Data show higher-than-expected rates of duodenoscope contamination

While the number of medical device reports associated with patient infections has declined by 62% since peaking in 2015, the FDA and duodenoscope manufacturers continue to address issues around device reprocessing.


Despite ongoing efforts to improve duodenoscope reprocessing, preliminary data from postmarketing surveillance studies conducted by all three U.S. duodenoscope manufacturers indicated “higher-than-expected” contamination rates after reprocessing, the FDA announced in a Dec. 10 safety communication.

After reprocessing, up to 3% of properly collected samples tested positive for more than 100 colony-forming units of organisms that are unlikely to cause serious infections, an indication of a reprocessing failure. Another 3% of samples tested positive for organisms of high concern, such as Escherichia coli and Staphylococcus aureus. The manufacturers (Olympus, Fujifilm, and Pentax) are conducting root-cause analyses to better understand these preliminary culturing results.

In a statement, the FDA emphasized that an individual patient's risk of acquiring an infection from an inadequately reprocessed medical device remains relatively low, considering the large number of these devices in use. A recent analysis of medical device reports showed that the number of reports associated with patient infections peaked at 250 reports in 2015 and has declined by 62% to fewer than 100 reports per year in 2017 and 2018, the agency noted. “We are hopeful that this decline is the result of a successful effort on the part of health care facilities to implement our enhanced safety measures,” the statement said.