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.
H.C. Alder & Associates, Palatine, IL.
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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