Recently, several colleagues have asked me if I think healthcare will ever fully adopt unique device identifiers. I can certainly understand their skepticism - after all it has been more than a decade since the U.S. FDA UDI rule was published with relatively little uptake beyond what was required by regulation - but I do not share their pessimism. There are just too many agreed upon healthcare priorities, such as improved supply continuity, post market surveillance, and demand planning, that UDI is key to achieving.
My optimism is supported by a new collaboration between two trade associations – AHRMM and SMI – that is based on their shared commitment to work with the FDA to maximize “implementation and use of the Unique Device Identifier (UDI) as a means to enhance patient safety, inform medical research through the use of real-world evidence, improve supply chain efficiency, and reduce costs.” Together, the associations plan to bring together multiple stakeholders from across the supply chain and clinical worlds to develop resources to advance the use of UDI in their respective settings.
During the most recent SMI Forum, providers and suppliers came together to discuss the new collaboration and consider the two primary pathways to UDI implementation (see image [POSITION]). One is focused on clinical improvement and regulatory compliance, while the other looks to support supply chain efficiency, but both require coordination and collaboration between providers and suppliers. Further, advancements in supply chain adoption of UDI can play an important role in supporting the clinical use cases for the standard identifiers. For example, supply chain as the keeper of the system of record for product information can ensure UDIs are included in the item master and other ERP supported systems, which in turn supports capture of UDIs in electronic health records. Knowing which devices were used on which patients is foundational to clinical research to understand the role of products in delivering better quality care and financial research to understand the true costs of care delivery, both of which were identified as key benefits of UDI by the forum participants.
Use of standard product identifiers can also play an important role in supporting inventory management, demand planning, and supply continuity. For example, during the pandemic, if providers had reported their burn rate and inventory levels of critical products using UDIs and if manufacturers, distributors, and the U.S. Strategic National Stockpile had used UDIs to manage inventory and logistics, we may have been able to better ensure products in short supply were delivered where they were needed most.
Those attending the UDI session also listed lack of a clear ROI for UDI as the biggest barrier to broader adoption. This is where the disconnect between UDI and its role in achieving other strategic objectives presents a problem. There is no real ROI for UDI adoption in and of itself. Instead, value is derived from using the UDI for things like measuring the cost per case, responding faster to recalls, and improving inventory management and demand planning.
Once this relationship is better understood, providers and suppliers can incorporate UDI into business cases and work plans to achieve those broader objectives. Along the way, the new collaboration between SMI and AHRMM plans to develop quick start guides to help providers and suppliers with the various steps, such as incorporating UDI in item masters and ERP systems, in EDI transaction sets, and in inventory management and contracting systems.
