FDA warns on using Custom Ultrasonics device on duodenoscopes

The FDA today reiterated its warning not to use the an automated endoscope reprocessor made by Custom Ultrasonics with a type of ‘scope called duodenoscopes, which have been linked to deadly “superbug” outbreaks.

Although the federal safety watchdog lifted the recall on Custom Ultrasonics’ endoscope reprocessors while the company looked to correct the violations that prompted the recall, the FDA said again today that the System 83 Plus devices should not be used with duodenoscopes.

The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March 2014, some of which led to patients’ deaths.

In Seattle, 39 people were infected at the Virginia Mason Medical Center between 2012 and 2014; 11 eventually died. All were critically ill when they were infected, but it was unclear if the bacterial infection contributed to their deaths, Seattle public health officials said at the time. Four patients in March 2015 were infected with bacteria from a contaminated scope and 67 more were at risk at Cedars-Sinai Medical Center in Los Angeles, weeks after UCLA Ronald Reagan hospital reported 8 patients were similarly infected and scores more potentially exposed; 3 of the UCLA patients eventually died.

In November 2015 the FDA ordered Ivyland, Pa.-based Custom Ultrasonics to recall all 2,800 of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.”

Custom Ultrasonics said at the time the superbug outbreak was linked to design changes made by the duodenoscope manufacturers that were not approved by the FDA.

“No AERs, including those of CUI, have been shown to cause these serious infections,” the company said in a statement. “The FDA has been working with medical device manufacturers, including Custom Ultrasonics, to develop improved procedures and protocols to assure that duodenoscopes can be safely reprocessed.”

In 2012 the FDA ordered Custom Ultrasonics to stop manufacturing and distributing all AER device models and components and ordered a recall after Custom Ultrasonics failed to obtain FDA clearance for significant software changes for the devices.

Today the FDA said hospitals should use other equipment to reprocess and sterilize duodenoscopes.

“The design of duodenoscopes is complex and therefore makes duodenoscopes harder to clean than most other flexible endoscopes. Because inadequately reprocessed duodenoscopes have been associated with patient infections and death, health care facilities should not use Custom Ultrasonics’ System 83 Plus AERs for reprocessing duodenoscopes, and should have transitioned to alternative methods of reprocessing these particular endoscopes,” the agency said.

In August 2015, the FDA published warning letters it sent to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan.

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