OF HOW YOU DECIDE WHERE TO GO IN OR WORK AT FDA IT’S SOMETHING THAT WE SHOULD BE CONCERNED ABOUT.

>> I THINK WHAT WE EXPECT TO SEE SOME CHANGE.

I THINK AS AWARENESS CHANGES, I THINK WE WILL SEE DIFFERENT INTENDED USES BUT KEEP IN MIND THAT FOR INDUSTRY TO — TO PRESENT WITH A NEW INTENDED USE THEY ALSO HAVE TO PROVIDE THE DATA TO SUPPORT THAT NEW INTENDED USE.  SO IT’S NOT GOING TO BE AN UNTHOUGHTFUL CHOICE THAT THEY MAKE.  IT’S SOMETHING THAT THEY HAVE TO THINK ABOUT AND SOMETHING THAT THEY ARE GOING TO HAVE TO ACTUALLY DO THE RIGHT AMOUNT OF TESTING AND MAKE SURE THAT THEY CAN ACTUALLY MEET THAT INTENDED USE.  SO, I THINK WE WOULD LIKE TO SEE WHAT WE HAVE TALKED INTERNALLY A LITTLE BIT ABOUT THIS NOT ONLY IS THIS GOING TO INCREASE THE AWARENESS OF THE MANUFACTURERS IT’S GOING TO INCREASE THE AWARENESS OF THE FDA SCIENTIFIC AND REVIEW STAFF ON HOW WE LOOK AT THESE SUBMISSIONS AS WELL.  I THINK THIS IS PROBABLY ALL A GOOD THING.

>> ALL RIGHT, THANKS.

>> DAVID BAQUIS:  ONE OTHER GENTLEMAN ONE OTHER THING I WANTED TO SAY BEFORE I FORGET.

JACK WAS TALKING ABOUT THE HE-75 STANDARD AND YOU KNOW NORMALLY THE ENTITY THAT PUBLISHED THAT CHARGES FOR IT.  AAMI.

ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION.

BUT WE WERE ACTUALLY ABLE TO WORK OUT AN AGREEMENT WITH THEM TO GET THE CHAPTER 16 PUBLISHED FOR FREE.  SO THAT YOU COULD ACCESS IT AS NO COST.  IS JIM RAGGIO IN THE ROOM AND CAROL.  THANK YOU AND NOW THE GENTLEMAN’S QUESTION.

>> ANDRE, ATTORNEY IN PRIVATE PRACTICE IN CHICAGO.  MY QUESTION FOR THE PANEL IS COULD YOU TALK A LITTLE BIT ABOUT WHAT YOU SEE THE ROLE OF INDEPENDENT THIRD PARTY SAFETY CERTIFICATION, WHETHER OR NOT THAT SHOULD BE BUILT IN THE STANDARD THAT WE ARE LOOKING AT NOW?

>> SAFETY CERTIFICATION INTEGRATED WITH ACCESSIBILITY CERTIFICATION MAY BE A PATH NOT YET.  WE ARE TALKING 10 YEARS NOW.  BUT A PATH AND THERE HAS BEEN INTERNAL DISCUSSIONS AD HOC WITH THE FDA AND OTHER ENTITIES ABOUT THIRD PARTY, THAT’S ONE OF THE REASONS WE WORK WITH ACCESSIBILITY AND METRICS INVOLVING PARTICIPANTS DIRECTLY AN COMING UP WITH OTHER APPROACHES LIKE A MED AUDIT HAS 600 QUESTIONS FOR ANY DEVICE YOU END UP ONLY THE 15 MOST RELEVANT QUESTIONS.

AND ALL OF THAT KIND OF THINK THING.  THE TALK OF HAVING A THIRD PARTY ENTITY THAT COULD INTEGRATE SAFETY — NORMALLY SAFETY AND EFFECTIVENESS AND PERFORMANCE ARE THE NAME OF THE GAME AT THE FDA ADDING ACCESSIBILITY THIS IS NEW.  THIS IS REALLY NEW.  PEOPLE AT FDA I CAN SAY WHO ARE BEHIND THIS.

BUT IT’S NOT PART OF THEIR MANDATE RIGHT?

BUT THE IDEA OF STARTING TO THINK ABOUT ACCESSIBILITY AND TYING THAT WITH SAFETY AND TRYING TO LOOK AT PRODUCTS LINES AND CERTIFY IT FOR CERTAIN SUBPOPULATIONS OF USERS COULD BE A REAL INTRIGUING POSSIBILITY.

AND THAT WOULD BE CERTIFICATION THIRD PARTY THAT IS SOMETHING THAT THE FDA HAS A LONG, LONG HISTORY OF DOING THAT TYPE OF THING.

>> DAVID BAQUIS:  OKAY.  LET’S GO AHEAD AND BREAK NOW, THANK YOU.

(SHORT RECESS TAKEN.)

>> DAVID BAQUIS:  WE HAD TWO CHOICES A LONG MORNING OR LONG AFTERNOON WE MADE IT A LONG MORNING AND SHORTER AFTERNOON.

WE ARE NOW READY TO GO TO OUR 5TH OF 6 PANELS IT WAS A LOGICAL SEQUENCING TO GO FROM HEARING STANDARDS TO TALKING TO PEOPLE REPRESENTING THE INTEREST OF MANUFACTURERS.

SO, WITH A SHORT INTRODUCTION WE ARE GOING TO HEAR FROM DAVID FISHER, EXECUTIVE DIRECTOR OF MITA, STANDS FOR MEDICAL IMAGING AND TECHNOLOGY ALLIANCE.  AND ALSO FROM BERNIE LIEBLER DIRECTOR OF TECHNOLOGY AND REGULATORY AFFAIRS AT ADVAMED WHICH IS THE ADVANCED MEDICAL TECHNOLOGY ASSOCIATION.  GO AHEAD AND PROCEED, PLEASE.  THANKS.

>> DAVID FISHER, MITA.  THANK YOU FOR INVITING ME HERE TODAY.  I AM DAVE FISHER, THE EXECUTIVE DIRECTOR OF THE MEDICAL IMAGING AND TECHNOLOGY ALLIANCE WE REPRESENTS RADIATION THERAPY SYSTEMS OUR MEMBERS COMPRISED 95% INCLUDING X-RAYS DIAGNOSTIC ULTRASOUND NUCLEAR MEDICINE MAGNET PARTICULAR RESONANCE.  MITA IS DIVISION OF NATIONAL ASSOCIATION WHICH IS A LONG STANDING ORGANIZATION.  SO WE ALSO BRING A BACKGROUND IN STANDARDS TO THIS DISCUSSION.

AS ALL OF YOU KNOW, HR3590 INCLUDED ESTABLISHMENT OF STANDARD OF ACCESSIBILITY FOR MEDICAL DIAGNOSTIC EQUIPMENT.  THE BILL STATES MAMMOGRAPHY AND X-RAY MACHINES WHICH OUR COMPANY MANUFACTURERS AS WELL AS INCLUDES OTHER DIAGNOSTIC RADIOLOGICAL EQUIPMENT, WHICH SEEMS TO IMPLY TO CT, MR MAGNETIC RESONANCE AND NUCLEAR IMAGING SCANNERS.  MY COMPANIES HAVE SOUGHT TO IMPROVE PICTURE CLARITY AND SENSITIVITY.

WE ALREADY TALKED ABOUT THE PRODUCTS THAT OUR COMPANIES MANUFACTURER AS WELL AS THE WHAT IS COVERED BY THE LEGISLATION.  AS I SAID BEFORE, MAMMOGRAPHY X-RAY CD, MRI ULTRASOUND, NUCLEAR MEDICINE WHICH GENERALLY IS ACTUALLY SOLD WITH CT.  AS WELL AS MULTI MODALITIES BELOW THAT.

BEFORE I GO ON TO THIS NEXT SLIDE, I WANT TO SUMMARIZE THE THREE POINTS THAT I THINK ARE IMPORTANT FROM OUR PERSPECTIVE.  FIRST THE PRODUCTS THAT WE OUR COMPANY — THE DIAGNOSTIC IMAGING PRODUCTS THAT MY COMPANIES MANUFACTURER SHOULD NEVER BE USED INDEPENDENTLY BY PATIENTS.  IN ALL CASES PHYSICIANS WRITE THE PRESCRIPTIONS FOR PROCEDURES.  TRAINED IMAGING STAFF NURSES OR TECHNOLOGISTS POSITION THE PATIENTS FOR SAFE PROCEDURES.

SECOND, THE PRODUCTS MITA MEMBERS MANUFACTURER ARE DIVERSE THEY DO SO IN DIFFERENT WAYS THEY ARE DEFINED DIFFERENTLY.  THEY MAY LOOK THE SAME, IN FACT THEY ARE VERY DIFFERENT.  THIRD, ALL OF THE PRODUCTS WE MANUFACTURER MUST BE CLEARED FOR SALE BY THE FOOD AND DRUG ADMINISTRATION.  THIS REQUIRES EXTENSIVE TESTING AND RISK MITIGATION PRIOR TO GOING ON THE MARKET.

THEY COULD BE INSTRUCTIVE TO BRING EVERYBODY UP TO THE SAME COMMON LEVEL OF UNDERSTANDING IF I GO THROUGH EACH MODALITY TO HELP FOLKS UNDERSTAND THE COMMONALITY AS WELL AS DIFFERENCES BETWEEN THE PRODUCTS.

FIRST, I WOULD LIKE TO TALK ABOUT MAMMOGRAPHY EQUIPMENT USES LOW DOSE TO DIAGNOSE AND SCREEN FOR BREAST CANCERS THEY OFFER EQUIPMENT THAT ASSURE ACTIONABILITY SOME OF THE FEATURE ENSURE THE SYSTEM CAN BE LOWERED TO ENABLE WHEELCHAIR ACCESS, THEY ARE ALSO SOLUTION PROTECTIVE FEATURES ASSURES MOBILITY IMPAIRMENTS PATIENTS ARE NOT YRED.  THE FRAME THAT HOLDS THE SYSTEM HAS THE ABILITY TO ROTATE 360 DEGREES, WHICH IS IMPORTANT IN PATIENTS SUFFERING FROM OSTEOPOROSIS ELDERLY OR INFIRM OR IN WHICH THE POSITIONING HAS TO BE ADOPTED TO ACCOMMODATE THE PATIENT, FOR EXAMPLE SOMEONE WHO IS CONFINED TO A HOSPITAL BED.

X-RAY EQUIPMENT IS THE OLDEST AND MOST COMMONLY USED FORM OF MEDICAL IMAGING.  IONIZING RADIATION TO SHOW INTERNAL STRUCTURE X-RAY SYSTEM CAN CONSIST OF A TABLE IN WHICH A PATIENT IS PLACED FOR EXAMINATION IN A SYSTEM WHICH EMITS X-RAYS AND CAPTURES THE IMAGES MANUFACTURERS OFFER ADJUSTABLE TABLES TO ASSIST THOSE WITH LIMITED MOBILITY.  IT’S IS BASED ON PATIENT WEIGHT.  THE CUSTOMER SPECIFICATIONS INCREASES THE SUPPORT IMPACTS THE AMOUNT THE TABLE CAN BE LOWERED.  MANUFACTURERS ALSO MARKET ADJUSTABLE CONFINED TO BED, U-ARM AND C-ARM DETECTORS ALLOWING THE RECEPTOR TO BE POSITIONED AROUND THE PATIENT.  IN THIS CASE BOTH THE PATIENT AND IMAGING EQUIPMENT ARE POSITIONED BY THE TECHNOLOGIST.  PORTABLE X-RAY SYSTEMS ARE ALSO NOW AVAILABLE.

ULTRASOUND EQUIPMENT.  ULTRASOUND IS VERY DIFFERENT THAN EQUIPMENT USES IONIZING RADIATION IT USES HIGH SOUND WAIVES TO LOOK INSIDE THE BODY.

IT NOT ONLY CAN PROVIDE VISUAL IMAGE BUT PROVIDE AUDIBLE SOUNDS OF BLOOD FLOW ALLOWING MEDICAL PROVISIONS TO USE SOUNDS TO ASSESS PATIENTS HEALTH.  OBSTETRICS IT’S ADAPT IN DIAGNOSING A WIDE RANGE OF CONDITIONS.  ULTRASOUND MACHINES ARE GENERALLY COMPACT HIGHLY ADAPTABLE FOR USE REGARDLESS OF PATIENT POSITIONING IT CAN BE USED ON A PERSON IN THEY SIT IN THE WAITING AREA ON EXAMINATION TABLE OR VIRTUALLY ANY POSITION.  TECHNOLOGY IS ADVANCED TO THE POINT WHERE THESE DEVICES HAVE BECOME PORTABLE ALLOWING EQUIPMENT TO GO TO THE PATIENT.

COMPUTED TOMOGRAPHY CT OR CAT SCANS.  CT IS THE ALSO USED IONIZING RADIATION OR X-RAYS TO TAKE FROM MULTIPLE ANGLES TO TAKE DETAILED PICTURES INSIDE THE BODY AND PROVIDE MUCH MORE INFORMATION.  CT SCANNERS ARE A LARGE MACHINE WITH SHORT TUNNEL IN THE CENTER WHERE THE X-RAY TUBE ROTATE AROUND THE PATIENT.  THIS IS CALLED A GANTRY.  THE TABLE SLIDES INTO AND OUT OF THE TUNNEL.  THE TECHNOLOGIST MUST MOVE TO AN ADJACENT ROOM THEY CAN SEE AND HEAR THE PATIENT AFTER POSITIONING THEM TO BE IN THE SCANNER.  VISUAL AND OR VISUAL OR AUDIBLE CUES MAY BE USED TO ENSURE PROPER POSITIONING WHAT THAT MEANS IS BREATHING, IT’S NOT MOVEMENT ON THE TABLE BUT BREATHING IN OR OUT HOLDING YOUR BREATH, THINGS LIKE THAT.

