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

E. M305 Supports

M305 provides the technical requirements for supports on medical diagnostic equipment. There were multiple significant changes made to the transfer supports section, including the addition of new requirements as well as the removal of structural strength requirements from the final rule. Additionally, changes were made to the vertical and horizontal standing supports requirements.

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.

2. Standing Supports

The proposed rule provided technical criteria for vertical and horizontal standing supports. For horizontal standing supports, the Access Board proposed a gripping surface of 4 inches long minimum, the top of which would be required to be located 34 inches minimum and 38 inches maximum above the standing surface (proposed M305.3.1). For vertical standing supports, the Access Board proposed a gripping surface of 18 inches long minimum, the bottom of which would be required to be located 34 inches minimum and 37 inches maximum above the standing surface (proposed M305.3.2). In the preamble to the MDE NPRM the Access Board sought input with question 38 on: a) the current configurations of standing supports, and their effectiveness for persons with disabilities; b) if there were any alternative technical criteria that would be appropriate; c) whether angled supports are effective; and d) whether there are industry standards for the structural strength of standing supports. NPRM, 77 FR at 6931. The Access Board received two comments, one of which addressed standing supports on mammography equipment (discussed above in Section IV.D.1 (Significant Changes – Standing Supports)) and one commenter (medical association) who noted that angled standing supports would be effective and that they are unaware of any industry standards regarding structural strength.

The MDE Advisory Committee reviewed the standing supports provision and while it supported the technical criteria in the proposed rule, the MDE Advisory Committee recommended adding additional criteria for standing supports on raised platforms with wheelchair spaces based on the recommended changes in requirements for standing supports for such diagnostic equipment (discussed above in Section IV.D.1 (Significant Changes – Standing Supports)). The Committee recommended that for single-ramped entry raised platforms with wheelchair spaces, the standing supports located on two sides of the platform have a minimum of 34 inches between supports, be integrated into the platform, and be a minimum of 32 inches in length (at least 80 percent of the platform length) at the platform entry edge. MDE Advisory Committee Report, 136-137, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. For standing supports on dual-ramped entry raised platforms with wheelchair spaces, the MDE Advisory Committee recommended the standing support, required on one side of the platform, be integrated into the platform and stretch the full length of the platform (40-inch minimum). Id.

The Access Board concurs with most of the MDE Advisory Committee’s recommendations; however, although the Committee’s recommendations pertained to diagnostic equipment with wheelchair spaces and standing spaces on raised platforms, the Access Board has decided to apply the recommended criteria to all diagnostic equipment for patients in a standing position that also contains a wheelchair space, regardless of whether the equipment standing surface is raised. In addition, the exception permitting only one standing support is conditioned on that support being positioned horizontally in relation to the standing surface, not vertically. Additionally, the Access Board has adopted the Committee’s recommendation regarding the length of these standing supports necessitating the Access Board to restructure the standing support provision, dividing it into length and height. In the final rule the Access Board permits diagnostic equipment that is required to have standing supports that also provides a wheelchair spaces with one entry to have standing supports with a gripping surface length equal to or greater than 80 percent of the overall length of the platform. For such diagnostic equipment with wheelchair spaces that permit pass-through from one end to the other, the final rule requires the length of the gripping surface of the standing support to be at least equal to the length of the platform.