FDA Orders Postmarket Surveillance of Duodenoscope Use in Health Care Facilities

The U.S. Food and Drug Administration has ordered Olympus America, Inc., Fujifilm Medical Systems, U.S.A., Inc., and Hoya Corp. (Pentax Life Care Division) – the three manufacturers who market duodenoscopes in the United States – to conduct postmarket surveillance studies to determine how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of  contamination of clinically used duodenoscopes.  Duodenoscopes – flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine – can accumulate bacteria that are not removed during conventional cleaning, allowing infections to be passed among patients.  The devices have been linked to outbreaks of the “superbug” bacteria CRE in hospitals across the country. [10/5/15]

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