Don't Use Custom Ultrsonics Reprocessors for Scopes: FDA

FDA is recommending that health care facilities stop using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for reprocessing duodenoscopes because of inadequate reprocessing validation and performance data. An agency safety notice says the reprocessors remain available to reprocess other flexible endoscopes. FDA says it continues to work closely with Custom Ultrasonics as it conducts additional reprocessing validation studies and takes steps to correct the violations identified during an April inspection. “The FDA’s ongoing investigation of duodenoscope reprocessing and endoscopic retrograde cholangiopancreatography (ERCP) associated infections in health care facilities has not demonstrated an association between Custom Ultrasonics AERs and bacterial infections with flexible endoscopes that are not duodenoscopes,” it adds.