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Unique Device Identification (UDI) Across The Device Landscape

3 April 2020

This session will discuss the current status of the US and Global UDI System, how UDI continues to be integrated into public policy, software applications, data and device communication standards to enhance data used for supply chain, clinical and regulatory decision making. In 2013 the FDA published the UDI regulation requiring device manufacturers to apply a unique device identifier to the label of most medical devices and to submit data to the FDA’s Global Unique Device Identification Database. AccessGUDID, the public portal for GUDID, contains over 2.5 million device model records. Vendors are beginning to take advantage of this global identifier, scanning the UDI to reduce patient exposure to expired and recalled product and to monitor long term outcomes. While there is no specific requirement that UDI be integrated into personal health or point of care devices, it is clear that in order to better track use of these devices, UDI data must flow smoothly from these devices to consuming applications this needs to be accomplished. Fortunately, standards from ISO/IEEE 11073 and IHE PCD are already well-positioned for this eventuality and will be discussed.


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