December 11, 2018

FDA issues statement on updated rates of duodenoscope contamination

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on December 10 issued a statement on an updated safety communication about rates of duodenoscope contamination obtained from preliminary postmarket data.

Interim results from sampling studies from device manufacturers−Olympus, Fujifilm, and Pentax− indicate higher-than-expected contamination rates after reprocessing.

Up to 3% of samples tested positive for more than 100 CFUs of “low-concern” organisms, which are unlikely to cause serious infections, but they are an indication of reprocessing failures.

An additional 3% of samples tested positive for “high-concern” organisms that are more often associated with disease, such as E coli, Staphylococcus aureus, and Pseudomonas aeruginosa.

The manufacturers are currently conducting root cause analyses to better understand these culturing results.

Because of the higher than expected contamination rates, the FDA updated recommendations for steps healthcare providers can take to enhance duodenoscope reprocessing, including:

  • careful inspection of the elevator recess
  • following manufacturer’s recommendations for inspection, leak testing, and maintenance of the duodenoscope
  • returning the duodenoscope to the manufacturer at least once a year for inspection, servicing, and maintenance.

The FDA also strongly encourages healthcare providers to consider initiating their own duodenoscope surveillance sampling and culturing to reduce infection risks.


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