Human Factors and Medical Devices
Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright.
- Research Organization:
- Food and Drug Administration, Rockville, MD (US)
- Sponsoring Organization:
- none (US)
- OSTI ID:
- 786656
- Report Number(s):
- ISSN 0003-018X; CODEN TANSAO; ISSN 0003-018X; CODEN TANSAO; TRN: US0109123
- Resource Relation:
- Conference: 1998 Winter Meeting, Washington, DC (US), 11/15/1998--11/19/1998; Other Information: Transactions of the American Nuclear Society, Vol. 79; PBD: 31 Dec 1998
- Country of Publication:
- United States
- Language:
- English
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