FDA Reissues Warning Against Use of Custom Ultrasonics' System 83 Plus AERs for Duodenoscope Reprocessing

Recently, the FDA has again issued a warning prohibiting healthcare facilities from using duodenoscopes manufactured by Custom Ultrasonics, as these devices have been linked to outbreaks of deadly “superbugs.”

Although the federal safety regulator has lifted the recall order for Custom Ultrasonics’ endoscope reprocessing equipment, the company continues to recall its products and is working to correct regulatory violations. The FDA once again emphasized that the System 83 Plus device must not be used with duodenoscopes.

Typically, physicians employ such devices during endoscopic retrograde cholangiopancreatography (ERCP) procedures, in which a reusable tube-shaped camera is inserted into the patient’s throat. In the United States, more than 500,000 ERCP procedures utilizing this equipment are performed annually. In February and March 2014, hospitals in Virginia, Connecticut, California, and Washington reported outbreaks of “superbugs,” with some hospitals even experiencing fatalities.

However, between 2012 and 2014, 39 patients were infected at the prestigious Virginia Mason Medical Center in Seattle, with 11 deaths. At the time, Seattle public health officials stated, “All patients were already critically ill at the time of infection, so it remains unclear whether the bacterial infections caused their deaths.” In March 2015, four patients at Cedars-Sinai Medical Center in Los Angeles were infected with the same bacterium, prompting more than 67 individuals to undergo screening. A few weeks later, UCLA Ronald Reagan Medical Center reported that eight patients had been infected with the same bacterium. A large number of patients had been exposed to these infected individuals, and three of them ultimately died.

Consequently, in November 2015, the FDA required Custom Ultrasonics to recall all 2,800 of its endoscope reprocessing devices. At the time, Custom Ultrasonics claimed that the outbreak of superbug infections was linked to the manufacturers of duodenoscopes, who had modified the design of the duodenoscopes without FDA approval.

A statement from Custom Ultrasonics said, “There is no clear evidence that AER devices, or even CUI devices, caused these infections. The FDA is now working with medical device manufacturers, including Custom Ultrasonics, to develop new protocols and improve procedures to ensure the safe manufacturing and use of duodenoscopes.”

In 2012, the FDA ordered Custom Ultrasonics to cease the production and sale of all automated endoscope reprocessors (AERs) and related accessories, and required the company to recall all such devices because it had made unauthorized modifications without FDA approval. On August 17 (U.S. time), the FDA officially issued a statement recommending that hospitals use alternative devices for disinfecting duodenoscopes.

The official explanation states: “The design of duodenoscopes is highly complex, making their cleaning more difficult than that of most flexible endoscopes. Because patient infections and deaths have been linked to improper processing of duodenoscopes, healthcare facilities should cease using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for duodenoscopes and gradually transition to alternative methods for processing these specialized endoscopes.”

In August 2015, the FDA issued warning letters to three major endoscope manufacturers in the U.S. market, and also warned non-compliant factories in the United States and Japan that were identified during inspections conducted in the spring.