Mercy Health Demonstration Project: Published in JAMIA

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

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Conclusion: The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model.