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Duodenoscopes Linked to Superbug Outbreak were Sold without FDA Approval

Mar 6, 2015

The specialized endoscopes implicated in the recent UCLA superbug outbreak were sold without approval from the U.S. Food and Drug Administration (FDA), CNN reports. The devices, known as duodenoscopes, are long flexible tubes with a camera attached used to visualize the gastrointestinal tracts. Recently, hospital officials at Ronald Reagan UCLA Medical Center said that contaminated scopes spread the superbug carbapenem-resistant Enterobacteriaceae (CRE) to seven patients from October to January; two of these patients died.

The duodenoscope implicated in the outbreak is Olympus' TJF-Q180V. Karen Riley, deputy director of strategy for the FDA's Office of External Affairs said the company starting selling the scope in 2010, but the agency did not realize that it was never cleared for the market until late 2013 or early 2014. "Why didn't we notice it? I don't know," said Riley, according to CNN.

Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic commented "Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" according to CNN. "Devices need to be regulated more vigorously. This is really disturbing." Dr. Nissen has previously testified about device safety problems in front of Congress. Olympus claims in a statement that it did not think approval was needed to sell the device. The company has now applied for that permission, and the application is pending.

The patients infected at UCLA had undergone routine endoscopic treatments, according to CNN. Hospitals officials believe that the deadly bacteria was spread by the two scopes used even though manufacturer's guidelines were followed. The facility has contacted 179 patients who underwent the same procedure and is offering home kits to screen for CRE.

Duodenoscopes are also newly implicated in another outbreak of CRE. CNN reports that four other patients at Cedars-Sinai Medical Center in Los Angeles were infected. The device was used in all four patients between August 2014 and January 2015. The medical center contacted 64 other patients who had a procedure with the scope.

The FDA requires manufacturers to seek approval if a change made to a device "could significantly affect the safety or effectiveness of the device." Olympus modified the elevator component of its TJF-Q180V. The company sealed up part of the device in an attempt to make it more resistant to infection, but this component is exactly what is implicated in the superbug outbreaks." The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," said Riley, according to CNN.

The FDA has now asked all three manufacturers of duodenoscopes to submit evidence showing that the scopes can be sterilized effectively. According to CNN, this effort has been unsuccessful thus far. The FDA's standard for disinfection is being able to eliminate 99.9999% of all microbes, but the data submitted by the companies has failed on this standard twice.

Riley said she doesn't know if the FDA will enforce any type of punitive action against Olympus for selling the scope without approval. Device safety expert Diana Zuckerman told CNN that they should. "It's like with kids. How do you teach your children to behave if there are no consequences when they misbehave?" she said.

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