Standards development organization GS1 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.
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.
UDI will be soon fully implemented in Europe, as it is one of the MDR cornerstones and novelties. So, the above strategies and guidance might be most likely also followed in the EU. Would you like to be constantly informed about the UDI implementation and about all the necessary changes to your Technical documentation related to it, please contact our Medical Devices Regulations experts. Obelis will be delighted to assist you and to help you preparing to face this new Compliancy challenge.
Turchi Davide