Medical-device complication reporting. A quality assurance mechanism.
As the primary users of medical devices, nurses have a responsibility to report device-related problems to the federal government's Device Experience Network (DEN). The procedures for reporting these problems are described. Nurses wishing to conduct research into problems with medical devices may wish to access the DEN data base. A Food and Drug Administration study using DEN data to study central venous catheter complications is offered as an example of this data base's role in research.
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D004868:Equipment Failure; D006801:Humans; D011785:Quality Assurance, Health Care; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000379:methods*