Medical Diagnostic Equipment Accessibility Standards Advisory Committee

Minutes

September 27 and 28, 2012

Agenda Thursday, September 27

10:00 a.m. - 5:00 p.m.

Welcome

Overview of Committee Purpose and Rulemaking Process

Introductions

Questions and Answers on Federal Advisory Committee Act

Review of Protocols

Review of Access Board’s Analysis of Comments on the Proposed Rulemaking for Medical Diagnostic Equipment Accessibility Standards

Discussion and Establishment of Committee’s Priorities

Public Comment Period

Agenda Friday, September 28

9:00 a.m. - 3:00 p.m.

Committee Work

Administration

New Business

Public Comment Period

Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

John LaViola, Hologic, Inc.
Milind Dhamankar, Siemens Medical Solutions
Carol J. Bradley, Sutter Health
Kaylan M. Dunlap, Evan Terry Associates
Joseph Drago, Scale-Tronix, Inc.
Mark E. Derry, NCIL
Jack DeBraal, Brewer Company
Jeffery Baker, MTI
JB Risk, MPI
Molly Follette Story, FDA
June Isaacson Kailes, HFCDHP & DREDF
Tamara James, Duke Univ.& Medical Ctr.
David Hausmann, Hausmann Industries
Don Brandon, ADA National Network (via teleconference)
Kevin Patmore, Stryker Medical
Elisabeth George, Phillips Healthcare/MITA
Jon Wells, Midmark Corporation
Kleo J. King, United Spinal Association
Lisa Iezzoni, Boston CIL (Chair)
Kat Taylor, Equal Rights Center
Renee Kielich, Hill-Rom Company, Inc.
Rochelle J. Mendonca, Univ. Sciences Phila.
Dennis Hancher, VA
John Jaeckle, GE Healthcare
Zita Johnson-Betts, DOJ
Maureen Simonson, PVA

Alternates Present:

Janice Carroll, Sutter Health
Jim Bostrom, DOJ
Ed Toerek, Phillips Healthcare
Kristen Barry, Equal Rights Center
Glenn Nygard, Hologic, Inc.
Steven Kachelmeyer, GE Healthcare
Jennifer Elee, CRCPD (via teleconference)
Zoltan Nagy, VA

Access Board Staff Present

Bruce Bailey
Rose Bunales
David Capozzi
Marsha Mazz
Rex Pace (Committee DFO)
James Raggio
Earlene Sesker

Others Present

Dennis Monty, Beth Israel Deaconess Med. Ctr.
Angela Scott, HHS
Gloria Romanelli, Amer. Coll. Radiology
Maureen McCloskey, PVA
Felix, Akinrinola, Siemens Healthcare
Rael Kepace, MITA
Mary Adams, DOJ | Janice Majewski, DOJ
Mary Matz, VHA
Richard Eaton, MITA
Jim Scott, Applied Policy
Brandy Wagstaff, DOJ
Mary Duranti, UPMC Dis. Resource Ctr.

Welcome and Introductions

The first meeting of the Medical Diagnostic Equipment Advisory Committee was called to order on Thursday, September 27, 2012 at 10:00 a.m. by the Access Board Executive Director, David Capozzi. The meeting took place in the Access Board conference room in Washington, DC. Mr. Capozzi welcomed the committee members and provided an overview of the Boards mission. The Chair, Lisa Iezzoni, M.D., M.Sc., was introduced and then committee members were then asked to introduce themselves with a brief statement of their organizations’ goals as a member of the committee.

Committee Purpose, Rulemaking Process, FACA and Operating Procedures

Marsha Mazz, Director of the Office of Technical and Information Services, briefed the committee on its purpose and the rulemaking process. James Raggio, the Board’s General Counsel, opened the floor to answer questions from the committee members on the Federal Advisory Committee Act and the committees operating procedures.

Recommended Committee Issues

The committee Designated Federal Officer, Rex Pace, gave a presentation outlining the requirements in the Notice of Proposed Rulemaking (NPRM) for Medical Diagnostic Equipment. The presentation also included an overview of the 51 comments received in response to the proposed requirements and the 46 questions in the NPRM. He noted that the major issues identified from the initial comment review were sent to the committee in a memo dated September 24, 2012. Although four major issues were identified, the memo proposed that the committee addresses transfer surface size and height during this first meeting as these issues are among the highest priorities of all commenters across many interests.

Members Priority Issues

The committee members each spoke for approximately 3 to 5 minutes concerning their organizations’ priority issues. Major issues stated by the committee were the transfer height, coverage clarifications, better definitions, more examples of types of equipment covered, scoping weight requirements, lift compatibility, cost, clinical use and understanding when designing equipment, availability of user preference, conflicting standards, accommodations for diverse disabilities, safety versus accessibility, size of transfer surface, how the standard will effect equipment manufacture production, transfer and positioning, caregiver safety, scale weight capacity, effective dates, bariatric needs, and bringing awareness to the need for more requirements for diverse disabilities

Establishment of Committee’s Priorities

After a discussion about individual priorities, the committee decided to start with the height and size of the transfer surface as suggested in the memo dated September 24, 2012. Ms. Mazz clarified the 17 to 19 inches currently proposed for transfer surface height, what is meant by the term “scoping” and how clear floor space around the equipment may be addressed. In response to concerns about conflicting standards the committee members were asked to name any standards that may possibly conflict with the proposed requirements in the NPRM. The potentially overlapping or conflicting standards mentioned by committee members were as follows:

International Electrotechnical Commission Standard
- 60601 Medical Electrical Equipment
  - 60601-1-6 Human Factors (directed to 62366)
  - 60601-2-44 CT Scanners
  - 60601-2-45 Mammographic X-ray Equipment
  - 60601-2-52 Safety and Performance of Medical Beds
ANSI/AAMI/IEC 60601-1
FDA Code of Federal Regulations for Medical Devices (Performance)
FDA 21CFR Part 11
Massachusetts Accessibility Code
Anthropometry of Wheeled Mobility Research

Multiple committee members requested more specifics about the equipment encompassed by the phrase “medical diagnostic equipment.” Each committee member proposed one or more specific type of equipment that might be considered medical diagnostic equipment and thus covered by the standards. This exercise prompted a lengthy discussion attempting to clarify what is classified as diagnostic equipment. One example that highlighted the complexities of classifying equipment involved dialysis chairs, where the major purpose is supporting patients during treatment (dialysis) but during which careful monitoring takes place. Does this monitoring constitute “diagnosis” for the purposes of this rule? The example also raised questions about whether being seated in a dialysis chair is necessary to receive dialysis. Another example involved infusion chairs: clearly, the purpose of these chairs is to support persons undergoing venous infusions (e.g., chemotherapy), but these persons are similarly carefully monitored. Dr. Iezzoni provided an example from several years ago in which a woman who uses a wheelchair was going to be denied outpatient chemotherapy for breast cancer because she couldn’t get into a chemotherapy/infusion chair.

After lengthy discussion, the committee agreed that the purpose of these types of chairs is treatment, not diagnosis. Nonetheless, the committee will consider including language in their report recommending that treatment chairs be accessible. A committee member asked if components of equipment can be diagnostic without classifying the entire piece of equipment as diagnostic. In an attempt to clarify equipment classification, Kevin Patmore of Stryker Industries agreed to convene a group of committee members immediately after the meeting adjourned for the day to develop an effective screening filter to identify devices that fall under the authority of the proposed rule. In response to a question from committee members, Mr. Pace gave a brief overview of the committee’s timeframe. Members of the committee thought that it would be helpful to have diagrams or pictures of different types of medical equipment as the discussions progress. Committee members were instructed to email links to their website or pictures to be shown when the discussions continued in the morning.

