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Will There be More Changes in the Expectations for Reporting Adverse Events Based on the Implementation of UDI?

Jean Sargent, Vice President of Healthcare Strategy and Implementation at USDM Life Sciences says adverse events reporting will become more and more imperative for all of the healthcare providers, as well as the medical device manufacturers. The FDA doesn't regulate the hospitals, so they can take it to a certain point. I'll liken it back to 2000. In 2000, being on the central service side, I was very involved when the FDA said "You can no longer manufacture your own product."

The FDA actually did start going into hospitals and making sure that the hospitals were not manufacturing their own product. There's going to be some way that the FDA is going to work with hospitals, to make sure they are capturing this information and therefore, reporting this information.

Now whether they end up using the joint commission or they end up using Medicare that demands having that UDI information for reimbursement - there will be methods that will be coming up down the road that will drive the adoption and implementation of the UDI within the hospitals.

USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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