USA – GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices

Standards development organization GS1 US unveiled an implementation guidance aimed at providing support for health care providers in capturing unique device identifiers (UDIs) for implantable devices.

The guidance takes up the issue related to the inability of electronic health records (EHRs) to handle UDI data, which the US Food and Drug Administration (FDA) has sought to achieve with a phased-in implementation of a nationwide UDI system. Yet having UDIs available for point-of-care (POC) scanning by health care providers became a legally-enforceable requirement under the 2013 UDI rule…