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FDA: Problems Persist With Duodenoscope Reprocessing

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April 18, 2019

By Jay Kumar

Despite progress made with the reprocessing of duodenoscopes over the last few years, the Food and Drug Administration (FDA) says continued improvement is necessary.

“A recent analysis of medical device reports submitted to the FDA indicates that the number of reports associated with patient infections peaked in 2015 at 250 reports and has declined by 62% to fewer than 100 reports per year in 2017 and 2018,” said Jeff Shuren, MD, director of the Center for Devices and Radiological Health, in a release. “Our recent actions have yielded improvements, but we also received reports of three deaths of U.S. patients in 2018 that were related to infections associated with duodenoscopes. That’s three deaths too many.”

The FDA analyzed 205 medical device reports received between October 15, 2018 and March 31, 2019 and found 45 reports of patient infection, one report of patient exposure, and 159 reports of device contamination, according to an FDA alert released last week.

Shuren noted that the FDA has actively worked to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, including evaluating the effectiveness of current duodenoscope reprocessing instructions in healthcare settings and releasing voluntary standardized protocols for scope surveillance sampling and culturing.

“As a result, we’ve made strides in mitigating infections associated with reprocessed duodenoscopes and have seen a dramatic decline in reports of patient infection,” he said. “But we’re 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 residence that can spread infections. Currently, that evidence is lacking, and we’re considering what additional regulatory actions may be necessary.”

The possible link between duodenoscope reprocessing and multidrug-resistant bacteria first arose in 2013. In 2015, the FDA ordered scope makers Olympus, Fujifilm, and Pentax to conduct postmarket surveillance studies to better understand the transmission of infections and assess the factors that contribute to them.

Recent sampling studies found that 5.4% of all properly collected samples tested positive for high-concern organisms, which is significantly higher than previously found (high-concern bacteria are more often associated with disease, such as E. coli and Staphylococcus aureus. 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.

“Let me be clear, the percent of contaminated samples based on these interim results shows that improvements are necessary and we are committed to taking additional steps to reduce infections and contamination even further,” Shuren said. “The FDA previously instructed the manufacturers to conduct root cause analyses following the preliminary results announced last December to better understand these culturing results. These analyses are currently underway with an analysis of the new collected samples, and final results are expected later in 2019.”

In addition, the FDA is doing the following:
 

  • Working with healthcare facilities and reprocessing personnel to understand their experiences implementing reprocessing protocols
  • Working with duodenoscope manufacturers to modify the reprocessing instructions to enhance the safety margin of methods used to clean and disinfect duodenoscopes
  • Encouraging the development of new technology and design features, such as disposable components, to enhance patient safety



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