AS PREVIOUSLY MENTIONED, CT PROCEDURES ARE PERFORMED ON PATIENTS WITH A VARIETY OF CONDITIONS.  IN ALL CASES TRAINED TECH AIDS THE PATIENT IN THE PLACEMENT ON THE TABLE — MANUFACTURERS TABLES WITH LIMITED ADJUSTABILITY.  THE REQUIREMENTS THAT TABLES BE ABLE TO SUPPORT A WIDE RANGES OF PATIENTS FROM CHILDREN WHO ARE OBESE PUTS LIMITS ON THE SUGGESTIBILITY.  MR OR MAGNETIC RESONANCE THE TRADITIONAL MRI USE HOOKS LOOKS LIKE CT MACHINE, THEY ARE COMPLETELY DIFFERENT.

MR IMAGING USES A POWERFUL MAGNETIC FIELD AND PULSES TO PRODUCE DETAILED IMAGES OF SOFT TISSUE AND BONE.  THIS IS A MAGNET, NO METAL CAN ENTER INTO THE ROOM, AND SOME PATIENTS ARE NOT ELIGIBLE FOR THE EXAMS BECAUSE THEY HAVE METAL IN THE BODY, PACE MAKERS, FOR EXAMPLE.  THEY LIE IN A TABLE THAT SLIDES INTO THE CENTER OF THE MAGNET.  THE MR SYSTEMS OFFER TABLES THAT CAN BE LOWERED FOR EASE OF PATIENT ACCESS AND PLACE.  IN ADDITION, THE DIFFERENT TYPES OF MR UNITS HAVE BEEN DESIGNED, THE MAGNET DOES NOT COMPLETELY SURROUND THE PATIENT.  THIS MAY EASE ACCESS WITH MOBILITY IMPAIRMENTS OR PATIENTS WHO ARE FEARFUL OF BEING IN ENCLOSED PLACE AS WELL AS OBESE PATIENTS.  AS WITH CT EQUIPMENT PATIENTS WAITING FOR MR EXAM MUST BE ASSISTED BY A TRAINED TECHNOLOGIST WHO POSITIONS THE PATIENT AS I MENTIONED EARLIER THE MR MACHINE IS A POWERFUL MAGNET.  SOMETIMES AS MUCH AS 3 TESLA BECAUSE IT CAN INTERFERE WITH THE MAGNET NET FIELD METAL ELECTRONIC OBJECTS ARE NOT ALLOWED IN THE ROOM.  METAL EXAMINATION TABLES WHEELCHAIRS ET CETERA.  FOR THOSE PATIENTS WHO RELY ON ASSISTANCE GETTING POSITION INTO THE BORER NONMETALLIC BOARD OR CHAIR MUST HELP THEM ON TO THE TABLE I AM GOING TO SHOW A PICTURE OF WHAT HAPPENS WHEN METAL GOES INTO AN MR MACHINE.  THIS WAS A TEST IT WASN’T THERE WAS NOBODY IN THE WHEELCHAIR WHEN THIS HAPPENED DON’T BE ALARMED BY WHAT YOU SEE, IT DOES PROVIDE A GOOD EXAMPLE OF HOW POWERFUL THE MAGNETS ARE.  THE PICTURE SHOWS MR, THE TUBE WITH A HOLE IN THE MIDDLE A WHEELCHAIR, YOU CAN SEE THERE IS A ROPE AROUND IT A TEST IT WAS SUCKED INTO THE BORE HOLE OF THE MR MACHINE BY THE POWERFUL MAGNET.

NUCLEAR IMAGING MULTI MODALITIES, THEY USE DIFFERENT TECHNIQUES, RADIOPHARMACEUTICALS WITH GAMA CAMERAS OR OTHER CAMERAS THAT SEE THE PHARMACEUTICALS TO FIND CANCERS OR METASTASES, SOMETIMES IN CORONARY CARE.  TYPICALLY THESE DAYS THE PET SCANS INSPECT ARE SOLD IN MULTI MODALITY SYSTEMS WITH THE CT SCANNER.  AND SO THE THINGS THAT APPLIED TO THE CT ALSO APPLY TO NUCLEAR.

NUCLEAR MEDICINE.

NOW, WE ARE HERE TO TALK THROUGH AT LEAST FROM OUR PERSPECTIVE WHAT THE ISSUES ARE THAT ARE IMPORTANT FOR CONSIDERATION.

I BELIEVE IT’S ESSENTIAL ACTIONS BY THE ACCESS BOARD SHOULD TAKE INTO ACCOUNT THE EXTREME DIVERSITY IN THE DESIGN AND PURPOSE SIMPLY A ONE SIZE FITS ALL WON’T BE EFFECTIVE IN ENSURING ACCESSIBILITY I HOPE IT’S CLEAR FROM WHAT I HAVE DESCRIBED IMAGING EQUIPMENT IS VERY DIFFERENT THAN WEIGHT SCALES FOR DENTIST’S CHAIRS WHICH ARE MENTIONED IN THE LAW.  THEY ARE ONLY ACCESSED THROUGH PHYSICIAN ORDER OR PRESCRIPTION SHOULD NOT BE OPERATED BY PATIENTS WHO SHOULD BE UNDER THE SUPERVISION OF A TRAINED IMAGING STAFF PERSON THROUGHOUT THE PROCEDURE FROM BEGINNING TO END.  IN ADDITION PRIOR TO THESE PRODUCTS GOING ON SALE FDA HAS TO CLEAR THEM AS SAFE AND EFFECTIVE.  MANUFACTURERS MUST PROVIDE EXTENSIVE DATA ON THE SAFETY AND EFFICACY INCLUDING RISK MITIGATION STRATEGIES.  IN SECTION 510, THERE IS CONSULTATION AND ACCESS BOARD ON THE REGULATIONS AND MANUFACTURERS BELIEVE IT’S ESSENTIAL ROBUST COLLABORATION TAKE PLACE ANY REQUIRED CHANGES TO OUR EQUIPMENT MAY REQUIRE FDA CLEARANCE WHICH HAS IMPLICATIONS ON HOW QUICKLY THE LATEST TECHNOLOGIES ENTER THE MARKET.

WE CERTAINLY APPRECIATE THE INCLUSIVENESS AND COLLABORATIVE NATURE OF THIS PROCESS.  WE ARE HOPEFUL IT WILL CONTINUE THE BEST STANDARDS ARE THOSE SUPPORTED BY ALL STAKEHOLDERS IN ADDITION AS A STANDARD SETTING BODY WE ARE AVAILABLE TO ASSIST ANY WAY THAT’S HELPFUL WE WOULD RECOMMEND RELIANCE ON ALREADY DEVELOPED STANDARDS SOME TALKED ABOUT HERE AS ISO WHERE APPROPRIATE.  WE BELIEVE THERE IS MUCH TO BE GAINED BY USING THE STANDARDS SUBJECT AS IMPORTANT IT’S ESSENTIAL THEY DON’T CONFLICT WITH ALREADY EXIST THAT INEVITABLY LEAD TO IMPLEMENTATION CHALLENGES.  THANK YOU FOR YOUR TIME.  I AM HAPPY TO TAKE QUESTIONS.

>> DAVID BAQUIS:  THANK YOU, THAT’S HELPFUL.  THAT WAS THE SPIRIT WE INVITED YOU FOR WAS COLLABORATION.  IT WILL BE USEFUL TO NOTE THERE IS ANY ISSUES THAT ARE OF CONCERN TO THE INDUSTRY SO WE CAN TRY TO DEAL WITH THOSE EARLY AND IT WOULD BE IDEAL IF THE INDUSTRY THEN SUPPORTS THE STANDARDS AND FEEL COMFORTABLE IMPLEMENTING THEM.

>> WE WOULD BE HAPPY TO SHARE CONCERNS AS WE SORT OF WORK THROUGH THE PROCESS AND ASSUMING THAT IT’S YOU KNOW A CONSENSUS BROADLY HELD I AM HELPFUL WE CAN GET TO A PLACE WHERE WE CAN SUPPORT IT AS WELL.

>> BERNIE, PLEASE PROCEED.

>> DAVID ASKED ME TO MAKE SURE THAT I READ EVERYTHING THAT I PUT UP THERE.  SO, THE TITLE SLIDE DIAGNOSTIC DEVICE ABILITY PRESENTATION TO THE MEETING OF THE ACCESS BOARD.  MY NAME AND OUR LOGO.

NEXT SLIDE.  THE QUICK AGENDA FOR THE TALK IS VERY SIMILAR TO DAVID’S IT’S WHO WE ARE, A LITTLE DISCUSSION OF DIAGNOSTIC DEVICES, PROBABLY A LOT OF DISCUSSION ABOUT VOLUNTARY CONSENSUS STANDARDS AND A COUPLE OF RECOMMENDATIONS.

NEXT SLIDE.

WELL, WHAT IS ADVA MED, THE FORMAL NAME IS ADVANCED MEDICAL TECHNOLOGY ASSOCIATION.  IN CONTRAST TO MITA, OUR MEMBERS MAKE VIRTUALLY EVERYTHING THAT’S CALLED A MEDICAL DEVICE AND THAT MEANS BAND-AIDS, TOOTHBRUSHES, I USUALLY DO THE QUICKIE DESCRIPTION CONDOMS TO SCANNERS IT’S LITERAL FROM THINGS THAT GO INTO YOUR POCKETS TO THINGS THAT COST A MILLION OR 2 MILLION AND NEED INSTALLATION IN THEIR OWN ROAMS ARE CARRIED AROUND BY THEMSELVES IN A TRUCK.  WE ARE THE WORLD’S LARGEST ASSOCIATION REPRESENTING MEDICAL DEVICE MANUFACTURERS.  OUR COMPANY MANUFACTURES 90% OF THE MEDICAL DEVICES SOLD IN THE U.S. AND 50% OF THOSE SOLD WORLDWIDE.

HOW DID I DO THAT?  THERE YOU GO — OKAY.

>> DAVID BAQUIS:  WE HAVE RECEIVED A LOT OF FEEDBACK ON THE USABILITY OF OUR MOUSE TODAY.  (LAUGHTER)

>> OKAY.  DEVICES IN GENERAL ARE INTENDED FOR USE FOR ALL PATIENTS.

AND SPECIFIC THEY HAVE SPECIFIC PATIENT POPULATIONS IN MIND.

MOST DIAGNOSTIC IMAGING WHICH WE HAVE DISCUSSED A LOT TODAY IS REALLY ADDRESSED AT EVERYBODY.  BUT MOST OF US WHEN WE VISIT ONE OF THESE MACHINES, IF YOU ARE ALREADY A PATIENT IN A HOSPITAL, YOU WILL VISIT IT EITHER IN A BED — RARELY IN A GURNEY THEY SEEM TO FROM MY EXPERIENCES AS COUPLE OF YEARS AGO TO MOVE ME AROUND IN MY BED WHEREVER I WENT RATHER THAN IN A GURNEY.  OR IN A WHEELCHAIR.

THEY INCLUDE IMAGING SYSTEMS AS WE HAVE DISCUSSED MOST OF THE THINGS THE — I MENTIONED GLUCOSE METERS HERE THE MORE I THINK ABOUT IT I THINK THAT’S A MISTAKE.  BUT ANCILLARY EQUIPMENT.  THAT CAN BE SOME OF THE THINGS THAT MOVE YOU TO IT AND THEN SLIDE OR FIT INTO IT OR MEET UP — MEET UP WITH THE EQUIPMENT.

AND I THINK THAT’S WHAT YOU MIGHT FIND THE GURNEYS FALL INTO THIS.

>> OKAY.  THE INDUSTRY GOAL IS TO LIMIT PATIENT DISCOMFORT AND INCONVENIENCE.

BUT THE TRUE GOAL IS TO PRODUCE A SAFE AND EFFECTIVE DEVICE.

AND THE WORD THAT WILL MOST OFTEN COME UP WITH WHEN YOU TALK TO ENGINEERS IN OUR INDUSTRY IS SAFETY.

IT’S AN INDUSTRY THAT’S TRULY OBSESSED WITH SAFETY.  IF YOU ARE UNCOMFORTABLE IT’S ONE THING IF YOU ARE INJURED OR WORSE IT’S ANOTHER THING.

AND SAFETY INCLUDES THE OPERATOR AND USER IS AN INTERESTING WORD TOO BECAUSE THAT CAN MEAN THE PATIENT OR IT CAN MEAN THE OPERATOR OF THE DEVICE.  SO THE TECHNICIANS IN THE X-RAY SUITE ARE USERS EVEN THOUGH THEY ARE THE OPERATORS.

AND THE PARENTS ARE ALSO USERS IN A DIFFERENT SENSE.

UNFORTUNATELY, TECHNOLOGY DOES NOT ALWAYS ALLOW US TO BE COMPLETELY SUCCESS.  AND THE CLASSIC EXAMPLE IS UNFORTUNATELY AGAIN IT KEEPS COMING UP ALL TIME IT’S VERY LARGE AND IT’S FAIRLY PERVASIVE IS THE MRI.  JUST ABOUT EVERYBODY GETS ASSISTED INTO AN MRI YOU JUST DON’T WALK INTO THE ROOM AND JUST GET UP ON THE TABLE.

IT DOESN’T REALLY WORK.  SO EVERYBODY GETS HELPED.

