The U.S. Food and Drug Administration on Wednesday advised health providers not to cancel surgical procedures involving the use of medical endoscopes.
Endoscopes have been linked to drug-resistant superbug outbreaks at two California hospitals in recent months, but the FDA said the benefits of performing such procedures still outweigh the potential risks.
The FDA stated Wednesday that it was not recommending hospitals begin canceling endoscopic retrograde cholangiopancreatography, or ERCP, for patients who need the procedure. This comes despite it receiving inquiries from health providers about whether they should continue performing ERCP after recent reports that one model of duodenoscope made by manufacturer Olympus currently does not have FDA clearance to be marketed.
FDA spokeswoman Leslie Wooldridge said Olympus made modifications to its TJF-Q180V model duodenoscope that the agency never cleared for use. The FDA had notified Olympus it would have to submit an application for 510(k) clearance, which requires medical-device makers to demonstrate that a product they intend to market is as safe and effective as similar types of devices already approved for use.
Olympus spokesman Mark Miller stated in an e-mail received Wednesday that the company markets its duodenoscope model, “based upon applicable 510(k) clearance guidelines.” The company received 510(k) clearance when it first introduced its duodenoscope model, he said, and it had decided modifications made to the device in 2010 did not warrant a new application “according to the FDA policy on modifications to 510(k)-cleared devices.”
But Wooldridge said the agency informed Olympus in March 2014 that it would need to submit a 510(k) application, which the company did in October. The Olympus duodenoscopes have been linked to recent outbreaks of carbapenem-resistant enterobacteriaceae, or CRE, that occurred at Ronald Reagan Medical Center at the University of California at Los Angeles and Cedars-Sinai Medical Center between August 2014 and January 2015.
In all, as many as 250 people were potentially exposed to CRE as a result of contaminated duodenoscopes at UCLA and Cedars-Sinai, resulting in 11 infected cases and two deaths.
Both facilities have stated that disinfection procedures recommended by Olympus and the FDA were strictly followed but that they were insufficient to protect against contamination. UCLA and Cedars-Sinai have since implemented additional safety measures such as the taking of culture samples to monitor for potential bacteria at Cedars, and the use of ethylene oxide gas sterilization at UCLA.
In its safety communication issued Feb.19, the FDA acknowledged the design of duodenoscopes, which are used for such procedures as draining fluids from pancreatic and bile ducts, made effectively cleaning and disinfecting the devices difficult and still carried a risk for infection even when recommended processes were accurately followed.
But in an interview with the New York Times published Feb. 25, FDA Chief Scientist Dr. Stephen Ostroff said the agency never reviewed the efficacy of manufacturers' instructions for cleaning and reprocessing duodenoscopes but have now requested evidence from manufacturers that shows their recommended cleaning procedures are effective.
Yet the agency's latest information for health providers still recommends they follow cleaning and disinfecting procedures “pursuant to the manufacturers instructions.”
The FDA stated no action has been taken against Olympus regarding its device because removing the scopes from the market would lead to a shortage, and that there was no evidence to support the idea that a lack of 510(k) clearance had a role in the infections.
The agency also pointed out that it has received reports of duodenoscope-associated infections regarding all three product makers, including Fujifilm and Pentax.
“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,” Wooldridge stated. “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.”
The FDA has received reports of duodenoscope-associated infections regarding all three product makers, including Fujifilm and Pentax, it noted.
Follow Steven Ross Johnson on Twitter: @MHsjohnson
