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

D. M304 Diagnostic Equipment Used by Patients in a Standing Position

M304 provides the technical requirements for diagnostic equipment used by patients in a standing position. There was only one significant change made to the requirement of standing supports on the diagnostic equipment.

1. Standing Supports

The proposed rule included a provision requiring standing supports on each side of the standing surface and compliance with the technical requirements for standing supports in proposed M305.3 (proposed M304.3). Question 38 in the MDE NPRM preamble requested input on the standing support configurations currently provided, their effectiveness for patients with disabilities, whether alternative criteria would be appropriate, whether angled standing supports are effective, and whether there are any industry standards for structural strength requirements. NPRM, 77 FR at 6931.

Two commenters responded to this question. One commenter, a medical association, indicated that standing supports for imaging equipment vary widely based on the type of environment and specific imaging equipment being used. For example, the standing support on a chest x-ray machine and mammography equipment is much different than a support on a fluoroscopic room table that can be moved from a recumbent to standing position. The second commenter, a manufacturer, expressed concerns that the proposed rule was treating supports on breast platforms as standing supports, explaining that this was not the supports’ intended purpose. This commenter argued that these supports are actually arm supports intended to ensure proper patient positioning during the diagnostic exam, and were not intended as an accessibility feature to assist the patient in standing.

The MDE Advisory Committee addressed the issue of standing supports for mammography equipment as well as that of standing supports for wheelchair spaces with raised platforms. For mammography equipment, the MDE Advisory Committee came to a consensus agreeing with the commenter that the “standing supports” on mammography equipment were actually positioning supports and the “primary use of these supports is for positioning of the arms during the imaging process to keep them out of the field of view of the image.” MDE Advisory Committee Report, 135, available at https://www.access-board.gov/guidelines-and-standards/health-care/about-this-rulemaking/advisory-committee-final-report. The MDE Advisory Committee noted that “[i]ndustry representatives posited that if a patient has limitations or balance issues severe enough to need standing assistance, then the healthcare provider should position her in a seated position for safe imaging.” Id. The MDE Advisory Committee recommended removing the requirements for standing supports on mammography equipment and instead adding a requirement for positioning supports. Additionally, the MDE Advisory Committee noted that:

• since the supports mount to the c-arm on many types of mammography equipment, they will move up and down with the breast platform. In these cases, they do not need to be as long as 18 inches to provide sufficient flexibility for patients to reach them. Industry representatives also indicated that there are controls in the area where these positioning supports are located. It is important that the patients’ hands do not accidentally hit these controls when they are holding the positioning supports. For this reason, industry will sometimes intentionally shorten the length of these handholds to less than the 18-inch proposal. Considering these factors, the full Committee agreed that a 12-inch long positioning support would be sufficient if it moved with the movable breast platform. Id.

The MDE Advisory Committee made two recommendations for standing supports on raised platforms with wheelchair spaces: one for single-ramped entry raised platforms, and a second for dual-ramped entry raised platforms. These recommendations would apply when the diagnostic equipment is designed to accommodate both persons seated in wheelchairs and standing persons. For single-ramped entry raised platforms, the MDE Advisory Committee recommended maintaining the requirement for standing supports on both sides of the diagnostic equipment. To address concerns raised by industry representative on the MDE Advisory Committee regarding the space on the platform needed to attach two sets of standing supports which must be outside the minimum clear space required for a wheelchair, the Committee recommended that dual-ramped entry raised platforms require only one standing support on one side of the platform. The MDE Advisory Committee explained that patients may have a stronger side, right or left, and therefore with only one standing support provided, they would need to be able to use their preferred side to hold onto the standing support. With a single entry ramp, supports on both sides are necessary to allow patients to choose to use the right or left side of their body, but on a dual entry ramp the patient can enter or exit on opposing sides to allow them to use their preferred side of their body with only one support. Id.

The Access Board concurs with the commenters and the MDE Advisory Committee that the supports on mammography equipment were intended as positioning supports, not standing supports. However, the Board has determined that an exception is not necessary due to the restructuring of this requirement in the final rule. In the final rule, standing supports are only required on diagnostic equipment used by patients in a standing position that provide a surface on which a patient would stand. This is discussed in greater detail below in Section V.C. (Section-by-Section Analysis – M304.2). Additionally, as discussed below in Section IV.E.1. (Significant Changes – Positioning Supports), the Access Board has elected not to include positioning supports for mammography equipment in the final rule.

With regard to the MDE Advisory Committee recommendations regarding standing supports on diagnostic equipment with raised platforms, the Access Board has decided to include an exception in the final rule for diagnostic equipment with entry and exit that permit pass-through from one end to the other to provide a standing support on only one side of the standing surface, provided that the standing support complies with the requirements in M305.3 for standing supports in a horizontal position. This exception would not just apply to diagnostic equipment on a raised platform designed both for people seated in wheelchairs and in standing positions, it would also apply to equipment designed solely for patients in a standing position and would apply regardless of whether the standing surface is raised on a platform or combined with a wheelchair space. For all other standing surfaces, the Access Board has retained the original requirement of standing supports on two sides of the standing surface from the proposed rule. While the MDE Advisory Committee spoke in terms of raised platforms, the Access Board believes the exception should be permitted where entry and exit permits pass-through from one end to the other, regardless of whether the standing surface is raised. Accordingly, the Access Board has decided to apply this exception to all diagnostic equipment which permits this type of entry and exit in final rule (M304.2.2).