The letter comes after a year of reprocessing validation testing and a voluntary medical device recall.
Today, the U.S. Food & Drug Administration issued a letter to health care providers about the change in reprocessing methods for certain urological endoscopes manufactured by Karl Storz. The administration warns about the risk of infections associated with urological endoscopes, and it has received many Medical Device Reports (MDRs) possible contamination issues associated with reprocessing these devices, including patient infections post procedure.
On April 1, 2022, Karl Storz initiated a voluntary urgent medical device recall of certain urological endoscopes. The company also issued an urgent field safety notice to instruct users to discontinue all high-level disinfection methods for all the Karl Storz affected urological endoscopes. The safety notice also said to discontinue liquid chemical sterilization for most of the affected urological endoscopes; instead, they should be sterilized after each use by an appropriate sterilization method as recommended in the accompanying instructions for use.
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 FDA letter states, “The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.”
After the FDA posted an earlier letter in April 2021, “about reported patient infections and possible contamination issues with reprocessed urological endoscopes, Karl Storz conducted reprocessing validation testing on a sample of flexible urological endoscopes and identified reprocessing failures following high-level disinfection,” the letter today said. “Inadequate reprocessing of urological endoscopes may increase the risk of patient infection.”
In March 2022, the question of sterilization and quality control processing for endoscopes led to the American National Standards Institute (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) updating their guidance for disinfection/sterilizing, storage, and quality control procedures of medical devices with the assistance of more than 100 experts.
Key recommendations include not using high-level disinfection methods or liquid chemical sterilization to reprocess affected urological endoscopes. Users must sterilize affected urological endoscopes after each use by using sterilization methods recommended in the instructions for use specific to each device. The affected urological endoscopes should not be used without access to an appropriate sterilization method recommended in the instructions for use.
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. Adverse or suspected adverse events are encouraged to be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.