Impact of the Safe Medical Devices Act on healthcare facilities.
The Safe Medical Devices Act (SMDA) of 1990 (Public Law 101-629) is a federal law that became effective November 28, 1991. The SMDA mandates all facilities that use medical devices (referred to as device user facilities) to report serious injuries, serious illnesses, and deaths to the U.S. Food and Drug Administration (FDA) and the manufacturer. The purpose of the act is to protect the public by ensuring that medical devices are not unsafe for their intended use.
Methodist Health Systems, Memphis, TN.
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D004282:Documentation / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D010934:Planning Techniques; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration