FDA: Duodenoscope Contamination Rates Higher Than Initially Reported

April 12, 2019
New findings from duodenoscope sampling studies show the number of high-concern organisms found on reprocessed duodenoscopes is nearly 2.5% more than what FDA originally reported back in 2018, the agency’s device center director announced Friday (April 12). High-concern organisms are associated with disease, such as E. coli and Pseudomonas aeruginosa . The findings come as one lawmaker reintroduces a bill that would require device makers to notify FDA before making postmarket design or reprocessing changes and would give FDA...

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