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Medical Devices / Regulatory Affairs

FDA Flags Concerns Over Reprocessed Duodenoscopes

April 16, 2019

CDRH Director Jeff Shuren said the center is considering regulatory actions because of ongoing concerns over contaminated duodenoscopes.

In 2015, the FDA required three manufacturers, Olympus, Fujifilm and Pentax, to conduct two postmarket surveillance studies of reprocessed duodenoscopes. The preliminary findings showed a three percent contamination rate for “high concern” organisms. But updated data showed that up to 5.4 percent of samples tested positive for “high concern” organisms, such as pathogenic E. coli or Staphylococcus.

When the sampling studies were designed, the FDA “expected to see a total contamination rate for any type of organism of less than one percent or as close to zero as possible for duodenoscopes,” Shuren said. ‘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.”

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