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  • Title: Safe Medical Devices Act of 1990: current hospital requirements and recommended actions.
    Author: Alder H.
    Journal: Healthc Facil Manag Ser; 1993 Sep; ():1-34. PubMed ID: 10132639.
    Abstract:
    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.
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