GREY:TSTIF - Post by User
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echo2on Apr 13, 2019 10:52am
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News Coverage of FDA Statements April 12
News Coverage of FDA Statements April 12https://www.massdevice.com/fda-duodenoscope-reprocessing-is-dirtier-than-we-thought/ "The FDA said today that new data show that the contamination rate for “high-concern organisms” in duodenoscopes is nearly twice as high as previously thought and warned the devices three major manufacturers to get their required post-market studies in gear." “For example, we are exploring whether supplemental measures, such as sterilization, in addition to meticulous cleaning, might offer a more effective option." https://www.cnn.com/2019/04/12/health/medical-scopes-superbug-infections-fda-bn/index.html "The FDA is actively working with reprocessing experts, medical device manufacturers, and other government agencies to advance innovative ways to decrease infection related to duodenoscopes," the agency said in its safety communication.
Shuren added in a statement Friday, "But we're continuing to evaluate the benefit-risk profile of these devices, and we'd like to see strong evidence that proper cleaning and reprocessing can virtually eliminate any bacteria residue that can spread infections. Currently, that evidence is lacking, and we're considering what additional regulatory actions may be necessary."
CDC Health Infection Control Practices Advisor Committee will hold a 2 day Meeting May 16-17 open to public to discuss the situation and options (registration required in advance) https://www.cdc.gov/hicpac/meeting.html