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.
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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.
On April 1, 2022, Karl Storz initiated a voluntary recall and issued an urgent field safety 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 will continue to work with Karl Storz to evaluate the root cause of reprocessing failures, and to ensure that an adequate supply of urological endoscopes are available for users and patient care.
The FDA continues to work with other device manufacturers to evaluate potential causes and contributing factors for patient infections associated with reprocessed urological endoscopes and develop mitigation measures to minimize the risk of infection.
The FDA will continue to keep healthcare providers and the public informed if new or additional information becomes available.
