The U.S. FDA is continuing to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, and is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by the company.
The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes, and ureterorenoscopes, used for viewing and accessing the urinary tract.
The FDA says it wants to ensure that health care providers and users are aware of the change in reprocessing methods for certain urological endoscopes by Karl Storz.
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 noticeExternal Link Disclaimer 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 will continue to monitor reports of patient infections or contamination issues with urological endoscopes, and work with manufacturers on adequate reprocessing methods and instructions.
Other recommendations by the FDA Include:
- 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.
The FDA recommendations from the April 2021 letter to health care providers have not changed for reprocessed urological endoscopes by other manufacturers.
The Administration says it 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 will continue to keep health care providers and the public informed if new or additional information becomes available.