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.

The Workgroup set out to satisfy this goal through three efforts:

  • Detailed analysis of data and device process flows
  • Site visits to hospitals to observe a live orthopedic surgery to enhance the participants’ understanding of the complexity of the operating room environment where the UDI is to be captured
  • Analysis of the various options for feasibility, benefits and challenge from the perspective of manufacturer and provider based on the process flows and site visit experiences

This white paper serves to document the Workgroup’s analysis, impressions, and insights in order to support the on-going industry efforts identify solutions to the challenges.

Download Release 1.1 >

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U.S. FDA UDI Rule

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Healthcare Providers

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