Here’s what you should know:
1. The washer and disinfector is intended for use with non-duodenoscope endoscopes only.
2. The FDA required the company to independently test its System 83 Plus water filtration system and inline disc filter.
3. The FDA also required independent testing for bronchoscopes and non-GI endoscopes. Custom Ultrasonics met all the criteria.
4. The company is still working with the FDA to validate System 83 Plus for duodenoscopes. The FDA said System 83 Plus shouldn’t be used for duodenoscopes in August 2016 after several superbug outbreaks.
More articles on gastroenterology:
Analysts predict the uncertain future of Ironwood Pharmaceuticals — 4 insights
GI center to know: Gastroenterology Associates
GI leader to know: Dr. Steven Condron of Avera Medical Group
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