FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors
This article was originally published in The Gray Sheet
The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.
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Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.
The US agency issued a safety communication Aug. 17 advising all health care facilities to stop using Custom Ultrasonics' System 83 Plus automated endoscope reprocessors to reprocess duodenoscopes, although facilities may continue to use the AERs to clean and sterilize other flexible endoscopes.
Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.