The Pentax Medical duodenoscope’s design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. Reducing reprocessing challenges, the thinking goes, will help prevent the potentially deadly superbug outbreaks that could result from them.
Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine. They’re used in more than 500,000 procedures each year in the United States, according to the FDA. They provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
“Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients in the U.S. We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess.”
FDA last month cleared GI Scientific‘s ScopeSeal duodenoscope protective device, meant to protect the distal end of a duodenoscope from contamination during procedures.
The agency over the summer pushed duodenoscope makers — including top manufacturers Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Pentax — to move away from designs that permanently attach endcaps, which can’t be removed for cleaning and sterilization.
FDA said earlier in the year that the problem was worse than previously thought when reports of deadly superbug infections started cropping up in 2015, with a contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa that’s around 5.4%.
Late last year, Olympus and a former senior executive in Japan pleaded guilty in federal court in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes. A previous LA Times and U.S. Senate committee investigation found that Olympus for years did not disclose problems to the FDA and the U.S. public, even as it issued warnings in Europe.
