title: An update to the medical device reporting requirements of the Safe Medical Device Act.
abstract: The Safe Medical Devices Act made hospitals, nursing homes, and a variety of other health care organizations responsible for identifying and reporting injuries associated with the use of medical devices. The Final Regulation for the Medical Device Reporting of adverse events became effective on July 31, 1996. The Final Regulations incorporate significant changes from the "Proposed Final Regulations," and these changes need to be conveyed to appropriate staff of all device user facilities. Changes include the mandated reporting of user error, the Food and Drug Administration emphasis on the device manufacturer as the prime investigator of adverse events, the 10-day reporting rule that now becomes effective as soon as the facility becomes aware of the event, and the clarification of definitions for user facilities. Staff education and training are no longer mandated by the regulations, but some education is required if compliance with the law is to be ensured.
authors.affiliation: DEVTEQ Walnut Creek, California, USA.
authors.forename: M
authors.initials: M
authors.lastname: Shepherd
authors.forename: E
authors.initials: E
authors.lastname: Furst
mesh_terms: D004868:Equipment Failure; D004864:Equipment and Supplies; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D006282:Health Personnel / Q000193:education; D006801:Humans; D007318:Inservice Training; D007878:Legislation as Topic; D011358:Product Surveillance, Postmarketing; D012308:Risk Management / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration