FDA investigating infections associated with reprocessed urological endoscopes

April 8, 2021

The U.S. Food and Drug Administration (FDA) is investigating numerous medical device reports (MDRs) describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes and cystourethroscopes – devices used to view and access the urinary tract, according to a news release.

Reprocessing these types of medical devices involves both cleaning and high-level disinfection or sterilization so the devices can be reused.

“The FDA is investigating potential causes and contributing factors associated with reported infections and contamination issues from reprocessed urological endoscopes. 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,” said Jeff Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health. “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.

From Jan. 1, 2017 through Feb. 20, 2021, the FDA received over 450 reports describing post-procedure patient infections or other possible contamination issues associated with reprocessing these devices. In those reports that provided the name of the device manufacturer, either Olympus Corporation or Karl Storz were cited.

Olympus submitted three reports citing patient death from a bacterial infection that occurred outside of the United States. Two of those reports were associated with a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. Lab tests confirmed the same infectious bacteria was present in both the forceps/irrigation plug and in the patient with the infection. The third patient death report involved a cystoscope that did not pass a leak test, indicating possible damage to the device, which could have been an underlying factor in the infection.

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