Public Comment Period

Committee Chair, Dr. Iezzoni, opened the floor to members of the audience to allow interested parties to give public comment. Maureen McCloskey from Paralyzed Veterans of America voiced support for the standards. She stated that equipment in the past was designed with the utility for the caregiver instead of accessibility. Dennis Monty from the Beth Israel Deaconess Medical Center in Boston shared how a settlement with the Department of Justice identified accessibility deficiencies that his institution is currently addressing. He expressed the concern that committee has a lot a work ahead of them but he feels they are heading in the right direction. Janice Carroll from Sutter Health wanted to add sleep studies to the diagnostic procedures that were identified during the meeting. She voiced her support for the committee work and made suggestions that the committee start with the more general procedure tables and then move on to specialties and suggested that there may be alternate way to obtain the same standard of care.

Wrap Up and Adjournment

The Chair and the DFO reviewed the times for future meetings. It was agreed that the first day will always be from 10 to 5 and the second day will end at 3. It was confirmed that the teleconference meeting scheduled for mid-November would be two full days. Committee members questioned if a teleconference will be as productive as face-to-face meetings. It was suggested that those individuals who can meet in Washington, DC, do so and that others would teleconference. This led to discussions of subcommittees which may also be done via teleconference. Further discussion of these issues were tabled until morning and the Chair adjourned the meeting.

September 28, 2012 (9:00 – 3:00)

Opening Remarks

Committee Chair, Dr. Iezzoni, opened the meeting. She informed members and alternative, in response to their inquiries, that either the member or alternate should be seated at the table to represent their organization. The person seated at the table, member or alternate, can change at any time if the issue warrants. She also used this time to propose that lunch be reduced to 30 minutes so the meeting can end at 2:30 instead of 3:00 to accommodate members’ flight schedules. The committee agreed to the new schedule.

Focus Group Report

The committee discussed recommendations presented from the group that met, led by Mr. Patmore, after the committee meeting adjourned, to see if there was a simple and effective screening filter that would identify medical diagnostic equipment that falls under the authority of the proposed rule. Six questions were developed to be used as filters in determining what equipment would be covered by the rule. Any device would be included as falling under the rule if the first 5 questions are answered yes and question six is answered no. The questions are as follows:

Is the product a medical device?
Does the medical device, according to its Instructions for Use (IFU), perform a diagnostic function?
Is it necessary that the patient have a physical interaction with the medical device, or its system, in order for the device to perform its intended diagnostic function?
Is it necessary that the patient have a physical interaction with the medical device, or its system, in order for the diagnostic procedure to be carried out?
Is it necessary that the medical device have a physical interaction with the patient to support or position the patient, or a portion of the patient, in order for the medical device to perform its intended diagnostic function?
Is there an equivalent means of facilitation (that meets the current standard of care) to perform the medical diagnostic procedure?

The committee raised concerns about possible overlap across some of the questions and need to refine the exact phrasing further. In addition, questions relating to transfer issues may possibly require restructuring when addressing other accessibility barriers. Dr. Iezzoni thanked Mr. Patmore and the group for their productive work, upon which the committee will build.

Committee Work

Transfer Height

For their initial technical discussion, the committee decided to begin with standard examining tables used in most doctors’ offices. A picture of this type of table was displayed to depict the standard size and height of the transfer surface. In discussing the height of the transfer surface, it was noted that most height-adjustable exam tables currently have a minimum height of 18 inches which complies with the 17 to 19 inch range specified in the NPRM. This led to a discussion on the question posed in the NPRM about increasing the maximum height to 25 inches to accommodate persons using larger power wheelchairs. The committee members representing manufactures explained the technology required to reach the proposed 25 inch maximum if the minimum were to remain at 17. A committee member expressed concerns that Occupational Safety and Health Administration (OSHA) standards concerning ergonomics for lifting and bending may prohibit too wide of a range. It was clarified that the measurement would be taken to the top of an uncompressed surface. The discussion then moved to lift compatibility and the height possibly prohibiting lift mechanisms, actuators and side rails when looking at stretchers and beds. It was decided that final discussions of the height issue would be tabled until the deliberations moved from standard exam tables.

Transfer Surface Width

Dr. Iezzoni opened the discussion by reminding the committee that the current proposed dimension for the transfer surface width is 30 inches wide minimum and 15 inches deep minimum. It became clear that it would assist committee discussions to see a demonstration of how persons who use wheelchairs or other mobility aids transfer onto examining tables. The Committee viewed several videos of transfers downloaded from Web sites accessed by certain committee members; several committee members who use wheelchairs described their preferences for transferring. The committee identified issues to be considered when determining the size of the transfer surface were safety, height, gap between, toe clearance, table overhang, transfer supports, cost, transfer board size, and patients’ reach. It was noted that the proposed location of the transfer surface may be a problem because it requires someone to transfer to the end of a table or bed and drag themselves backward. Some committee members expressed concerns that 30 inches is too wide for a smaller person attempting to reach the transfer supports on the opposite side of the table and for clinicians trying to examine the patient on the table. Others felt that in today’s population of larger people, the proposed transfer surface size may be too small. Concerns were voiced that if the dimensions require larger tables then larger rooms would also be necessary, perhaps resulting in separate rooms for people with disabilities. It was noted that the typical table currently in most doctors’ offices is 28 inches wide. A committee member explained that the current 28 inches is the result of health care professionals wanting a width less than 30 inches while some patients wanted more than 30 inches. A proposal was made for 29 inches as a compromise between the proposed 30 inch width and the current 28 inch width. As determined from anthropometric studies referenced at the meeting, 29 inches represents the sum of the hip width required by the 95th percentile male plus two hand widths assuming that seated individuals may stabilize themselves using their hands, palm down, on an exam surface. Discussions will continue on this issue at the next meeting.

Transfer Surface Depth

The discussion shifted from the width of the table to the depth. Some members voiced concern that the proposed 15 inches is too narrow and would result in a very uncomfortable seat. Some committee members clarified that the proposed standard is specific to the transfer area not the entire seat. Information was presented from a book entitled, The Measure of Man and Woman: Human Factors in Design, by Henry Dreyfuss. Mr. Pace clarified, in response to committee questions, that the 15 inch dimension was derived from the shower seat dimensions in the current ADA Standard. It was proposed that the depth be increased to 17 inches. Discussions will continue on this issue at the next meeting.

Subcommittees

The committee discussed and strongly endorsed the need to establish subcommittee to effectively address specific equipment accessibility issues. The creation of six subcommittees was proposed, as follows: (1) exam tables and chairs; (2) beds and stretchers; (3) equipment with bores; (4) mammography machines; (5) other radiologic equipment; and (6) weight scales. Committee members voiced concerns that practitioners and researchers are not being included in discussions pertaining to the use of specific types of equipment and how accessibility may affect the usability. Ms. Mazz noted, for clarification, that anyone can be a member of the subcommittee; thus specialists who are not committee members can participate.

Public Comment Period

Committee Chair Dr. Iezzoni, opened the floor to members of the audience to allow interested parties to give public comment. Gloria Romanelli from the American College of Radiology requested permission to suggest members for some of the subcommittees. She requested that the dates for the subcommittee meeting be available to the public. Richard Eaton from the Medical Imaging & Technology Alliance expressed concerns that the planned teleconference may not be as efficient as a face to face meeting. Maureen McCloskey from Paralyzed Veterans of America suggested the inclusion of someone from an acute rehabilitation facility. She also suggested clarification on the type of transfer and the devices from which people may be transferring.

