UDI and Regulators: Enhanced Safety Analyses

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UDI and Regulators: Enhanced Safety Analyses

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A pilot project from Mercy, a high-performing health system in the Midwest, integrated unique device identifiers (UDIs) into hospital inventory systems and patients' medical records. The pilot helped improve safety, enhance care quality, and support operational efficiencies. If adopted more broadly, the UDI system can benefit the entire health care system.

Joseph Drozda Jr., M.D., director of outcomes research at Mercy and leader of the UDI pilot project, explains some of these benefits. For example, when captured in claim forms and electronic health records, UDI can help FDA track down patients who have received faulty, failed, or recalled devices.