36 CFR Part 1195 Standards for Accessible Medical Diagnostic Equipment - Preamble

d. Unobstructed Transfer

The MDE NPRM proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer (proposed M301.2.3 and M302.2.3). As explained in the MDE NPRM preamble, the unobstructed access requirement was to ensure that armrests, side rails, stirrups, or other equipment parts attached to the diagnostic equipment did not impede the patient’s ability to transfer. NPRM, 77 FR at 6923. The final rule retains the proposed requirements for unobstructed transfer for diagnostic equipment used in a supine, prone, or side-lying position, as well as diagnostic equipment used in the seated position, and has added a new exception described below.

In the preamble to the MDE NPRM the Access Board noted that it was considering permitting equipment parts to extend a maximum of three inches horizontally beyond the edge of the transfer side. The Access Board explained that “[t]he 2004 ADA and ABA Accessibility Guidelines provide a gap of 3 inches between the edge of the shower seat and the shower compartment entry, and the gap does not appear to interfere with transferring onto and off of the shower seat.” NPRM, 77 FR at 6924. The Access Board sought input from the public in the MDE NPRM preamble question 17, on whether equipment parts should be permitted to extend a maximum of three inches horizontally beyond the edge of the transfer sides, provided that they did not extend above the top of the transfer surface. Id. Six of the eleven commenters who responded to this question supported permitting equipment parts to extend up to three inches horizontally beyond the edge of the transfer surface. However, these commenters were primarily manufacturers who also expressed concerns about the cost of equipment redesign if a provision permitting the three-inch gap was not included in the final standards. The other five commenters, disability rights advocates and an accessibility consultant, did not support allowing equipment parts to extend up to three inches horizontally, unless they were removable. These commenters raised concerns that the equipment parts would impede transfer. Additionally, a manufacturer, responding to question 9 in the MDE NPRM, explained that all beds, stretchers, and cots have side rails that can be moved to allow unobstructed access for transfer.

The MDE Advisory Committee reviewed the comments. The Committee observed that transfer supports provide handholds that facilitate transfers onto and off of the equipment, and that some types of diagnostic equipment have components that create a gap between the transfer surface and the outer edge of the equipment on the side used for transfer. MDE Advisory Committee Report, 78-82, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee reviewed the 2010 ADA Standards for shower compartment seat requirements, which allows a three-inch gap between the edge of a seat and the shower compartment entry, to determine if these gaps presented a problem to individuals attempting to transfer. The MDE Advisory Committee also considered anthropometric data from the Impact of Transfer Setup on the Performance of Independent Transfers study by the VA Pittsburgh Healthcare System in collaboration with the Human Engineering Research Laboratories at the University of Pittsburgh. Id. This study examined the transfer experience with an adjustable height transfer surface. This study is available at http://herl.pitt.edu/ab/. The MDE Advisory Committee explained that “[t]he results showed that 95% of subjects could transfer when the seat and surface are at the same height with a 3.5-inch gap. This data helped inform the recommendation for the exception since the 3-inch criteria is less than that used in the research and should assure effective transfers for most.” MDE Advisory Committee Report, 79, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended allowing a maximum three-inch obstruction protruding from the transfer sides, “placing a limit on the size of the gap between the transfer surface and the outer edge of the equipment on the side used for transfer,” that applies to both the long length (width) and short length (depth) transfer sides. Id. The Committee also recommended special consideration for stretchers, to incorporate the provision of IEC 60601-2-52 to establish a maximum vertical obstruction at no less than one inch below the top of the transfer surface. Id.

Based on the comments received and the MDE Advisory Committee recommendations, the Access Board is persuaded that a gap of up to three inches between the transfer side and the wheeled mobility device will not impede transfer given that accessible diagnostic equipment will be required to be adjustable. In addition, the Access Board is not persuaded that special consideration for stretchers is necessary in order to accommodate the IEC 60601-2-52 prohibition against vertical obstructions within one inch of the top of the patient surface. The final rule would not permit obstruction above the patient surface; consequently, by meeting the IEC requirements manufacturers will meet the MDE Standards.

Accordingly, the final rule includes an exception permitting obstructions of no more than three inches deep beyond the transfer side of the transfer surface provided that such obstructions do not protrude above the top of the transfer surface. A common example of this type of obstruction is articulating side rails on stretchers that move out of the way during transfer, but create a gap between the transfer surface and the mobility device. The exception allowing obstructions of up to three inches is included in each of the new provisions for unobstructed transfer for diagnostic equipment used in the supine, prone, or side-lying position (M301.2.4), and diagnostic equipment used in the seated position (M302.2.5), as Exception 1.

As noted above, the Access Board has retained the original exception from the MDE NPRM, permitting temporary obstructions provided that they can be repositioned out of the way during transfer. In the final rule, the Board moved this provision to Exception 2 to accommodate the new exception discussed above, and added language to specify that this exception may also apply to obstructions that qualify for Exception 1. For example, side rails that create a gap of three inches from the transfer side of the diagnostic equipment to the mobility device when moved out of the way for transfer, but also protrude above the top of the transfer surface when in place as a side rail.