Wrap Up and Adjournment

The Chair addressed concerns pertaining to the teleconference and agreed to check into the feasibility of video conference in lieu of traveling to Washington, DC, for those who cannot be present. She stated that future meeting dates will be sent to the committee members via email. The meeting was adjourned.

December 3 and 4, 2012

Agenda Monday, December 3

10:00 - 5:00

Welcome and call to order

Approve agenda

Approve minutes of the September 27 – 28, 2012 Committee meeting

Formation of subcommittees

Review of transfer surface size and presentation by Edward Steinfeld, Arch. D., AIA, Director of the Center for Inclusive Design and Environmental Access

Committee work

Public Comment Period

Agenda Tuesday, December 4

9:00 - 2:30

Review of permitted obstructions to the transfer surface

Committee work

Administration

New Business

Public Comment Period

Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

Carol J. Bradley, Sutter Health
Kat Taylor, Equal Rights Center
Kleo J. King, United Spinal Association
Dennis Hancher, VA
Molly Follette Story, FDA
Elisabeth George, Philips Healthcare
Jeffery Baker, MTI
Lisa Iezzoni, Boston CIL (Chair)
Mark E. Derry, NCIL (via teleconference)
Hans Beinke, Siemens Medical Solutions
Kaylan M. Dunlap, Evan Terry Associates
Don Brandon, ADA National Network (via teleconference)
Jack DeBraal, Brewer Company
Renee Kielich, Hill-Rom Company, Inc.
Rochelle J. Mendonca, Univ. Sciences Phila
JB Risk, MPI (via teleconference)
June Isaacson Kailes, HFCDHP & DREDF
Zita Johnson-Betts, DOJ
Mary Ann Spohrer (via teleconference)
David Hausmann, Hausmann Industries
Tamara James, Duke Univ. & Medical Ctr.
Maureen Simonson, PVA
Joseph Drago, Scale-Tronix, Inc.

Alternates Present:

Austin Schreiber, Stryker Medical
Janice Carroll, Sutter Health
Richard M. Eaton, MITA
Steven Kachelmeyer, GE Healthcare
Glenn Nygard, Hologic, Inc.
Bob Menke, Midmark Corporation
Kristen Barry, Equal Rights Center
Sarah DeCosse, DOJ\

Access Board Members and Staff Present:

Rose Bunales
David Capozzi
Marsha Mazz
Rex Pace (Committee DFO)
James Raggio
Earlene Sesker

Others Present:

Dennis Monty, Beth Israel Deaconess Med. Ctr.
Brian Helms, US Army HFPA
Ed Steinfeld, UB IDEA
Michelle Lustrino, Hologic, Inc.
Jim Scott, Applied Policy
Jonathan Young, Midmark
Vienalyn Tankiamco
Paul Farber
W.E. Martin, Martin Innovations
Myra Martin, Martin Innovations
Denise Garcia, INOVA Health System
Gloria Romanelli, Amer. Coll. Radiology
Mary Adams, DOJ
Janice Majewski, DOJ
Maria Caudill
Jim Bostrom, DOJ

Opening Remarks and Approval of Minutes

The Committee Chair, Lisa Iezzoni, opened the meeting. The committee approved the minutes from its September meeting and did a roll call.

Transfer Surface Size: Presentations and Discussion

The Brewer Company, Midmark Corporation, and Martin Innovations exhibited exam tables and chairs in the meeting room. Rex Pace gave a PowerPoint presentation reviewing the proposed requirements for the size of the transfer surface. He provided information regarding background materials consulted for the proposed dimensions including: comments received from the Disability Rights Education and Defense Fund (DREDF) in response to the U.S. Department of Justice Advance Notice of Proposed Rulemaking on equipment and furniture; the dimensions for rectangular seats in roll-in showers from the 2004 ADA and ABA Accessibility Guidelines; and the ideal chair width recommended in Architectural Graphic Standards for auditorium seating. The committee also reviewed anthropometric data from a variety of sources.

Dr. Edward Steinfeld, Director of the Center of Inclusive Design and Environmental Access at the University of Buffalo, gave a presentation on the Wheeled Mobility Anthropometry Project. He provided a brief analysis of measurements of individuals using wheeled mobility devices he considered relevant for establishing the width and depth of seating surfaces for wheeled mobility device users. Dr. Steinfeld’s data was obtained from subjects seated in their mobility devices, not while transferring from one surface to another. Very little data specific to dimensions for transfer surfaces is available to the committee. Nonetheless, the results of the Wheeled Anthropometry project indicated that a seating surface can have a width of 28 inches and accommodate the 95th percentile of the population of wheeled mobility device users studied. Dr. Steinfeld reported that his research data suggested that a depth of 15 inches would provide an adequate seating surface for the average user in his sample.

Based on the Dr. Steinfeld’s presentation and the dimensions included in the proposed rule, the discussion focused on 28 inches versus 30 inches minimum width. The committee decided that additional information from practitioners is necessary before consensus can be achieved on the width of the exam table transfer surface. The committee also discussed the proposed 15 inch minimum depth. Committee members raised concerns that the proposed depth is too short; they agreed that a 17inch minimum depth would be more appropriate.

Committee members discussed whether the committee should take into consideration the needs of individuals who are obese in determining the size and capacity of the transfer surface. Several committee members felt uncomfortable with the word “bariatric” because it presupposes therapeutic choices of persons who are obese. Furthermore, obese individuals require diagnostic services for conditions beyond their obesity. Committee members also noted the need to define “obese,” and suggested relying on definitions used by federal agencies, such as the Centers for Disease Control and Prevention. The members decided, although morbidly obese persons can be people with disabilities, this is a special population with very specific requirements which may not be appropriate for the majority of people with disabilities.

Permitted Obstructions: Presentation and Discussion

Rex Pace gave a PowerPoint presentation outlining the proposed requirement that the transfer surface have two unobstructed sides. Mr. Pace focused on the question in the proposed rule about permitting equipment parts located below the transfer surface to extend outward horizontally for 3 inches maximum. Mr. Pace presented an overview of relevant information form “The Impact of Transfer Setup on the Performance of Independent Wheelchair Transfers”, a study by the University of Pittsburgh and sponsored by the Access Board. The data indicated that a horizontal gap between the wheelchair seat and the transfer surface is more tolerable when the seating surfaces are aligned vertically. Although some committee members expressed concerns that the sample was not representative of the population of individuals with disabilities, the committee determined that the 3 inch horizontal gap between the wheelchair seat and the transfer surface in the proposed rule is acceptable provided that the transfer surface height is adjustable allowing the wheelchair seat to be vertically aligned with the transfer surface. The discussion then moved to equipment that is adjustable and possible low height requirements and associated limitations of the equipment in providing lower heights. As with the width issue, committee members did not reach consensus regarding an appropriate low height for a transfer surface. They suggested that input from experienced clinicians could assist decision-making. The committee agreed that the availability and configuration of transfer supports needs to be addressed in more detail and in conjunction with the transfer surface requirements.

Subcommittees

Six subcommittees were proposed at the last meeting: (1) exam chairs and tables; (2) stretchers and beds; (3) mammography; (4) imaging equipment with bores; (5) other imaging equipment; and (6) weight scales. After a discussion, the committee decided to proceed with the subcommittees on mammography and weight scale equipment. Formation of other subcommittees was put on hold pending presentations by health care practitioners and imaging equipment experts at the next committee meeting in January 2013.

Committee members volunteered for the subcommittees on mammography and weight scales. Mammography subcommittee members are Mary Anne Spohrer, June Kailes, Maureen Simonson and Carol Bradley. Weight Scale subcommittee members are June Kailes, Kleo King, James Drago, John Wells, Kaylan Dunlap, Kat Taylor and Bob Menke. The plan is to notify all committee members about subcommittee meetings, which will be held by teleconference, so anyone can join the discussion.

