For years, the FDA has warned the industry of the risks of improperly cleaned and reusable endoscopes designed to visualize the stomach and intestines. Now, it’s doing the same with urological scopes following the reports of patient deaths from bacterial infections outside the U.S.
The agency said it is investigating “numerous medical device reports” describing contamination issues and the patient-to-patient transfer of pathogens from devices used to view and access the urinary tract, bladder and kidneys, including cystoscopes, ureteroscopes and cystourethroscopes.
“We are very concerned about the three reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” the FDA’s device center director, Jeff Shuren, M.D., said in a release.
“While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling,” Shuren said. “Although we believe that the risk of infection is low based on available data, we’re reminding healthcare providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.”
The agency said it has received more than 450 reports of post-procedure infections or contamination issues, spanning January 2017 through February of this year—including devices manufactured by Olympus and Karl Storz, and potentially other, unnamed companies as well.
Of the three reported patient deaths, two were linked to an irrigation accessory plug that controls water flow to the internal workings of the endoscope. The third involved a cystoscope that did not pass a leak test, indicating possible damage to the device, the FDA said.
The agency noted that these medical reports themselves are not evidence of a faulty product and said it has not yet concluded whether specific devices may pose higher risks than others.
The FDA is also reviewing information on other types of endoscopes. Reprocessing these devices involves physical cleaning plus high-level disinfection and sterilization procedures—but their small, intricate and enclosed components can sometimes harbor biological material between uses.
The agency has been tracking issues with larger duodenoscopes since 2015. It issued warning letters and required manufacturers to perform postmarket safety studies before ultimately urging the industry to move away from durable, reusable designs in favor of devices with disposable or modular components.
In late 2019, the agency cleared its first duodenoscope with a single-use head, developed by Pentax Medical, as well as its first fully disposable scope from Boston Scientific. These were flanked by green lights for a kit with additional cleaning tools from Olympus as well as a sterile sheath to seal the front end of the scope, designed by GI Scientific.