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This is the Preamble to the Final MDE Standards. Click here to view the Final MDE Standards.

2. Armrests Requirement

In the MDE NPRM, the Access Board required diagnostic equipment used by patients in the seated position to provide armrests (proposed M302.3.2). The only commenter that addressed whether armrests should be required was a manufacturer who requested that beds, cots, and stretchers be excluded from the requirements as they are required to have side rails per IEC 60601-2-52. The MDE Advisory Committee addressed the armrest provision during their discussions of transfer supports and explained that “armrests serve a similar function, and occupy the same physical space as the transfer supports as described in the MDE NPRM. The MDE NPRM requires transfer supports for all chairs, so the additional equipment for armrests for chairs was not only redundant, but could potentially create a physical conflict between the two devices.” MDE Advisory Committee Report, 104, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended that armrests not be required, but if provided they cannot obstruct transfer supports. Additionally, the Committee noted that transfer supports meeting the final requirements, would provide support like that of armrests and enhance patient stability if left in place after a transfer from a mobility device. Id.

After review of the comment and the recommendations of the MDE Advisory Committee, the Access Board is persuaded that requiring armrests as well as transfer supports is redundant and has the potential to cause conflict between the two devices. Therefore, the Access Board has removed the provision requiring armrests from the final rule.

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