FDA Alert: Change in Reprocessing Methods for Certain Karl Storz Urological Endoscopes

The U.S. Food & Drug Administration recently issued a letter to healthcare providers regarding changes to reprocessing methods for certain urological endoscopes manufactured by Karl Storz, due to infection risk. The letter can be found here. An excerpt follows:

“As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being changed updated by Karl Storz. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.”

The letter continues, “In April 2021, the FDA communicated about reported patient infections and possible contamination issues with reprocessed urological endoscopes. At the FDA’s request, Karl Storz conducted reprocessing validation testing on a sample of flexible urological endoscopes and identified reprocessing failures following high-level disinfection. Inadequate reprocessing of urological endoscopes may increase the risk of patient infection.”

The letter adds: “On April 1, 2022, Karl Storz initiated a voluntary recall and issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all affected urological endoscopes and discontinue liquid chemical sterilization for most of the affected urological endoscopes. The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use. The FDA wants to ensure that healthcare providers and users are aware of the change in reprocessing methods for certain urological endoscopes by Karl Storz. The FDA will continue to monitor reports of patient infections or contamination issues with urological endoscopes, and work with manufacturers on adequate reprocessing methods and instructions.”

The FDA recommends the following:

• Review the recall notice from Karl Storz.
• Do not use high-level disinfection methods or liquid chemical sterilization to reprocess affected urological endoscopes.
• Sterilize affected urological endoscopes after each use by using sterilization methods recommended in the instructions for use specific to each device.
• Do not use affected urological endoscopes if you do not have access to an appropriate sterilization method recommended in the instructions for use. Karl Storz will provide instructions for returning the affected endoscopes.
• Be aware that Karl Storz will provide updated instructions for use for affected urological endoscopes.
• Do not use damaged devices or those that have failed a leak test, as they could be a potential source of contamination.
• Develop schedules for routine inspection and regular maintenance as specified in the manufacturer’s instructions.
• Discuss the benefits and risks associated with procedures involving reprocessed urological endoscopes with your patients.