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.