Karl Storz Recall
As you may be aware Karl Storz issued a recall regarding several of their scopes. In turn they issued updated sterilization protocols. The FDA recommendations pertaining to the recall and updated sterilization procedures are outlined below. If you have any questions or comments related to this, please reach out the FUS Executive Office at email@example.com.
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.
- Change in Reprocessing Methods with Certain Karl Storz Endoscopes. U.S. Food and Drug Administration. Published 2022. Accessed April 5, 2022.