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

M302 Diagnostic Equipment used by Patients in a Seated Position (Section-by-Section Analysis)

M302 in the final rule establishes the technical criteria for diagnostic equipment used by patients in a seated position such as examination chairs.

M302.1 General (Section-by-Section Analysis)

The MDE NPRM proposed that all diagnostic equipment used by patients in a seated position must comply with the technical requirements of proposed section M302. As discussed in Section IV.B.5. (Significant Changes – Exception from the Requirements of M302 for Weight Scales with Integral Seats), in response to public comment and evidence presented to the MDE Advisory Committee, in the final rule the Access Board has added an exception to this requirement for weight scales that contain wheelchair spaces and also provide a seat integral to the equipment. This new exception exempts these weight scales from compliance with M302’s requirements for the seat, as long as the wheelchair space complies with the requirements in M303.

M302.2 Transfer Surface (Section-by-Section Analysis)

This is an introductory section.

M302.2.1 Adjustability (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface height range for diagnostic equipment used by patients in a seated position of 17 inches minimum and 19 inches maximum. The Access Board received multiple comments on this provision and the MDE Advisory Committee provided four recommendations. As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability) in the final rule the Access Board has renamed this provision and now requires the transfer surface to be adjustable to: (1) a low transfer position height at or between 17 inches and 19 inches; (2) a high transfer position of 25 inches; (3) at least four additional transfer positions located between the low and high transfer positions and separated by one inch minimum increments; (4) measured from the floor to the top of the uncompressed transfer surface.

M302.2.2 Sunset Provision (Section-by-Section Analysis)

As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability), this is a new provision added to the final rule in conjunction with the new requirement of a low height range in M302.2.1. It provides a sunset for the low transfer height provision of five years from the date of publication of this rule in the Federal Register. The Access Board intends to complete the necessary research to determine an appropriate minimum low transfer height prior to the effective date of the sunset, and will update this provision in a subsequent rulemaking.

M302.2.3 Size (Section-by-Section Analysis)

The MDE NPRM proposed a transfer surface size for diagnostic equipment used by patients in the seated position of 21 inches wide and 15 inches deep (proposed M302.2.2). The Access Board also solicited comment in question 16 on whether the transfer surface size proposed for seated position diagnostic equipment was sufficient to facilitate independent transfer. NPRM, 77 FR at 6924. Two of the seven commenters who responded supported the proposed requirements. One commenter, a manufacturer, although in agreement with the 21-inch width, stated that the 15 inches deep requirement should be increased to 17 inches, a disability advocate recommended increasing the width to 23 inches, two of the commenters, accessibility consultant and disability advocate, stated that the proposed dimensions were insufficient citing concerns for persons of larger stature or who are obese and may be unable to safely transfer to a surface of that size. One commenter, a manufacturer, recommended harmonizing with the requirements for the seated position with those of the supine, prone, or side-lying position transfer surface size.

The MDE Advisory Committee considered the dimensions for rectangular seats in roll-in showers from the 2010 ADA Standards for Accessible Design and the “ideal” chair width recommended in Architectural Graphic Standards for auditorium seating. MDE Advisory Committee Report, 77, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The Committee also reviewed anthropometric data from a variety of sources. Id. Many Committee members expressed concern about the adequacy of the transfer surface depth. Id. The Committee recommended increasing the minimum depth of the transfer surface from 15 inches to 17 inches, noting that existing equipment already meets or exceeds this dimension. Id. The Committee recommended retaining the 21-inch width requirement, noting that it was sufficient to facilitate independent transfer. Id.

Based on the commenters’ responses and the MDE Advisory Committee recommendations, the Access Board has decided to increase the transfer surface size for equipment used by patients in a seated position to 17 inches deep and retain the 21-inch-wide requirement from the proposed rule.

