News Items & Articles:
FDA RELEASES UDI FINAL RULE
The Food and Drug Administration published advanced notification of the final ruling on unique device identification (UDI) regulation.
CLICK HERE TO VIEW THE FINAL UDI REGULATION
Impact: The UDI rule in and of itself does not put any regulatory requirements on providers. However, providers are instrumental to a UDI system's success; if providers don't use the unique identifiers, much of the intended value of UDI will be lost.
Benefits: A unique medical device identifier will provide an important means for hospitals to better track medical devices for use in patient care, act in event of safety recalls, and manage their supply chains. UDIs also can be incorporated into electronic health records.
Reports, Pilots, Case Studies
- Data Standards Adoption Survey Report (PDF)
- Perfect Order and Beyond: BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Implementation (PDF)
- Report on the Data Standards Adoption Pilot Project Conducted by Center for Innovation in Healthcare Logistics (CIHL) at Washington Regional Medical Center
Standards Tools & Resources
- FDA Unique Device Identification (UDI) Online Resource Site
- Provider Toolkits for GS1 Standards
- Hospital Checklist for Software System Readiness for Implementing GS1 Standards (PDF)
- GS1 Healthcare US Implementation Guide
- LRIM Tool (Levels, Readiness, and Impacts Model – free tool allows providers to run various scenarios for GLN and GTIN adoption)
- GS1 Standards Advocates
- GS1 Healthcare US Website
- GS1 Healthcare Reference Book
- Standards Sunrise Dates