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Search results for "Human Factors Engineering"
- Device Malfunctions
- Human Factors Engineering
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.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Journal Article > Review
Bach TA, Berglund L, Turk E. BMJ Open Qual. 2018;7:e000202.
Alarm fatigue limits the utility of physiologic monitoring devices intended to keep hospitalized patients safe. The authors conducted a literature review and interviewed experts to identify best practices to optimize device alarms. They present a step-by-step guide to alarm improvement that incorporates a human factors engineering approach.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; August 29, 2006.
This news release announces a seizure of infusion pumps that have a "key bounce" defect that could result in over-infusion of medication.
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.
Journal Article > Study
Laxmisan A, Malhotra S, Keselman A, Johnson TR, Patel VL. J Biomed Inform. 2005;38:200-212.
Using the concepts of "sharp" and "blunt" ends of practice, this article explores health professionals' differing opinions on biomedical device-related errors. Investigators requested that study participants express their views on events surrounding three true-error scenarios. Analysis of the transcribed responses revealed that interpretation varied widely between groups. While clinicians focused on clinical and human factors, biomedical engineers focused on device-related issues, and administrators emphasized documentation and training. The authors conclude that individual expertise largely mediates an error analysis, as no single interpretation provides a comprehensive view of all contributing factors.