Don’t Use Custom Ultrasonics Endoscope Reprocessors: FDA

FDA has revised a 11/2015 safety communication about Custom Ultrasonics and an agency order to recall all of its Automated Endoscope Reprocessors (AERs) due to the company’s continued violations of a 2007 consent decree. A recent company recall strategy was found inadequate, the agency says, and because it has not demonstrated that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the agency recommends that health care facilities transition to alternative methods to reprocess flexible endoscopes as soon as possible.



FDA says its actions are intended to minimize the risk of patient infections associated with reprocessed endoscopes, including duodenoscopes and scope accessories. About 2,800 AERs are currently in hospitals and outpatient clinics throughout the U.S. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.