Health Affairs March 7, 2023
A Unique Device Identifier (UDI) is an individualized alphanumeric signature associated with a single medical device. Since 2013, the Food and Drug Administration (FDA) has mandated the placement of UDIs on Class II and III medical devices. As only a few institutions are actually tracking UDIs, their tremendous potential to transform patient care, quality, safety, and research remains largely unrealized.
In this article, we propose that the Centers for Medicare and Medicaid Services (CMS) mandate inclusion of a UDI in billing claims so that hospitals are incentivized to build UDI capture systems. We further highlight five key areas in which this data capture will transform surgery: (1) improving quality and safety, (2) facilitating collection of real-world evidence, (3) ensuring price...
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