Letter to health care providers: change in reprocessing methods with Karl Storz endoscopes

The FDA issued an updated letter to health care providers regarding reprocessed urological endoscopes manufactured by Karl Storz.

The US Food and Drug Administration (FDA) is currently investigating the risk of patient infections and contamination issues associated with reprocessed urological endoscopes manufactured by Karl Storz—including cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes—used for viewing and accessing the urinary tract.1

In April 2021, the FDA announced reports describing patient infections post procedure and other contamination issues associated with reprocessing these devices. 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 products.

All health care providers must be aware of this change in reprocessing methods for certain urological endoscopes by Karl Storz. The FDA will continue to monitor reports of patient infections or contamination issues and work with the manufacturer to identify adequate reprocessing methods and instructions.

The FDA’s recommendations are as follows:

  • 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.

Reference

  1. Change in Reprocessing Methods with Certain Karl Storz Endoscopes. U.S. Food and Drug Administration. Published 2022. Accessed April 5, 2022.