The outbreak has been linked to at least two deaths and another seven confirmed cases of patients infected with carbapenem-resistant Enterobacteriaceae (CRE), an aggressive bacteria that is difficult to treat and is often deadly.
The Olympus endoscopes are deployed down a patient’s throat during the procedure, and recent reports have suggested that even when the cleaning instructions provided by the manufacturer are followed, the design of the device may allow bacteria to become trapped and infect patients.
Olympus began selling the endoscope, TJF-Q180V, in 2010 without FDA approval. However, the FDA did not notice until late 2013 or early 2014, according to the CNN report.
According to FDA regulations, manufacturers must receive clearance for a new model if it includes changes that, “could significantly affect the safety or effectiveness of the device.”
The new ERCP endoscope model included a modification for the exact part that is implicated in the outbreaks, the elevator channel. This piece was sealed up in attempt to make it more resistant to infection, however the changes do not seem to have worked.
Olympus said they did not think they needed to get the FDA’s approval to sell the device. Olympus initially applied for permission at the request of the FDA in 2014. The application is still pending.
Jeffrey Newman represents whistleblowers.