Duodenoscope Contamination Rates Still Lethally High: FDA

Megan Brooks


April 12, 2019

The latest interim results from US Food and Drug Administration (FDA)–mandated postmarket surveillance studies of duodenoscopes continue to show unacceptably high contamination rates after reprocessing, with deaths and infections still occurring, the FDA said today.

The agency said three deaths were reported last year in the United States that were related to contaminated duodenoscopes. "That's three deaths too many," Jeff Shuren, MD, director of the Center for Devices and Radiological Health, said in a statement.

Late in 2018, the FDA received additional medical device reports (MDRs) of patient infections and device contamination. An analysis of 205 MDRs received between October 15, 2018, and March 31, 2019, includes 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination, in addition to the deaths.

The FDA is "continuing to evaluate the benefit-risk profile of these devices, and we'd like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections. Currently, that evidence is lacking, and we're considering what additional regulatory actions may be necessary," said Shuren.

The FDA first became aware of a potential association between multidrug-resistant bacteria and reprocessed duodenoscopes in 2013. In 2015, the FDA ordered duodenoscope makers Olympus, Fujifilm, and Pentax to conduct postmarket surveillance studies to better understand the transmission of infections and assess the factors that contribute to their occurrence.

Preliminary results of the "sampling" studies released last December showed a 3% contamination rate for "high-concern" bacteria associated with disease, such as Escherichia coli and Staphylococcus aureus, as reported by Medscape Medical News.

However, in the latest interim results, up to 5.4% of all properly collected samples tested positive for "high-concern" organisms, "which is significantly higher than the earlier results reported," Shuren said.

Additionally, up to 3.6% of properly collected samples tested positive for low- to moderate-concern organisms; in the earlier analysis, the rate was 3%. Although these organisms don't usually lead to dangerous infections, they are indicative of a reprocessing failure, Shuren said.

"When the sampling studies were designed, the FDA expected to see a total contamination rate for any type of organism of less than 1% or as close to zero as possible for duodenoscopes," he added.

The FDA is weighing whether additional recommendations are necessary to help healthcare facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates to less than 1%. For example, the agency is exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might add value.

The three manufacturers are also conducting "root cause" or "human factor" analyses. Final results are expected later this year.

Last March, the FDA sent warning letters to all three duodenoscope manufacturers regarding failure to comply with their surveillance study commitments.

"While the firms have made some progress toward completing these studies, they are still not in compliance with the timetable they agreed upon to complete these studies. If the companies continue to fail to adequately respond to our concerns, the FDA will take additional action," Shuren said.

The FDA is also working with the manufacturers on new duodenoscope designs that might reduce the risk for contamination, as well as disposable duodenoscopes that would eliminate the need for reprocessing.

Shuren emphasized that an individual patient's risk of acquiring infection from an inadequately reprocessed medical device remains "relatively low," given the large number of such devices in use.

He also noted that MDRs involving patient infections declined after the FDA implemented safety measures to improve reprocessing techniques. A recent analysis of MDRs found that the number of reports involving patient infections peaked in 2015 at 250 and then declined by 62% to fewer than 100 per year in 2017 and 2018.

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