AND ON THE OTHER HAND THE OPEN MRI HAS BEEN ONE OF OUR MORE REMARKABLE SUCCESSES.  THIS TERMS OF PATIENT COMFORT.  BECAUSE WHEN THEY FIRST CAME OUT, WHAT YOU REALLY HEARD FROM PEOPLE IS YOU HAD ONE OF THOSE COULD YOU STAND IT?  OH, THEY GOT — I COULDN’T EVEN GET IN OR GOD I HAD THEM TAKE ME OUT IN 5 MINUTES PEOPLE GET CLAUSE TREMENDOUS PHOBIC AND WITH GOOD REASON YOU ARE IN A REALLY SMALL TUBE.  AND WE ARE NOT USED TO THAT.

WELL, IN OPEN MRI ELIMINATES THE REALLY SMALL TUBE AND ELIMINATES THE YOU KNOW THE FEELING THAT YOU WANT TO POUND ON IT AND KICK.

SO, YOU KNOW, THAT CHANGED A LOT FOR A LOT OF FOLKS.

SO, WE SOMETIMES DON’T MAKE IT BUT ACTUALLY WE CAN EVEN TURN AROUND TO STUFF THAT WE WHERE WE COULDN’T MAKE IT AND AT LEAST MAKE IT BETTER FOR SOME FOLKS.

WHAT IS THE INDUSTRY APPROACH TO DOING THIS, AND I THINK I SHOULD SAY THAT ADD THE COMPANY I HANDLE STANDARD ALL VIRTUALLY ALL STANDARDS ISSUES, AND I AM THE CHIEF U.S. DELEGATE TO THE COMMITTEE THAT WRITES THE IEC60601-1 STANDARDS WHICH COVERS THE ESSENTIAL BASIC SAFETY STANDARD FOR ALL ELECTROMEDICAL DEVICES.  WHICH A COUPLE OF YEARS AGO WE LOST THE VOTE ON WAS EXPANDED TO COVER, I KNOW THIS WILL ANNOY SEVERAL PEOPLE, BUT AIDS TO THE HANDICAPPED.

PART OF THE REASON THAT WE LOST THE VOTE, IS WE OBJECTED TO THE LANGUAGE.

UNFORTUNATELY, IN EUROPE, THEY DON’T CARE ABOUT THE LANGUAGE.

SO, IN THIS COUNTRY YOU WOULD PROBABLY HAVE SAID AIDS TO THE DISABLED OR YOU KNOW ASSISTED — BUT IT COVERS THAT AND IT NOW COVERS HOME USE DEVICES.

SO, LARGELY, IF IT’S A MEDICAL DEVICE AND IT’S GOT A BATTERY OR YOU PLUG IT IN OR IF IT’S PERMANENTLY WIRED THAT’S THE STANDARD THAT COVERED IT.  I DON’T KNOW OF A COMPANY THAT DON’T COMPLY WITH 60601.  ESPECIALLY IF IT’S AN INTERNATIONAL COMPANY.  ALMOST EVERYBODY THAT MAKES THIS KIND OF STUFF SELLS INTERNATIONAL.  IT’S THE STANDARD THEY NEED TO COMPLY WITH TO SELL IN EUROPE.  IT’S THE STANDARD THEY NEED IT COMPLY WITH TO SELL IN CANADA, AUSTRALIA, JAPAN AND TO A LARGE EXTENT FDA DOESN’T SAY IT THAT WAY IN THE U.S.

AND SOMEBODY MENTIONED THIRD PARTY CERTIFICATION I THINK IT WAS THE LAST PANEL TALKING ABOUT THIRD PARTY CERTIFICATION ALMOST ALL OF THESE COUNTRIES GO THROUGH A THIRD PARTY CERTIFICATION FOR THE 60601.

AND THAT BY THE WAY IS THAT MAIN STANDARD PLUS A LOT OF SPECIFIC STANDARDS PLUS A LOT OF WHAT WE CALL COLLATERAL STANDARDS.  WHICH INCLUDES ELECTROMAGNETIC COMPATIBILITY, ALARMS AND FOR TODAY I KNOW THAT WAS A LONG STORY TO GET TO A QUICK OPINION MUCH LINE A USABILITY STANDARD.

WE WROTE THE USABILITY STANDARD SEVERAL YEARS AGO, AND HAD SUFFICIENT SUCCESS WITH IT THAT ISO TALKED TO THE COMMITTEE AND SAID THEY WANTED TO EXPAND THAT.  SO NOW THERE IS A STANDARD ISO STANDARD 62366 WHICH IS FOR ALL MEDICAL DEVICES.  I KNOW JACK SAID THE USABILITY TESTING ISN’T QUITE THE SAME, AND I AM NOT GOING TO DISAGREE WITH THAT, BUT IT FALLS INTO A LARGER PICTURE OF HOW WE ADDRESS MEDICAL DEVICE DESIGN NOW.  AND I HAVE BEEN DOING THIS STUFF FOR ABOUT 20 YEARS, AND IT’S CHANGED.  IT’S CHANGED A GREAT DEAL.

BECAUSE THE THINGS THAT ARE BASIC IN THE STANDARD THAT I THINK MOST OF YOU WOULD EXPECT AND DON’T EACH THINK ABOUT, BUT THE SEPARATION OF PIECES INSIDE THE DEVICE SO THAT THEY DON’T SHORT.

DOUBLE INSULATION OR HAVING ROUNDED WIRE — GROUNDED WIRE IN IT.  THE FACT IF YOU GO TO MOVE A MEDICAL DEVICE BIG PIECE OF EQUIPMENT WHEN YOU SHOVE IT, IT DOESN’T GO (INDICATING) ON THE PERSON THAT HAPPENED TO HAVE THE UNFORTUNATE BAD LUCK STANDING NEXT TO YOU.  WHEN THE DOC COMES IN PUTS HIS CUP OF COFFEE TURNS AROUND AWAY AND WAVES HIS ARM IT DOESN’T KILL THE DEVICE.

IT DOESN’T SHORT IT.  IT DOESN’T PUT YOU THE PATIENT IN DIFFICULTY BECAUSE THEY CAN NO LONGER SEE WHAT IS HAPPENING.

WE HAVE GOT THOSE DOWN PRETTY WELL.  I MEAN PEOPLE KNOW HOW TO MAKE SAFE STUFF.

SO, THE EMPHASIS HAS SHIFTED, AND 60601 REQUIRES RISK MANAGEMENT.  ANOTHER STANDARD THAT WE WROTE A FEW YEARS AGO RISK MANAGEMENT FOR MEDICAL DEVICES.

AND BY THE WAY, FDA EFFECTIVELY IS — YOU KNOW, DOESN’T IN SO MANY WORDS SAY, YOU GOT TO DO THE SAME THING, BUT YEAH YOU HAVE TO DO THE SAME THING.

SO, DEVICE DESIGN IS HEAVILY DEPENDENT ON RISK MANAGEMENT.  DEVICE IMPROVEMENT IS HEAVILY DEPENDENT ON RISK MANAGEMENT.  RISK MANAGEMENT LEADS YOU STRAIGHT TO HUMAN FACTORS ENGINEERING.  BECAUSE IN RISK MANAGEMENT, YOU HAVE TO LOOK AT WHAT ARE THE RISKS THAT CAN BE PRESENTED BY THE USE OR MISUSE OR EXPECTED MISUSE OR ANTICIPATED MISUSE OF THE DEVICE.

SO THAT’S REALLY HOW CAN THIS DEVICE PUT THE USER EITHER USER THE OPERATOR OR THE PATIENT OR A BYSTANDER IN PERIL.

THAT’S THE WAY MEDICAL DEVICES ARE DESIGNED.  AND WHEN SOMEBODY FILES AN MDR WHICH IS A MEDICAL DEVICE REPORT ABOUT WHAT THEY CALL AN ADVERSE EVENT.  MEANING SOMEBODY WAS, YOU KNOW, INJURED OR KILLED OR SOMETHING LIKE THAT, OR COULD HAVE BEEN, YOU GO BACK IN YOUR RISK MANAGEMENT SYSTEM AND YOU SEE WHAT YOU NEED TO FIX AND YOU FIX IT.  AND THAT OFTEN LEADS TO IMPROVEMENTS.

SO THAT’S OUR APPROACH.

AND FDA SORT OF LEADS YOU TO THAT PARTIALLY WITH WE HAVE WHAT’S CALLED DESIGN CONTROLS, AND IT IN THE QUALITY SYSTEM REGULATION, AND DESIGN CONTROLS, AGAIN, LEADS YOU STRAIGHT INTO HAVING RISK MANAGEMENT AND HUMAN FACTORS ENGINEERING.

AND WE ALSO HAVE A SECTION THAT ADDRESSES WHAT THEY CALL COMPLAINT HANDLING.

EVERY MEDICAL DEVICE LOOK ON THE PACKAGE FOR YOUR TOOTHBRUSH THERE IS AN 800 NUMBER THAT YOU CAN CALL.  AND YOU CAN TELL THEM THAT YOU THINK THAT THE COLOR DAY GLOW ORANGE IS REALLY DANGEROUS.

YOU KNOW.

THE PERSON THAT HEARS THIS WILL THINK ARE CRAZY.  GUARANTEED.  BUT THEY WILL WRITE IT DOWN AND THEY WILL SEND IT TO THE QUALITY PEOPLE.

AND THEY WILL EVALUATE IT.  UNLESS YOU GAVE A LOT MORE INFORMATION THEY WILL PROBABLY DECIDE IT DOESN’T NEED AN INVESTIGATION.

ON THE OTHER HAND, IF YOU TOLD THEM THIS YOUR ELECTRIC WHEELCHAIR TOOK OFF WHILE YOU WERE SITTING AT THE CORNER WHEN THE POLICE CAR WENT BY, YOU WILL GET A DIFFERENT LEVEL OF ATTENTION.

MUCH DIFFERENT LEVEL OF ATTENTION.

AND THEY WILL INVESTIGATE IT AND COME AND TALK TO YOU AND THEY WILL GO TO THE MANUFACTURER AND BY THE WAY THE REPORT WILL GO TO THE MANUFACTURER.

AND EVERYBODY WILL TRY TO FIGURE OUT WHY THIS HAPPENED.  AND BY THE WAY THIS HAS HAPPENED.

I DON’T THINK IT HAPPENS VERY MUCH LATELY.  I THINK THAT, AGAIN, IT’S A PROBLEM THAT’S PRETTY MUCH BEEN SOLVED.  BUT I WOULDN’T SWEAR IT’S GONE AWAY FOREVER.

BUT WE USE THESE TO MAKE THE THINGS BETTER.

AND TO BE QUITE HONEST IF YOU REALLY HAVE A PROBLEM ARE HAVING PROBLEMS ONE WAY TO GET TO THE COMPANY IS NOT TO YELL AT THEM NOT TO SCREAM AND COME IN AND YELL AT SOMEBODY LIKE ME IS TO CALL THE PERSON ON THE PHONE AND LET THEM POLITELY WHAT THE DIFFICULTY IS YOU HAVE HAVING TROUBLE YOU THINK IT’S UNFORTUNATE THAT YOU CAN’T ENTER OR THE ACCESS TO THE WHATEVER IT IS IS DIFFICULT, AND THAT YOU ARE PERSON WITH THIS, THIS, THIS, AND THIS CONSIDERATION.

THEY WILL LISTEN.

BECAUSE THEY WANT TO MAKE A GOOD PRODUCT.  THEY WANT YOU TO BE YOUR HEALTH TO BE IMPROVED.  THAT’S THE WHOLE POINT.  WELL, I KIND OF WORKED US THROUGH VOLUNTARY CONSENSUS STANDARDS BECAUSE YOU CAN TELL THAT YOU REALLY DO DO THIS STUFF.  I HAVE BEEN INVOLVED WITH IT FOR A VERY LONG TIME.  OUR RECOMMENDATIONS IS SIMPLE.  INCORPORATE THE STANDARDS THEY KNOW HOW TO COMPLY WITH THEM.  AND THEY WILL DO A BETTER JOB OF COMPLYING WITH THEM THAN THEY WILL OF FEELING SOMETHING, THEY ARE HAD TOTALLY UNFAMILIAR WITH.  SECOND, PLEASE INCLUDE US.  I MEAN I REALLY APPRECIATE THIS INVITATION, AND I HOPE THIS CONTINUES.

FROM OUR END, WE WILL GLADLY HOOK YOU UP WITH INDUSTRY DESIGN EXPERTS, OR INDUSTRY HUMAN FACTORS EXPERTS.  I MEAN, ED WHO WAS MENTIONED BEFORE WORK FOR ABBOTT THEY ARE ONE OF OUR BIGGEST MEMBERS I KNOW ED WELL.

I PROBABLY KNOW SOME OF THE OTHER PEOPLE THAT YOU NEED TO KNOW.

AND WE WILL GLADLY SET UP MEETING WITHS THE INDUSTRY OR HOST MEETINGS.

WE ARE MORE THAN HAPPY TO WORK WITH YOU.

WE HAVE NO DESIRE FOR — TO WORK AGAINST ANYBODY.  AND AS I SAY YOU KNOW IF YOU MAKE MEDICAL DEVICES YES WANT TO MAKE MONEY I WOULD HOPE SO IT’S AMERICA IT’S BUSINESS IT’S CAPITALISM BUT YOU ARE IN THIS BUSINESS BECAUSE IT’S BETTER THAN MAKING CIGARETTES.

YOU KNOW, YOU GO HOME AND YOU SLOPE AT NIGHT.  YOU SLEEP WELL.  AND I MEAN I SAT AT MEETINGS WITH A FRIEND OF MINE WITH WHOM I HAVE GONE AROUND THE WORLD TO STANDARDS MEETINGS AND SOMETIMES IT’S NOT AS FRIENDLY AS WE WOULD LIKE IT TO BE.

