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 transparency, (4) promoting health equity, and (5) improving outcomes research. The Landscape In 2013, the FDA mandated that medical device manufacturers assign a UDI to each device. The UDI is a numeric or alphanumeric code printed onto the device packaging. Each UDI contains two components: the device identifier (DI) and the production identifier (PI). The UDI not only allows one device to be distinguished from another (through the DI) but also provides clear information on when the device was […]
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