title: Human factors and the FDA's goals: improved medical device design.
abstract: The Food and Drug Administration's new human factors design requirements for medical devices were previewed by the director of the FDA's Center for Devices and Radiological Health (CDRH) at AAMI/FDA's Human Factors in Medical Devices Conference held in September 1995. Director Bruce Burlington, MD, said the FDA plans to take a closer look at how new medical devices are designed to ensure proper attention has been paid to human error prevention. As a medical practitioner who has witnessed use-related deaths and injuries, Burlington stressed the importance of the medical community's reporting use errors as they occur and manufacturers' creating easy-to-use labeling and packaging. He also called for simplicity and quality of design in medical products, and asked for a consolidated effort of all professionals involved in human factors issues to help implement and further the FDA's new human factors program. An edited version of his presentation appears here.
authors.forename: D B
authors.initials: DB
authors.lastname: Burlington
mesh_terms: D003258:Consumer Behavior; D004348:Drug Labeling; D004349:Drug Packaging / Q000592:standards*; D004867:Equipment Design; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000592:standards*; D006804:Ergonomics / Q000379:methods*; D006293:Health Promotion; D006801:Humans; D007049:Iatrogenic Disease / Q000517:prevention & control*; D008508:Medication Errors; D014481:United States; D014486:United States Food and Drug Administration