The FDA says medical devices at the center of serious bacterial outbreaks at hospitals in Philadelphia and California did not have its approval.
Earlier versions of the Olympus-made endoscopes did get green-lighted, but the company did not seek clearance when it modified the device in 2010.
At least 15 people, including eight at a Philadelphia hospital authorities have not named, are believed to have contracted the bacterial infection Carbapenem-resistant Enterobacteriaceae, or CRE.
Chris Lavanchy with medical device watchdog group the ECRI Institute says sterilizing endoscopes has long been a challenge.
“It’s not news that these devices are difficult to clean properly,” he said. “But I think with the emergence of CRE, its made it even more of an issue, and increased the visibility of the difficulty of cleaning these instruments.”
He says it isn’t clear if the newest version of this endoscope made that process harder.
“It is difficult to say that the change made it worse, in fact maybe it is better than it was before.”
Olympus, which has its American headquarters in Center Valley, Pa. points out that devices made by competitors have also been linked to outbreaks. FDA data shows 135 infections in 2013-2014 related to endoscopic retrograde cholangiopancreatography, the procedure these scopes are used in.
“The emergence of drug-resistant microorganisms is a challenge to the entire healthcare community,” the company said in a statement.
“Olympus is working with relevant medical societies and our customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with endoscopic procedures.”
The FDA says more than 500,000 procedures are performed each year involving these scopes, and only a small fraction of transmissions reported. It is reviewing Olympus’s application for the device, which was submitted in October 2014, but won’t pull the units from the market.
“While we are working to determine what more can be done to reduce the incidence even further, the risk of transmission of multi-drug resistant bacteria must be weighed against the consequences of not seeking necessary treatment,” writes the agency.
“Pulling these devices from the market would prevent hundreds of thousands of patients from access to this beneficial and often life-saving procedure. The FDA believes at this time that the continued availability of these devices is in the best interest of the public health.”