Automated reprocessors validated for use in specific duodenoscopes

The FDA had requested validation testing data from all companies that have automated endoscope reprocessors labeled to reprocess endoscopes because of the potential association with patient infection.


System 83 Plus automated endoscope reprocessors (AERs) by Custom Ultrasonics may now be used to process certain duodenoscopes, the FDA announced on April 10.

The agency had requested validation testing data from all companies that have AERs labeled to reprocess endoscopes because of the potential association between reprocessed endoscopes and patient infection.

The FDA determined that the data show that the AERs can achieve high-level disinfection of the Olympus TJF-180V and Pentax ED-3490TK duodenoscopes. The AERs are approved to be used with only these types of duodenoscopes. The FDA has created a webpage for posting up-to-date information about AERs and reprocessing validation.