Transcription of A CONTINUING EDUCATION ARTICLE MEDWATCH
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A CONTINUING EDUCATION ARTICLE MEDWATCH
N 1994, an A rmy medical cl i n i creported a problem during attempts toresuscitate an infant. FDA's investigationd i s c ove red that the ex p i rat o ry ch a n n e lhad become occluded after a lubricantwas used in reconnecting the endotra-cheal tube and the connector. FDA subse-quently issued a Public Health Advisory,Occluded Endotracheal Tubes(February28,1994) to manufacturers,users,andforeign governments (1).Healthcare practitioners are the pri-mary users of medical devices for directpatient such,they are in the bestposition to recognize problems (such as inthe example above) that result from theuse of medical devices. According to a1986 General Accounting Office report(2),82% of all device-related incidents arediscovered by nurses or physicians. Theoutcome of a device-related adverse eventor product problem,as with any othermedical product ( ,drug,biologic,orspecial nutritional product),can be seriousand result in illness,injury,or even death.
to remain in general use, but are subject to an FDA request for safety and effective- ... are only as safe as the information known at that moment in time.
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