Dive Brief:
- The manufacturer of the endoscope tied to two CRE deaths at UCLA had never obtained clearance to sell the device, says a spokeswoman at the Food and Drug Administration.
- Karen Riley, deputy director of strategy for the FDA's Office of External Affairs, told CNN that Olympus began selling their TJF-Q180V duodenoscope in 2010, but that the FDA only realized in "late 2013 or early 2014" that the company had never asked for approval.
- After the FDA requested that they apply last year, Olympus did so, and the request is still pending. Olympus released a statement saying that the company didn't think it needed to get the FDA's approval for the device.
Dive Insight:
It's easy to see where the FDA's rules leave room for confusion and/or argument. They say that a manufacturer needs to apply for approval if a new model of device involves updates that "could significantly affect the safety or effectiveness of the device."
In this case, Olympus modified precisely the part of the TJF-Q180V duodenoscope that is being eyed in the CRE outbreaks, and had done so in an effort to reduce the risks of infection, CNN reports.
"The company clearly made these modifications to make the device safer, but it seems to be that it wasn't safer," Riley told the media. She added that duodenoscope manufacturers Pentax and Fujifilm, were granted approval to sell devices similar to the Olympus TJF-Q180V.
Meanwhile, news has broken of duodenoscope-related superbug outbreaks at two more hospitals, but the FDA does not plan to take duodenoscopes off the market because it believes their benefits still outweigh their risks.