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

Posted 31 January 2019 | By Ana Mulero 

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.

“Many manufacturers have chosen to use GS1 standards to implement the US FDA UDI rule,” according to GS1. “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.” GS1 said it established a POC scanning working group to support this effort.

The guidance is a result of the feedback the working group gathered from providers who either already implemented GS1 standards for POC scanning or are in the process of doing so, as well as EHR vendors. It sets forth two essential implementation efforts related to data readiness and system readiness.

“The ability for hospitals to scan surgical implant UDIs is essential to realizing the full benefits” of FDA’s UDI rule, said Angela Fernandez, VP of community engagement at GS1 US. “POC scanning not only saves time and increases accuracy, but it also helps improve patient safety. When accurate data and implant identification is stored in the patients’ EHRs, providers can facilitate better care.”

Guidance

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