April 5, 2022

FDA: Reprocessing changes for certain Karl Storz urological endoscopes

Editor's Note

The Food and Drug Administration (FDA) on April 4 issued a letter to healthcare providers and users saying the agency is aware that current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by the company.

In the letter, the FDA notes that on April 1, Karl Storz initiated a voluntary recall and instructed users to:

  • discontinue all high-level disinfection methods for all affected urological endoscopes
  • discontinue liquid chemical sterilization methods for most affected urological endoscopes
  • sterilize the affected urological endoscopes after each use by a sterilization method recommended in the instructions for use.

The FDA says it sent the letter to ensure that healthcare providers and users are aware of the changes in reprocessing methods, and that it will continue to monitor reports of patient infections or contamination issues with urological endoscopes.

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