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Web Resource > Multi-use Website
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.
Journal Article > Study
Weissman JS, Annas CL, Epstein AM, et al. JAMA. 2005;293:1359-1366.
In order to better understand the opinions and experiences of hospital leaders with mandatory state reporting systems, this survey study collected data from a random sampling of chief executive and chief operating officers. Results demonstrated substantial concern about the impact of these systems on internal reporting systems and the potential for encouraging litigation while limiting patient safety efforts. Vignettes illustrating hypothetical errors and the types of errors most and least likely to be reported are included. The authors discuss challenges in balancing the importance of reporting systems with the legal and regulatory factors that likely foster the findings in this study.