FDA updates information about AERs


The U.S. Food and Drug Administration (FDA) has updated the “Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation” webpage to communicate that Medivators’ CER Optima AER shows adequate validation test results for open and closed channel duodenoscopes. The FDA continues to update the “AER Validation Testing Status” section of the webpage as it accepts validation test results from AER manufacturers. Read more about FDA’s evaluation of AERs.

<< return to Advocacy Updates