Public Comment December 3, 2012

Dennis Monty from the Beth Israel Deaconess Medical Center in Boston reported that his institution formed a patient advisory group with members representing the disability community. Mr. Monty also stated that he researched information on the typical old exam table and found the width to be 26.5 inches; thus any improvement on that dimension is welcome. Gloria Romanelli from the American College of Radiology suggested that clinician and manufacture presentations be to the entire committee not just subcommittees. Dr. Willis Martin described his practice experiences and why he designed the exam table and chair on display throughout the meeting. Janice Carroll from Sutter Health stated that they have a value management team that provides input when acquiring equipment. At the end of this process, which included input from caregivers, patients and clinicians they decided, on tables adjustable within a range of 17 inches to 19 inches in height and that are 28 inches wide. They also suggested that exam tables and weight scales should have a 400 lb. weight capacity. Additionally, Ms. Carroll voiced concerns for the ergonomic impact on caregivers should the committee recommend a 30 inch wide exam table She also noted that space limitations could preclude the use of wider exam tables.

Public Comment December 4, 2012

Dennis Monty from the Beth Israel Deaconess Medical Center in Boston voiced concerns if the recommendations result in ramps to equipment. Dr. Willis Martin thanked the committee for the opportunity to show his equipment and stated that although he owns a very small company he will support whatever the committee decides. Brad Baker from MTI (Medical Technology Industries) addressed concerns about a table width of 30 inches minimum and a transfer height of 18 inches. Paul Farber expressed concerns that a requirement for adjustability may prohibit any incremental manual adjustment.

Future Meetings

The committee discussed changing the dates for the next meeting, scheduled for the day after inauguration, because of travel and lodging costs and availability. The committee was given to the end of the week to make travel arrangements and notify Rex Pace or Earlene Sesker of any problems.

Wrap Up and Adjournment

The Chair reminded the committee members to make their reservation for the next meeting as soon as possible. The meeting was adjourned at approximately 2:30.

January 22 and 23, 2013

Agenda Tuesday, January 22

10:00 - 5:00

Welcome and call to order
Approve agenda
Approve minutes of the December 3 – 4, 2012 Committee meeting
Review transfer support location and configuration
Presentations by medical practitioners and clinicians on the use of medical diagnostic equipment in relation to transfer surfaces
Committee work
Public Comment Period

Agenda Wednesday, January 23

9:00 - 2:30

Presentations by medical practitioners and clinicians on the use of medical diagnostic equipment in relation to transfer surfaces
Committee work
Administration
New Business
Public Comment Period
Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

John LaViola, Hologic, Inc.
Kevin Patmore, Stryker Medical
Jon Wells, Midmark Corporation
Elisabeth George, Philips Healthcare
Kat Taylor, Equal Rights Center
Molly Follette Story, FDA
Mark E. Derry, NCIL
Maureen Simonson, PVA
John Jaeckle, GE Healthcare
Joseph Drago, Scale-Tronix, Inc.
Rochelle J. Mendonca, Univ. Sciences Phila
Jack DeBraal, Brewer Company (via teleconference)
Don Brandon, ADA National Network (via teleconference)
Mary Ann Spohrer, CRCPD (via teleconference)
Tamara James, Duke Univ. & Medical Ctr.
Lisa Iezzoni, Boston CIL (Chair)
Renee Kielich, Hill-Rom Company, Inc.
Kleo J. King, United Spinal Association
June Isaacson Kailes, HFCDHP & DREDF
Zita Johnson-Betts, DOJ
Hans Beinke, Siemens Medical Solutions
Kaylan M. Dunlap, Evan Terry Associates
Jeffery Baker, MTI
Carol J. Bradley, Sutter Health
JB Risk, MPI (via teleconference)

Alternates Present:

John Metellus, Siemens Medical Solutions
Bob Menke, Midmark Corporation
Glenn Nygard, Hologic, Inc. (via teleconference)
Sarah DeCosse, DOJ
Janice Carroll, Sutter Health
Richard M. Eaton, MITA

Access Board Members and Staff Present:

Rex Pace (Committee DFO)
David Capozzi
James Raggio
Earlene Sesker
Matthew McCollough
Marsha Mazz
Rose Bunales

Others Present:

Darren Walters, MTI
Michelle Lustrino, Hologic, Inc.
Heather Boyd, Applied Policy
Jim Scott, Applied Policy
Dennis Monty, Beth Israel Deaconess Med. Ctr.
Jonathan Young, Midmark Corporation
Gloria Romanelli, Amer. Coll. Radiology
Dee Kumpar (via teleconference)
Christian Hendrickson (via teleconference)
Cathy Ellis, National Rehab. Hospital
Mary Adams, DOJ
Douglas Coldwell, Univ. of Louisville
Irene Bowen, ADA One, LLC
Janice Majewski, DOJ
Jim Bostrom, DOJ
Paul Farber (via teleconference)
Cara Brickley (via teleconference)
Theresa Branham, Amer. Coll. of Radiology
Alexa Rosenbloom (via teleconference)
Angela Scott (via teleconference)
Barbara Ridley, Alta Bates Summitt Med. Ctr. (via teleconference)
Lauren Snowden, Kessler Institute for Rehab. (via teleconference)
Michael Yochelson, MedStar National Rehab. Network
Willa Crolius, Instit. for Human Centered Design
Nuket Curran, UPMC Ctrs. for Rehab. Services (via teleconference)

Opening Remarks and Approval of Minutes

The Committee Chair, Lisa Iezzoni, opened the meeting. The committee approved the minutes from its December meeting and did a roll call.

Exceptions and Transfer Supports: Presentation and Discussion

Rex Pace gave a PowerPoint presentation explaining how exceptions are used when writing accessibility guidelines and reviewing the proposed requirements for the transfer supports.

Presentations and Discussion

Medical practitioners, clinician and manufactures were in attendance to present information to the committee. The presenters were Willa Crolius (Institute for Human Centered Design), Barbara Ridley (Alta Bates Summit Medical Center), Cathy Ellis (National Rehabilitation Hospital), Michael Yochelson (MedStar National Rehabilitation Network), Lauren Snowden (Kessler Institute for Rehabilitation, Nüket Curran (UPMC Centers for Rehabilitation Services), Elisabeth George (Philips Healthcare), Michelle Lustrino (Hologic), John LaViola (Hologic),John Jaeckle (GE Healthcare), John Metellus (Siemens Healthcare), Douglas Coldwell (University of Louisville) and Theresa Branham (American College of Radiology). The practitioners and clinicians provided information on how people transfer onto medical diagnostic equipment. The manufacturers described current mammography, DEXA and other radiological equipment highlighting elements that currently comply and those that may not be able to comply with the proposed standards.

Based on the presentations each committee member stated their current thoughts concerning the 28 inches versus 30 inches minimum width and the minimum height of 17 inches. The committee questioned their authority to mandate alternate methods to obtain accessibility to equipment requiring redesign. They expressed concerns that requiring redesign taking 5 to 10 years where alternate method can be achieved in a shorter period of time. Jim Raggio explained the scope of the Access Board work, based on statute, as mandating specification for the equipment. Mr. Raggio discussed alternate methods as something that will possibly be decided by FDA and/or DOJ. Several committee members felt that how the industry defines medical equipment (space in room included/ancillary pieces) and is different than how it may be defined for this standard. Zita Johnson-Betts Several clarified that although the committee can discuss alternate means of providing accessibility the Access Board does not have the authority to write standards addressing alternate means of accessibility.

