Volume 53, Number 5
Public Policy Matters: U.S. Health Care Bill Mandates Accessible Diagnostic Equipment
By Daryle J. Gardner-Bonneau
H.R. 3590, the Patient Protection and Affordable Care Act, recently signed into law, contains many provisions; one that involved significant efforts on the part of several HFES members amends Title V of the Rehabilitation Act of 1973 to add a new section that mandates the establishment of standards for accessible medical diagnostic equipment. In this short article, I address the content of the legislation, what it means for health care, and how this legislative mandate was achieved.
The amendment to the Rehabilitation Act of 1973 requires that within 24 months of the date of enactment, the Architectural and Transportation Barriers Compliance Board (a.k.a. the United States Access Board), in consultation with the U.S. Food and Drug Administration (FDA), shall "promulgate regulatory standards setting forth the minimum technical criteria for medical diagnostic equipment used in (or in conjunction with) physician's offices, clinics, emergency rooms, hospitals, and other medical settings." These standards "shall ensure that such equipment is accessible to, and usable by, individuals with accessibility needs, and shall allow independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible." These standards are to cover a variety of equipment, including examination tables and chairs, weight scales, mammography equipment, and x-ray machines used for diagnostic purposes by health care personnel.
This provision in the U.S. health care reform bill addresses a long-standing need of patients with disabilities but will, at the same time, address the needs of many older adult patients who, though not defined specifically as having disabilities, may have mobility issues that affect their ability to access these types of equipment. The accessibility needs of health care professionals who use this medical equipment in their practices are also subsumed under this provision.
The path to success in getting this provision into the legislation was through the combined effort of researchers, industry representatives, standards developers, advocacy groups, and legislators. One of the key groups involved was the Rehabilitation Engineering Research Center on Accessible Medical Instrumentation (RERC-AMI), which is funded by the National Institute on Disability and Rehabilitation Research.
RERC-AMI collected data documenting the extent of the accessibility problem and worked with manufacturers (including Midmark, an examination table maker) to demonstrate that design improvements were possible in the instrumentation. A fall 2005 RERC-AMI workshop on this topic resulted in the publication of a book, Medical Instrumentation: Accessibility and Usability Considerations (2007). In addition, a number of articles on the work of the RERC were published in Ergonomics in Design (Gardner-Bonneau & Kailes,2010; Lemke & Winters, 2008) and other publications (e.g., Story, Schwier, & Kailes, 2008). Finally, the new Association for the Advancement of Medical Instrumentation (AAMI) standard, ANSI/AAMI HE-75: 2009, Human Engineering - Design of Medical Devices, includes Section 16 (Accessibility considerations) that was heavily influenced by this work as well.
We can expect to see significant new technical standards in this area as the FDA and the U.S. Access Board work to implement this provision of the health care bill during the coming months.
References and Additional Information
Association for the Advancement of Medical Instrumentation. (2010). Human engineering - Design of medical devices (ANSI/AAMI HE-75:2009). Arlington, VA: Author.
Gardner-Bonneau, D. J., & Kailes, J. I. (2010). Accessible health care: More than getting through the door. Ergonomics in Design, 18(1), 5-10.
H.R.3590, Patient Protection and Affordable Care Act. Section 4203, Removing Barriers and Improving Access to Wellness for Individuals with Disabilities. 111th Congress, 156 Congressional Record (2010).
Kailes, J., Premo, B., & Richards, C. (2007). Exploring key issues on accessible medical equipment and instrumentation: Summary of meetings. Pomona, CA: Western University of the Health Sciences, Center for Disability Issues and the Health Professions.
Lemke, M. R., & Winters, J. M. (2008). Removing barriers to medical devices for users with impairments. Ergonomics in Design, 16(3), 18-25.
Shapiro, J. (2007, September 13). Medical care often inaccessible to disabled patients. National Public Radio, Morning Edition. Retrieved from http://www.npr.org/templates/story/story.php?storyId=14362338
Story, M., Schwier, E., & Kailes, J. (2009). Perspectives of patients with disabilities on the accessibility of medical equipment: Examination tables, imaging equipment, medical chairs, and weight scales. Disability and Health Journal, 2, 169-179.
Winters, J. M., & Story, M. F. (Eds.). (2007). Medical instrumentation: Accessibility and usability considerations. Boca Raton, FL: CRC Press.
Daryle Gardner-Bonneau is an HFES Fellow and principal of Bonneau and Associates, a human factors consultancy in Portage, Michigan.
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