Scopes linked to superbug outbreak lacked FDA clearance

A model of endoscope that has been linked to outbreaks of deadly, drug-resistant bacteria at hospitals in Philadelphia, Los Angeles, and elsewhere was on the market for years without clearance, the Food and Drug Administration said Wednesday.

The device in question is a hard-to-clean type of duodenoscope marketed since 2010 by Olympus Corp., which has its U.S. headquarters in the Lehigh Valley.

Also Wednesday, a second Los Angeles hospital reported that four patients had tested positive for this type of "superbug" bacteria after being treated with a duodenoscope. It was not immediately clear whether the model that lacked FDA approval was involved.

At least six hospitals nationwide have reported superbug infections in patients who have been treated with this class of device in recent years. The FDA says the vast majority of patients who undergo these procedures, involving treatment of the bile and pancreatic ducts, are not at risk.

Olympus said it did not seek FDA clearance for its new model scope because it was not significantly different from a previous version that the agency had signed off on.

Still, when the FDA learned more than a year ago that the new model was on the market, it told Olympus that it must apply for permission to continue selling it. The company did so in October, but the agency has since asked for more data before giving its approval, officials said.

The model at issue, the TJF-Q180V, was one of two Olympus duodenoscopes in use by a Philadelphia hospital at the time of a 2014 bacterial outbreak, said Jeff Moran, a spokesman for the Philadelphia Department of Public Health. That same model was used on patients who became infected in recent months at Ronald Reagan UCLA Medical Center, according to CNN.com.

The agency also has concerns even on other duodenoscopes it has approved. The FDA has said that the intricate design of scopes made by three manufacturers - Olympus, Pentax Medical, and Fujifilm - renders them very difficult to clean.

Also Wednesday, ECRI Institute, a Plymouth Meeting-based nonprofit that evaluates medical devices, issued a "high priority hazard report" on duodenoscopes.

In the report, a team of physicians, engineers, and infection-control specialists recommended routine culturing of the scopes to ensure that they were free from bacteria after cleaning.

In the Philadelphia outbreak last year, eight people treated with the scopes were infected with bacteria resistant to a class of last-resort antibiotics called carbapenems. Two died, though the deaths were not clearly caused by the infections, city health officials have said. They have declined to name the hospital.

At the UCLA hospital, seven patients tested positive for a superbug after being examined with one of the $40,000 devices, and two died. Up to 179 people were exposed.

The second cluster of cases in L.A. was reported Wednesday by Cedars-Sinai hospital. Four patients tested positive for the bacteria after being treated with the scopes even though technicians had meticulously followed the manufacturer's disinfection procedure, the hospital said.

Other outbreaks have been reported at hospitals in Seattle and the Chicago suburb of Park Ridge.

This type of endoscope is used in 500,000 procedures a year nationwide, according to the FDA. Officials are concerned that fear of infection will deter patients from seeking a treatment for which there is little alternative. The scopes can be used to drain fluids from pancreatic and bile ducts that are blocked by tumors or gallstones.

Olympus, with its U.S. base in Center Valley, Pa., is aware of 95 complaints of infections in patients who had the procedure with the TJF-Q180V, says a Feb. 19 notice the company posted on its site for health-care professionals. The notice suggests this model is even harder to clean than others.

"While all endoscopes, including duodenoscopes, require thorough reprocessing after patient use in order to be safe, the TJF-Q180V requires careful attention to cleaning and reprocessing steps to ensure effective reprocessing," the notice states.

In a March 2014 letter to Olympus, the FDA said the company would have to seek approval for the new model because it was different from its predecessors in a key respect: It contained a special channel that was sealed and therefore would not come into contact with disinfectant during the normal cleaning process.

Reprocessing and disinfection of all kinds of endoscopes and other devices are handled by surgical processing technicians. New Jersey and New York are the only two states that require certification of these employees, according to the Chicago-based International Association of Healthcare Central Service Materiel Management.

It is a complex, multistep process that takes at least an hour. The cleaning manual for the Olympus TJF-Q180V is 106 pages.