MDE Advisory Committee Meeting Minutes: February 26 and 27, 2013

February 26 and 27, 2013
Washington, DC

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.