FDA Does About-Face With Maker of Scope Washers

FDA rescinds recall of Custom Ultrasonics endoscope washers amid controversy over duodenoscope disinfection procedures

Varun Saxena

FDA backed off from a stern letter previously sent to Custom Ultrasonics, which demanded the firm remove and recall all of its machines to disinfect endoscopes in the wake of several patient deaths and injuries from contaminated duodenoscopes.

The Ivyland, PA-based company announced that the FDA has changed course, and is permitting the firm's automated endoscope reprocessors to remain on the market and clean all types of endoscopes other than duodenoscopes.

"The root cause analysis performed by outside third parties has implicated the 'elevator or lifter' mechanism of these duodenoscopes, which were marketed without FDA clearance. No AERs, including those of CUI (Custom Ultrasonics), have been shown to cause these serious infections," the company said in a statement.

The FDA's rescinded recall is raising questions. For until last year's well-publicized outbreak of the deadly bacteria CRE in Los Angeles, the agency largely ignored poor duodenoscope design and disinfection despite revelations that it was aware of 142 instances of contamination since 2010.

"It is certainly troubling for the FDA to order the removal of a medical device it has linked to patient injuries and deaths and then to abruptly reverse course with no clear explanation," Custom Ultrasonic's former director of infection control, Lawrence Muscarella, told the Los Angeles Times, adding, "This may be unprecedented in the history of medical device regulation."

The newspaper cites a Senate investigation, which discovered that nine of the 16 hospitals that suffered from duodenoscope-related infections used Custom Ultrasonics reprocessers, even though the company's market share is less than 20%.

Custom Ultrasonics and the FDA don't have a very friendly history. The agency ordered a recall of the firm's reprocessers in 2012, but rescinded the demand after modifications were made to the disinfection device.

After the company failed to comply with the now-rescinded recall issued in November 2015, the agency posted a plea on its website in February, requesting hospitals to "transition to alternative methods to reprocess flexible endoscopes as soon as possible." 

Custom Ultrasonics' repressors are still uncleared to clean duodenoscopes. In the wake of the safety scare, the FDA has certified reprocessors from ASP, Medivators, and Steris to clean duodenoscopes following liquid chemical sterilization validation testing. 

The FDA has also cleared the redesigned duodenoscope of market leader Olympus.

The agency said it did not clear the prior version of the device, adding to mounting public anger over the hundreds of sick and the score of dead patients. Olympus has claimed the old version of its duodenoscope was given the OK under the clearance of a similar endoscopic device.    

Varun Saxena is a contributor to Qmed.

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