Medical device reporting: a new challenge for perioperative nurses.
A variety of illnesses and other complications have been attributed to problems resulting from use of medical devices, implants, and instruments. A new law has implications for all health care facilities using medical devices. The Safe Medical Devices Act (SMDA) of 1990 mandates the reporting of complications related to the use of medical devices to the United States Food and Drug Administration. Reporting requirements of the SMDA could challenge the efficiency of information systems in health care facilities and add to the responsibilities of staff nurses. In the following article, the author discusses some implications of the new law.
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D004869:Equipment Safety; D006801:Humans; D007603:Jurisprudence; D016528:Postanesthesia Nursing / Q000295:instrumentation*; D011182:Postoperative Care / Q000295:instrumentation*; D014481:United States