Preliminary results of the FDA's surveillance studies of duodenoscopes identified "higher-than-expected" contamination rates after reprocessing.
The federal agency said 3 percent of samples collected during the studies tested positive for "low-concern" organisms, which are not likely to cause serious infections, but indicate a "reprocessing failure." An additional 3 percent of samples tested positive for "high-concern" bacteria, which are more often linked to diseases like Escherichia coli and Pseudomonas aeruginosa.
The federal agency recommends healthcare facilities that use duodenoscopes closely follow manufacturer reprocessing instructions and consider using extra reprocessing measures to curb the risk for infection transmission, such as microbiological culturing, sterilization and a liquid chemical sterilant processing system.
The FDA's final results are expected to be released next year.
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