FDA supports transition to fully disposable duodenoscopes, components

FDA supports transition to fully disposable duodenoscopes, components

The FDA has issued an updated safety communication supporting the transition to fully disposable duodenoscopes and those with disposable components.According to data from 522 completed post-market surveillance studies, the use of removable components to facilitate cleaning leads to decreased contamination compared with older duodenoscope models (0.5% vs. 6%). Given cleaning concerns, the updated safety communication recommends the use of innovative scopes that facilitate or eliminate the need for reprocessing.Although manufacturers no longer market fixed endcap duodenoscopes in the U.S.,Read More

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