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US FDA Says Custom Ultrasonics Device May Be Used To Disinfect Certain Duodenoscopes

 
• By Sue Darcey

Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.

US FDA notified health-care facilities April 10 thatCustom Ultrasonics Inc.'s System 83 Plus automated endoscope reprocessors (AERs) can effectively achieve high level disinfection of the Olympus Corp. TJF-180V and the Pentax Medical ED-3490TK duodenoscopes. However, the System 83 Plus is notvalidated for the reprocessing of Fujifilm Medical Systems USA Inc. duodenoscopes, or duodenoscopes with open elevator wire channels, FDA stated in the April 10 notice.

The decision comes as a partial resolution of a Nov. 12, 2015, action by FDA, when the agency issued a rare recall order to Custom Ultrasonics to remove all of its AERs from health-care facilities due to Custom Ultrasonics' violations of the FD&C Act, and violations of a 2007 consent decree with FDA involving use of the AERs. Also see "FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors" - Medtech Insight, 16 November, 2015

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