Questions Remain On Incorporating UDIs Into Health Care System

Article preview from "The Gray Sheet"- November 27, 2013

As part of implementation of unique device identifier requirements, hospitals will need to capture the unique codes in electronic health records and claims forms, but the logistics of doing so are still being worked out.

Questions Remain On Incorporating UDIs Into Health Care System

Article preview from "The Gray Sheet"- November 27, 2013

While companies prepare to implement the unique device identification requirements, questions remain on how the UDIs will be incorporated by hospitals into electronic health records and insurance claims forms. Those steps are essential for UDIs to fulfill their intended purpose of improving device surveillance and data collection, and aiding in recalls and adverse event reporting.

Device companies have until September 2014 to ensure all class III devices have a UDI entered into FDA’s global UDI database under a rule issued in September. They have until 2015 for class II/I implantable and life-sustaining/life-supporting devices, 2016 for remaining class II devices, and 2018 for remaining class I and nonclassified devices.

FDA was the central player in finalizing the regulation, creating the global database and issuing a draft guidance document to help companies move forward with the requirements. But a crucial next step for UDI implementation is to ensure that hospitals and other providers put the identifiers to real-world use, and that is, to some extent, out of FDA’s control.

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