The Food and Drug Administration has given marketing clearance to a newly redesigned duodenoscope that is expected to improve patient safety.
The manufacturer of the device, Olympus Corporation of the Americas in Center Valley, PA, is voluntarily recalling duodenoscopes already on the market that have been linked to life-threatening, antibiotic-resistant infections among patients in several facilities, including Virginia Mason Medical Center in Washington state. (For more information, see “FDA says to inform patients about risk of endoscopy linked to CRE infections,” Same-Day Surgery, April 2015, at bit.ly/1VvCxBv.) Olympus will repair the recalled devices and is replacing the parts of the closed-channel tip of the duodenoscope to reduce the risk of bacterial infections.
The actions follow a report released by Sen. Patty Murray (D-WA) showing that the manufacturer knew the scopes could not be reliably cleaned and could present a threat to patients’ lives. (To access the report, go to 1.usa.gov/1SisZfg.) “These devices exposed far too many patients and their families to unacceptable risks, and I am pleased to see that the FDA and manufacturers have taken additional actions to protect patients in the future,” said Murray. “The steps taken today are important, but there is much more we need to do to make sure the FDA can respond quickly and appropriately when problems with medical devices occur.”
The report recommends legislative and regulatory changes, including:
- requiring that unique device identifiers be included in medical data to allow the FDA to more quickly identify risks associated with a given device;
- strengthening FDA guidance regarding clearance of modified medical devices by manufacturers.
In other news, Fuji has issued revised manual reprocessing instructions for its ED-530XT duodenoscope to replace those provided in the original device labeling, the FDA reported.
Facilities using the duodenoscope should train staff on the new validated instructions and implement them as soon as possible. The FDA also encourages facilities to apply the revised instructions to Fuji’s 250 and 450 duodenoscope models.
“While formal validation testing with the revised reprocessing instructions is ongoing for Fuji’s 250 and 450 duodenoscope models, FDA … believes that the revised reprocessing instructions for the ED-530XT duodenoscope are more robust because of additional pre-cleaning, cleaning and high-level disinfection steps and, for that reason, should increase the safety margin of the 250 and 450 duodenoscope models,” the agency said. (For more information, go to 1.usa.gov/1kLDKId. Same-Day Surgery tweeted about Fuji on Jan. 6 @SameDaySurgery.)