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.

 

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank

Journal Healthcare
Authors Terrie L. Reed, Joseph P. Drozda Jr., Kevin M. Baskinc, James Tcheng, Karen Conway, Natalia Wilson, Danica Marinac-Dabic, Theodore Heise, Mitchell W. Krucoff
Year Published 2016
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Abstract

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.

The mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system

Journal Healthcare
Authors Joseph P. Drozda Jr., Curtis Dudley, Paul Helmering, James Roach, Lisa Hutchison
Year Published 2016
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Summary

This article examines results of the FDA-sponsored UDI demonstration where prototype UDIs of coronary stents were scanned and captured in Mercy’s electronic information system. The demonstration revealed improved inventory management and cardiac catheterization laboratory supply tracking. The resulting benefits of incorporating UDIs into the electronic information system included preventing procedure delays, lowering cost, and increasing revenue. Challenges with the demonstration ranged from technology integration to inventory management application and data limitations. The authors conclude the UDI system can be extended to all medical devices and implemented in most hospitals.