A consulting approach to unique device identifier (UDI) adoption

The Food and Drug Administration (FDA) has mandated all medical device manufacturers to label their products with a unique device identifier (UDI) and update a global device database (GUDID) with a broad category of product information. Once fully adopted, the UDI system will improve patient safety and bring about a host of other significant benefits, including the ability to trace a medical device as it moves through the healthcare ecosystem right from the device manufacturer all the way to insurance claim records.

However, UDI adoption is not a simple IT transformation project. It requires changes to processes (production, operations, data management etc.) as well as the way in which the organization is managed. This point of view describes the changes required from an organization perspective and details out the ideal strategy for UDI adoption. The future of healthcare, in a fully UDI-compliant state, is also envisioned in the form of an illustrative use case.

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