December 11, 2018
2 min read

FDA warns of ‘higher-than-expected’ contamination rates after duodenoscope reprocessing

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Interim surveillance findings reported by the three manufacturers of duodenoscopes in the United States indicate “higher-than-expected” rates of contamination in the instruments after they are reprocessed, the FDA said.

Specifically, up to 3% of properly collected samples tested positive for “high concern” organisms such as Escherichia coli or Staphylococcus aureus that are more often associated with disease, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

The results are from post-market surveillance studies conducted by Fujifilm, Olympus and Pentax. The three duodenoscope manufacturers were warned earlier this year by the FDA to comply with a federal order to determine whether health care facilities could properly decontaminate the devices, which are difficult to clean and have been associated with nosocomial transmission of dangerous bacteria.

“These flexible, lighted tubes are vital for minimally invasive, life-saving procedures to diagnose and treat problems in the pancreas and bile duct. However, because they contain many small working parts that come in contact with a patient’s bodily fluids, they must be thoroughly cleaned and disinfected between each use to prevent transmission of infections,” Shuren said.

The FDA helped bring charges against Olympus for failing to adequately report infections in Europe in 2012 and 2013 that were associated with one of its duodenoscopes. According to Shuren, Olympus was fined $80 million and ordered to forfeit $5 million after pleading guilty to three counts of distributing misbranded devices in interstate commerce.

The company is also required to undertake enhanced compliance measures. In a statement, Olympus said the settlement would not impact the availability of its products and services worldwide.

“We rely on manufacturers to report infections associated with duodenoscopes, as well as other adverse events caused by medical devices, to the FDA in a timely manner — generally within 30 days of learning about the event,” Shuren said. “When this does not occur, patients’ safety and sometimes their lives may be put at risk. When this happens, the agency can and does take action.”

Earlier this year, the FDA released new voluntary protocols for surveillance sampling and culturing of duodenoscopes in an effort to reduce infections and cleared the use of reprocessors for certain duodenoscopes.

In a new safety communication, the agency said it released interim findings from the studies “to inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after reprocessing. Facilities and staff that reprocess duodenoscopes are reminded of the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes.”

Shuren said the risk for acquiring an infection from an inadequately reprocessed medical device “remains relatively low given the large number of such devices in use” and noted a recent analysis that indicated there has been a 62% decline in infection reports associated with medical devices from a high of 250 reports in 2015. – by Gerard Gallagher


FDA safety communication. Accessed December 11, 2018.

FDA statement. Accessed December 11, 2018.