MDE Advisory Committee Meeting Minutes: September 27 and 28, 2012

Thursday, September 27, 2012 thru
Friday, September 28, 2012
Washington, DC

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.

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 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:

  1. Is the product a medical device?
  2. Does the medical device, according to its Instructions for Use (IFU), perform a diagnostic function?
  3. 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?
  4. 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?
  5. 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?
  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 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.