Olympus Endoscopes Linked to UCLA Infection Outbreak Sold Without FDA Approval: Report

On the heels of a recent superbug infection outbreak at UCLA, which exposed 179 patients to threatening antibiotic-resistant bacteria, a CNN report reveals that the manufacturer of the endoscope linked to the problems never obtained proper FDA approval to sell the device on the market, yet did so any way.  

The report revealed Olympus Corp, the manufacturer of the duodenoscope used during the endoscopic retrograde cholangiopancreatography (ERCP) procedures that exposed nearly 200 people to the superbug at UCLA Medical Center in February, did not have FDA approval to sell the medical device in the United States.

The outbreak has been linked to at least two deaths and another seven confirmed cases of patients infected with carbapenem-resistant Enterobacteriaceae (CRE), an aggressive bacteria that is difficult to treat and is often deadly.

The Olympus endoscopes are deployed down a patient’s throat during the procedure, and recent reports have suggested that even when the cleaning instructions provided by the manufacturer are followed, the design of the device may allow bacteria to become trapped and infect patients.

Olympus began selling the endoscope, TJF-Q180V, in 2010 without FDA approval. However, the FDA did not notice until late 2013 or early 2014, according to the CNN report.

According to FDA regulations, manufacturers must receive clearance for a new model if it includes changes that, “could significantly affect the safety or effectiveness of the device.”

The new ERCP endoscope model included a modification for the exact part that is implicated in the outbreaks, the elevator channel. This piece was sealed up in attempt to make it more resistant to infection, however the changes do not seem to have worked.

Olympus said they did not think they needed to get the FDA’s approval to sell the device. Olympus initially applied for permission at the request of the FDA in 2014. The application is still pending.

Two other endoscope manufacturers, Pentax Medical and Fujifilm Holdings Corp, applied for approval for similar models and were granted clearance.

The FDA may be hesitant to completely remove the device from the market, as duodenoscopes are used in procedures that can be lifesaving. More than 500,000 ERCP procedures are done with the duodenoscopes every year in the U.S.

ERCP is a procedure that threads the endoscope through a patients mouth, down their throat, stomach and into their intestine to drain fluid from pancreatic and biliary ducts. These duodenoscopes have been linked to other infections for years.

FDA Advises Doctors to Continue ERCPs For Now

Following the UCLA infection outbreak, the FDA issued a safety communication last month, warning about the difficulties cleaning endoscopes, particularly duodenoscopes.

On March 4, the agency issued an update to that warning (PDF), recommending healthcare providers do not cancel ERCP procedures performed with the endoscope in question for patients who need the procedures as part of their healthcare plan.

In addition, the FDA recommended doctors inform patients of the risks and benefits of using the endoscope and report all suspected problems or infections to the FDA.

The FDA is calling for an advisory hearing that will focus on the regulations concerning the cleaning of the duodenoscopes, although a date for the hearing has not been announced.

In addition, the FDA is asking all three endoscope manufacturers to submit evidence that the duodenoscopes can be thoroughly cleaned, reaching the FDA standard of removing 99.999 percent of all microbes. So far no company has been able to provide adequate evidence this can be done.

The announcements came on the heels of news of another superbug outbreak at Cedars-Sinai Medical Center in Los Angles, in which another four patients were infected with a drug-resistant bacteria following an ERCP procedures. Similar outbreaks stemming from cleaning issues with the duodenoscopes may have exposed 64 others since August.