Subcommittees

After a discussion, the committee decided to proceed with the subcommittees on mammography and weight scale equipment. The committee decided that the proposed subcommittees for imaging equipment with bores and other imaging equipment should be combined into a committee named radiological equipment. Additionally it was decided that beds are not usually for diagnosis thus the subcommittee proposed for stretchers and beds would focus only on stretchers. Mr. Pace agreed to start scheduling dates for the subcommittee meetings.

Public Comment

Dennis Monty from the Beth Israel Deaconess Medical Center in Boston stated that he found the presentations to be very informative but wanted to remind the committee that ensuring proper weight capacity is important no matter what other specifications are mandated

Wrap Up and Adjournment

The Chair thanked everyone for their participation and reiterated how important it is to start subcommittee meeting as soon as possible. The meeting was adjourned at approximately 2:07.

February 26 and 27, 2013

Agenda Tuesday, February 26

10:00 - 5:00

Welcome and call to order - Approve agenda - Approve minutes of the January 22 – 23, 2013 Committee meeting - Review and discussion of subcommittee work - Presentations by manufacturers on exam tables and chairs - Committee work - Public Comment Period

Agenda Wednesday, February 27

9:00 - 2:30

Committee work - Review and discussion on the depth of wheelchair spaces - Administration - New Business - Public Comment Period - Adjourn**
**

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

Lisa Iezzoni, Boston CIL (Chair)
Jeffery Baker, MTI
Jim Bostrom, DOJ (ex officio)
Don Brandon, ADA National Network
Carol J. Bradley, Sutter Health
Jack DeBraal, Brewer Company
Mark E. Derry, NCIL
Joseph Drago, Scale-Tronix, Inc.
Kaylan M. Dunlap, Evan Terry Associates
Molly Follette Story, FDA (ex officio)
Elisabeth George, Philips Healthcare
David Hausmann, Hausmann Industries, Inc.
John Jaeckle, GE Healthcare
Tamara James, Duke Univ. & Medical Ctr.
Zita Johnson-Betts, DOJ (ex officio)
Renee Kielich, Hill-Rom Company, Inc.
Kleo J. King, United Spinal Association
Rochelle J. Mendonca, Univ. Sciences Phila
Kevin Patmore, Stryker Medical
Maureen Simonson, PVA
Mary Ann Spohrer, CRCPD
Kat Taylor, Equal Rights Center
Jon Wells, Midmark Corporation

Alternates Present:

Bradley Baker, MTI
Janice Carroll, Sutter Health
Sarah DeCosse, DOJ (ex officio)
Richard M. Eaton, MITA
Bob Menke, Midmark Corporation
Zoltan Nagy, DVA (ex officio)
Glenn Nygard, Hologic, Inc.

Access Board Members and Staff Present:

Rex Pace (Committee DFO)
Rose Bunales
David Capozzi
Marsha Mazz
Matthew McCollough
James Raggio
Earlene Sesker

Others Present:

John Eyraud
Jim Scott, Applied Policy
Jonathan Young, Foxkiser
Dennis Monty, Beth Israel Deaconess Med. Ctr.
Michelle Lustrino, Hologic, Inc.
Darren Walters, MTI
Mark Tobolowisk, Foxkiser
Bill Hecker, Hecker Design, LLC
Paul Farber
Chava Kintisch
Heather Boyd, Applied Policy
Jesse Lin
Barbara Silken
Gloria Romanelli, Amer. Coll. Radiology
Janice Majewski, DOJ

Opening Remarks and Approval of Minutes

The Committee Chair, Lisa Iezzoni, opened the meeting. The committee approved the minutes from its December meeting and did a roll call.

The Committee Chair, Lisa Iezzoni, opened the meeting. After roll call the committee approved the minutes from its January 2013 meeting following several clarifications and agreement on one edit.

Subcommittee Reports

The chairpersons for the Stretchers, Imaging Equipment with Transfer Surfaces, and Mammography Equipment subcommittees gave status reports to the full committee. The chairpersons for the Exam Tables and Chairs and Weight Scale subcommittees also addressed the committee, but since these subcommittees had not yet convened, their discussions only involved meeting dates

The Stretchers Subcommittee update included videos of transfers onto stretchers and the use of overhead lifts. Subcommittee chairperson, Renee Kielich, led the discussions. Because stretchers are usually accessed from the long side and not at the foot end, the group is looking at a recommendation to require unobstructed transfer to the side only. Much of the subcommittee’s presentation and resulting committee discussion centered on the proposed Standards’ provision for transfer surface height. Subcommittee members noted that the vertical stack configuration of stretcher equipment components aims to create compact and maneuverable patient transport devices but the necessary components presently produce surface heights well above those being considered. Another challenging consideration is cushion thickness, which typically ranges from 2 to 5 inches; furthermore, cushions are often purchased separately form the stretcher. The subcommittee will continue to deliberate these issues.

Next, John Jaeckle, subcommittee chairperson, led the discussion concerning Imaging Equipment with Transfers. Because of the broad scope of equipment covered, the subcommittee decided to discuss imaging technologies grouped into the following categories: (1) equipment with bores; (2) magnetic resonance (MR); (3) DEXA (bone density); (4) interventional; (5) conventional x-ray and fluoroscopic; and (6) prone breast biopsy table. Several important technology and design aspects of the equipment subgroups were addressed. The subcommittee has decided that the equipment under their purview should be accessed from the long side only and, like the Stretchers subcommittee, is considering only requiring access to the side and not at the foot end. Transfer supports are also being considered to offset the narrowness of imaging equipment scanning beds and tables. The difficulty of providing lift clearances in the bases of imaging equipment and the alternative of overhead lifts were also discussed. The subcommittee will continue to discuss details of these issues.

Carol Bradley, subcommittee chairperson, led discussions concerning the Mammography Equipment subcommittee. Diagrams of a typical mammography equipment profile highlighted the important considerations and clarified important terminology. As major issues, the subcommittee has identified knee and toe clearance size under the breast platform and the possibility that base supports for the equipment are likely to extend into this area. A recommendation to enlarge the depth of the knee space beyond what was proposed in the Notice of Proposed Rulemaking (NPRM) is under consideration. The committee is also deliberating whether base supports at the floor level of the knee and toe space interfere with the footrests of wheelchairs and whether they might be permitted to overhang such supports. In addition, the committee is considering proposed standing supports provisions and how such supports may be affected by height adjustability of the breast platform, including support size and distance from its front edge. The subcommittee will be moving forward on these issues.

Manufacturer Presentations

Several manufacturers presented information on technical and cost considerations for exam tables and chairs as requested at the preceding advisory committee meeting. Darren Walters, MTI and Bob Menke, Midmark Corporation led these presentations. The first presentation addressed a number of performance and efficacy considerations for examination chairs focusing on lifting mechanisms to adjust seat height, impact of height on the health care practitioner, and the relationship of exam chair footrests to seat height. The presentation revisited some of the recommendations made at the January meeting by the practitioners and clinicians about acceptable transfer surface heights. A key point was made that, while it may be technically possible for an exam chair to go even lower than what the committee is considering, there may be undesirable and unintended consequences. Benefits and limitations of the telescoping, scissor and cantilevered lift systems were reviewed. Concerns were voiced that lowering the equipment could affect the equipment effectiveness and positioning for proper exams. The committee discussed at length the different lifting systems used for adjustable height equipment and the viability of achieving the heights being considered. The presentation referred to relevant requirements for height in the ADA and ABA Accessibility Guidelines and guidance adopted by the US Department of Justice.

