| MedWatch - The FDA Safety Information and Adverse Event Reporting Program Today, the FDA issued an update to the previous safety communication on duodenoscopes to provide new information on completed postmarket surveillance studies (also known as 522 studies) as well as updated information on the transition to fully disposable duodenoscopes and those with disposable components. The FDA continues to encourage duodenoscope manufacturers to transition away from fixed endcap duodenoscopes to disposable/disposable component duodenoscopes with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes. Questions? If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE). | | | |
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