Safe Medical Devices Act of 1990: current hospital requirements and recommended actions.
Since the Safe Medical Devices Act of 1990 was signed into law, a great deal of confusion has surrounded it. This document reviews the current status of user reporting and device tracing--including the MEDWatch program--and the status of the final regulations. In addition, readers will learn what it all really means for hospitals and what incidents must now be reported to the FDA.
Alder
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H.C. Alder & Associates, Palatine, IL.
D004869:Equipment Safety / Q000592:standards*; D004865:Equipment and Supplies, Hospital / Q000592:standards; D005568:Forms and Records Control; D007882:Legislation, Hospital; D010934:Planning Techniques; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration