>> 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)