Healthcare Matters

Earlier this month, the FDA released a proposed rule that medical devices distributed in the United States carry a unique device identifier, or UDI. A 120-day comment period, lasting until November 7, 2012 will allow industry stakeholders to digest, comment and perhaps shape the proposed new ruling. We’ve provided a great deal of coverage to the proposed ruling, as the promise it holds for the healthcare supply chain is, in fact, transformative.

Editors Note: Most recently, we benefited from a series of guest posts from Karen Conway, executive director of industry relations for GHX and editor of The Healthcare Hub. In order, here are the links to her three part series. Part I, Part II, Part III.

The Strategic Marketplace Initiative (SMI) is a “consortium of executives representing healthcare providers; medical products, pharmaceuticals and supply chain distribution companies; and service businesses united to reengineer and advance the future of the healthcare supply chain…” SMI is a not-for-profit 501 (c) (6) that does a great job interacting with its members and sharing what it learns. The company has an excellent reputation for living up to its charter; it has achieved critical industry mass and the collaboration it facilitates is widely acknowledged as valuable.

So it’s highly appropriate and a very good thing that SMI has decided to create and host a UDI Community Bulletin Board. It’s not only right-on-time, providing SCM professionals a forum throughout the FDA’s “comment period,” but I think it’s safe to assume that a gathering place like this can become a hugely valuable resource by shedding light on the tricks, traps, standards and best practices that will define UDI implementations.

Tom Hughes, Executive Director of SMI said, “We encourage all members of the healthcare supply chain community to use this new on-line forum to promote an open, active dialogue about the proposed UDI ruling.  SMI wants to help everyone understand and share information about the impact, concerns, and challenges that UDI adoption may present.”

SMI is a GS1 Healthcare US Advocate and has been an early supporter of data standards adoption in the healthcare supply chain.  This new UDI Community Bulletin Board, designed to promote a professional exchange and sharing of opinions, will be in operation during the FDA’s 120 day comment period, which runs until November 7, 2012.  The healthcare supply chain community and the public at large are encouraged to utilize the Bulletin Board to post their comments and related information about the UDI ruling. As said, let’s hope they keep the site up indefinitely.

—Tom Finn