BUT IN THE END, YOU KNOW, IT’S A LITTLE NERDY.  I MEAN BELIEVE ME.

(LAUGHTER)

>> BUT IN THE END, YOU DO KNOW THAT YOU ARE PRODUCING SOMETHING THAT PROBABLY ALONG THE WAY IS SAVING A COUPLE OF LIVES THAT’S NOT A BAD THING TO DO AND IT’S NOT A BAD FEELING THANK YOU.

(APPLAUSE)

>> DAVID BAQUIS:  THANK YOU, BERNIE.  WE WERE JUST TALKING ABOUT THE AGENDA, DR. IEZZONI IS HERE.  SO, WE ARE GOING TO SWITCH THINGS AROUND WE ARE GOING TO GO STRAIGHT TO THE NEXT PANEL AND TAKE QUESTIONS FOR BOTH PANELS AFTER THAT.  THANK YOU VERY MUCH.  READY FOR INTRODUCTIONS IT’S OUR PLEASURE TO INTRODUCE TWO ESTEEMED PHYSICIANS, WE WERE FORTUNATE IN PLANNING THE AGENDA EVERYBODY INVITED ACCEPTED IT WAS EASY TO SET UP THIS MEETING.  SO HOPE TO HEAR ABOUT RESEARCH THAT HELPS SUPPORT MEDICAL EQUIPMENT STANDARDS AS WELL AS OTHER INFORMATION THEY CAN SHARE FROM THEIR EXPERIENCES.  LISA IEZZONI IS A PROFESSOR OF MEDICINE AT HARVARD, AUTHORING NUMEROUS PROFESSIONAL ARTICLES AND JOURNALS.  WE WILL HEAR FROM DR. MARGARET STINEMAN, PROFESSOR OF PHYSICAL MED AND REHABILITATION AT UNIVERSITY OF PENNSYLVANIA, PROVIDING ADDITIONAL RECOMMENDATIONS FOR RESEARCH AND PERHAPS HELP US UNDERSTAND THE ROLE OF A PHYSIATRIST.  GO AHEAD, PROCEED PLEASE.

>> OKAY.  IS THERE ACTUALLY ANY WAY TO HAVE THE LIGHT A LITTLE BIT UP IN THE ROOM SINCE I AM NOT DOING POWERPOINT SO I CAN HAVE A LITTLE LIGHT ON MY ALL RIGHT THANK YOU VERY MUCH FOR HAVING ME I APOLOGIZE I HAVEN’T BEEN ABLE TO BE HERE FOR THE FULL MEETING I WAS AT ANOTHER MEETING ACROSS TOWN.  SO I APOLOGIZE IF I SAY THINGS THAT YOU HAVE ALREADY HEARD ONCE TWICE THREE TIMES TODAY.  BUT SOMETIMES THESE THINGS BEAR REPEATING TODAY I WAS ASKED TO SPEAK TO YOU AS RESEARCHER 22 YEARS IT HAS INFORMED MY RESEARCH.  THE 54 MILLION PERSONS LIVING IN THE U.S. WITH DISABILITIES GENERALLY FACE THE SAME RISK OF DEVELOPING ACUTE CHRONIC HEALTH CONDITIONS NONETHELESS DISABILITIES ARE DIVERSE, MANY OF CAUSED BY SERIOUS MEDICAL CONDITIONS.

MANY DISABILITIES ARE CAUSED BY SERIOUS MEDICAL CONDITIONS THAT LEAD PERSONS WITH A NARROW MARGIN OF HEALTH.  MOST PERSONS WITH DISABILITIES NEED THE SAME SCREENING PREVENTIVE SERVICES, AND HERE I INCLUDE BOTH DENTAL AND EYE, AS DO OTHER PEOPLE.  FURTHERMORE, THEY MAY NEED SPECIALIZED SERVICES SPECIFICALLY TO DIAGNOSE AND TREAT THEIR UNDERLYING MEDICAL CONDITIONS.

MY RESEARCH ON HEALTHCARE FOR PERSONS WITH DISABILITIES HAVE USED THREE PRIMARY SOURCES OF INFORMATION.

FIRST PEOPLE WITH DISABILITIES EITHER THROUGH IN-DEPTH INDIVIDUAL INTERVIEWS OR FOCUS GROUP INTERVIEWS, SECOND LARGE FEDERAL GENERAL PURPOSE HEALTH SURVEYS AND THIRD INFORMATION FROM CANCER REGISTERIES MAINTAINED BY THE NATIONAL CANCER INSTITUTE SUPPLEMENTED BY MEDICARE CLAIMS FILES.

THE LAST TWO SOURCES OF INFORMATION CAN ONLY OFFER INFERENCES OR CLUES ABOUT THE POTENTIAL BARRIERS CAUSED BY MEDICAL EQUIPMENT.  SO I WILL START MY PRESENTATION THERE.

OUR INITIAL STUDIES USED GENERAL PURPOSE NATIONAL HEALTH SURVEYS FOCUSED ON ROUTINE SCREENING SERVICES AS THOSE RECOMMENDED BY THE U.S. PREVENTIVE SERVICE TASK FIRST THE FIRST SURVEY THE DISABILITY SUPPLEMENT NHISD PERFORMED IN 1994 AND 95.  15 OR 16 YEARS AGO.

IT REMAINS THE MOST IN-DEPTH NATIONAL SURVEY ON DISABILITY IN AMERICA.

WE ALSO ANALYZE THE 2001 MEDICAL EXPENDITURE PANEL SURVEY.  CONDUCTED BY THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY.

BEFORE WE VIEWING IT’S IMPORTANT TO NOTE MANY FACTORS MAY EXPLAIN LOWER RATES OF SCREENING AND PREVENTIVE SERVICE USE AMONG PERSONS WITH DISABILITIES INCLUDING COMPETING HEALTH DEMANDS, AND PEOPLE’S INDIVIDUAL PREFERENCES.  NONETHELESS EQUIPMENT IN ACCESSIBILITY LIKELY CONTRIBUTES TO LOWER LEVELS OF SERVICE USE AMONG PERSONS WITH DISABILITIES.

ACCORDING TO THE NHISD, WOMEN WITH MAJOR PROBLEMS WALKING WERE 45% MORE LIKELY TO GET PAP SMEARS.  THIS GAP HAD NARROWED USING THE 2001 DATA ALTHOUGH WOMEN WITH MAJOR MOBILITY PROBLEMS WERE LESS LIKELY THAN OTHER WOMEN TO RECEIVE PAP SMEARS.  EITHER SURVEY ASKED QUESTIONS ABOUT WHY WOMEN DIDN’T RECEIVE THE TESTS SOME FRACTION IS DUE TO DIFFICULTIES GETTING ON TO FIXED HEIGHT EXAMINATION TABLES.  ALSO, ACCORDING TO THE NHISD, WOMEN WITH MAJOR DIFFICULTIES WALKING WERE 30% LESS LIKELY TO GET MAMMOGRAMS RECOMMENDED EVERYONE OR TWO YEARS OR WOMEN 40 OR OLDER WITH GRADE B LEVEL OF EVIDENCE.

ONE POTENTIAL EXPLANATION FOR SOME FRACTION OF THIS DIFFERENCE WAS PROBABLY INACCESSIBLE MAMMOGRAPHY EQUIPMENT.  HOWEVER, WHEN WE REPEATED THE ANALYSES TO THE EXTENT POSSIBLE USING THE 2001 DATA, THESE DIFFERENCES HAD DISAPPEARED.  HOWEVER, THE 2001 DATA FOUND WOMEN WHO WERE DEAF OR HARD OF HEARING WERE 20% LESS LIKE THAN OTHER WOMEN TO OBTAIN MAMMOGRAMS.  THE REASONS FOR THIS ARE UNCLEAR FROM THE SURVEY FINDINGS SUGGEST ONE POSSIBILITY BASED ON A QUALITATIVE STUDIES LATER.

WITH FUNDING FROM THE NATIONAL CANCER INSTITUTE WE LOOKED AT PATTERNS OF CANCER STAGE OF DIAGNOSIS AND TREATMENT FOR PATIENTS UNDER 65 DIAGNOSES OF BREAST COLON LUNG OR PROSTATE CANCER WE USED REGISTERIES MERGED WITH MEDICARE CLAIMS TO COMPARE PERSONS ON MEDICARE BECAUSE OF DISABILITY WITH THOSE OF OTHER INDIVIDUALS.

WE FOUND A NUMBER OF DISPARITIES INVOLVING BREAST AND LUNG CAN CANCERS MOST WERE FINDINGS OF BREAST CANCER.  EARLY STAGE BREAST CANCER WOMEN HAVE TWO BASIC TREATMENTS THAT OFFER SIMILAR CANCER FREE SURVIVAL RATES.

EITHER A MASTECTOMY OR BREAST CONSERVING SURGERY LUMPECTOMY FOLLOWED BY RADIATION THERAPY.

WOMEN CHOOSING LUMPECTOMIES NEEDED THE FOLLOW-UP RADIATION TO HAVE SURVIVAL AS MASTECTOMY.  WOMEN WITH DISABILITIES DIAGNOSED WITH STAGE 2 WERE 24% LESS LIKELY THAN OTHER WOMEN TO GET LUMPECTOMY AFTER ACCOUNTING FOR THE BREAST OTHER TUMOR CHARACTERISTICS THAT NOT SO TROUBLING IT COULD RELATE PRIMARILY TO PATIENT PREFERENCE SUCH AS DESIRE OF DISABLED WOMEN NOT TO RECEIVE RADIATION THERAPY WHICH REQUIRES DAILY VISITS FOR MANY WEEKS.  HOWEVER, WHAT WAS DEEPLY TROUBLES WAS THE FINDING RELATED TO THE USE OF RADIATION THERAPY FOR WOMEN RECEIVING LUMPECTOMIES WE FOUND WOMEN WITH DISABILITIES RECEIVING THAT WERE 17% LESS LIKELY THAN OTHER WOMEN TO RECEIVE FOLLOW-UP RADIATION THERAPY.  AGAIN, ACCOUNTING FOR WOMEN’S DEMOGRAPHIC AND BREAST TUMOR CHARACTERISTICS, THAT MEANS THEY GOT LESS QUALITY CARE.  IT WAS NOT SURPRISING WOMEN WITH DISABILITIES WERE MORE LIKELY TO DIE FROM BREAST CANCERS THAN OTHER WOMEN.  MANY FACTORS COULD EXPLAIN THE RADIATION FINDING INCLUDING PREFERENCES AND DIFFICULTIES WITH TRANSPORTATION TO RADIATION THERAPY FACILITIES.

HOWEVER, IT IS ALSO POSSIBLE THAT SOME FRACTION OF THE DIFFERENCE IS PLAINED BY PROBLEMS WITH PHYSICAL ABSCESS TO PHYSICAL RADIO THERAPY EQUIPMENT.

I HAVE SOMETIMES ALONG WITH ONE OTHER COLLEAGUE CONDUCTED RESEARCH INTERVIEWS WITH 200 ADULTS WITH DISABILITIES, INCLUDING PERSONS WITH MOBILITY PROBLEMS, PERSONS WHO ARE BLIND OR LOW VISION, PERSONS WHO ARE DEAF OR HARD OF HEARING AND PERSONS WITH PSYCHIATRIC DISABILITIES.

I HAVE ALSO INTERVIEWED MORE THAN 30 PHYSICIANS AND 20 PHYSICAL AND OCCUPATIONAL THERAPISTS WE HEARD ABOUT INACCESSIBLE MEDICAL EQUIPMENT CAUSING INCONVENIENCE AND SOMETIMES PHYSICAL HAZARDS RISK AND FALSE AND REPEATED TESTING INCREASING RADIATION EXPOSURE.  THE DOWNSTREAM EFFECT WAS PEOPLE WOULD REFUSE TO SEE OR DELAY OBTAINING SERVICES THUS COMPROMISING THEIR HEALTH.  IN MY BRIEF TIME TODAY I CAN ONLY GIVE HIGHLIGHTS OF A FEW FINDINGS.  DIFFICULTIES GETTING ON TO FIXED HEIGHT EXAMINATION TABLES WERE UNIVERSAL CONCERN EXPRESSED BY PEOPLE WITH MOBILITY DISABILITIES INTERVIEWEES DISMISSED AS UNHELPFUL STEP TOOLS OR FIXED HEIGHT EXAMINATION DISABLED.  ONE WOMAN COUNTED JUST STEP ON THE STEP I SAY I CAN’T I HAVE NO THIGH MUSCLE IN EITHER LEG.

OFTEN PERSONS AGREE TO ABBREVIATED EXAMINATIONS IN THE WHEELCHAIRS BECAUSE TRANSFERS TO TABLES WERE IMPOSSIBLE.  WHILE BEING EXAMINED IN THE WHEELCHAIR MIGHT BE ACCEPTABLE IN CERTAIN CIRCUMSTANCES IT REPRESENTS SOMEBODY STANDARD QUALITY CARE ESPECIALLY IN THE CONTEXT OF ANNUAL PHYSICAL EXAMINATION FOR EVALUATION OF SPECIFIC COMPLAINTS INVOLVING THORAX OR PELVIC AREAS.

ONE WOMAN WHO WAS QUADRIPLEGIC FOR POLIO GOT CARE FOR BREAST CANCER AT KAISER IN NORTHERN CALIFORNIA 2004 THREE YEARS AFTER THE SETTLEMENT OF JULY 2000 ADA LAWSUIT.  ALTHOUGH THE WOMAN LIKED HER SURGEON EVERY PROCEDURE SHE DID ON ME POST SURGERY SHOULD HAVE BEEN DONE WITH ME SUPINE AND WASN’T.

