Implementation Guidance: Point-of-Care Scanning
As medical device labelers mark their products with unique device identifiers (UDIs) per the U.S. Food and Drug Administration’s (FDA) Unique Device Identification Rule*, these UDIs are available for point-of-care (POC) scanning by healthcare providers.
Many labelers have chosen to use GS1 Standards to implement the U.S. FDA UDI 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.).
This guidance document was developed to support U.S. healthcare providers using GS1 Standards to implement of point-of-care scanning systems and capture unique device identifiers for implantable devices. It provides an implementation overview, defines data and system readiness recommendations, identifies key implementation steps, and delivers a summary of GS1 Standards as well as GDSN attributes that support POC scanning.