April 11, 2018

FDA: System 83 Plus AERs complete validation testing

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on April 10 notified healthcare facilities that Custom Ultrasonics (Ivyland, Pennsylvania) has completed validation testing of the System 83 Plus (ie, System 83 Plus, System 83 Plus 2, and System 83 Plus 9) automated endoscope reprocessors (AERs) with specific duodenoscopes.

The FDA has determined that the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V and the Pentax ED-3490TK duodenoscopes. The System 83 Plus is not validated for reprocessing of Fujifilm duodenoscopes or duodenoscopes with open elevator wire channels.

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