FDA updates information on validated duodenoscope reprocessors
The Food and Drug Administration today posted updated information on which makers of automated endoscope reprocessors for duodenoscopes have completed validation testing with adequate results. The agency requested validation testing data from all companies that have AERs labeled to reprocess duodenoscopes due to the potential association between reprocessed duodenoscopes and patient infection. The agency continues to work with manufacturers as they validate that their reprocessors can effectively clean and disinfect duodenoscopes, and will update the information when it accepts validation results for other manufacturers.
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