M302.2.4 Transfer Sides (Section-by-Section Analysis)

In the MDE NPRM, the transfer side provision for diagnostic equipment used by patients in the seated position required transfer surfaces to have the option to transfer from a mobility device onto one short side (depth) and one long side (width) of the surface, and provide unobstructed transfer to the surface. The Access Board received multiple comments and recommendations from the MDE Advisory Committee, which are discussed above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location). In the final rule, the Access Board retained this provision, but made editorial changes to clarify the location of the transfer sides and to relocate the language concerning unobstructed transfer into a new section M302.2.5. The transfer sides are still intended to allow a patient to choose to transfer onto either of two adjoining sides of the transfer surface. Additionally, based on comments and recommendations from the MDE Advisory Committee, the Access Board has decided to add an exception to this provision to accommodate chairs with fixed footrests which prevent transfer onto the adjoining sides. This is discussed in Section IV.B.1.b. (Significant Changes – Transfer Surface Location). As explained above, in order to provide patients with the ability to choose what side of their body they use to transfer, chairs with fixed footrests will provide the ability to transfer from either opposing side of the transfer surface. This allows the patient to choose to transfer from their right or left side and prevents the patient from having to transfer onto a fixed footrest.

M302.2.5 Unobstructed Transfer (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as they could be repositioned during transfer. This requirement is identical to the unobstructed transfer requirement in M301.2.4, and this provision is discussed in the Section V.C.2.d. (Section-by-Section Analysis – M301.2.4). The final rule retains the requirement for unobstructed transfer, but has been reworded to specify that each transfer surface must provide two unobstructed sides for the patient to transfer.

Additionally, as discussed above in the Section IV.B.1.d. (Significant Changes – Unobstructed Transfer), the final rule includes a second exception to the unobstructed transfer provision which permits obstructions of no more than three inches to extend beyond the transfer side of the transfer surface, provided that such obstructions do not protrude above the top of the transfer surface.

M302.3 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 M302.3.2, described below, to replace the word “stirrups” with the term “leg supports.”

M302.3.1 Transfer Supports (Section-by-Section Analysis)

In the MDE NPRM the Access Board proposed that transfer supports must be provided for use with transfer sides on diagnostic equipment used by patients in the seated position, and that these transfer supports must comply with the technical requirements in M305.2 of the proposed rule. There were no comments on this provision and no recommendations by the MDE Advisory Committee. Based on the restructure of the transfer surface provisions, described above in Section IV.B.1.b. (Significant Changes – Transfer Surface Location), and the additional technical criteria added to the transfer supports provisions, discussed above in Section IV.E.1 (Significant Changes – Transfer Supports), the Access Board has made editorial changes to this section. The technical requirements for transfer supports is in M305.2 of the final rule and has been reorganized to mirror the two types of transfer surfaces (end and side) in the final rule for diagnostic equipment used by the patient in the supine, prone, or side-lying position. The transfer surface required for diagnostic equipment used by patients in the seated position is similar to the new end transfer surface and therefore, diagnostic equipment used by patients in the seated position is required to comply with the transfer support provisions for end transfer supports. Additionally, the Access Board has included cross-references to the new transfer support requirements in M305.2.

M302.3.2 Leg Supports (Section-by-Section Analysis)

The MDE NPRM did not propose to require stirrups to provide a method of supporting, positioning, and securing the patient’s legs for diagnostic equipment used by patients in the seated position. However, in response to question 23, on whether diagnostic equipment used by patients in a seated position that provide stirrups should have to provide such support, the Board received six comments. NPRM, 77 FR at 6926. All six commenters concurred that when stirrups are provided for use with diagnostic equipment used by patients in the seated position, a method must be provided for supporting, positioning, and securing the patient’s legs. The MDE Advisory Committee did not address this provision.

The Access Board concurs with the commenters, and the final rule requires that where stirrups are provided on seated diagnostic equipment, leg supports must also be provided and must comply with the technical requirements for leg supports in M305.4. This will ensure that patients with limited leg strength and control will be able to keep their legs in the appropriate position for examination.

M302.3.3 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 seated position in M302. 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.

M302.4 Lift Compatibility (Section-by-Section Analysis)

The MDE NPRM proposed to require that diagnostic equipment used by patients in the seated position be usable with a patient lift and comply with either the proposed clearance in base (proposed M302.4.1) or clearance around base (proposed M302.4.2) technical requirements. This requirement is identical to the lift compatibility requirement for diagnostic equipment used by patients in the supine, prone, or side-lying position, and is discussed in the Section-by Section Analysis for M301.4. In the final rule the Access Board has made an editorial change to clarify the type of lift; namely portable patient lift, reduced the lift clearance to 39 inches and clarified that the clearance provisions only apply when the diagnostic equipment is being used with the portable patient lift. See Section V.C.4. (Section-by-Section Analysis – M301.4.) Additionally, as discussed above in Section IV.B.3. (Significant Changes – Lift Compatibility Exception), the Access Board has added an 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.