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

M305.4 Leg Supports (Section-by-Section Analysis)

As discussed above in Section V.C.3.b (Section-by-Section Analysis – M301.3.2) and Section V.C.7.b (Section-by-Section Analysis – M302.3.2), the technical requirements for leg supports from M301 and M302 have been relocated to M305 Supports. The MDE NPRM proposed that where stirrups are provided, they must provide a method to support, position, and secure the patients legs. Four commenters (medical association, accessibility consultant, disability rights organization, and a state agency) agreed with requiring leg supports when stirrups are provided.

The MDE Advisory Committee agreed that, for procedures that use stirrups and require the leg to be stable, there must be a method to support the patient’s legs. The Committee referenced ANSI/AAMI HE75 which recommends that “[f]or patients with limited leg strength and control, instead of stirrups that support only the foot and require active user leg strength, leg supports that support both the foot and the leg should be used to assist patients in keeping their legs in the appropriate position.” MDE Advisory Committee Report, 105, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee recommended adding additional language to this provision to clarify that “where the equipment provides stirrups, it must also provide an alternate method to support, position, and secure the patients legs (specifically including sufficient support of the patient’s thigh, knee, and calf to stabilize the leg). This method will either supplement or serve as a substitute for the stirrups.” Id.

After reviewing the MDE Advisory Committee recommendations, the Access Board has decided that the proposed provision is sufficient to require the leg support advocated by the MDE Advisory Committee and has therefore not adopted the MDE Advisory Committee recommendation to require an alternate method of leg supports. However, in the final rule the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to the MDE Advisory Committee recommendation and to provide consistency with the headings of other support provisions that are based on the body part supported.