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.