The afternoon presentation focused on the cost and benefit analysis based on the implementation of key provisions in the proposed Standard affecting exam tables. The presentation covered the present availability of accessible height adjustable exam tables and how this would change in the future with different scenarios based on the low heights being considered for the transfer surface. The presentation also emphasized that 18% of existing rooms in the United States are equipped with adjustqble height tables that can achieve a 19 inches low height providing a head start to maximize the availability of accessible rooms at a lower cost if the 19 inches is adopted as the standard. Committee discussions were interspersed between segments of the presentation with consideration given to research methodology, the baselines used, and health care practice issues affecting the selection and purchase of diagnostic equipment. A key issue addressed in the presentation is that no adjustable height exam tables are currently available that lower to 17 inches above the floor.

Discussions during and after the presentations did not produce consensus about the minimum transfer surface height. The committee decided to refer the issue to the Exam Tables and Chairs subcommittee for further review and discussion. The full committee will then consider the Subcommittee’s recommendation.

Transfer Support Location and Configuration

Rex Pace clarified issues concerning transfer supports using the PowerPoint previously presented at the January 2013 committee meeting. The committee went through the issues listed on the decision status chart for transfer support location and configuration in an effort to achieve consensus on recommendations. The committee had extensive discussions on the placement, use (transfer, positioning, and safety) and length of transfer supports. Additionally, the committee discussed at length the proposed Standards allowance of non-circular transfer supports. Member polling indicated that there is consensus for the gripping surface cross section and clearances as proposed in the NPRM. However, two members expressed their position that only gripping surfaces with circular cross sections should be permitted. The committee agreed that the Exam Table and Chairs subcommittee will look in depth at transfer support issues and offer guidance on location, dimensions, and height.

Depth of Wheelchair Space

Rex Pace gave a PowerPoint presentation reviewing the proposed Standard’s provisions for the depth of a wheelchair spaces. He also reviewed the NPRM’s questions on increasing this depth for wheelchair spaces entered from the front or rear in light of recent research and possible exceptions for wheelchairs spaces located on raised platforms. The follow-up questions and discussions mostly focused on a wheelchair space necessary to accommodate larger power wheelchairs and scooters. Committee members expressed a range of views from support for an increase in depth to no opinion. No majority view emerged with a substantial number of members stating that they had no experience to evaluate the question or could not anticipate a situation where this increase would be meaningful. The committee has decided not to change the proposed wheelchair depth. The committee decided that efforts will focus on possible exceptions for wheelchairs spaces located on raised platforms. The committee concluded that the issue primarily pertains to weight scales; therefore, the recommendations of the Weight Scales Subcommittee will factor significantly in the committee’s future discussions on the issue.

Final Report

Lisa Iezzoni led the discussion on the organization and timeline for completion of the committee’s final report. The committee decided that the so-called “parking lot” issues added to the status decision chart be addressed in the final report. The parking lot issues identified so far are the nature of diagnostic equipment, obesity considerations, alternate means of access, recommended research, interventional procedures and situations where patients are sedated prior to transfer, and future Rulemaking topics including children standards. In addition to Dr. Iezzoni, two committee members and two alternates volunteered to be part of an editorial committee to produce the final report (Carol Bradley, Janice Carroll, John Jaeckle, and Bob Menke).

Exhibits

The Hill-Rom Company and Stryker Medical exhibited stretchers in the meeting room. A mobile floor lift was also exhibited by Hill- Rom. Medical Technology Industries, Inc., exhibited several exam chairs. The equipment was referred to during committee discussions and members and the public examined the stretchers and exam chairs at their convenience.

Public Comment

A commenter expressed views on the proposed knee and toe clearances and shape and placement of non-circular grab bars (transfer supports).

Wrap Up and Adjournment

Dr. Iezzoni thanked everyone for their participation and the meeting was adjourned.

March 26 and 27, 2013

Agenda Tuesday, March 26

10:00 - 5:00

Welcome and call to order
Approve agenda
Approve minutes of the February 26 – 27, 2013 Committee meeting
Decision status chart and final report updates
Review and discussion of subcommittee work:
- Stretchers Subcommittee- Imaging Equipment with Transfer Surfaces Subcommittee- Mammography Equipment Subcommittee- Exam Tables and Chairs- Weight Scales Subcommittee
Committee work
Public Comment Period

Agenda Wednesday, March 27

9:00 - 2:30

Committee work
Review of recommendations made
Administration
New Business
Public Comment Period
Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

Lisa Iezzoni, Boston CIL (Chair)
Jeffery Baker, MTI
Don Brandon, ADA National Network
Carol J. Bradley, Sutter Health
Mark E. Derry, NCIL
Joseph Drago, Scale-Tronix, Inc.
Kaylan M. Dunlap, Evan Terry Associates
Molly Follette Story, FDA (ex officio)
Dennis Hancher, DVA (ex officio)
David Hausmann, Hausmann Industries, Inc.
John Jaeckle, GE Healthcare
Tamara James, Duke Univ. & Medical Ctr.
Zita Johnson-Betts, DOJ (ex officio)
June Isaacson Kailes, HFCDHP & DREDF Jack DeBraal, Brewer Company
Renée Kielich, Hill-Rom Company, Inc.
Kleo J. King, United Spinal Association
Rochelle J. Mendonca, Univ. Sciences Phila
Kevin Patmore, Stryker Medical
Mary Ann Spohrer, CRCPD
Jon Wells, Midmark Corporation

Alternates Present:

Bradley Baker, MTI
Kristen Barry, Equal Rights Center
Janice Carroll, Sutter Health
Richard M. Eaton, MITA
Dee Kumpar, Hill-Rom Company, Inc.
Bob Menke, Midmark Corporation
Glenn Nygard, Hologic, Inc.

Access Board Members and Staff Present:

Rex Pace (Committee DFO)
Rose Bunales
David Capozzi
Marsha Mazz
James Raggio
Earlene Sesker

Others Present:

Heather Boyd, Applied Policy
Mary Lou Breslin, DREDF
Michelle Lustrino, Hologic, Inc.
Janice Majewski, DOJ
Dennis Monty, Beth Israel Deaconess Med. Ctr.
Chris Palamountain
Gloria Romanelli, Amer. Coll. Radiology
Angela Scott, HHS
Jim Scott, Applied Policy
Barbara Silken
Mark Tobolowisk, Foxkiser
Darren Walters, MTI
Kara Webb
Jeff Yanke
Jonathan Young, Foxkiser

Opening Remarks and Approval of Minutes

The Committee Chair, Lisa Iezzoni, opened the meeting. After roll call the committee approved the agenda for the current meeting and minutes from its February 2013 meeting following several clarifications and agreement on edits.

Decision status chart

Rex Pace reviewed the Decision Status Chart. He reported that all of the issues listed in the chart have been or are being addressed by the full committee or subcommittees. He indicated that the “parking lot issues,” intended as place holders, have been added to the bottom of the chart. Plans are for the committee to discuss parking lot issues but these topics may not result in direct recommendations if not a part of the original proposed standard. Subcommittees

Subcommittee Reports

Each subcommittee chair gave a presentation outlining their deliberations and stating the issues that they have reached consensus on to date. Subcommittee chairs then led discussions of unresolved issues with input from committee and subcommittee members.

