Recommendations on Standards for the Design of Medical Diagnostic Equipment for Adults with Disabilities, Advisory Committee Final Report

Standing Supports [M305.2]

Recommendation: The final recommendation of the subcommittee is to remove the requirement for standing supports in reference to mammography equipment. Instead, positioning supports should be required. To be useful, positioning supports must shaped for grasping, positioned within the reach range of all users, and be 12 inches long minimum when located on the moving c-arm or 18 inches long minimum when in a fixed location.

Rationale

The original criteria proposed in the NPRM included vertical standing supports on both sides of the equipment that were 18 inches in length. During discussion, there was general agreement that the real use of these supports is for positioning, and thus, not meant to support the full weight of the patient or to keep a patient in a standing position during the exam. Industry 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. 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. For these purposes, the equipment criteria should designate these supports as positioning supports and be designed with the structural strength required for positioning activities.

Furthermore, since many types of mammography equipment mount the supports on the c-arm, 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.