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Olympus, the manufacturer of the endoscope involved in two superbug deaths at UCLA, never had FDA approval to sell the device. The device is used in patients with gastrointestinal complaints.

The FDA was unaware, until 2013, that Olympus started selling its TJF-Q180V duodenoscope (or ERCP endoscope) in 2010, without receiving clearance from the “oversight” agency to bring it to market, according to Karen Riley of the FDA’s Office of External Affairs.

“Devices need to be more vigorously regulated. This is really disturbing,” said Dr. Steven Nissen, chief of cardiovascular medicine at Cleveland Clinic, who testified to Congress about device safety problems.

Olympus released a statement saying it didn’t know FDA approval was needed to sell the device, but it has since applied for permission at the request of the agency. The application is pending.

UCLA Outbreak

From October to January, seven patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug carbapenem-resistant Enterobacteriaceae or CRE, which is extremely resistant to all types of antibiotics. Two of those patients died.

The patients contracted CRE following routine endoscopic treatment. According to hospital officials, two medical scopes still carried the deadly bacteria even after disinfection guidelines were followed. Another 170 others who had endoscopic procedures during the same months have been contacted by the medical center and offered home tests to screen for the bacteria.

Four patients at Cedars-Sinai Medical Center have also been infected with the superbug and linked to a contaminated duodenoscope. The scope was used on all four patients during August and January 2015.

Sixty-four other patients who had a procedure with the same scope have been notified by mail, “out of an abundance of caution.”

FDA Rules

A manufacturer must seek clearance for new models if it includes “significant changes that can affect the safety or effectiveness of the device.”

The newer model of the Olympus sealed the elevator channel, with the intention of making it imperious to infection. And, while the company made these changes to make the device safer, it appears it is not safer.

The agency is reluctant to remove the device from the market because the procedures can be lifesaving says, Riley.

“More than 500,000 of these procedures are done every year in the U.S., and the risk of bacterial transmission is actually really very, very low,” she said. “We believe the benefits outweigh the risks.”

Fujifilm and Pentax, two other duodenoscope manufacturers, applied for and were granted clearance to market devices similar to Olympus’ TJF-Q180V.

Disinfection Protocols under Scrutiny

The agency is requesting all three companies submit evidence showing the scopes can be cleaned thoroughly; but it doesn’t look promising.

Twice the companies submitted data that failed to show that cleaning could get rid of 99.9999% of all microbes on the scope- the FDA’s standard for disinfection, said Riley.

It is yet to be determined if Olympus will be penalized by the FDA for failure to get approval before selling the device.

What Should Patients Do?

Patients that have undergone a procedure involving use of a duodenoscope should discuss the benefits and risks of the procedure and any alternatives with their health care provider.

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