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

Journal Journal of the American Medical Informatics Association
Authors Drozda, Joseph P.; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E.
Year Published 2017
Link to article

Abstract

OBJECTIVE: 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.

METHODS: Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors.

RESULTS: The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model.

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.

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

Read the article

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
Link to publication

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.

You’re invited to join the AHRMM Learning UDI Community High Risk Implant Work Group!

This Work Group is tasked with:

·         Defining criteria that identify high risk implants

·         Developing an API to be used to query the GUDID for the items that meet this criteria

The work of this group ties directly to the X12 proposal to include Device Identifiers (DI) in the claims forms and comments to the FDA recommending a more refined list of high risk implants whose DI would be included in claims, as opposed to all items/all DIs.

The LUC High Risk Implant Work Group Charter can be found at: http://www.ahrmm.org/resources/learning-udi-community/pdfs/work-groups/high-risk-criteria-implants-work-group-summary-statement-103116.pdf.

Please contact AHRMM (ahrmm@aha.org) with questions or if you are interested in joining this important Working Group or visit the Learning UDI Community website at: http://www.ahrmm.org/resources/learning-udi-community/index.shtml for information about other LUC Working Groups.