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: