The U.S. Food and Drug Administration (FDA) recently posted these news items:
Reprocessing Karl Storz Urological Endoscopes
The FDA is aware 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 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 urological endoscopes. The affected urological endoscopes should be sterilized after each use by an appropriate sterilization method recommended in the instructions for use. More Information.
Revised EUA Guidance for COVID-19 Vaccines
On March 31, 2022, the FDA revised its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19. The revised guidance updates recommendations for the clinical data to support effectiveness of a COVID-19 vaccine that has been modified to target a particular SARS-CoV-2 variant of concern. The revised guidance also provides the most up-to-date recommendations based on lessons learned during the COVID-19 public health emergency and submissions by sponsors. More Information.