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

M301.3 Supports (Section-by-Section Analysis)

This is an introductory section. An editorial change was made to this section as a result of the change in M301.3.2, described below, to replace the word “stirrups” with the term “leg supports.”

M301.3.1 Transfer Supports (Section-by-Section Analysis)

The MDE NPRM proposed to require transfer supports to be provided for use with transfer sides on diagnostic equipment used by patients in the supine, prone, or side-lying position, and that these transfer supports comply with the technical requirements for transfer support in M305.2. There were no public comments and no recommendations by the MDE Advisory Committee on this provision. The only change in the final rule was to update the cross reference to applicable transfer surfaces to accommodate the changes made to transfer surfaces, described above in Section IV.B.1. (Significant Changes – Transfer Surface).

M301.3.2 Leg Supports (Section-by-Section Analysis)

In the MDE NPRM, the Access Board proposed to place the requirements for stirrups on diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule the Access Board has decided to move the technical requirements for stirrups to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that when stirrups are provided on diagnostic equipment used in the supine, prone, or side-lying position leg supports must also be provided and comply with the technical requirements in M305.4. Additionally, in the final rule, the Access Board has made an editorial change in terminology, from stirrups to leg supports, in response to an MDE Advisory Committee recommendation to draw a distinction between stirrups which often only support the feet and leg supports which would support the legs when the patient’s feet are in the stirrups and to provide consistency with the headings of other support provisions which are based on the body part supported.

M301.3.3 Head and Back Support (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed to place the requirements for head and back support for diagnostic equipment used by patients in the supine, prone, or side-lying position in M301. In the final rule, the Access Board has decided to move the technical requirements for head and back support to M305, which includes all of the technical requirements for supports. Therefore, in the final rule, this provision instructs that where diagnostic equipment is used in a reclined position it must provide head and back support that complies with the technical requirements in M305.5.

M301.4 Lift Compatibility (Section-by-Section Analysis)

The MDE NPRM proposed to require that diagnostic equipment used by patients in the supine, prone, or side-lying position be usable with a patient lift and comply with either the proposed clearance in base (proposed M301.4.1) or clearance around base (proposed M301.4.2) technical requirements. One manufacturer commented on this provision, asserting that the proposed requirement was unclear and should clearly state that the diagnostic equipment only has to be compatible with either the clearance around base or the clearance in base provisions. The Access Board considered this comment, but finds that the language is clear as written. This provision clearly states that diagnostic equipment shall comply with clearance in base or clearance around base. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, and a change to clarify that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift.

Additionally, question 27 in the MDE NPRM preamble requested input on whether the final rule should provide an exception from the lift compatibility requirements where the diagnostic equipment is designed for use with overhead lifts. As discussed above in Section IV.B.3. (Significant Changes – Lift Compatibility Exception), the Access Board has decided to add this exception for diagnostic equipment that meets the following three criteria: fixed overhead patient lifts are provided for use with the diagnostic equipment; the use with the fixed overhead patient lift with the diagnostic equipment is permitted by an enforcing authority; and the diagnostic equipment is clearly labeled as not compatible with portable patient lifts.

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.

M301.4.2 Clearance Around Base (Section-by-Section Analysis)

The MDE NPRM proposed certain requirements to provide clearance around the base of the diagnostic equipment to allow the legs of the portable floor lift to straddle the base of the diagnostic equipment with a solid base that sits on or close to the floor. The proposed rule required a minimum clearance of 6 inches high measured from the floor and 36 inches deep measured from the edge of the examination surface. NPRM, 77 FR at 6927. The width of the base permitted within this clearance would be 26 inches maximum at the edge of the examination surface and was permitted to increase at a rate of 1 inch in width for every 3 inches in depth. Id. In addition, where the width of the examination surface is less than 26 inches, the clearance depth would be the full width of the examination surface. Id. The Access Board sought public input in question 26 in the MDE NPRM, on whether the proposed dimensions for clearance around the base of the equipment was sufficient to allow for the use of portable floor lifts. Id.

Two commenters, both manufacturers, responded to this question. One commenter recommended clarifying that the exam table must be compatible with a patient lift and meet the six-inch clearance, but not when the table is at its lowest level for independent transfer. This manufacturer indicated that its adjustable table does not have a six-inch minimum clearance when at its lowest position, but does meet the standard when the table is raised. The other commenter asserted that the proposed dimensions are not sufficient to accommodate the various portable floor lifts and recommended that the Access Board instead provide technical criteria for the portable patient lift to be usable with diagnostic equipment since it is more cost effective to change the floor lift, than to change the diagnostic equipment. Additionally, this manufacturer reported that all but one of its examination and procedure tables currently meet the clearance around base provision, but opined that if the proposed increase in width of the transfer surface of examination tables and chairs to 30 inches by 15 inches is adopted then it would be required to redesign the examination tables and chairs to have a larger base which would interfere with the ability to meet this clearance around base provision. The MDE Advisory Committee did not address this provision, and thus provided no recommendations on the clearance around the base requirements.

The Access Board has reviewed the comments and has decided to retain the provision from the proposed rule. In the final rule, the Access Board has decided to decrease the size of the transfer surface (See final M301.2.3) and thus the commenter’s concern regarding an increase in base size is not applicable. As described above, M301.4 does not require the 6-inch height clearance to be maintained when the equipment is lowered to the minimum low height for independent transfer as required by M301.2.1, because portable patient lifts will only be used when independent transfer is not possible. Finally, a portable patient lift is not medical diagnostic equipment and, therefore, not within the purview of the Access Board’s regulatory jurisdiction. However, portable patient lifts are integral to ensuring that patients with disabilities who are unable to independently transfer are otherwise able to use the medical diagnostic equipment. Therefore, the Access Board has provided the technical criteria necessary for the portable floor lift to be usable with medical diagnostic equipment.