Imaging Equipment with Transfer Surfaces

(Presentation: Subcommittee on Imaging Equipment with Transfer Surfaces Presentation, March 26, 2013)

John Jaeckle, subcommittee chairperson, described the subcommittee’s recommendations as follows: Unobstructed transfer will not be required to the “foot” or “head” end but will be required on each side of the equipment except designs where transfer is only possible to one side because of necessary component configuration. The 28 inches wide minimum and 17 inches deep minimum transfer surfaces should be positioned along the long dimension of the scanning/imaging bed/table. The width of the patient scanning/imaging bed/table (side to side) at the designated transfer location will be 28 inches minimum or the maximum possible/practicable, but in all cases a minimum of 17 inches. The transfer support will be located opposite the transfer side and extend horizontally along the side of the patient scanning/imaging bed/table at least the minimum width of the transfer surface. The subcommittee intends to adopt the transfer height recommended by the exam tables and chairs subcommittee with exceptions for certain types of equipment such as DEXA.

Exam Tables and Chairs

(Presentation: Examination Tables and Chairs Subcommittee Report March 26, 2013)

Kleo King, subcommittee chairperson, reported the following recommendations: If exam chairs have bolsters or contour corners/sides the transfer surface height should be taken from the highest point and the seat dimensions at the center point. The memo on mobility device seat height provided to the subcommittee by the IDeA Center was reviewed. The height of the transfer support above the top of the transfer surface should be as proposed, 6 inches minimum to 19 inches maximum, with 1 ½ inch maximum from side of transfer surface to the transfer support. Additionally, the transfer support should be a minimum of 15 inches long for tables.

Stretchers

(Presentation: Stretcher Subcommittee Report March 26, 2013)

Renée Kielich, subcommittee chairperson, indicated subcommittee agreement on the following recommendations: Unobstructed transfer should be required to the sides only and not at the “head” or “foot” end of stretchers. The 28 inches by 17 inches transfer surface will be located with the long dimension parallel to the stretcher sides. Transfer supports should be positioned within the dimensions of the long side of the transfer surface parallel to the patient support surface edge and not more than 3 inches from the patient transfer surface edge. The 3-inch dimension accounts for the rotating/folding rails used on many designs. Additionally, transfer supports should be located on at least one side of the patient transfer surface, be at least 15 inches long, conform to the shapes specified in the ADA/ABA Guidelines for grab bars, and be located a minimum of 6 inches and a maximum of 19 inches above the transfer surface.

Mammography Equipment

(Presentation: Proposed Mammography Equipment Features Criteria - MDE Committee March 28, 2013)

Carol Bradley, subcommittee chairperson, reported subcommittee consensus that the proposed overall depth of knee and toe clearance should be increased to 27 inches minimum with 20 inches minimum to the top of the knee under the breast platform. While the subcommittee is still deliberating on allowances for the base supports of equipment to extend into the knee and toe clearance at the floor level, it is expected that it should be no more than 1½ inch high.

Weight Scales

(Presentation: Subcommittee on Weight Scales, March 27, 2013)

June Kailes, subcommittee chairperson, reported subcommittee consensus that the platform width should be 32 inches minimum. Based on the memo addressing wheelbase dimensions of mobility devices provided by the IDeA Center, the subcommittee agreed that the minimum platform length needs to be 36 inches to accommodate wheelchairs but questions about accommodating scooters was still being debated. Ramps up to a raised platform weight scale should slope no steeper than 1:8 and have 2 inches high minimum edge protection on each side of the ramp surface.

Final Report

Lisa Iezzoni led the discussion on the committee’s final report. Dr. Iezzoni reviewed the draft outline and addressed several key issues to consider in writing and editing the report. Ensuing questions and discussions expounded on the issues raised. It was decided that the subcommittee will submit recommendations and commentary to the editorial committee for completion of the committee’s final report.

Wrap Up and Adjournment

Dr. Iezzoni thanked everyone for their participation and the meeting was adjourned.

May 7 and 8, 2013

Agenda Tuesday, May 7

10:00 - 5:00

Welcome and call to order
Approve agenda
Approve minutes of the March 26 – 27, 2013 Committee meeting
Review and discussion of subcommittee recommendations:
- Imaging Equipment with Transfer Surfaces Subcommittee- Exam Tables and Chairs- Stretchers Subcommittee- Mammography Equipment Subcommittee- Weight Scales Subcommittee
Committee work
Public Comment Period

Agenda Wednesday, May 8

9:00 - 2:30

Review and discussion of Committee recommendations
Final report discussion
Administration
New Business
Public Comment Period
Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee

Members Present:

Lisa Iezzoni, Boston CIL (Chair)
Jeffery Baker, MTI
Jim Bostrom, DOJ (ex officio)
Don Brandon, ADA National Network
Carol J. Bradley, Sutter Health
Jack DeBraal, Brewer Company
Mark E. Derry, NCIL
Joseph Drago, Scale-Tronix, Inc.
Kaylan M. Dunlap, Evan Terry Associates
Elisabeth George, Philips Healthcare
David Hausmann, Hausmann Industries, Inc.
John Jaeckle, GE Healthcare
Tamara James, Duke Univ. & Medical Ctr.
Zita Johnson-Betts, DOJ (ex officio)
June Isaacson Kailes, HFCDHP & DREDF
Renée Kielich, Hill-Rom Company, Inc.
Kleo J. King, United Spinal Association
Rochelle J. Mendonca, Univ. Sciences Phila
Kevin Patmore, Stryker Medical
Maureen Simonson, PVA
Mary Ann Spohrer, CRCPD
Molly Follette Story, FDA (ex officio)
Kat Taylor, Equal Rights Center
Jon Wells, Midmark Corporation

Alternates Present:

Janice Carroll, Sutter Health
Sarah DeCosse, DOJ ( ex officio)
Richard M. Eaton, MITA
Dee Kumpar, Hill-Rom Company, Inc.
Bob Menke, Midmark Corporation

Access Board Members and Staff Present:

Rex Pace (Committee DFO)
Matthew McCollough
James Raggio
Earlene Sesker

Others Present:

Mary Adams, DOJ (ex officio)
Mark Goler
Michelle Lustrino, Hologic, Inc.
Janice Majewski, DOJ
Maureen McCloskey
Dennis Monty, Beth Israel Deaconess Med. Ctr.
Gloria Romanelli, Amer. Coll. Radiology
Angela Scott, HHS
Jim Scott, Applied Policy
Doug Thistlewait
Mark Tobolowisk, Foxkiser
Darren Walters, MTI
Nataly Wiekerneiut
Jeff Yanke

Opening Remarks and Approval of Minutes

The Committee Chair, Lisa Iezzoni opened the meeting. After roll call the committee approved the agenda for the current meeting with one modification to include time to take a group photo and approved minutes from its March 2013 meeting with the correction of one typo.

Subcommittees

Each subcommittee chair presented their final recommendations for consensus of the full committee. Consensus of the full committee was reached on all of the recommendations except for the transfer surface minimum height.

Imaging Equipment with Transfer Surfaces

(Presentation: Subcommittee on Imaging Equipment with Transfer Surfaces Final Presentation May 7, 2013; John Jaeckle, Chair)

The subcommittee’s recommendations are as follows: Unobstructed transfer will not be required to the “foot” or “head” end but will be required on each side of the equipment except designs where transfer is only possible to one side because of necessary component configuration. The 28 inches wide minimum and 17 inches deep minimum transfer surfaces should be positioned along the long dimension of the scanning/imaging bed/table. The width of the patient scanning/imaging bed/table (side to side) at the designated transfer location will be 28 inches minimum or the maximum possible/practicable, but in all cases a minimum of 17 inches. The transfer support will be located opposite the transfer side when the depth of the transfer surface is greater than 24 inches and extend horizontally along the side of the patient scanning/imaging bed/table at least the minimum width of the transfer surface. Positioning supports will be located opposite the transfer side when the depth of the transfer surface is greater than 24 inches. The positioning support will extend horizontally along the side of the patient scanning/imaging bed/table and be 12 to 16 inches in length and 3 to 6 inches above the transfer surface. It will be located at a position designated by the manufacturer for optimal positioning assistance. The maximum distance from the transfer surface to either the transfer support or the positioning support is 1.5 inches. However, an exception of up to 3 inches is acceptable for foldable, collapsible, removable, and articulating supports. The subcommittee intends to adopt the transfer height recommended by the exam tables and chairs subcommittee with exceptions for certain types of equipment such as DEXA. Additionally, the subcommittee recommends that overhead lifts be allowed in lieu of the provisions for clearances in or around the base of equipment to accommodate the legs of portable floor lifts.

