FDA Clears Validation Testing For Automated Endoscope Reprocessors
This article was originally published in The Gray Sheet
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.
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The US agency issued a safety communication Aug. 17 advising all health care facilities to stop using Custom Ultrasonics' System 83 Plus automated endoscope reprocessors to reprocess duodenoscopes, although facilities may continue to use the AERs to clean and sterilize other flexible endoscopes.
The agency sped up release of a final guidance on reprocessing reusable devices, including a strict set of protocols for endoscope cleaning, disinfection data, and design guidelines, following reports of serious bacterial infections linked to duodenoscopes.
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