'Superbug' scopes lacked FDA clearance; Feds ask hospitals not to cancel surgeries

The FDA said the Olympus TJF-Q180V duodenoscope, one of the scopes tied to the CRE cases, is still pending clearance while being marketed to hospitals.

The U.S. Food and Drug Administration is advising hospitals not to cancel procedures requiring duodenoscopes and said there is no evidence that the lack of federal clearance on one of the scopes tied to recent “superbug” cases in California contributed to the infections.

The announcement comes one day after Cedars-Sinai Medical Center said four patients contracted CRE infections from organ scopes used to examine their liver, bile ducts or pancreas. In February, two people died from infections tied to similar scopes at UCLA's Ronald Reagan Medical Center.

[Also: 'Superbug' infections hit Cedars-Sinai]

The FDA said the Olympus TJF-Q180V duodenoscope, one of the scopes tied to the CRE cases, is still pending clearance while being marketed to hospitals.

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Patients who need endoscopic retrograde cholangiopancreatography surgeries, or ERCP, should receive them, the FDA said, advising hospitals to disinfect any scopes they think may be tied to an infection.

However, the FDA said distributors shouldn’t shelve the Olympus scopes because that could cause a dangerous shortage of the devices. According to the FDA, duodenoscopes are used nationally in 500,000 procedures a year.

According to CNN, the Olympus TJF-Q180V scope first hit the supply chain market in 2010 without asking for FDA clearance. However, the FDA didn’t realize that until late 2013 or early 2014.

Olympus said it did not believe clearance was needed.

“Olympus Medical Systems Corp. made a decision, based upon FDA policy, that a modification to our previously FDA cleared duodenoscope did not require a new 510(k) application to FDA prior to marketing the modified duodenoscope in the U.S. in 2010,” the company said in a statement.

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