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FDA Clears Validation Testing For Automated Endoscope Reprocessors

FDA has found that validation test data for three automated endoscope reprocessors – including Medivators’ Advantage Plus and DSD Edge, and Steris’ System 1E Liquid Chemical Sterilant Processing System – are adequate.

Two makers of automated endoscope reprocessers (AERs) – Medivators, a Cantel Medical Corp. company, and Steris Corp. – recently received FDA clearances for validation test data for devices they sell.

AERs are used to reprocess endoscopes, such as duodenoscopes, which were the cause of resistant bacteria outbreaks over the past three years, resulting in patient illness and deaths. (See Also...

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