Duodenoscopes Are Contaminated at a Higher Rate than Previously Assumed, Says FDA

January 7, 2019 | Strategic Insights for Ambulatory Care


​Early results of an ongoing assessment of reprocessed duodenoscopes reveal that the devices are contaminated at a higher rate than expected, the U.S. Food and Drug Administration (FDA) announced in a December 10, 2018, safety communication. In 2015, FDA ordered three manufacturers to conduct postmarket surveillance studies addressing rates of duodenoscope contamination after reprocessing and is providing interim results to remind healthcare facilities of the importance of manual cleaning prior to disinfection and sterilization of duodenoscopes and to inform patients of the safety issue. With 10% of samples collected, FDA has found a 3% contamination rate for both low-concern and high-concern organisms after reprocessing. FDA said the studies were designed assuming a contamination rate of less than 0.4%. High-concern organisms include those more commonly associated with disease, such as Escherichia coli and Pseudomonas aeruginosa.

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