MDE Advisory Committee Meeting Minutes: December 3 and 4, 2012

December 3 and 4, 2012
Washington, DC

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.