Strategic Marketplace Initiative (SMI) Releases Summary Report: “Introducing UDI Labeling Strategies into the Surgical Setting”

Scituate, MA (October 8, 2015):    The Strategic Marketplace Initiative (SMI®) today released a summary report focused on introducing UDI labeling strategies for non-sterile implantable products in the surgical setting.  This report is the result of work organized by SMI, a leading healthcare supply chain organization, and a team of manufacturers, providers, and expert collaborators. This industry resource is available at no-charge on the SMI website:

In early 2015, SMI was asked to work with surgeons and surgical professionals to gather user input on the impact of unique device identification labeling strategies for non-sterile implants. SMI compiled a team from healthcare provider organizations, device manufacturers, industry experts and clinicians. This SMI team worked for over six months to plan and execute the simulation of two surgeries using three UDI labeling strategies:  (1) Implants in procedural trays with corresponding inventory sheets, (2) Implants with the UDI direct marked on the product; and (3) implants delivered in sterile packaging.   The simulated surgeries, along with feedback from surgical teams, helped the SMI team better understand the impact of these labeling strategies and to determine if these strategies enable the UDI product data to be captured and recorded successfully. The team compiled their findings and recommendations for the industry into the report.   

Dennis Orthman, SMI Senior Director said, “SMI was pleased to coordinate this collaboration of surgical professionals, providers, manufacturers, and experts. We believe the collective findings represent another positive step forward in the industry-wide effort to adopt and use unique device identification. The special nature of smaller implantable devices, combined with the traditional processes to manage the supply chain of these devices, represents a significant challenge that requires all stakeholders to continue working together to seek effective solutions.”  

This summary report is available for download, at no cost on the SMI website at:  This resource, along with 29 other downloadable tools and solutions are available on the SMI website, and are designed to help industry professionals address real supply chain issues and challenges.