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FDA recommends tighter controls on reusable medical devices

Accreditation Insider, March 17, 2015

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In the wake of several high-profile superbug outbreaks in hospitals across the country, the Food and Drug Administration (FDA) last week announced new recommendations for reusable medical devices, according to Reuters. The move is a response to reports that hundreds of patients may have been exposed to pathogens such as antibiotic-resistant superbugs after duodenoscopes were not properly cleaned before they were reused.

The FDA’s recommendations apply to most medical devices intended for repeated use such as duodenoscopes, bronchoscopes, and endoscopes. Among the recommendations, the FDA will now demand proof from manufacturers that their device disinfection instructions are effective. The recommendations are based on draft proposals the FDA released in 2011 but never put into place, Reuters reported.

Previously, the FDA believed that transmission of infection by duodenoscopes took place when hospitals failed to follow manufacturers’ instructions for reprocessing devices between use. The agency recently concluded that infections can be transmitted even when instructions are followed properly because of the design of the scopes.

Read the FDA recommendations.



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