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

M301.4.1 Clearance in Base (Section-by-Section Analysis)

The MDE NPRM proposed certain clearance requirements beneath the diagnostic equipment to allow sufficient space for the legs of a portable patient lift to fit underneath the equipment so that the patient could be raised out of their mobility device, moved over to the medical diagnostic equipment, and then be lowered onto the transfer surface. The proposed requirement could be met by providing an open area beneath the equipment, or by configuring the equipment with a wide slot recessed into the base enclosure. NPRM, 77 FR at 6927. The MDE NPRM proposed a clearance in the base of 44 inches wide minimum, 6 inches high minimum measured from the floor, and 36 inches deep minimum measured from the edge of the examination surface. Where the width of the equipment is less than 36 inches wide, the proposed rule required the clearance to extend the full width of the equipment. Id. Additionally, the Access Board proposed to permit equipment components to be located within 8 inches maximum of the centerline of the clearance width. Id. The Access Board sought input in question 25 in the MDE NPRM preamble, on whether the proposed dimensions for the clearance in base requirement is sufficient to allow for the use of portable floor lifts. Id.

Six commenters responded to the question. One commenter, a manufacturer, concurred with the proposed provision. Another commenter, a medical association, explained that portable lifts are a problem in older outpatient facilities due to limited space. Another commenter, a manufacturer, raised concerns about requiring floor based patient lifts with MRI systems, explaining the concern about the significant structural support required in the patient bed which makes the under bed clearance impractical and the concern about requiring non-ferrous materials in the MRI room. This commenter explained a preference for fixed overhead lifts. Three commenters (two manufacturers and one medical association) raised concerns with the six-inch vertical clearance measured from the floor requirement. One manufacturer explained that the proposed six-inch vertical clearance requirement would encompass 100 percent of all portable patient lifts on the market, and that several portable patient lifts only require 2.5 inches clearance, such as those designed to be used with stretchers. This commenter asserted that the proposed six-inch vertical clearance would require redesign of every medical bed and stretcher on the market, and recommended reducing the required clearance. One commenter (medical association) noted that it would be difficult to meet the six-inch clearance from the floor when the table is lowered to 17 inches to allow for transfer. The final commenter explained that a standard that only required either compliance with clearance in the base or clearance around the base, was attainable, but warned that if both were required it would impose significant redesign costs and would increase product costs. This commenter further posited that it would be more cost effective to redesign the lift than the diagnostic equipment. These three commenters also raised concerns that this provision was in conflict with the prevailing standard used by manufacturers for medical beds and stretchers, IEC 60601-2-52, which contains requirements for lift clearance under the equipment.

The MDE Advisory Committee recommended reducing the equipment base clearance for stretchers from 44 inches wide minimum to 39 inches wide minimum. The Committee noted that this was to harmonize the MDE Standards with IEC 60601-2-52, which provides requirements for stretchers and includes lift clearance at the 39-inch width. MDE Advisory Committee Report, 106-107, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report.

The Access Board has reviewed the comments and the recommendations from the MDE Advisory Committee and is persuaded by the arguments in favor of harmonizing the lift clearance requirements with the IEC 60601-2-52. Accordingly, the Access Board has adopted the recommendation from the MDE Advisory Committee, but has decided to apply the reduction in lift clearance width to all medical diagnostic equipment that complies with the clearance in base provision because a lift that deploys effectively under a stretcher should also function properly under other less constrained diagnostic equipment. Secondly, the Access Board has decided to retain the six-inch height clearance requirement but agrees with the commenters that the diagnostic equipment should not have to meet the six-inch height clearance requirement when in position for independent transfer. Therefore, the final rule clarifies that the lift compatibility requirements only apply when the diagnostic equipment is being used with the portable lift, as a lift will only be used when independent transfer is not possible.