Custom Ultrasonics notified healthcare facilities the AERs are not suitable for use in May 2016. The FDA’s most recent safety communication reiterates that recommendation and also notes providers can still use the AERs for other endoscopes.
In February 2016, the FDA issued a safety communication recommending healthcare facilities using Custom Ultrasonics’ System 83 Plus AERs should “transition to alternative methods to reprocess flexible endoscopes.” After that, the agency reviewed reprocessing validation data from Custom Ultrasonics as well as literature on the AERs. This culminated in Custom Ultrasonics issuing an urgent medical device recall for all System 83 Plus, System 83 Plus 2 and System 83 Plus 9 AERs. The recall stated “they should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.”
The FDA is continuing to work with Custom Ultrasonics’ on additional reprocessing validation studies. Thus far, there has been no indication that providers should not use the company’s AERs to clean flexible endoscopes that are not duodenoscopes.
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