GS1 Standards

GS1 Standards In Healthcare: Medical Devices

As medical device manufacturers mark their products with unique device identifiers (UDI) per the U.S. Food and Drug Administration’s (FDA) UDI Rule, these UDIs are available for point-of-care (POC) scanning by healthcare providers. Many manufacturers have chosen to use GS1 Standards to implement the rule. Thus, for many healthcare providers, their first experience using GS1 Standards in their operations will come from the implementation of POC scanning systems to capture UDIs from implantable devices.

To support this effort, GS1 US® established the GS1 Healthcare US® Point of Care Scanning Workgroup to gather feedback from providers who have implemented or are in the process of implementing GS1 Standards for POC scanning, and solution providers of associated supporting systems (e.g., scanning, electronic health record (EHR), enterprise resource planning (ERP), device inventory management systems, POC, etc.).

The Workgroup:

  • examined key aspects of a POC scanning project,
  • gathered implementation insights and lessons learned (e.g., challenges, issue resolution steps, key enablers, etc.), and
  • identified key steps that can be used to plan an implementation project (e.g., assessment of current state, communication plan, data readiness, etc.).

The culmination of that work was the development of this guidance document to support healthcare providers implementing POC scanning systems using GS1 Standards.

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