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

2.4.3 Impetus for Manufacturers to Improve MDE Accessibility

MDE manufacturers have strong ties to health care professionals and interests in meeting patient care needs. They are committed to making devices that improve and expand the capability of clinical practitioners to provide high quality care. Their design processes are centered around delivering high quality medical devices based on advice primarily from medical professionals, although some manufacturers occasionally seek input from patients during the design phase (e.g., by asking persons with disabilities to test different design options). Manufacturers must follow FDA quality system regulations that require them not only to verify that their devices operate per design but also to validate that the devices meet the needs of health care professionals. MDE manufacturers also are aware of the existing requirements under the ADA and the Rehabilitation Act. Furthermore, highly-publicized legal settlements with medical providers that have required the provision of accessible medical equipment are driving increased demand and an expanding market for accessible MDE.^O Equipment designed for accessibility that is currently on the market has satisfied these settlement agreements

Thus, the needs of their institutional and clinical customers strongly influence MDE manufacturers. Health care facilities that would be required to acquire equipment to satisfy new accessibility regulations will quickly look to equipment manufacturers for solutions that are compliant, cost effective, and functional in their workflows and work environments. Being able to fulfill this customer need will thus become both a design input consideration as well as a point of competition among manufacturers.

However, some accessibility design changes will require significant investments to accomplish. For technologies that sell relatively few units annually (e.g., certain highly specialized imaging systems), these design costs may be spread over these few sales, increasing the purchase prices for individual units. For commonly-used items, such as examination tables and chairs, manufacturers could benefit from producing equipment designed for accessibility given the potential for increased demand for these accessible products both in the United States and abroad.

Notes

^O Examples of settlements include Metzler v. Kaiser Permanente, Olson v. Sutter Health, University of California San Francisco Medical Center. Full settlement agreements are available online: http://thebarrierfreehealthcareinitiative.org/?page_id=16