FOR INSTANCE, THE PERSON INSERTED A CATHETER FOR EASIER INTRAVENOUS ACCESS DURING CHEMOTHERAPY RIGHT AFTER IT WAS INSTALLED.  I WAS LIGHTHEADED FALLING OVER IN THE CHAIR WHILE ACCESS, THE SURGEON SAYS YOU NEED TO BE LYING DOWN.  BUT THE KAISER STAFF COULD NOT GET THE WOMAN ON THE FIXED HEIGHT EXAMINATION TABLE.  THE SAME WOMAN HAD TROUBLE WITH CHEMOTHERAPY WHICH IS VIRTUALLY ALWAYS DONE IN OUTPATIENT SETTINGS.  THE CLINICS INFUSION CHAIRS AND BEDS WERE INACCESSIBLE SO THE WOMAN WAS TOLD SHE WOULD RECEIVE THERAPY SEATED IN HER WHEELCHAIR.  SHE WONDERED WHAT WOULD HAPPEN IF SHE NEEDED TO LIE DOWN.  I AM LOOKING AROUND THERE IS NO HEIGHT ADJUSTABLE TABLES.  THERE IS CERTAINLY NO LIFT.  A CASCADE OF ACTIVITY ENSUED, THE CLINIC SAID WE CANNOT TREAT YOU HERE BECAUSE YOU ARE NOT AMBULATORY.  THIS IS AN AMBULATORY TREATMENT FACILITY YOU HAVE TO BE TREATED — YOU HAVE TO BE ADMITTED TO THE HOSPITAL.  I HIT THE ROOF.  THEY ENLISTED AID OF LEGAL ADVOCACY AND GOT THEM TO OBTAIN A LIFT AND TRAIN THE STAFF TO USE IT.  THIS COULD HAVE BEEN INVOLVED ACCESSIBLE INFUSION BEDS AND CHAIRS.  HOWEVER, MY INTERVIEWS FOUND PHYSICIANS PRACTICING IN SETTINGS WITH AUTOMATICALLY ADJUSTABLE TABLES ARE SOMETIMES UNCERTAIN HOW TO USE THE EQUIPMENT.

FURTHERMORE, IN BUSY PRACTICES WITH MULTIPLE CLINICIANS SCHEDULING SPECIFIC PATIENTS FOR THE ONE ROOM WITH THE ACCESSIBLE TABLE IS COMPLICATED.  ONE PHYSICIAN ADMITTED I DON’T THINK SHE HURT HERSELF WHEN SHE WAS TOLD ME THIS WHEN INSIDE A ROOM WITH ACCESSIBLE TABLE SHE NEVER USES THE AUTOMATIC LIFT FEATURE SHE KEEPS IT FIXED AT A HEIGHT CONVENIENT FOR HER QUOTE, I AM BUSY I HAVE GOT ONLY 15 MINUTES PER PATIENT, IT’S TOO LONG FOR THE TABLE TO GO UP AND DOWN MY PATIENTS DON’T COMPLAIN THEY JUST GET UP ON TO THE TABLE USING A STOOL.

NOT BEING ABLE TO BE WEIGHED WAS VIRTUAL UNIVERSAL COMPLAINT AMONG PERSONS WITH MOBILITY DISABILITIES.

THIS IS ESPECIALLY A PROBLEM BECAUSE AS OUR NHISD ANALYSIS SHOWED PEOPLE WITH LOWER EXTREMELY PERSONS ARE 2.5 TIMES MORE LIKELY THAN PERSONS WITHOUT THE IMPAIRMENT TO BE OBESE WITH BODY MASS GREATER THAN 30 KILOGRAMS PER METER SQUARE.  SOME WITH SPINAL CORD INJURY JOKED WEIGHING THE SAME AS THE DAY OF INJURY BECAUSE THEY WERE NOT WEIGHED SINCE.  A WOMAN BEING PREGNANT DESCRIBED BEING WEIGHED ON FREIGHT SCALES IN HOSPITAL BASEMENTS OR LOADING DOCKS.  ONE WOMAN AS TEENAGER DEVELOPED BREAST CANCER IN THE LATE 3’S THE DOSAGES ARE DETERMINED BASED ON THE WOMAN’S WEIGHT.  THE CANCER PROVIDER DIDN’T HAVE WHEELCHAIR ACCESSIBLE SCALE.  TO DETERMINE THE WEIGHT, SHE LIFTED HER OUT OF THE WHEEL CHAIR STANDING ON TO THE SCALE RETURNED HER TO THE CHAIR AND WEIGHED HIMSELF ALONE.  AS THIS EXAMPLE SHOWS, LACK OF ACCESSIBLE EQUIPMENT PRESENTS RISK NOT ONLY FOR PATIENTS BUT CARE PROVIDERS WHO MUST LIFT THE PATIENTS.

RADIOLOGY EQUIPMENT INCLUDING THE MAMMOGRAPHY MACHINES RAISED CONSIDERABLE CONCERNS.

ONE WOMAN WHEELCHAIR USER DESCRIBED NEEDING TWO MAMMOGRAM TECHNICIANS TO HELP HER GET HER SCREENING MAMMOGRAM, ONE TO HOLD HER IN POSITION WHILE THE IMAGE WAS TAKEN THE OTHER CONTROL THE — THE TECHNICIAN WHO HELD THE WOMAN IN PLACE IT NOT HAVE ANY PROTECTION TO SHIELD HER FROM THE RADIATION SHE WOULD GET WHEN THE IMAGE WAS TAKEN.

THE TECHNICIAN JOKED THAT SHE WAS PAST CHILD BEARING AGE NONETHELESS HER THYROID AND OTHER ORGANS ARE SENSITIVE TO RADIATION EXPOSURE INSISTING THE PATIENT PUT THIS RADIOLOGY TECHNICIAN AT RISK.  RESERVATIONS ABOUT EQUIPMENT WERE NOT LIMITED TO PERSONS WITH PHYSICAL DISABILITIES SOME WOMEN WHO COMMUNICATE USING ASL DESCRIBE DIFFICULT SITUATIONS IN MAMMOGRAPHY SUITES UNLESS ASL INTERPRETER ACCOMPANIES THEM THEY MAY BE UNABLE TO FOLLOW INSTRUCTIONS FROM THE MAMMOGRAPHY TECHNICIAN WHO DISAPPEARS BEHIND THE RADIATION FIELD WHEN TAKING THE IMAGE.  WITHOUT BEING ABLE TO SEE OR HEAR THE TECHNICIAN THE WOMEN MAY BE UNAWARE OF WHEN TO HOLD HER BREATH TO AVOID MOTION ART FACT WHILE THE EQUIPMENT GENERATES THE MAMMOGRAM IMAGE BECAUSE OF THIS COMMUNICATION PROBLEM A TECHNICIAN NEEDED TO TAKE MANY FAMILIAR FEE IMAGES TO OBTAIN ONE WITHOUT MOTION ART FACT.  EXPOSING WITHIN DEAF WOMAN TO UNNECESSARY RADIATION AND DISCOMFORT.  A SIMPLE SYSTEM OF READILY VISIBLE LIGHT VIEWS COULD RECTIFY THE SITUATION.  PLEASE RECALL FINDINGS ABOUT BREAST CANCER TREATMENT WOMEN WITH DISABILITIES HAD SIGNIFICANTLY LOWER RATES OF RADIATION THERAPY FOLLOWING BREAST CONSERVING SURGERY.  ACCESS BARRIERS MIGHT HAVE ADDED TO THE FINDING.  SEVERAL WOMEN WITH MOBILITY DISABILITIES WHO DEVELOPED BREAST CANCER NEEDED RADIATION THERAPY REPORTED PROBLEMS GETTING ON TO THE TABLE.  ONE WOMAN’S HUSBAND LIFTED HER ON TO THE TABLE FOR EACH OF THE 26 RADIO THERAPY SESSIONS.

A WOMAN WITH MULTIPLE SCLEROSIS WENT TO A FACILITY WHERE WITHIN OUT OF FOUR TABLES AUTOMATICALLY MOVED UP AND DOWN.  SOMETIMES SHE ARRIVED FOR THE SESSION AND THE AUTOMATIC TABLE WAS UNAVAILABLE.  THEY HAD SO MANY PATIENTS GOING THERE RESERVING THE TABLE WOULD HAVE BEEN A LOGISTICALLY NIGHTMARE ALL THE RADIATION THERAPY MACHINES KEPT BREAKING DOWN.  CLOSE QUOTE

RADIO THERAPY STAFF USED VELCRO STAFF TO KEEP ONE WOMAN SECURED ON THE TABLE WITH CP POSITIONING THE ARM WAS PROBLEMATIC “YOU HAD TO KEEP YOUR ARM OVER THE HEAD, THE POSITION I CAN’T MAINTAIN.  I SAID, I AM NOT GOING TO BE ABLE TO DO THIS WE ARE GOING TO HAVE TO DO SOMETHING.  THEY SAID WHAT.  I SAID TIE IT THERE FIX IT OR BRACE IT.  THEY ARE ALL KINDS OF POSITIONING DEVICES THEY COULD HAVE USED VELCRO STRAPPING BUT THEY DID NONE OF THAT THEY ENDED UP USING MASKING TAPE EVERY SINGLE TIME.”

I HAVE COUNTLESS ADDITIONAL STORIES ABOUT PHYSICAL ACCESS BARRIERS INVOLVING MEDICAL EQUIPMENT IN CONCLUSION I WANT TO MAKE SEVERAL POINTS, NUMBER ONE, BARRIERS PRESENT RISK TO PATIENTS OBVIOUS RISK FALSE AND DISCOMFORT OTHER RISKS INCLUDE EXCESSIVE EXPOSURE TO RADIATION AND DIAGNOSTIC DELAYS FROM INADEQUATE PHYSICAL EXAMINATIONS NUMBER TWO BARRIERS PRESENT RISK TO CLINICAL STAFF, THE OBVIOUS RISK INCLUDE INJURIES FROM LIFTING PATIENTS BUT OTHER RISKS CAN INCLUDE EXPOSURE TO RADIATION AND PROFESSIONAL RISKS FROM NOT PROVIDING ADEQUATE QUALITY CARE.  THREE, THE PROBLEMS CAUSED BY PHYSICAL BARRIERS DO NOT ONLY INVOLVE PLACING PATIENTS ON EQUIPMENT.  COMMUNICATION BARRIERS AND DIFFICULTY WITH REQUIRED POSITIONING ONCE ON THE EQUIPMENT CAN CAUSE FURTHER PROBLEMS.  FOUR, TRAINING PERSONNEL AND MAKING APPROPRIATE ACCOMMODATIONS IS CRITICAL.  FINALLY, IT’S ESSENTIAL TO INCLUDE PERSONS WITH DISABILITIES AS ACTIVE PARTNERS.  ADOPTING UNIVERSAL DESIGN PERSPECTIVE ENSURING MEDICAL EQUIPMENT HAS DIVERSE FEATURES AND OPTIONS ADAPTED TO ACCOMMODATE WILL BE CRITICAL.  INCLUDING PEOPLE WITH A RANGE OF DISABILITIES AS INTEGRAL MEMBERS OF THE DESIGN TEAM IS ESSENTIAL.  THANK YOU.

>> DAVID BAQUIS:  THANK YOU VERY MUCH.

(APPLAUSE)

>> DR. STINEMAN.

>> FIRST, I WANT TO VERY QUICKLY ACKNOWLEDGE THE ACADEMY FOR PHYSICAL MED AND REHABILITATION THAT ASKED ME TO COME HERE AS WELL AS DAVID BAQUIS, WITH THE ACCESS BOARD OTHER FOLKS INSTRUMENTAL ALICE KRUGER PRESIDENT OF VIRTUAL ABILITY WHO HELPED RUN FOCUS GROUPS WITH PEOPLE WITH DISABILITIES AND DR. ELIZABETH SANDEL CHIEF OF PM AND R AT KAISER REHABILITATION CENTER, WHO WAS REMARKABLE WITH SOME OF HER INSIGHTS THAT I WILL SHARE.

THE FIRST QUESTION IS, WHY ARE STANDARDS IMPORTANT?  I THINK THAT DR. IEZZONI REALLY ILLUSTRATED THAT I AM NOT GOING TO TALK A LOT ABOUT THAT.  BUT JUST SAY PEOPLE WITH DISABILITIES ARE LESS LIKELY TO GET MEDICAL AND DENTAL CARE AND PREVENTIVE SERVICES.

AND MANY, MANY PEOPLE HAVE PUBLISHED ON THAT INCLUDE JUNE KAILES AS WELL AS DR. IEZZONI.

THE OTHER MAIN ISSUE THERE IS THAT HIGHER QUALITY DIAGNOSTIC SCREENING EXPERIENCES INCREASE THE COMPLIANCE IF YOU HAVE A HORRIBLE EXPERIENCE ARE NOT GOING TO GO BACK.  SO, THIS COULD MAYBE EXPLAIN WHY PEOPLE WITH DISABILITIES HAVE HIGHER MORTALITY RATES FOR CANCER THIS IS SHOWN IN THE LITERATURE AS WELL AS WOMEN BEING DIAGNOSED AT HIGHER STAGINGS OF CANCER.

THE NEXT SLIDE ACTUALLY SAYS, THIS ISN’T THE SCARIEST MEDICAL DIAGNOSTIC EQUIPMENT.  IT HAS A PICTURE OF A VERY STERN LOOKING HEALTH PROFESSIONAL THAT HAS JUST PUT ON THE GLOVE AND IS THRUSTING HER HAND TOWARDS THE PATIENT AND THE NEXT SLIDE AFTER THIS SAYS THIS MIGHT BE THE SCARIEST.  AND IT’S THE PICTURE OF THE EXAM BED FROM HOW IT WOULD LOOK IF YOU ARE SITTING IN A WHEELCHAIR.  AND THEN THE INTERESTING THING ABOUT THIS IS THAT THIS SLIDE ACTUALLY HAS MANY ISSUES IN IT.

