This week the U.S. Food and Drug Administration revealed it is probing several medical device reports (MDRs) of patient infections and other potential contamination problems related to reprocessing urological endoscopes, such as cystoscopes, ureteroscopes and cystourethroscopes—scopes for seeing and entering the urinary tract. Reprocessing these kinds of medical devices entails both cleaning and high-level disinfection or sterilization so the devices can be reused.
“FDA is looking at possible causes and contributing factors related to reported infections and issues with contamination related to reprocessed urological endoscopes,” stated Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We are seriously concerned about the three reported deaths—outside of the United States—linked to these infections, and we’re moving quickly to inform health care providers and the public about what we know and what remains an emerging issue.”.
“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 continued. “While we feel that the risk of infection is low based on data available, we’re reminding health care professionals how critical it is to adhere to labeling and reprocessing directions to thoroughly clean and reprocess the devices, including accessory components.”. We seriously consider all adverse event reports and urge reporting to the FDA early in order to assist us in identifying and understanding the risks of reprocessed medical devices better.”
Cystoscopes, cystourethroscopes and ureteroscopes are endoscopes used in urology that enable health care professionals to visualize and enter the urinary tract (e.g., urethra, bladder, ureters and kidneys) in diagnostic and treatment procedures.
From Jan. 1, 2017 to Feb. 20, 2021, more than 450 MDRs reported post-procedure patient infection or other potential contamination problems relating to reprocessing these devices have been received by the FDA. In those where the name of the device firm was given, either Karl Storz or Olympus Corporation were listed. MDRs may be submitted by mandated reporters, for example, importers and manufacturers and device user facilities, or by voluntary reporters.
Olympus filed three reports of patient death due to bacterial infection that had taken place outside the U.S. Two of those reports involved a forceps/irrigation plug, an accessory device used to manage water flow and allow access to the working channel of the endoscope. Laboratory tests revealed the same infectious bacteria in both the forceps/irrigation plug and the infected patient. The third report of patient death was a cystoscope that failed a leak test, suggesting potential damage to the device, which may have been a contributing factor to the infection. Whether and to what extent the reported infections or patient co-morbidities played a role in the patient deaths is unknown.
Note that MDRs alone are not the absolute proof of a defective or defective medical device and cannot be utilized to calculate or compare rates of event occurrence. The FDA continues to evaluate these reports, but the agency has not yet concluded that any particular manufacturer or brand of these devices is linked with increased risks compared to others.
The Letter to Health Care Providers released today offers guidance on how to reprocess and use these devices, such as adhering to the reprocessing instructions, not using a device that has failed a leak test, creating schedules for regular device inspection and maintenance, and informing patients of the possible benefits and risks of procedures involving reprocessed urological endoscopes.
Providing safety for reprocessed medical devices, which are utilized in more than one patient, is a collaborative effort between the FDA and other federal agencies, public health infrastructure, state and local health departments, medical device manufacturers, health care facilities, professional organizations and others. The FDA is actively involved to understand better the etiology and risk factors for transmission of infectious agents and to develop solutions to reduce patient exposure.
The measures the FDA is taking on urological endoscopes today draw from the agency’s experience with duodenoscopes. From 2015 on, the FDA has communicated and acted regarding duodenoscope infection related to reprocessing, including issuing postmarket safety studies and revising sampling and culturing requirements. The agency also refined its guidance in 2015 to cover more device types that require reprocessing validation data. The FDA has sent Warning Letters to manufacturers and safety communications to the public and health care providers and conducted a public Advisory Committee meeting soliciting information on how best to reprocess medical devices. In addition, the FDA has prompted manufacturers to switch to devices that have features eliminating the need for reprocessing and assisted manufacturers in revising and validating their reprocessing instructions.
The issues FDA has found with urological endoscopes and duodenoscopes might extend to similar devices. Accordingly, the agency is also examining data on other endoscope types.
The FDA will continue to provide updates to health care providers and the public if new or further information comes in about adverse events and other topics concerning reprocessing urological endoscopes.
The FDA, a branch of the U.S. Department of Health and Human Services, ensures the safety, effectiveness, and security of human and animal drugs, vaccines and other biologic products intended for human consumption, and medical devices. In addition, the agency ensures the safety and security of our food supply, cosmetics, dietary supplements, products emitting electronic radiation, and for tobacco product regulation.
