FDA Updates Information on Automated Endoscope Reprocessors

November 29, 2016

Earlier this month, the Food and Drug Administration (FDA) updated its webpage, “Information About Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation” to communicate that Medivators’ CER Optima AER shows adequate validation test results for open and closed channel duodenoscopes. The FDA is looking into all critical factors contributing to patient infections associated with exposure to duodenoscopes and how best to mitigate them, including how AERs are used in clinical settings. The FDA continues to update the “AER Validation Testing Status” section of the webpage as it accepts validation test results from AER manufacturers.