Scopes in Superbug Cases Skirted FDA Clearance

As many as 179 patients have been exposed to a drug-resistant bacterial strain, thanks to a reusable but hard-to-clean medical device.

Nancy Crotti

Cedars-Sinai Medical Center in Los Angeles announced on Wednesday that four patients had contracted a potentially deadly superbug linked to a reusable but hard-to-clean medical device, the New York Times reported.

Meanwhile, Olympus, whose duodenoscopes have been implicated in the spread of the drug-resistant bacterial strain carbapenem-resistant Enterobacteriaceae (CRE), has been selling them without FDA 510(k) clearance related to modifications made in recent years. The agency, though, is allowing sales to continue.

At least seven patients were infected and two died from CRE at UCLA's Ronald Reagan Medical Center from October to January. The hospital believes that 179 patients may have been exposed to CRE from a contaminated, reprocessed duodenoscope.

Olympus began selling its TJF-Q180V duodenoscope in 2010 without 510(k) clearance, which the FDA noticed in late 2013 or 2014, according to a CNN report. Olympus' TJF-Q180V includes a modification to the part of the device that has been implicated in the superbug outbreaks, the news network said.

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions in the pancreas, bile duct and gallbladder, including life-threatening jaundice, and pancreatic and biliary cancers, according to Olympus. The company told Qmed.com that it did not believe it needed FDA clearance for selling the modified duodenoscope, but has since applied for it at the agency's request. That application is pending, and the company said it is cooperating with the agency.

The FDA has said that duodenoscopes' movable "elevator" mechanism at the tip, while improving efficiency and effectiveness, are challenging to disinfect.

"At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections," Olympus said in its statement, and the FDA agreed. The agency will continue to allow sales of the duodenoscopes made by OIympus and competitors Fujifilm Holdings and Pentax, a subsidiary of Ricoh, it said in a statement.

"FDA is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available to the Agency, we believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year," the statement said.

"The FDA's analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers," the agency continued. "At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections."

The uptick in reprocessing has cut into the bottom line of some medical device companies, which have watched in dismay as their products were cleaned and then resold by a third party. Reprocessed devices, however, have proven to be popular among hospitals, as they often cost substantially less than new devices and are billed as a "greener" alternative to brand-new devices.

Although the FDA requires reprocessed devices to meet certain specifications related to cleanliness, sterility, and functionality, critics of the process--which include many device companies--point out that reprocessed medical devices represent a safety risk. Either they could cause bacterial infection, or the sterilization process itself could cause potentially risky unintended mechanical changes to the device.

Nancy Crotti is a contributor to Qmed and MPMN.

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