April 4, 2022
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.
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 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 health care 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.
- 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.
The FDA recommendations from the April 2021 letter to health care providers have not changed for reprocessed urological endoscopes by other manufacturers.
Urological endoscopes are used by health care providers to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract (for example: urethra, bladder, ureters, and kidneys) depending on the intended use and design of the device.
Since 2017, the FDA has evaluated medical device reports that describe patient infections post-procedure or other possible contamination issues associated with reprocessed urological endoscopes. There are multiple possible root causes for these issues, including inadequate reprocessing or maintenance issues (for example, device failed leak testing), reprocessing instructions in the labeling (including cleaning of accessory components), and device design (including specific device components). Based on the available data, we continue to believe the risk of infection is low. However, health care providers and users should be aware that patient infections associated with reprocessed urological endoscopes can and do occur.
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 health care providers and the public informed if new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with reprocessed urological endoscope devices.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE):
- Email: [email protected]
- Phone: 800-638-2041 or 301-796-7100
- April 1, 2021: Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers