Specific, Measurable, Achievable, Results-oriented, Time-bound. SMART is a working group focused on supporting pilot projects that will result in improved capture and exchange of unique device identifiers (UDIs) and other structured device data across the medical device ecosystem.

The SMART pilot projects are the result of the MDEpiNet hosted SMART Informatics Think Tank held February 24-25, 2015. The Think Tank included participation from stakeholders representing expertise in every domain of the medical device ecosystem—patients, clinicians, hospitals and healthcare systems, medical device manufacturers, multiple government agencies, vendors of electronic health records (EHRs) and other technology vendors, informaticians, academic researchers, and payers.

The original goal was creation of six pilot projects that would improve the ability to evaluate medical devices through improved data capture at the point of use. During ongoing project team meetings, the SMART working group recognized the value of collaborating and merging the teams into three pilot projects based on device type.

These pilots will share common resources and learning through a coordinating or data learning center that will provide access to standards, lessons learned, and tools for use in all device areas.

The SMART pilot projects are in various stages of funding readiness, but each have defined project plans and a commitment to coordinating their efforts to show how UDIs will improve patient care and healthcare system operations.

VANGUARD Venous Access: National Guideline and Registry Development
Electronic Health Record (EHR) Minimum Data Set

If you would like to participate in the SMART project, contact


VANGUARD is designed create a national/international central venous access registry including creation of domain-specific supplemental data elements. The VANGUARD proposal will follow a similar parallel design to BUILD using clinical data and structured capture of UDI as a means to populate a clinical registry. VANGUARD will include a broader range of clinical specialties by focusing on central venous catheters, which are not as well documented as cardiac catheters.

Funding: The Society of Interventional Radiologists provided funding for VANGUARD to meet and further refine the pilot and seek additional funding sources.

Baskin_KevinKevin Baskin




durack_jeremyJeremy Durack



EHR Minimum Data Set

This pilot is designed to develop an initial core EHR device-focused minimum data set that can be reused by all SMART Working Group pilots.

As such, the EHR minimum data set pilot will be a cornerstone in the establishment of a SMART Data Coordination Center with a mission to define, document, and archive tools, alliances, and lessons learned from the SMART pilots into a public domain archival library.

Funding: This pilot will be staffed by a project manager donated by Cook Medical and will coordinate existing activities funded by the Office of National Coordinator for Health IT, American College of Cardiology, National Library of Medicine, and the FDA Unique Device Identification Informatics Team.

Kathleen-HewittKathleen Hewitt




Neal_FearnotNeal Fearnot