Preliminary results from the US Food and Drug Administration's (FDA's) mandated postmarket surveillance studies of duodenoscopes show "higher-than-expected" contamination rates after reprocessing, according to an article on the Medscape website.
The FDA said 3 percent of properly collected samples tested positive for more than 100 colony-forming units of "low-concern" organisms.
These organism are unlikely to cause serious infections but are, nevertheless, an indication of a "reprocessing failure."
An additional 3 percent of properly collected samples tested positive for "high-concern" bacteria that are more often associated with disease.
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