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Insights from the FDA UDI Conference

December 7, 2011 | Blog | 0 comments

I attended the U.S. Food and Drug Administration’s (FDA) UDI Conference last week in Cambridge, viagra Mass. on behalf of my client GHX, where representatives from across the healthcare industry (healthcare providers, device manufacturers, regulators, trade associations, distributors, GPOs, etc.) came together to discuss how they would comply with the FDA’s pending UDI rule and what benefits stakeholders could derive from the use of unique device identifiers (both in the operational and clinical realms).

The industry has been anxiously awaiting the proposed rule, which, according to Jay Crowley, Sr. Adviser for Patient Safety with the FDA Center for Devices and Radiological Health, could be out before the end of this year. During his keynote presentation, Crowley noted that the agency is still anticipating that the final rule will be issued in the fall of 2012.

During the conference presentations, providers and suppliers expressed their unique challenges around UDI implementation and there was some finger pointing/accusations on why healthcare is in such a bad state in the first place when it comes to device tracking – one provider even suggested that hospitals should charge device manufacturers for the time/labor required to manage product recalls (you can imagine the eye rolling among the suppliers in the audience).

But despite the differing opinions, just about everyone in attendance agreed that an industry-wide solution to device tracking requires providers and suppliers to put aside their differences and work together. Everyone stands to benefit from the FDA’s UDI system but only if everyone puts it to use

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. As one presenter stated – “a standard isn’t a standard unless everybody is using it.”




Kara L. Nadeau

Founder and President of KLN Communications, Inc.

http://www.klncommunications.com