Abstract
It is estimated that over 650,000 patients in the United States undergo Endoscopic Retrograde Cholangio-Pancreatography (ERCP) annually. Several outbreaks of infections associated with duodenoscopes have been reported in recent years. Following clinical procedures, duodenoscopes are reprocessed using manual cleaning, automated cleaning, and high-level disinfection, according to the manufacturer’s Instructions for Use (IFU). To date, the contamination rates of duodenoscopes following the reprocessing procedure has not been investigated in a large-scale, multicenter, real-world study. As part of this study, we have assessed the contamination rates of duodenoscopes following reprocessing, as part of the Post Market Surveillance (PMS) studies of the Olympus duodenoscopes, ordered by the US Food and Drug Administration (FDA).
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