FDA Safety Alert about Infections Tied to Reprocessed Urological Endoscopes

On April 1, 2021, the US Food and Drug Administration (FDA) issued a safety alert in the form of a letter to health care providers regarding infections linked to reprocessed urological endoscopes. In this announcement, the FDA notes they have received numerous Medical Device Reports (MDRs) that describe patient infections post procedure or other possible contamination issues associated with reprocessing these devices.¹

“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.”² -- Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health

The problems the FDA has identified with urological endoscopes and duodenoscopes may apply to similar devices. Therefore, the agency is also reviewing information on other types of endoscopes.²

Since 2017, the FDA has received over 450 Medical Device Reports (MDRs) which describe patient infections post procedure or other possible contamination issues associated with reprocessing these urological devices.¹ Three of those adverse events included patient death; all three describe patients who developed Pseudomonas aeruginosa infections post procedure; one involved a cystoscope that did not pass a leak test.¹

FDA Recommendations (view full detail here):

• Carefully follow IFU reprocessing instructions, including precleaning, leak testing, cleaning, and either sterilization or disinfection + rinsing + drying
• Do not use damaged devices or those that fail leak test
• Develop schedules for routine inspection & maintenance
• Discuss benefits/risks associated with procedures involving reprocessed urological endoscopes with patients

Per the safety alert, "the potential causes and contributing factors associated with the reported infections or contamination issues are under review, including reprocessing methods, reprocessing instructions in the labeling, and device design."¹ They encourage health care providers to report any adverse events or suspected adverse events experienced with cystoscopes, ureteroscopes and cystourethroscopes devices using the MedWatch Voluntary Reporting Form.

Given overwhelming evidence of potential points of failure in endoscope reprocessing via traditional high-level disinfection, ASP’s recommendation is simple:

This aligns with FDA recommendations. U.S. Food and Drug Administration guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. Guidance for Industry and Food and Drug Administration Staff states, “Users should be instructed to thoroughly clean [semi-critical devices] and then reprocess them by sterilization. If the device design does not permit sterilization (e.g., device materials cannot withstand sterilization), then high level disinfection should be used.”³

Disinfection and sterilization is necessary to ensure the safe reuse of medical devices. Sterilization is a process that destroys or eliminates all forms of microbial life whereas disinfection eliminates many or all pathogenic microorganisms, except bacterial spores.

i ASP AEROFLEX^™ AER also comes standard with a water filter.

ii Does not eliminate pre cleaning or manual cleaning; Health Care facilities should follow their own policies and procedures related to the reprocessing of endoscopes to ensure they are complying with all steps recommended by the device manufacturers and are consistent with current standards and guidelines. Not all endoscopes can be automatically cleaned but may be high-level disinfected. It is recommended that endoscopes with open/closed elevator wire channels be manually cleaned as per manufacturer’s instructions in addition to using the cleaning cycle of the EVOTECH^® System. Please refer to the EVOTECH^® ECR User Guide and specific connection diagrams for more detailed information regarding cycle capabilities.

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Here are some resources available on the ASP website you can use to help educate your teams on these important issues.

• Endoscope Reprocessing Resource Hub
• Endoscope Reprocessing in the Age of COVID-19
• Challenges in Achieving Effective High-Level Disinfection in Endoscope Reprocessing
• Flexible Endoscope Reprocessing: The Journey of a Dirty Endoscope
• Vaporized Hydrogen Peroxide Gas Plasma Technology Explained
• Comparative Evaluation of the Microbicidal Activity of Low-Temperature Sterilization Technologies to Steam Sterilization
• Automatic Assurance Through ASP AEROFLEX™ AER with AUTOSURE™ MRC Monitor
• STERRAD® Sterility Guide
• Get model-specific scope connection diagrams from ASP today