The full committee reached consensus on the above recommendations presented by the imaging subcommittee except the recommended 17 inches depth for the transfer surface when located parallel to the patient scanning/imaging table side. The full committee reached consensus that when the transfer surface is positioned in this manner the depth should be 21 inches.

Exam Tables and Chairs

(Presentation: Examination Tables and Chairs Subcommittee Report May 7, 2013; Kleo King, Chair)

The subcommittee’s recommendations are as follows: If exam chairs have bolsters or contour corners/sides the transfer surface height should be taken from the highest point and the seat dimensions at the center point. The transfer surface for tables shall be17 inches deep by 28 inches wide. The transfer surface for chairs shall be 17 inches deep by 21 inches wide. Chairs that need to be approached from the side (i.e. dental chairs, podiatry chairs) must have a transfer surface on both sides 21 inches wide by 17 inches deep. The height of the transfer surface shall be a minimum of 19 inches above the finished floor. Transfer supports should be mounted on both sides of the transfer surface and be movable/removable so they do not obstruct the transfer surface while in position for transfer. The support should be rated to support 250 pounds of force in direction of use. The height of the transfer support above the top of the transfer surface should be as proposed, 6 inches minimum to 19 inches maximum, with 1 ½ inch maximum from side of transfer surface to the transfer support. As long as the transfer support is located in the 6 inch minimum by 19 inch maximum area and is a minimum of 15 inches long, the support can be positioned in any direction. The transfer support should be a minimum of 15 inches long for tables and overlap the minimum depth of the transfer surface by at least 80%. The transfer support gripping surface shall be free of sharp or abrasive elements and shall have rounded edges. Interruptions along gripping surface, such as supports and spacers to prevent patient entrapment shall not obstruct the bottom of the transfer support for more than 20% of its length. Additionally, the subcommittee recommends, but does not mandate, that the support have height adjustability. The subcommittee also recommends that armrests not be required on exam chairs and similar equipment used by patients in a seat position. If provided armrests cannot interfere with transfer supports.

The full committee reached consensus on the all of the above recommendations presented by the exam tables and chairs subcommittee except the recommended 19 inch minimum height for the transfer surface. This issue will be discussed in section of the final report dedicated to the views for each of the main minimum heights considered since the full committee could not reach consensus.

Stretchers

(Presentation: Stretcher Subcommittee Report May 7, 2013)

The subcommittee’s recommendations are as follows: The minimum transfer height should be 17 inches to the uncompressed top of the transfer surface with some exception. The exception will permit a low height of 21” adjustable to a higher height of 25” maximum to allow for working components, such as oxygen containers, integral to the device when used as a transport device. Unobstructed transfer should be required to the sides only and not at the “head” or “foot” end of stretchers. The 28 inches by 17 inches transfer surface will be located with the long dimension parallel to the stretcher sides. Transfer supports should be positioned within the dimensions of the long side of the transfer surface parallel to the patient support surface edge and not more than 3 inches from the patient transfer surface edge. The 3-inch dimension accounts for the rotating/folding rails used on many designs. The transfer support gripping surface shall be free of sharp or abrasive elements and shall have rounded edges. Interruptions along gripping surface, such as supports and spacers to prevent patient entrapment shall not obstruct the bottom of the transfer support for more than 20% of its length. Additionally, transfer supports should be located on at least one side of the patient transfer surface, be at least 15 inches long, conform to the shapes specified in the ADA/ABA Guidelines for grab bars, and be located a minimum of 6 inches and a maximum of 19 inches above the transfer surface. The subcommittee also recommended a change in the text for the requirement on stirrups to clarify that the stirrup itself may not be providing the required leg support. In an effort to harmonize with the current international standard (IEC 60601-2-52) the subcommittee changed the lift clearance width requirement to 39 inches.

The full committee reached consensus on the all of the above recommendations presented by the stretchers subcommittee except the recommended 17 inch minimum height with exceptions for the transfer surface. This issue will be discussed in a section in the final report dedicated to the differing views on the minimum low height since the full committee could not reach consensus.

Mammography Equipment

(Presentation: Mammography Equipment Subcommittee Final Recommendations - MDE Advisory Committee May 7, 2013; Carol Bradley, Chair)

The subcommittee’s recommendations are as follows: The breast platform should be measured to a minimum height of 34 inches. The proposed overall depth of knee and toe clearance should be increased to 28 inches and the knee clearance depth at 27” above the ground should be 18 inches minimum. The unobstructed floor space should be 17 inches minimum. The base supports of equipment shall be permitted to extend into the knee and toe clearance at the floor level no more than 1½ inch high.

The full committee reached consensus on the all of the above recommendations presented by the mammography equipment subcommittee except the recommended 28-inch minimum height for the breast platform. The full committee reached consensus on a 26-inch minimum.

Weight Scales

(Presentation: Subcommittee on Weight Scales, May 8, 2013; June Kailes, Chair)

The subcommittee’s recommendations are as follows: The platform should be a minimum of 32 inches wide and 40 inches long. Ramps up to the raised platform weight scale should slope no steeper than 1:2 for up to 2 inches high, 1:8 and for greater than 2 and up to 3inches, and 1:12 for greater than 3 inches high. Two inches high minimum edge protection should be required opposite the entry ramp on single ramp scales and on each side of dual entry ramps unless the platform is less than or equal to 1 ½ inches high. Standing supports should be required on one side of the platform for dual ramp entry and two sides of the platform for single ramp entry with 34” minimum width between standing supports. Additionally, the supports should extend for a distance of 80% minimum the length of the platform beginning immediately at the end of the entry ramp.

The full committee reached consensus on the above recommendations presented by the weight scales subcommittee except the ramp slopes for the raised platform. The full committee reached consensus on slopes no steeper than 1:2 for up to 1 1/2 inches high, 1:8 and for greater than 1 ½ and up to 2 ½ inches, and 1:12 for greater than 2 ½ inches high. Additionally, the full committee agreed on clarifying the 80% recommendation by including specific dimensions for the length of the standing support. Consensus was reached on a 32 inches minimum for single ramp scales and 40 inches minimum for dual ramp scales.

Final Report

Lisa Iezzoni led the discussion on the committee’s final report. The subcommittees were asked to submit their reports to the editorial committee as soon as possible. It was decided that the final committee meeting will be held by teleconference on either Thursday, June 13th or Monday, June 17th, 2013. The editorial committee agreed to have the draft final report to the full committee for review the week before the final committee meeting.

Wrap Up and Adjournment

Dr. Iezzoni thanked everyone for their participation and the meeting was adjourned.

Monday, June 17, 2013 (Teleconference)

Agenda Monday, June 17

1:00 - 4:30 (ET)

Welcome and call to order
Approve agenda
Approve minutes of the May 7 – 8, 2013 Committee meeting
Review of draft final report
Final report discussion and decisions
Public comment period
Adjourn

Note: Lunch will be on your own at a time each day conducive to the work of the Committee