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

2.6 Brief History of Section 4203 of the Patient Protection and Affordable Care Act

The Section 4203 provisions of the Patient Protection and Affordable Care Act (ACA), which required this accessibility standard setting, apply exclusively to medical diagnostic equipment and thus leave unaddressed equipment used only for therapeutic purposes. Therefore, to set the full context for the MDE Advisory Committee’s role and the recommended accessibility standards, this section briefly reviews the origins of what became Section 4203.

In 2002, the National Institute on Disability and Rehabilitation Research (NIDRR) in the U.S. Department of Education awarded a five-year grant to Marquette University and its collaborators^R to form the Rehabilitation Engineering Research Center (RERC) on Accessible Medical Instrumentation. One of the major projects funded by the grant was a study about the types of medical equipment that were most difficult for patients with disabilities to use and what caused any use difficulties discovered. The project used research methods that included (in chronological order) a national online survey, a series of regional focus groups, and a set of targeted usability studies.^{21, 35, 36}

The national survey results showed that the following five types of medical equipment were moderately difficult, extremely difficult, or impossibly difficult to use by ≥ 50% of the respondents:

• Exam tables (n = 291) 75.0%

• X-ray equipment (n = 258) 68.0%

• Rehabilitation/exercise equipment (n = 203) 55.3%

• Weight scales (n = 222) 53.1%

• Exam chairs (n=262) 49.6%

The project staff found that, with the exception of rehabilitation/exercise equipment, the other four most-reported categories of inaccessible medical equipment were exam tables, x-ray equipment, weight scales, and exam chairs – which are all essential for basic health care.

The researchers investigated the details of use difficulties through a series of regional focus groups with individuals who had a variety of disabilities and then conducted a set of targeted usability studies of the most inaccessible types of medical equipment to observe and characterize the sources of the difficulties. They also participated with the Association for the Advancement of Medical Instrumentation’s Human Factors Engineering Committee (AAMI/HE) to include a chapter on Accessibility Considerations into its standard, HE75:2009, “Human factors engineering – Design of Medical Devices.” The chapter provided recommendations for the types of medical equipment named above to increase its accessibility for patients with disabilities.

In 2007, as the RERC-AMI was finishing its projects, members of the U.S. Senate and the House of Representatives introduced legislation to address the problem. In the Senate, Senator Tom Harkin (D-IA) introduced S. 1050 and in the House, Representative Nita Lowey (D-NY) introduced the companion bill, H.R. 3294. Titled the “Promoting Wellness for Individuals with Disabilities Act,” the bills sought to establish standards for basic medical equipment, among other provisions. These bills were later incorporated into the ACA as Section 4203, “Removing Barriers and Improving Access to Wellness for Individuals with Disabilities.” As described in Section 1.1, this ACA provision adds to Title V of the Rehabilitation Act of 1973 a new Section 510, “Establishment of standards for accessible medical diagnostic equipment.” The law requires the US Access Board, in consultation with the U.S. Food and Drug Administration (FDA), to develop such standards, which are to apply specifically to examination tables, examination chairs (e.g., for eye or dental examinations and procedures), weight scales and imaging equipment (e.g., mammography equipment, x-ray machines).

Notes

^R Western University of Health Sciences, University of California - San Francisco/Berkeley, University of Connecticut, University of Wisconsin-Milwaukee

Section 2: References

²¹. Story MF, Schwier E, Kailes JI. Perspectives of patients with disabilities on the accessibility of medical equipment: Examination tables, imaging equipment, medical chairs, and weight scales. Disabil Health J. 2009;2(4):169-179.e1.

^35. Story MF, Winters JM, Premo B, Kailes JI, Schwier E, Winters JM. Focus Groups on Accessibility of Medical Instrumentation. Atlanta, GA: Proceedings of RESNA 2005 Conference; 2005.

^36. Winters JM, Story MF, Barnekow K, et al. Accessiblity of Medical Instrumentation: A Natilonal Healthcare Consumer Survey. Atlanta, GA: Proceedings of RESNA 2005 Conference; 2005.