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