Endoscopes Linked to CRE Superbug Outbreak Sold Without FDA Approval

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The manufacturer of a specialized medical instrument called a duodenoscope linked to at least 2 CRE superbug deaths at the Ronald Reagan UCLA Medical Center never received approval to sell the device, according to the U.S. Food & Drug Administration (FDA). Hospital officials believe the duodenoscopes passed the deadly bacteria even after disinfection guidelines were followed.

What’s the Problem?

Olympus began selling its TJF-Q180V duodenoscope in 2010, but the FDA wasn’t aware that the company hadn’t requested clearance to market the device until 3 or 4 years later, according to CNN.

“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. “Devices need to be regulated more vigorously. This is really disturbing.”

Superbug Outbreak Linked to 2 Deaths; 179 Potentially Exposed at UCLA

At least 7 patients at the Ronald Reagan UCLA Medical Center were infected with Carbapenem-Resistant Enterobacteriaceae (CRE) bacteria between Oct. 2014 and Jan. 2015, according to hospital officials. Two of those infected died as a result of their complications.

The patients caught the superbug after undergoing routine medical treatments which involved the use of Olympus duodenoscopes. Hospital officials believe 2 scopes that still carried the bacteria even after disinfection protocol was followed passed the superbug from patient to patient.

Scope Design Change ‘Not Safer’

FDA guidelines mandate that a manufacturer must request clearance for a new model if it includes design changes that “could significantly affect the safety or effectiveness of the device.” The Olympus TJF-Q180V duodenoscope includes a modification to the exact part of the device that’s suspected of carrying the CRE bacteria.

Olympus sealed up the scope’s “elevator channel” — a part used to navigate through tight spaces and allow for attachments such as catheters or guide wires — hoping to make it harder for bacteria to survive.

“The company clearly made these modifications to make the device safer, but it seems to be that it wasn’t safer,” said Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs.

Olympus finally applied for permission to sell the TJF-Q180V duodenoscope in 2014, at the FDA’s request. That application is still pending. Two other duodenoscope manufacturers, Pentax and Fujifilm, did apply for and received clearance to market models similar to Olympus’.

Olympus Issues New Reprocessing Instructions for Duodenoscopes

March 26 – Olympus Corp. has provided customers with new instructions for sanitizing the duodenoscopes linked to the CRE outbreaks. FDA said it is reviewing Olympus’ new guidelines as part of a broader evaluation of the duodenoscope.

More Infections Linked to Olympus Endoscope

March 31, 2015 – More patients may have been infected with CRE via contaminated Olympus duodenoscopes than previously suspceted, health officials have warned. Many feel the recent outbreaks would’ve gone unnoticed if health departments hadn’t gone the extra mile to gather samples of CRE bacteria and investigate the links. Few states have conducted such research to detect potential outbreaks.

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