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Human Factors Engineering Team, Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (OCER), Division of Device User Programs and Systems Analysis (DDUPSA), 1350 Piccard Drive, HFZ-230, Rockville, MD 20850.
Human factors engineering (HFE) helps improve human performance and reduce the risks associated with use error. The U.S. Food and Drug Administration (FDA) works with manufacturers to ensure the application of HFE in the design of new products. In addition to providing information on these design issues, this site facilitates the reporting of unsafe incidents with medical devices.
Kerber R. The Boston Globe. June 23, 2005;Business section:E1.
This article reports on problems with medical devices and discusses whether manufacturers should directly notify patients regarding defects.
Mohr H, Weiss M. Associated Press. November 27, 2018.