THAT WE HAVE TALKED ABOUT TODAY.

FIRST OF ALL, IT’S A FIXED EXAM HEIGHT TABLE.  SECOND OF ALL IT’S SHOVED IN THE CORNER OF THE ROOM HOW COULD OTHER PERSON IN A WHEELCHAIR WHEEL UP THERE AND EVEN TRANSFER IF THEY COULD.  THIS SHOWS THE IMPORTANCE OF POSITIONING THE DEVICES IN THE ENVIRONMENT.  BUT ALSO THERE IS SOME OTHER SUBTLE REAL BIG ISSUES IF YOU LOOK CLOSELY THE AT THE SLIDE YOU WILL SEE IT LOOKS LIKE THERE IS ELECTRICAL EQUIPMENT THAT HAS BEEN PLUGGED IN AND PROBABLY THE WIRES GOING ACROSS THE AREA WHERE A PERSON MIGHT BE WALKING.  THAT MIGHT BE USING A CANE MIGHT HAVE MOBILITY RESTRICTIONS AND WHAMO AND FINAL ISSUE WITH THE SLIDE IT SHOWS SOME INFORMATION THAT’S WRITTEN ON A WALL AND WHAT ABOUT PEOPLE WHO HAVE VISUAL DIFFICULTIES.  THE NEXT SLIDE SHOWS A WORLD WAR I EXAM TABLE THE REASON WE CHOSE THAT IS THE QUESTION IS HAVE WE PROGRESSED?  I MEAN THIS THING IS RICKETY SMALL AND THIN.

(LAUGHTER)

>> PATIENT IS NOT FITTING ON IT VERY WELL.  SO, WHAT’S DIFFERENT FROM TODAY?

NEXT SLIDE.  UNIVERSAL DESIGN ACCESS IS NOT NECESSARILY UNIVERSAL.  SO, IF A UNIVERSAL — ACCESSIBILITY FEATURE FOR A PERSON WITH ONE TYPE OF DISABILITY MAY ACTUALLY NEGATIVELY INFLUENCE THE USABILITY FOR THOSE WITHOUT DISABILITY OR WITH SOME OTHER TYPE OF DISABILITY.  THIS IS A VERY IMPORTANT PRINCIPLE.

IN THAT YOU HAVE TO LOOK CAREFULLY AT THE DESIGN IN TRYING TO FIGURE OUT HOW IT’S AFFECTING OTHER GROUPS OF PEOPLE.

TO REALLY UNTANGLE THIS, SHOW THE NEXT SLIDE.  YOU HAVE TO THINK ABOUT CATEGORIES OF DISABILITIES.  AND THIS IS JUST ONE APPROACH AND I HAVE ACTUALLY CHANGE IT BASED ON WHAT I HAVE HEARD TODAY.

FIRST, THERE IS PHYSICAL DISABILITIES WHICH IS MOBILITY LIMITATIONS PARALYSIS SKELETAL DEFORMITIES ARTHRITIS AFFECTING POSITIONING.  SECOND IS SENSORY PROBLEMS LOW VISION BLINDNESS LOW HEARING OR DEAFNESS.  INTELLECTUAL OR LANGUAGE DISABILITIES SOMETHING WE HAVEN’T TOUCHED ON TOO MUCH BUT IT’S INCREDIBLY IMPORTANT.  FOUR IS MENTAL HEALTH DISORDERS.  5 IS PEOPLE USING VENTILATORS OR OTHER TYPES OF EQUIPMENT AND WE HEARD ABOUT THOSE WITH CATHETERS AND COLOSTOMIES THAT ARE UNABLE TO HAVE MANY DIAGNOSTIC TREATMENTS TODAY BASS OF THESE DEVICES.

NEXT SLIDE.  SOME STANDARDS DO EXIST IN THAT WE TALKED ABOUT THE ADA TODAY THE ACCESS TO MEDICAL CARE FOR INDIVIDUALS WITH DISABILITIES DISABILITY RIGHTS SECTION U.S. DEPARTMENT OF JUSTICE.  THERE IS A LOT OF STANDARDS ACTUALLY OUT THERE FOR PHYSICAL DISABILITIES BUT FEWER FOR OTHER TYPES OF DISABILITIES.

SO, I DECIDED TO USE AS MY EXAMPLES MAINLY IDEAS FOR PEOPLE WITH SENSORY DISABILITIES AND THESE CAME OUT OF SOME OF OUR PANELS THAT WE DID.

FIRST DEVICES TO FACILITATE COMMUNICATION WITH THE USER WHO IS VISION OR HEARING IMPAIRED.

THESE ARE CRITICALLY IMPORTANT.

SECOND, ANOTHER AREA THAT CAME UP A LOT WERE SOME OF THE DIGITAL DIAGNOSTIC EQUIPMENT MUST INTERFACE WITH HOME MONITORING AND COMMUNICATION DEVICES SO, FOR EXAMPLE, OUR SOCIETY IN MEDICINE WE ARE GOING TO BE USING MORE AND MORE TELEMEDICINE.  MEDICAL HOMES CONCEPTS WHERE PEOPLE MIGHT BE INPUTTING THINGS INTO A COMPUTER THAT GOES TO SOME KIND OF CENTRAL REPOSITORY.  AS THIS HAPPENS IT’S CRITICALLY IMPORTANT TO SEE IF THESE MONITORING DEVICES ARE GOING TO INTERFACE WITH TELECOMMUNICATION DEVICES FOR DEAF PEOPLE.  THEY DON’T.

THEY ARE DIGITAL.  AND EVIDENTLY SOME OF THE PEOPLE THAT WE TALKED TO SAID THAT THEIR COMMUNICATION DEVICES DID NOT ACTUALLY WORK WITH SOME OF THESE THINGS THAT WERE BEING IN DEVELOPMENT.

ANOTHER REALLY INNOVATIVE IDEA THAT CAME OUT OF THE PANELS WAS TRANSPARENT FACIAL TASKS FOR LIP READING.  SO IF A CLINICIAN IS DOING A PROCEDURE WITH A DEVICE AND HAS TO GIVEN INSTRUCTION TO THE PERSON WHO HAS HEARING IMPAIRMENT, THE PERSON WOULD BE ABLE TO LEAD THEIR LIPS THROUGH THE MASK.  THE OTHER BIG AREA WAS OF COURSE WE ALREADY TALKED ABOUT THE FAMOUS MRI MACHINE WHICH EVERYBODY LOVES.

AND PEOPLE SUGGESTED THAT IF IT IS NOT ONE OF THE NEWER TYPE MODELS IF YOU CAN’T MAKE IT SO IT’S IMPARTIAL MAGNET WOULD BE TO HAVE MIRRORS IN THE MRI DEVICE SO THAT THE PERSON WHO IS INSIDE IT COULD SEE THE ENVIRONMENT OUTSIDE AND NOT BE FRIGHTENED.  I THINK THIS IS A VERY BIG ISSUE FOR PATIENTS THAT HAVE COGNITIVE LIMITATIONS THAT BECOME PARTICULARLY FRIGHTENED AND YOU CAN’T COMMUNICATE WITH THEM EASILY.  AND WHAT HAPPENS IN THE MEDICAL WORLD IS WE ARE OFTEN ASKED TO SEDATE THESE PATIENTS.  SO THAT THEY CAN HAVE THOSE PROCEDURES.  AND DO YOU KNOW HOW DANGEROUS IT IS TO TAKE A PATIENT THAT HAS DISABILITIES SEDATE THEM AND PUT THEM IN A TUBE WHERE THEY ARE NOT GOING TO BE EASILY ACCESSED?

I MEAN, SO I THINK IT’S CRITICAL TO FIGURE OUT WAYS OF MAKING THESE DEVICES SO THAT PEOPLE CAN TOLERATE THEM.  OTHER IDEAS WERE SIGNALING LIGHTS THAT WOULD INDICATE THE AMOUNT OF TIME THAT HAS PASSIONED THROUGH THE PROCEED DOOR THE AMOUNT OF TIME THAT IS LEFT IN THE PROCEDURE.  AND ANOTHER AREA SIMPLE THINGS LIKE FOR X-RAY EQUIPMENT WHERE ARE GOING BE ASKED TO HOLD YOUR BREATH TO CREATE A SWITCH THAT WOULD TURN ON A LIGHT THAT WOULD SAY, HOLD YOUR BREATH JUST BEFORE THE X-RAY WAS TAKEN.

AND THEN BREATHE WHEN IT WAS RELEASED.

SO THAT WOULD BE A WAY FOR A PERSON WITH HEARING PROBLEMS TO BE ABLE TO FOLLOW DIRECTIONS.

SO THE NEXT SLIDE ISSUED.  FIRST THERE IS STILL LIMITED RESEARCH TO STATE THERE IS SOME RECOMMENDED STANDARDS THAT EXIST BUT THE DEGREE OF DISSEMINATION ACROSS THE COUNTRY IS NOT KNOWN AND AT LEAST IT’S QUITE SPOTTY IT APPEARS.

RECOMMENDATIONS MAY BE PARTICULARLY INSUFFICIENT FOR SOME TYPES OF DISABILITY SUCH AS PEOPLE WHO HAVE COGNITIVE IMPAIRMENT.

PEOPLE WITH DISABILITIES IN OUR PANELS ACTUALLY EMPHASIZE THE IMPORTANCE OF DESIGNING DEVICE THAT ALLOW PATIENTS TO HAVE AS MUCH CONTROL AS POSSIBLE UNDERSTANDING THAT MOST OF THESE PROCEDURES YOU DO NEED A CLINICIAN OR TECHNOLOGIST THAT HAS BEEN TRAINED THERE ARE CERTAIN THINGS THAT YOU COULD DESIGN IN THE PROCEDURE WHERE THE PERSON COULD HAVE SOME CONTROL OF WHEN SOMETHING HAPPENS.

AND THEY ALSO EMPHASIZE PEOPLE INTERACTIONS ARE MOST IMPORTANT AS PEOPLE NEED TO BE ASKED WHAT THEY NEED AND SO THAT WHEN YOU LOOK AT FIELD LIKE HUMAN ENGINEERING PART OF THAT IS ENGINEERING THE DEVICES SO IT ENCOURAGES THE INTERFACE WITH THE CLINICIAN AND THE PATIENT.  NOW, RECOMMENDATIONS FOR RULE MAKING, ONE THOUGHT WOULD BE TO HAVE INTERNET BASED NATIONAL ACCESSIBILITY DATABASE CLEARINGHOUSE FOR PATIENTS, FAMILY MEMBERS, PROVIDERS, MANUFACTURERS WHERE EVERYBODY CAN SHARE INFORMATION ABOUT DEVICE ACCESSIBILITY WHICH IS FREE ACCESS.  THE SECOND IDEA WOULD BE TO HARNESS SOME OF THE SOCIAL MEDIA SITES LINKING CONSUMERS RESEARCH MANUFACTURERS INPUT AND DEVELOPING LOW COST NO COST TRAINING PROGRAMS ON USE OF ACCESSIBILITY EQUIPMENT FOR PROVIDERS THAT COULD BE ACTUALLY DOWNLOADED AT ANY TIME.

NEXT SLIDE RECOMMENDATION WOULD BE TO HARNESS EXISTING ORGANIZATIONS AND PLEASE INCLUDE INDEPENDENT LIVING AND ADVOCACY ORGANIZATIONS THAT NIDRR CENTER ON REHAB ENGINEERING AT MARQUETTE UNIVERSITY THAT SPOKE EARLIER.  OF COURSE THEY HAVE INCREDIBLE INFORMATION THAT COULD HARVEST THE KAISER PERMANENTE MODEL SYSTEM FOR MEETING THE NEEDS WITH DISABILITIES IS ANOTHER.  THERE ARE OTHER EXAMPLES THROUGHOUT THE DAY.

IN TERMS OF NEXT SLIDE — ASSESSING STANDARDS, AS YOU GO THROUGH IN TERMS OF LOOKING AT DIFFERENT STANDARD POSSIBILITIES HERE ARE POTENTIAL QUESTIONS TO ASK.  FIRST WHAT IS THE EQUIPMENT FOR.  SECOND WHAT IS THE STRATEGY NEEDED FOR DESIGN CHANGE.  THIRD, FOR WHAT TYPES OF DISABILITY IS IT ACCOMMODATING AND HOW WILL IT HELP.  FOURTH, WILL THE DESIGN CHANGE HINDER ACCESSIBILITY OR SAFETY FOR OTHER GROUPS.  5TH, ARE THERE SAFETY ISSUES AND PROVIDER EDUCATIONAL NEEDS.  SIX, WHAT ARE THE ENGINEERING CHALLENGES.  SEVEN WHAT ARE THE INCREMENTAL COSTS.  8 HAS THE STRATEGY TO INCREASE ACCESSIBILITY DECREASED USABILITY OR EFFECTIVENESS, AND I ADDED THAT AFTER JACK WINTER’S TACK SO THIS IS ONGOING THOUGHT PROCESS IN MY MIND.

CONCLUSIONS, DISPARITIES ARE GREATEST FOR THOSE IN GREATEST NEED.  THIS IS A PARADOX REALLY WHEN YOU THINK ABOUT IT.  IT’S BOTHERED ME THROUGHOUT MY ENTIRE MEDICAL CAREER THE PATIENTS WHO NEED THE MOST CARE HAVE THE MOST DIFFICULTY GETTING IT.

