Facilities strive to comply with new Act. The long-term effects of the Safe Medical Devices Act are still unknown.
Unlike previous medical device laws, the Safe Medical Devices Act of 1990 (SMDA), which became effective November 28, 1991 applies to "device-user facilities" such as hospitals and long-term care facilities. Final regulations are scheduled for release later this spring. The SMDA's primary goals are to: Ensure all devices currently in or entering the marketplace are safe and effective Enable the U.S. Food and Drug Administration (FDA) to learn quickly about serious problems with medical devices Remove defective devices (old and new) from the market To achieve these goals, Congress has given the FDA new review and enforcement powers, including the authority to impose fines on those in violation of the law. Incidents in which a medical device caused or contributed to the death, serious illness, or serious injury of a patient are referred to as medical device-reportable (MDR) events. A user must report MDR deaths to the FDA and to the manufacturer (if known). Serious illnesses and serious injuries caused by or attributed to the use of a device must be reported to the device manufacturer or, if the manufacturer is unknown, to the FDA. Facilities must report MDR events to the FDA semiannually and maintain incident files for two years after reporting the MDR event. The FDA may assess civil penalties against parties that do not comply with the SMDA's reporting provisions. Healthcare facilities must develop and implement employee training and education programs to help physicians, nurses, and other allied health employees identify and report MDR events.
Schuster
D K
DK
Butler
K H
KH
D003219:Confidentiality; D004282:Documentation; D004869:Equipment Safety / Q000592:standards*; D005161:Facility Regulation and Control / Q000331:legislation & jurisprudence; D005568:Forms and Records Control; D006268:Health Facilities / Q000331:legislation & jurisprudence* / Q000592:standards; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration