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2019 | OriginalPaper | Buchkapitel

The United States’ Journey to Achieve Accessibility of Medical Devices

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Abstract

Medical devices in the United States were exempt from any accessibility requirements until 2017, when the U.S. Access Board issued its Final Rule on medical device accessibility. This presentation will discuss how the American journey to address medical device accessibility problems proceeded from about 2004 until the final regulation was issued. Lessons learned along the way will be presented, and it is hoped that these lessons will assist other countries that may be pursuing the development of standards or legislation on medical device accessibility. In addition, this paper describes the content of the Final Rule, the aspects of accessibility that are covered, and the specific guidance provided for increasing the accessibility of medical instrumentation.

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Literatur
1.
Zurück zum Zitat 42 United States Code (USC). Public Law 101-336 (1990). Americans with Disabilities Act, 26 July 1990 42 United States Code (USC). Public Law 101-336 (1990). Americans with Disabilities Act, 26 July 1990
2.
Zurück zum Zitat 29 United States Code (USC) 794(d). Section 508 of the Rehabilitation Act of 1973, as amended in 1998 29 United States Code (USC) 794(d). Section 508 of the Rehabilitation Act of 1973, as amended in 1998
3.
Zurück zum Zitat 447 U.S. Code (USC) 255. Section 255 of the Telecommunications Act of 1996 447 U.S. Code (USC) 255. Section 255 of the Telecommunications Act of 1996
4.
Zurück zum Zitat Winters JM, Story MF, Barnekow K, Kailes JI, Premo B, Schwier E, Danturthi S, Winters, JM (2007) Results of a national survey on accessibility of medical instrumentation for consumers. In: Winters JM, Story MF Medical instrumentation: accessibility and usability considerations, pp 13–27. CRC Press, Boca Raton Winters JM, Story MF, Barnekow K, Kailes JI, Premo B, Schwier E, Danturthi S, Winters, JM (2007) Results of a national survey on accessibility of medical instrumentation for consumers. In: Winters JM, Story MF Medical instrumentation: accessibility and usability considerations, pp 13–27. CRC Press, Boca Raton
5.
Zurück zum Zitat Winters JM, Story MF (eds) (2007) Medical instrumentation: accessibility and usability considerations. CRC Press, Boca Raton Winters JM, Story MF (eds) (2007) Medical instrumentation: accessibility and usability considerations. CRC Press, Boca Raton
6.
Zurück zum Zitat ANSI/AAMI HE75 (2009) Human factors engineering – design of medical devices. Association for the Advancement of Medical Instrumentation (AAMI), Arlington, VA ANSI/AAMI HE75 (2009) Human factors engineering – design of medical devices. Association for the Advancement of Medical Instrumentation (AAMI), Arlington, VA
7.
Zurück zum Zitat Gardner-Bonneau DJ, Kailes JI (2010) Accessible health care: more than just getting through the door. Ergonomics in Design, Winter:5–10 Gardner-Bonneau DJ, Kailes JI (2010) Accessible health care: more than just getting through the door. Ergonomics in Design, Winter:5–10
8.
Zurück zum Zitat Public Law (PL) 111-148 Patient Protection and Affordable Care Act, 23 March 2010 Public Law (PL) 111-148 Patient Protection and Affordable Care Act, 23 March 2010
9.
Zurück zum Zitat 36 CFR Part 1195 Standards for accessible medical equipment. Federal Register, 9 January 2017 36 CFR Part 1195 Standards for accessible medical equipment. Federal Register, 9 January 2017
Metadaten
Titel
The United States’ Journey to Achieve Accessibility of Medical Devices
verfasst von
Daryle Gardner-Bonneau
Copyright-Jahr
2019
DOI
https://doi.org/10.1007/978-3-319-96071-5_147