The FDA yesterday recommended that healthcare providers move away from a type of infection-prone duodenoscope in favor of devices that can better be sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.”
In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as previously thought. Back in 2015 the federal safety watchdog warned Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary following a string of deadly “superbug” infections attributed to their duodenoscopes. The FDA ordered the companies to run post-market surveillance studies to assess the effectiveness of reprocessing the scopes; last year it sent the trio another set of warning letters over their failure to comply with that order. In April the agency told the firms to get the required post-market studies in gear.
Yesterday the agency said that the most recent studies “continue to show elevated rates of contamination, including the presence of high concern organisms, defined as organisms that are more often associated with disease transmission, such as E. coli and Pseudomonas aeruginosa.”
In light of that, the bureau urged a move away from designs that permanently attach endcaps, which can’t be removed for cleaning and sterilization, in favor of ‘scope designs that use disposable endcaps the FDA says could cut contamination rates in half. There are two such ‘scopes available on the U.S. market: Fujifilm’s ED-580XT and Pentax Medical’s ED34-i10T; Cook Medical is also working on a disposable duodenoscope that has yet to win 510(k) clearance.
“Because of our concerns of high contamination rates associated with conventional, fixed endcap duodenoscopes, we have asked each duodenoscope manufacturer to transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes when they become available,” the FDA said. “We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability. We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models.”
As of last December, the FDA thought that the contamination rate for high-concern bugs was 3%. In April the new data showed that number to be more like 5.4%.
As of July 26, the most recent study from Pentax showed a 4.9% rate of high-concern contamination (32 of 653). As of July 12, the four ‘scopes made by Olympus showed a collective high-concern contamination rate of 5.0% (75 of 1,488), ranging from 4.1% to 22.2%. (Fujifilm “has not enrolled a sufficient number of sites or collected a sufficient number of samples to establish a real-world contamination rate,” according to its post-surveillance report).
The FDA had also ordered the companies to run human factors studies on how comprehensible their reprocessing instructions for use are in real-world settings.
“The results from Fujifilm and Olympus suggest that users frequently had difficulty understanding and following manufacturers’ RIFU and as a result, were not able to successfully complete reprocessing,” according to the FDA. “We are continuing to work with manufacturers to conduct additional testing and revise reprocessing manuals, as appropriate.”
The FDA said it also asked manufacturers to include real-world contamination rates on their fixed-cap duodenoscope labeling and ordered them to run studies on their disposable-cap models, for later inclusion on their labels.
“We encourage device manufacturers to develop innovative approaches for the entire duodenoscope reprocessing procedure to provide a high margin of safety and reduce the risk of infection associated with reprocessed duodenoscopes. Such approaches may require collaboration among stakeholders, including manufacturers of duodenoscopes and reprocessing devices, to test and validate the use of innovative reprocessing approaches and to demonstrate a relative reduction in infection risk in a real-world setting,” the agency said.