New data show even higher rates of duodenoscope contamination
The FDA is exploring additional steps to reduce contamination rates, which were higher in postmarket surveillance studies than the agency initially anticipated.
Up to 5.4% of all properly collected samples of reprocessed duodenoscopes tested positive for high-concern organisms in postmarket surveillance studies, the FDA recently reported in a statement. This rate is significantly higher than the 3% contamination rate reported in December 2018.
In addition, up to 3.6% of properly collected samples tested positive for low- to moderate-concern organisms, which typically do not lead to dangerous infections but are indicative of a reprocessing failure, the FDA said in its update. In December, this rate was reported to be up to 3%.
When these sampling studies were designed, the agency expected to see a total contamination rate of less than 1% for any type of organism, the statement said. The results show that improvements are necessary, and the FDA is exploring additional steps to reduce contamination rates. Root-cause analyses from the manufacturers are currently under way, and final results are expected later in 2019, the FDA said.