Urological Endoscope Recall and Updated Reprocessing Guidelines

 

To: Hospital and ASC healthcare providers     From: HFEMSD   The FDA notified healthcare providers on April 4, 2022, that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by Karl Storz. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.   On April 1, 2022, Karl Storz initiated a voluntary recall 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 notification updates an April 1, 2021, letter to healthcare providers about medical device reports that describe patient infections post-procedure or other possible contamination issues associated with reprocessed urological endoscopes. There were 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). At that time, FDA assessed the risk of infection to be low.    Health care providers and users should be aware that patient infections associated with reprocessed urological endoscopes can and do occur, and always carefully follow the reprocessing instructions described in the manufacturer’s instructions for use.   A HAN is being issued to all participating Colorado healthcare providers outlining the details of the recall and updated reprocessing guidelines.   Healthcare providers are asked to report any infections following Karl Storz endoscope use to both CDPHE and the FDA (reporting instructions in the link below).   For any regulatory questions or concerns please reach out to Erica Brudjar - erica.brudjar@state.co.us   Please report associated infections to CDPHE’s HAI program by calling 303-692-2700 (303-370-9395 after hours) or emailing Kristen Marshall at kristen.marshall@state.co.us. FDA Recall notice and reporting instructions.