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Maker of Medical Device that Started a Superbug Outbreak Started Selling the Devices Without FDA Clearance

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Superbug Outbreak Device sold the w/o FDA Clearance

Superbug Outbreak Device sold the w/o FDA Clearance

The manufacturer of the endoscope that infected seven people at Ronald Regan UCLA Medical Center with a deadly superbug outbreak never obtained permission from the U.S. Food and Drug Administration (FDA) to sell the device.

CNN reported that it learned that Olympus never received FDA clearance before it began selling its TJF-Q180V duodenoscope in 2010, and the agency didn’t realize it until late 2013 or early 2014.

“Can you imagine a prescription drug getting out on the market that didn’t go through the approval process?” asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who’s testified to Congress about device safety problems. “Devices need to be regulated more vigorously. This is really disturbing.”

Olympus said in a statement viewed by CNN that the company didn’t think it needed to be cleared by the agency to sell its duodenoscope, but now at the request of the FDA, it has applied for that permission. The application is still pending.

Seven patients treated at Ronald Regan UCLA Medical Center contracted the deadly superbug CRE, or carbapenem-resistant Enterobacteriaceae, from October to January, after undergoing routine endoscopic treatments, hospital officials say. Two of those patients died. Two of the scopes used in the procedures are being blamed for the outbreak. Hospital officials believe the devices harbored the deadly bacteria even after they were disinfected according to Olympus’ specific instructions, according to CNN.

Per FDA rules, the maker of a medical device must seek the agency’s clearance before it starts selling a new model that includes changes that “could significantly affect the safety or effectiveness of the device.” The duodenoscope in question includes a modification to the exact part of the scope that is believed to have harbored the potentially fatal bacteria, CNN reported.

For the new model, Olympus sealed up that part of the device in an apparent attempt at making it more difficult for the device to harbor bacteria, but their efforts failed. The FDA is now asking Olympus and the makers of two other scopes that have been linked to CRE, Pentax and Fujifilm, to submit evidence that the devices can be thoroughly cleaned. The agency told CNN that things aren’t going so well. Twice the companies have 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.

It’s unclear whether or not the FDA will penalize Olympus for selling the device without its approval. disclaimer: This article: Maker of Medical Device that Started a Superbug Outbreak Started Selling the Devices Without FDA Clearance was posted on Tuesday, March 10th, 2015 at 4:03 pm at and is filed under Medical Device Lawsuits.

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