SMI, AHRMM, Form UDI workgroup in partnership with the FDA

July 19, 2024- Strategic Marketplace Initiative (SMI®), the Association for Health Care Resource & Materials Management (AHRMM), have co-developed a collaborative workgroup in an effort to re-energize and re-focus the Unique Device Identification (UDI) system, and to move the industry forward regarding UDI implementation. The UDI system was established in 2013 by the FDA to identify medical devices in the United States from manufacturing to patient use and its adoption and use will result in improvements in managing device recalls, submitting claims, ensuring accuracy of implant registers, all resulting in better patient care, outcomes and safety.

SMI began their journey with the UDI system in early 2015 working with surgeons and surgical professionals to gather user input on the impact of UDI labeling strategies for non-sterile implants. SMI Executive Director, Jane Pleasants, explained “SMI has been focused on advancing UDI for many years. 2024 is SMI’s 20th Anniversary, so this is the perfect time to refocus our efforts with this dedicated workgroup in partnership with AHRMM” The workgroup consists of provider and supplier members from the SMI community, as well as representatives from AHRMM’s Learning UDI Community (LUC), and participation by the FDA.

The AHRMM LUC, established in 2017, is a health care collaborative effort designed to address issues impacting the adoption and implementation of the UDI by developing a common understanding and approach thereby providing a more consistent, consensus-based processes across the health care ecosystem.

Guided by SMI’s Key Strategic Collaboration Council, one of the first efforts of the workgroup will be to create quick start guides which will be released later this year. Nancy LeMaster, AHRMM LUC Advisor said “UDI Quick Start Guides will provide a framework for other organizations to implement UDI, along with additional resources including AHRMM’s LUC training video and NESTcc UDI Playbook”.

Karen Conway, CEO of Value Works, expressed her confidence in the widespread adoption of UDI, citing strong support from this new collaboration.  Conway said, “Together, these two organizations plan to bring multiple stakeholders from across the supply chain to develop resources to advance the use of UDI. During the most recent SMI Forum, providers and suppliers came together to discuss this new collaboration and to consider the two primary pathways for UDI implementation.” SMI members meet twice annually at Forums to discuss industry challenges and share learnings and best practices.

To learn more about UDI Adoption and Implementation visit: Learning UDI Community | AHRMM

To learn more about SMI, visit:  www.smisupplychain.com

To learn more about AHRMM, visit: Advancing the Health Care Supply Chain | AHRMM

To learn more about the FDA’s work on UDI visit: UDI Basics | FDA

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