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

1. Transfer Supports

The MDE NPRM proposed requirements for transfer supports that applied to all transfer surfaces (proposed M305.2). The requirements were the same for transfer surfaces on diagnostic equipment used by patients in the supine, prone, or side-lying position, as well as diagnostic equipment used by patients in the seated position. The proposed standards required transfer supports to be located within reach of the transfer surface and not obstruct transfer, be capable of resisting vertical and horizontal forces of 250 pounds applied to all points, and not rotate in their fittings. The latter two requirements were taken from the 2004 ADA and ABA Accessibility Guidelines for grab bars. 36 CFR Part 1191, App. D. In the preamble to the MDE NPRM, the Access Board posed multiple questions about whether the final rule should include more specific requirements regarding location, length, size, height, and angle for transfer supports; and whether transfer supports should be allowed to rotate in their fittings. The Access Board received 31 comments to these questions and the MDE Advisory Committee made 10 recommendations regarding the transfer support section.

In response to the comments and the recommendations of the MDE Advisory Committee, and in consideration of the changes to the final rule regarding types of transfer surfaces, the Access Board has made multiple changes and additions to the transfer support requirements, located at M305.2. Specifically, the Access Board has added technical specifications to the requirements for location (M305.2.1) and length (M305.2.2) based on the type of transfer support required; has added new technical requirements for height (M305.2.3), cross section (M305.2.4), absence of surface hazards (M305.2.5), gripping surfaces (M305.2.6), and clearance (M305.2.7); and has made changes to the fittings provision (M305.2.8). These new and revised provisions are based on the 2004 ADA and ABA Accessibility Guidelines for grab bars and handrails, 36 CFR Part 1191, App. D. Finally, the Access Board has removed the requirement for structural strength for transfer supports and has decided not to add any positioning support requirements in the final rule. Each requirement is discussed in detail in the Section-by-Section Analysis below.

a. Structural Strength

The MDE NPRM proposed to require transfer supports to be capable of resisting vertical and horizontal forces of 250 pounds at all points (proposed M305.2.2). The Access Board sought input in question 18, on whether current transfer supports are capable of resisting vertical and horizontal forces of 250 pounds at all points. NPRM, 77 FR at 6925. Four commenters (three manufacturers and one accessibility consultant) addressed this requirement: the accessibility consultant concurred with the proposal and the other three commenters opposed this provision. Two of those opposing the 250-pound requirement asserted that very few supports would be able to withstand 250 pounds of force applied to all points in all directions and that the requirements should differ depending on the force vector or live load applied. The remaining opposing commenter supported compliance with the prevailing industry standard IEC 60601 instead of the proposed provision.

The MDE Advisory Committee recommended revising the language proposed in the MDE NPRM to require transfer supports to resist vertical and horizontal forces of 250 pounds at locations determined by the intended use of the equipment. The Committee indicated that “during committee discussions manufacturers stated that industry is required to test the most vulnerable spots on the transfer support. Industry must follow testing parameters found in other standards.” MDE Advisory Committee Report, 103, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

After reviewing the comments received and the recommendations from the MDE Advisory Committee, the Access Board has decided to remove this section in the final rule. The prevailing standard used by industry, IEC 60601 adopted under the ANSI/AAMI ES 60601 series in the U.S., contains provisions that address the structural strength of supports. ANSI/AAMI ES60601-1:2005/(R)2012, available at http://my.aami.org. The IEC 60601 Standard applies to a wide range of medical equipment including much of the diagnostic equipment covered by the MDE Standards and contains allowances for risk assessment not found in accessibility standards, such that support features on diagnostic equipment that will sustain transfers in a safe manner even without a specific provision in the MDE Standards. Id. Accordingly, it is not necessary for the Access Board to address the structural strength of transfer supports in the final rule as it is already covered by industry standards.

b. Positioning Supports

The Access Board noted in the MDE NPRM preamble that it was considering adding positioning supports to the final rule and sought public input with question 24 on whether positioning supports should be required in the final rule. NPRM, 77 FR at 6927. Six commenters responded: two commenters (disability rights organizations) recommended adding positioning supports; two commenters (manufacturers) recommended providing positioning supports within reach of the patient; one commenter (an accessibility consultant) recommended flexibility to allow for design based on use; and the final commenter (a manufacturer) raised concerns about the technical impact for MRI machines. Additionally, as discussed above in Section IV.D.1 (Significant Changes – Standing Supports) and below in Section V.C.17 (Section-by-Section Analysis – M305.2), the MDE Advisory Committee made recommendations to add requirements for positioning supports on mammography equipment and imaging equipment with transfer surfaces having depths greater than 24 inches.

After review of the comments and the MDE Advisory Committee’s recommendations, the Access Board has decided not to require positioning supports in the final rule. Although the Access Board considers positioning supports to be helpful, even necessary in some instances, given the wide range of diagnostic equipment addressed by the final rule, we have insufficient information on which to base a meaningful requirement that could apply to all types of equipment. Additionally, where transfer supports are provided, they can also serve to assist patients to position themselves.