Custom Ultrasonics' controversial automated endoscope reprocessor receives limited duodenoscope approval — 4 insights

The FDA granted Custom Ultrasonics' System 83-plus Automated Endoscope Reprocessor approval to reprocess Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes.

Here's what you should know:

1. Custom Ultrasonics completed a series of validation tests, confirming System 83 can clean and disinfect these models to a high degree.

2. All centers must follow the instructions in the updated operator's manual which describes the newly validated process.

3. System 83-plus cannot be used to reprocess Fujifilm duodenoscopes or duodenoscopes with open elevator wire channels.

4. The FDA and Custom Ultrasonics have been embroiled in a dispute since January 2007 over System 83-plus. The automated endoscope reprocessor has been recalled multiple times, and the FDA has been working with Custom Ultrasonics to get the system and the company back in regulatory compliance.

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