Draft Meeting Minutes 1

**US Access Board Medical Diagnostic Equipment Accessibility Standards Advisory Committee**  **Draft Meeting Minutes**  **Thursday, September 27, 2012 thru Friday, September 28, 2012**  **Washington, DC MEMBERS PRESENT:_________________________________________________________**  John L aViola, Hologic, Inc. Kevin Patmore, Stry ker Medical Milind Dhamankar , Siemens Medical Solutions Elisabeth George, Phillips Healthcare/MITA Carol J. Bradley , Sutter Health Jon Wells, Midmark Corporation Kaylan M. Dunlap, Evan Terry Associates Kleo J. King, United Spinal Association Joseph Drago, Scale

- Tronix, Inc. Lisa Iezzoni, Boston CIL (Chair) Mark E. Derry , NCIL Kat Taylor, Equal Rights Center Jack DeBraal , Brewer Company Renee Kielich, Hill

- Rom Company , Inc. Jeffery Baker, MTI Rochelle J. Mendonca, Univ. Sciences Phila. JB Risk, MPI Dennis Hancher, VA Molly Follette Story , FDA John Jaeckle, GE Healthcare June Is aacson Kailes, HFCDHP & DREDF Zita Johnson

- Betts, DOJ Tamara James, Duke Univ.& Medical Ctr. Maureen Simonson, PVA David Hausmann, Hausmann Industries Don Brandon, ADA National Network (via teleconference)
**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. Janice Majewski, DOJ Angela Scott, HHS Mary Matz, VHA Gloria Romanelli, Amer. Coll. Radiology Richard Eaton, MITADraft Meeting Minutes 2

Maureen McCloskey , PVA J im Scott, Applied Policy Felix, Akinrinola, Siemens Healthcare Brandy Wagstaff , DOJ Rael Kepace, MITA Mary Duranti, UPMC Dis. Resource Ctr. Mary Adams, DOJ **September 27, 2012 (10:00** 

**– 5:00)** 
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 propose d 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 propose d 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 definition s , more examples of ty pes of equipment covered , scoping weight requirements, lift compatibility , cost, clinical use and understanding when design ing 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
Establish ment 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. MazzDraft Meeting Minutes 3

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 di agnostic equipment .” Each committee member proposed one or more specific ty pe of equipment that might be considered medical diagnostic equipment and thus covered b y the standards. This exercise prompted a lengthy discuss ion attempting to clarify what is classified as diagnostic equipment. One example that highlighted the complexities of classif yi ng equipment involved dialysis chair s , where the major purpose is supporting patients during treatment (dial ys is) but during which c areful monitoring take s place. Does this monitoring constitute “diagnosis” for the purposes of this rule? The example also raised questions about whether being seated in a dialy sis chair is necessary to receive dialy sis. Another example involved infusion chairs: clearl y, the purpose of these chairs is to support persons undergoing venous infusions (e.g., chemotherap y), but these persons are similarly carefully monitored. Dr. Iezzoni provided an example from several years ago in which a woman who uses a wh eelchair was going to be denied outpatient chemotherap y for breast cancer because she couldn't get into a chemotherap y

/infusion chair. After length y discussion, the committee agreed that the purpose of these ty pes 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 dia gnostic. In an attempt to clarify equipment classification, Kevin Patmore of Stry ker 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 continue d in the morning

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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 P aral yz ed V eterans of America voiced support for the standards. She stated that equipment in the past was designed with the uti lity for the caregiver instead of accessibility . Dennis Monty from the Beth Israel Deaconess Medical C ent e r 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. Sh e 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 alway s be from 10 to 5 and the second day will end at 3. It was confirmed that the teleconference meeting scheduled for mid

-Nov ember would be two full day s. 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 t o discussions of subcommittees which may also be done via teleconference. Furthe r discussion of these issue s were tabled until morning and the Chair adjourned the meeting. **September 28, 2012 ( 9:00**

**– 3:00)**  Opening Remarks Committee Chair, Dr. Iezzoni , o pened 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 member s ’ 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 adjo ur ned , to see if there was a simple and effective screening filter that would identify medical diagnostic equipment that fall s un der the authority of the proposed rule . Six questions were developed to be used as filters in determining what equipment would be covered b y the rule. An y device would be included as falling under the rule if the first 5 questions are answered yes and que stion six is answered no
. The questions are as follows:
1. Is the product a medical device? 2. Does the medical device, according to its Instructions for Use ( IFU ) , perform a diagnostic function?Draft Meeting Minutes 5

3. Is it necessary

that the patient have a phy sical interaction with the medical device, or its sy stem, in order for the device to perform its intended diagnostic function? 4. Is it necessary

that the patient have a phy sical interaction with the medical device, or its sy stem, in order for the diagnostic procedure to be carri ed out? 5. Is it necessary

that the medical device have a phy sical 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? 6. 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 possibl y 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 table s used in most doctors’ offices. A picture of this ty pe 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 currentl y 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 po sed in the NPRM about increasing the maximum height to 25 inches to accommodate persons using larger power wheel chairs. 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. Itwas 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 d eliberations move d from standard exam tables. Transfer Surface W

idth 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. Itbecame 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 video s of transfers downloaded from Web sites accessed b y certain committee members ; s everal committee members who use wheelchairs describ ed their preferences for transfer

ring

. 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 patient s’ reach. It was noted that the proposed location of the transfer surface may be a problem because it requir es 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 supportsDraft Meeting Minutes 6

on the opposite side of the table and for c linicians trying to examine the patient on the table

. O thers 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 a lso be necessary , perhaps result ing in separate rooms for people with disabilities. It was noted that the ty

pical 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 pro fessionals wanting a width less than 30 inches while some patients want ed 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. A s determined from anthropometric studies referenced at the meeting, 29 inches represents the sum of the hip width required b y the 95th percentile male plus two hand widths assuming that seated individuals may stabilize themselves using their hands, palm do wn, 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. So m e 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. In formation was presented from a book entitled , The Measure of Man and W oman: 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 co ntinue on this issue at the next meeting.
Subcommittees The committee discussed and strongl y endorsed the need to establish subcommittee to effectivel y 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) mammograph y machines ; (5) other radiologic equipment ; and (6) w eight s cales

. Committee members voiced concerns that practitioners and researchers are not bein g included in discussions pertaining to the use of specific types of equipment and how accessibility may a ffect 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 Coll ege of Radiology reque sted 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 M edical Imaging & T echnology A lliance expressed concerns that the planned teleconference may not be as efficient as a face to face meeting. Maureen McCloskey from Paral yz ed Veterans of America suggested the inclusion of someone from an acute rehabilitation facility . She also suggested clarification on the ty

pe 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 travel ing to Washington, DC , for those who cannot beDraft Meeting Minutes 7

present. She stated that future meeting dates will be sent to the committee members via email. The meeting was adjourned.