IT’S WEIRD.

IT’S SAD.

THERE NEEDS TO BE A BALANCE BETWEEN OVER AND UNDER REGULATION.  ADA STANDARDS FOR DIAGNOSTIC EQUIPMENT SHOULD NOT STATE “EVERYONE MUST TAKE THE FOLLOWING STEPS”

IN FACT THEY SHOULD BE TIED TO REALITY AND TO REMEMBER THE GOAL.

FINAL SLIDE, PLEASE, THE GOAL OF HEALTHCARE SHOULD BE EQUAL ACCESS TO AND INCLUSION OF ALL PEOPLE REGARDLESS OF TYPE OR LEVEL OF DISABILITIES.  PREVENTION DIAGNOSIS, MONITORING AND TREATMENT.

MONITORING AND TREATMENT.  HERE IS WHERE I FELT IT WAS REALLY IMPORTANT TO STATE OR TO ASK A QUESTION WHAT IS THE SENSE OF DIAGNOSING IF WE CAN’T MONITOR AND TREAT.

AND BECAUSE OF THAT I THINK THAT THE REGULATIONS REALLY DO NEED TO GO A LITTLE FURTHER AND LOOK AT THE MONITORING OF CONDITIONINGS ONCE THEY HAVE BEEN DIAGNOSED.

AND ALSO ROSEMARY EMPHASIZED HOW DIAGNOSTIC EQUIPMENT AND HOSPITALS ARE NOT MADE FOR PEOPLE WITH DISABILITIES, AND THIS IS TRUE, I CAN TELL YOU I TRY TO STAY OUT OF THEM.  AND I WORK IN THEM.

I MEAN, I — IT’S REALLY CRAZY.

THERE IS SOME WONDERFUL WONDERFUL THINGS THAT THEY CAN DO BUT THERE ARE ALSO DANGERS AND I MEDICINE IS MIRACULOUS BUT I WANT TO SAY THAT THERE ARE DANGERS.

IN CLOSING, I WILL SAY IT IS VERY EXCITING THAT THIS ACCESS BOARD IS IN POSITION TO BEGIN CHANGING THIS WORLD.  AND HOW BEST TO APPLY THE RESOURCES WE HAVE GIVEN THE COMPLEXITY AND GIVEN THE DIVERSITY OF THE NEED IN OUR POPULATION OF PEOPLE WITH DISABILITIES TO REALLY GET THE GREATEST BANG FOR WHAT WE DO.  THANK YOU.

(APPLAUSE).

>> DAVID BAQUIS:  THANK YOU.  WE HAVE 20 MINUTES REMAINING.  LET’S SEE WHO HAS QUESTIONS PEOPLE WHO HAVEN’T SPOKEN BEFORE PERHAPS.  WOMAN IN THE BACK HERE.

>> THANK YOU PROFESSOR OF MECHANICAL ENGINEERING.  FIRST OF ALL AMAZING I AM GLAD TO SEE OTHER ENGINEERS TRYING TO TEACH ACCESSIBILITY TO OTHER PEOPLE AND GLAD TO SEE THE LAST PRESENTATIONS INCLUDE OTHER THAN MOBILITY ISSUES IN ACCESSIBILITY BECAUSE I THINK THAT SHOULD BE THERE.  THIS ACTUALLY A COMMENT I WANT TO MAKE ON THE WHOLE DAY HERE SPECIFICALLY DIRECTED TO THE ACCESS BOARD IS THAT THERE IS AMAZING DATA AND RESEARCH THAT PEOPLE HERE HAVE DONE THEY HAVE GREAT RECOMMENDATIONS, BUT FROM ENGINEERING POINT OF VIEW, THE RECOMMENDATION NEEDS TO BE BASED ON THE NEED WHAT IS THERE AND NOT THE SOLUTION.  FOR EXAMPLE, ONE OF THE SOLUTIONS WAS THAT THE TABLES NEED TO BE MOTORIZED THE WHILE THAT IS GREAT AT THE SAME TIME, YOU WILL LIMIT THE MANUFACTURER TO USE MOTOR TO PROVIDE CERTAIN FUNCTION WHEN THE FUNCTION IS WHAT YOU NEED TESS A LITTLE BIT OF A WORDING SUGGESTION ON ALL OF THE STANDARDS BECAUSE YOU REALLY LIMIT THE INNOVATION AND COST EFFECTIVENESS IF YOU FORCE THEM TO BE MOTORIZED TRUE NEED IS ADJUSTABLE HEIGHT WITHOUT PUMPING OR WHATEVER THEY CURRENTLY HAVE IT DO.

>> DAVID BAQUIS:  THANK YOU.  OKAY.  IS THERE ANYBODY ELSE WHO HAS A QUESTION HELP ME SEE.  OKAY.  THERE IS A WOMAN HERE AND THEN GENTLEMAN TO THE SIDE.

>> JUST A QUICK COMMENT MORE THAN A QUESTION.  MISS DUNLAP OUR FIRST SURVEYED MILLIONS OF SQUARE FEET OF HOSPITALS AND MEDICAL OFFICES OVER THE COUNTRY, TWO THINGS THAT WE WOULD HOPE THAT THE BOARD WOULD CONSIDER WHILE WRITING THE STANDARDS DR. STINEMAN SHOWED A PHOTOGRAPH OF AN EXAM TABLE SHOVED UP IN THE CORN NERVE WE HOPE YOU CONSIDER THE SPACE REQUIREMENTS NEEDED FOR TRANSFERS AND LIFT EQUIPMENT YOU CAN TAKE A BEAUTIFUL ACCESSIBLE EXAM TABLE AND SHOVE IT IN THE CORNER IT’S NOT REALLY ACCESSIBLE TO MANY PEOPLE.

THE OTHER THING THAT WE SEE WOULD BE PERTAINING TO SCOPING.  FOR EXAMPLE, ALS CLINIC WHERE MOST IF NOT ALL OF THE PATIENTS ARE POWER WHEELCHAIR USERS AND JUST HAVING ONE ACCESSIBLE EXAM TABLE IN THE CLINIC IS NOT PROVIDING A VERY GOOD SERVICE TO THOSE PATIENTS.  THANK YOU.

>> THANK YOU CERTAINLY THE SPACE NEEDED FOR A LIFT WOULD BE A DESIGN ISSUE THAT WE COULD DISCUSS.  AND THE SCOPING ISSUE IS SOMETHING THAT YOU MIGHT BE ABLE TO GIVE FEEDBACK TO WITH REGARD TO THE DEPARTMENT OF JUSTICE ANPRN.

MARGARET STINEMAN>> COULD YOU SAY THERE IS ONE OTHER THING ABOUT THE LIFT IT NEEDS TO BE COMPATIBLE WITH THE TABLES AND OTHER EQUIPMENT.

>> BOB GRACE WITH THE INSTITUTE FOR MEDICINE AND COMMUNITY HEALTH.  MOST OF THE TALK ABOUT STANDARDS PERTAIN TO THE MANUFACTURER OR THE HOSPITAL OR THE PROVIDER SO FAR IN THE DISCUSSION AND I AM WONDERING IF THERE ISN’T AN IMPORTANT ROLE FOR THE STATE OR SOME ENTITY AT A COMMUNITY LEVEL TO SEE TO WHAT EXTENT WITHIN A GEOGRAPHICAL AREA CERTAINLY TYPES OF EQUIPMENT ARE NOT AVAILABLE IN SUFFICIENT QUANTITY TO ELIMINATE THE DISPARITIES THAT ARE BEING DESCRIBED HERE.

IN OTHER WORDS, FROM THE SETTLEMENT AGREEMENT IN THE DEPARTMENT OF JUSTICE THAT WE HEARD ABOUT BEFORE A CERTAIN PERCENTAGE OF ROOMS HAD TO BE ACCESSIBLE WITHIN A HOSPITAL.  BUT IN OUR VERY DECENTRALIZED HEALTHCARE SYSTEM, IF WE ARE GOING TO GET THE SYSTEM TO FUNCTION AS A SYSTEM AT A GEOGRAPHICAL LEVEL LIKE AT A COMMUNITY LEVEL, I THINK WE HAVE TO PAY ATTENTION TO THE SUFFICIENT QUANTITY OF ACCESSIBLE EQUIPMENT THAT MEETS ALL OF THE KINDS OF ISSUES THAT ARE BEING RAISED HERE.  IT MAY NOT BE SOMETHING AN INDIVIDUAL PROVIDER CAN BE 100% ACCESSIBLE ALTHOUGH HOSPITALS PROBABLY SHOULD BE.  I AM JUST WONDERING SO FOR EXAMPLE IN MASSACHUSETTS, I USED TO REMEMBER THAT BREAST CANCER SCREENING CLINICS HAD REQUIREMENTS FOR ACCESSIBLE EQUIPMENT AND TRAINING FROM THE STAFF TO BE ABLE TO — FOR THE STAFF TO BE ABLE TO USE THAT ACCESSIBLE EQUIPMENT.  IT WAS A LICENSE LICENSING REQUIREMENT ENFORCED BY THE STATE.

IT SEEMS TO ME THAT A LOT OF THE VALUE OF THE ACCESS BOARD’S STANDARDS NEED TO BE UTILIZE IN THAT MECHANISM.  AND I AM EAGER TO GET FEEDBACK ON THAT IDEA.

>> CAN I JUST SAY BOB THAT THE EXAMPLE OF THE WOMAN NEEDING THE MAMMOGRAPHY WHERE THE TECHNICIAN HAD TO HOLD HER IN PLACE THE TECHNICIAN WAS POSE EXPOSED IN RADIATION IT HAPPENED IN MASSACHUSETTS THAT WAS ME.  I SAID TO THE TECHNICIAN YOUR THYROID.  YOU KNOW AND IN FACT, THE STATE HAS LOOKED AT ACCESSIBILITY OF MAMMOGRAPHY EQUIPMENT THROUGHOUT THE STATE BUT IT OBVIOUSLY DOESN’T TRANSLATE DOWN TO THE INDIVIDUAL WOMAN HAVING AN EXPERIENCE WHERE SHE GETS COMFORTABLE MAMMOGRAPHY AND IS TEMPTED TO GO BACK AGAIN.

TO GET THAT.

AND LET ME ALSO SAY IMPLICIT IN WHAT YOU JUST SAID I MIGHT BE OVER READING IT IS THE NOTION THERE SHOULD BE CENTERS OF EXCELLENT OR SPECIFIC PLACES THAT PEOPLE WITH DISABILITIES CAN GO BECAUSE THEY ARE ACCESSIBLE AND THEY SHOULD GO THERE.

THAT GETS AWAY FROM THE ENTIRE KIND OF GOAL OF THE ADA WHICH IS TO HAVE EQUAL ACCESS.

AND IN FACT, BECAUSE OF THE WAY THAT HEALTHCARE IS FINANCED IT WOULD NOT BE FINANCIALLY FEASIBLE FOR INSTITUTIONS TO BE THE CENTERS OF EXCELLENCE FOR PEOPLE WITH DISABILITIES BECAUSE THEY DON’T GET PAID EXTRA MONEY FOR THE EXTRA TIME THAT IT MAY TAKE TO DO THAT.

AND THE ONLY PLACES THAT ARE ABLE TO SERVE IN THAT CAPACITY ARE PLACES WHERE THE HUGE PHILANTHROPIC DONOR BASE WILLING TO SUBSIDIZE THE RED INK COMING THROUGH THERE.  IF IT WAS IMPLICIT IN YOUR COMMENT I WOULD URGE YOU TO THINK POINT CONTENT, IT’S IN THE FINANCIAL VIABLE FOR WITHIN THE ADA TO HAVE SEPARATE BUT EQUAL IF YOU WILL FACILITIES FOR PEOPLE WITH DISABILITIES THAT ARE EQUAL.

>> DAVID BAQUIS:  THE ISSUE OF SCOPING WOULD BE HANDLED OUTSIDE OF OUR RULE.  HOWEVER YOUR COMMENT WILL BE A MATTER OF PUBLIC RECORD, SO THAT ENTITIES THAT IMPLEMENT OUR STANDARDS IN THE FUTURE WOULD HAVE THAT COMMENT.

ANYBODY ELSE WHO HAS A QUESTION OR COMMENT WHO HASN’T HAD A CHANCE TO SPEAK YET? IF YOU COULD KEEP IT TO LESS THAN TWO MINUTES DORIS? 

>> ALL RIGHT.  I THINK AS YOU LOOK AT THIS, YOU NEED TO ONE LOOK AT EQUIPMENT AND WHETHER THERE IS DIFFERENCES IN THE EQUIPMENT THAT ARE USED IN A VARIETY OF ENVIRONMENTS, WHAT I MEAN IS THE EQUIPMENT MAY BE DIFFERENT IN HOSPITALS BIGGER IN SIZE AND MASS WHATEVER AS OPPOSED TO COMMUNITY CLINICS, WHICH MAY — WELL, I HAVE SEEN SOME THAT HAVE INACCESSIBLE EQUIPMENT.

BUT ARE VERY IMPORTANT FOR LOW INCOME PEOPLE WITH DISABILITIES.

