MDE Advisory Committee Meeting Minutes: May 7 and 8, 2013

May 7 and 8, 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  
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.