White Paper: Examining UDI Capture & Orthopedic Implants

In 2016, GS1 US® established the Orthopedic Implant Workgroup to support industry’s effort to analyze challenges to making the full U.S. FDA Unique Device identifier (UDI) for non-sterile orthopedic implants available at the point-of-use. The Workgroup was comprised of device manufacturers, healthcare providers, and hardware and software solution providers. The goal of the Workgroup was to examine current processes to identify requirements and challenges to maintaining UDI Device Identifier (DI) and Production identifier (PI) information with the implant, and evaluate UDI capture options in terms of benefits and challenges from both the manufacturer and provider perspective.