AND THE OTHER — THE OTHER THING THAT I WANTED TO MENTION IS THAT I THINK THAT THE ADJUSTABLE LEVEL EXAM TABLE IS EXTREMELY IMPORTANT AS IT RELATES TO OR NOT EXAM TABLE BUT THE TABLES THAT ARE USED IN IMAGING EQUIPMENT, AND ACCESSIBLE MAMMOGRAM EQUIPMENT BECAUSE I HAVE HAD CAT SCAN AND MRI VERY RECENTLY.  AND IT IS THERE ARE ISSUES WITH IT WITH REGARD TO IT BEING SO NARROW SO THE DESIGN OF THE EQUIPMENT, I THINK AND THE TABLES USED HAS TO BE LOOKED AT.  AND LASTLY THE WHOLE THE ISSUES BROUGHT UP WITH REGARD TO PEOPLE WITH SENSORY DISABILITIES I AM WONDERING IF — I SECOND THE RECOMMENDATION AS A PERSON WITH A HEARING IMPAIRMENT OF HAVING SIGNALING LIGHTS PERHAPS NOT JUST SIGNS BUT LIGHTS BECAUSE OF SOME SORT SO THAT ONE DOESN’T HAVE TO READ A SIGN IF YOU HAVE BOTH VISION AND HEARING IMPAIRMENTS.

WITH THE SUGGESTIONS THAT WERE MADE BECAUSE I HAVE DONE AN MRI AND ONE OF THE QUESTIONS I HAVE FOR THE MANUFACTURER THIS IS A QUESTION FOR THE MANUFACTURER AND THE BOARD IS AT THE TIME HAD, DIDN’T HAVE HEARING AIDS AND SO THERE WAS AN ISSUE OF BECAUSE THEY WERE BROKEN THERE WASN’T AN ISSUE OF MY HAVING TO TAKE THEM OUT.  BUT IF YOU GO IN AN MRI MACHINE OR A CAT SCAN, IS THERE — ARE THERE GOING TO BE PROBLEMS IF SOMEBODY IS TRYING TO WEAR A HEARING AID BECAUSE — BECAUSE RIGHT NOW THE INSTRUCTIONS THEY GIVE YOU ARE THROUGH YOUR EARS THROUGH THE MICROPHONE SYSTEM THAT THEY HAVE.

>> DAVID BAQUIS:  THANK YOU.  SHOULD WE MOVE ON TO THE NEXT QUESTION WE HAVE ONE FROM JOE CIRILLO.

>> JOSEPH CIRILLO:  >> THAT WAS A QUESTION FOR THE MANUFACTURERS ARE THEY NOT HERE?

>> BERNIE, DID YOU GET THE QUESTION?

>> THE FACT IS THAT I ACTUALLY DON’T KNOW VERY MUCH ABOUT HEARING AIDS.  AND YOU KNOW I REPRESENT THE MANUFACTURERS FROM THE POINT OF VIEW OF THE TRADE ASSOCIATION.

AND IT’S A QUESTION THAT’S NEVER COME UP.  I UNFORTUNATELY CAN’T ANSWER YOU.  I MEAN, YOU KNOW YOU COULD ASK ONE OF THE MANUFACTURERS

>> HI, I AM LOREN FROM THE FDA, I AM BOARD CERTIFIED DIAGNOSTIC I WORKED 30 YEARS MRI’S AND CT’S SIMPLE ANSWER TO THE QUESTION MRI WILL TURN OUT THE HEARING AIDS.  THE TECHNOLOGIST COMMUNICATING TO YOU IN THE ROOM.  THAT’S NOT AN ANSWER I HAVE A SIMPLE — IT’S IN THE A QUESTION I HAVE A SIMPLE ANSWER FOR.

>> THANK YOU.  GO AHEAD, JOE.

>> JOSEPH CIRILLO:  THINKING ABOUT WHAT WE HAVE BEEN HEARING ABOUT THE NEW REGULATIONS AND ALL OF THE OTHER THINGS TO TRY TO GET IMPLEMENTED, LUCKILY HOSPITAL LOCATIONS THERE ARE LIMITED NUMBER OF ARCHITECTS AND ENGINEERS THAT DO HOSPITAL WORK WHEN YOU ARE TALKING ABOUT TRAINING THEM AND EVERYTHING, CONTINUING EDUCATION PROGRAMS ARE AVAILABLE, THERE ARE A NUMBER OF WAYS TO DISSEMINATE THE INFORMATION.

BUT THINK ABOUT THIS, I JUST WENT TO A DOCTOR AT MY HOME, AND MY GENERAL PRACTITIONER, HE IS IN A BUILDING WITH ABOUT 30 OTHER DOCTORS.

THE BUILDING WAS DESIGNED BY AN ARCHITECT.  BUT NONE OF THESE SUITES WERE LAID OUT BY ARCHITECT THEY WERE ISSUED PERMITS TO INSTALL EQUIPMENT, AND THEY INSTALLED IT AS THEY SAW FIT.  I HAVE A MOBILITY PROBLEM BALANCE PROBLEM AND I HAD I HAD TO CLIMB UP ON THE EXAM TABLE.  WHAT I AM GETTING AT I WAS THE STATE BUILDING COMMISSIONER AT RHODE ISLAND WE APPROVED I WAS ON THE ARCHITECTURAL BOARD I AM SAYING THAT THE SYSTEM FALLS APART OUTSIDE OF THE HOSPITAL SYSTEM BECAUSE THERE IS NO CONTROL OF ALL OF THESE THOUSANDS AND THOUSANDS OF INSTALLATIONS OF ALL OF THIS EQUIPMENT WE ARE TALKING ABOUT.  YOU CAN GO TO A DOCTOR FOR MAMMOGRAPHY, COLONOSCOPY, WHATEVER, IT’S IN THE PRIVATE OFFICE I GO TO THAT TYPE OF FACILITY.  I DON’T GO TO RHODE ISLAND HOSPITAL FOR THAT I GO TO MY DOCTOR WHO HAS A LAB AND HE DOES IT — NOW HOW MUCH THAT WAS DONE BY AN ENGINEER OR ARCHITECT OR ANYBODY ELSE.  I REALLY DON’T THINK SO.  I SEE A LOT OF HEADS PEOPLE SHAKING THEIR HEADS AGREEING WITH ME THAT I THINK IS ONE OF THE BIGGEST PROBLEMS THE TABLE IN THE CORNER SORT OF BROUGHT THAT TO MY ATTENTION.  AND I WORRY ABOUT THAT.

AND I THINK THAT THAT IS ONE OF THE THINGS THAT WE HAVE TO WORK WITH AIA, THE PE ASSOCIATION YOUNG LADY IN THE BACK TALKING ABOUT ENGINEERING.

AND TRY TO GET THEM TO UNDERSTAND THAT AT THAT LEVEL IN THROUGH THE CODE PERMIT PROCESS WE HAVE TO GET THIS SO THAT ALL OF THESE OTHER OFFICES AND MEDICAL FACILITIES ARE ALSO DONE BY PROFESSIONALS THEN WE MIGHT HAVE A BETTER CHANCE TO GET EVERYTHING INSTALLED PROPERLY.

>> I THINK THAT YOU ARE RIGHT ON TARGET IN THAT WE NEED TO LOOK AT MACHINE PERSON INTERFACES IN TERMS OF THE INTERFACE BETWEEN THE MACHINE AND THE PATIENT AND ALSO THE CLINICIAN.  WE NEED TO LOOK AT PERSON INTERFACES BETWEEN THE PERSON AND THE CLINICIAN.  BUT WE ALSO HAVE TO LOOK AT MACHINE PERSON ENVIRONMENT INTERFACES.  AND SO THAT THE EFFECTIVENESS OF THE DIAGNOSTIC EQUIPMENT IS REALLY GOING TO DEPEND ON THE HUMAN ENGINEERING, THE ENVIRONMENTAL ENGINEERING A GOOD UNDERSTANDING OF THE DISABILITIES THAT PEOPLE HAVE AS WELL AS THE PHYSIOLOGY THAT YOU ARE TRYING TO FIGURE OUT IN TERMS OF DOING THE DIAGNOSIS.

SO WE REALLY KIND OF NEED WHAT IS BEING TERMED BIO PSYCHO ECOLOGICAL MODEL WHICH TAKES INTO ACCOUNT ALL OF THESE INTERACTIONS.

>> DAVID BAQUIS:  THANK YOU.  WE HAVE TIME FOR ONE FINAL QUESTION FROM THE WOMAN IN THE BACK WITH THE BLACK SHIRT ON, THEN WE WILL HAVE SOME WRAP UP COMMENTS.  THANK YOU.

>> THIS HAS BEEN AN EYE OPENER, SHARON SWEEZY.  RIGHT NOW I AM SPEAKING FOR MYSELF INDIVIDUALLY.  I AM A WHEELCHAIR USER AS OF 2002, ACTUALLY.

I HAVE EXPERIENCED MANUAL CHAIR AND THE POWER CHAIR.  I HAVE EXPERIENCED BEING DENIED DIAGNOSTIC TESTS JUST EVER SO RECENTLY.

I HAVE GOTTEN TO THE PART HUMILIATION AND EMBARRASSMENT IS NOT EVEN PART OF MY LIFE ANYMORE BECAUSE I CAN ONLY EXPECT IT DAILY BUT CRAPPING ON TO SOMETHING HE JUST SAID, I BELIEVE THAT PART OF THE PROBLEM OF ACCESS CAN BE CURED BY MAKING IT MANDATORY THAT ANY STUDENT OF MEDICINE ARCHITECTURE ENGINEERING MUST LIVE IN A WHEELCHAIR AT LEAST A MONTH, THEY MUST AT LEAST EXPERIENCE COGNITIVE TRAINING FOR VISUAL IMPAIRMENT AND HEARING IMPAIRMENT.  AND THE INABILITY TO COMMUNICATE VERBALLY.  FOR AT LEAST TWO DAYS ONCE THEY UNDERSTAND WHAT WE ARE GOING THROUGH, BECAUSE THE ONLY OTHER WAY THEY WILL LEARN IS WHEN THEY BECOME GOD FORBID A MEMBER OF THE DISABILITY COMMUNITY.

THEN THEY WILL UNDERSTAND WHEN SOMEONE SAYS, I CAN’T STAND UP, THEY DIDN’T SAY, I WON’T.

>> I WOULD SUGGEST ALL OF THOSE STUDENTS HAVE THE EXPERIENCE TOGETHER.  SO THAT THE BEGIN NEAR THE MEDICAL DOCTOR IN TRAINING THE NURSE IN TRAINING THE ARCHITECT IN TRAINING HAVE AN UNDERSTANDING OF ALL OF THE DIFFERENT DIVERSE FIELDS SO THAT WHEN THINGS ARE PUT TOGETHER AS YOU ARE SAYING, THEY WILL FIT.

>> DAVID BAQUIS:  THERE IS A STAKEHOLDER GROUP WHO EXPRESSED INTEREST IN TODAY’S MEETING I FORGET THE EXACT NAME OUT OF MASSACHUSETTS THEY ARE FOCUSSED SPECIFICALLY ON RAISING AWARENESS ABOUT DISABILITY ISSUES IN EDUCATION AND MEDICINE.  MS LONG — THE ALLIANCE.  THERE IS A PLACE TO SEND THAT COMMENT.  AT THIS POINT I WOULD LIKE TO, FIRST, THANK ALL OF THE SUPPORT I RECEIVED WITH THE ACCESS BOARD STAFF KATHY JOHNSON SITTING ON THE SIDE THERE AS WELL AS OUR I.T. CREW AND EARLENE AND TOO MANY TO NAME.

(APPLAUSE)

>> DAVID BAQUIS:  AND I WON’T BE ABLE TO DO IT WITHOUT FDA.  WE ARE LOOKING FORWARD TO CONTINUING THAT PARTNERSHIP.

THE OTHER THING THAT I WANT TO REMIND YOU OF WE DID INTEND AFTER A LITTLE EDITING WORK TO PUT THE TRANSCRIPT OF TODAY’S SESSION ON OUR WEBSITE SO THEN IF YOU MISSED PART OF IT YOU CAN CATCH UP IF YOU WANT TO SHARE IT WITH OTHERS IT WILL BE THERE.

I DON’T TAKE FOR GRANTED THOSE WHO HAVE TO TRAVEL.

I USED TO TELL PEOPLE WHEN I STARTED MY CAREER I WAS SO EXCITED THAT I GET TO TRAVEL THEY SAID WHAT DO YOU MEAN YOU GET TO TRAVEL I “HAVE” TO TRAVEL.  SO, THANK YOU VERY MUCH FOR COMING OUT, I WANT TO GIVE GARY TALBOT A CHANCE TO SAY CLOSING REMARKS AND THEN WE WILL TURN IT TO NANCY STARNES.

>> GARY TALBOT:  THANK YOU DAVID, I WANTED TO SAY THANK YOU AGAIN TO EVERYBODY FOR TRAVELING IN SPENDING THE DAY WITH US THIS HAS BEEN AN EYE OPENING EXPERIENCE FOR MANY OF THE BOARD MEMBERS AND STAKEHOLDERS HERE, THANK YOU EVERYBODY, TRAVEL SAFE AND THIS IS THE BEGINNING OF THE PROCESS, THANK YOU.  NANCY?

>> NANCY STARNES:  THIS IS NANCY STARNES VICE-CHAIRMAN OF THE ACCESS BOARD THANK YOU ALL FOR COMING WE ENCOURAGE YOUR CONTINUED PARTICIPATION YOU MAY RUN INTO MORE PEOPLE WHO HAVE COMMENTS AND QUESTIONS FOR US TO CONSIDER THIS IS NOT THE END OF THE OPPORTUNITY FOR PROVIDING INPUT TO US.  I KNOW THERE WAS ONE GENTLEMAN BACK THERE WHO HAD HIS HAND RAISED NEVER GOT TO SPEAK.  DON’T LET IT DISCOURAGE YOU, WE ARE INTERESTED IN YOUR CONTINUING DIALOGUE THANK YOU FOR BEING HERE AND SAFE TRAVELS WHEREVER YOU MAY GO.

>> DAVID BAQUIS:  THANK YOU.

(APPLAUSE)