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Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration

2017; Oxford University Press; Volume: 25; Issue: 2 Linguagem: Inglês

10.1093/jamia/ocx041

1527-974X

Joseph P. Drozda, James Roach, Thomas Forsyth, Paul Helmering, Benjamin Dummitt, James E. Tcheng,

Biomedical and Engineering Education

The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration's informatics architecture.