The BUILD proposal combines into one initiative 3 of the 6 projects developed by the MDEpiNet SMART Informatics Think Tank, which was a multi-stakeholder assembly of device manufacturers, system architects, informaticists, supply chain professionals, clinicians, and researchers, many of whom will be working on this initiative. The purpose of the Think Tank projects was to further MDEpiNet's goal of supporting the FDA in strengthening the medical device postmarket surveillance system. The 3 pilot projects included in BUILD significantly overlap in leveraging unique device identifiers (UDIs) as the index to connect data sources and move information on devices to clinicians and researchers to assess device effectiveness and safety and support innovation. They are the Extension of UDI Implementation Pilot; Medical Device Data Capture and Exchange: Leading Practices and Future Directions; and Electrophysiology structured reporting Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS systems (ePulse). The Extension of UDI Implementation Pilot builds on a previous FDA demonstration whereby UDI were incorporated in the electronic information systems of a single health system resulting in integration of clinical and device data and the creation of a database that was useable for device surveillance and research. This process will be replicated at 2 additional health systems and a distributed data network of the 3 systems will be developed using the National Cardiovascular Data Registry's (NCDR) CathPCI as the hub. The Medical Device Data Capture and Exchange project builds a consortium of hospital organization, manufacturer and other stakeholder leaders that will collaboratively work to outline the current environment of UDI use; assess project outcomes; and conceptualize innovative solutions for capture and exchange of implantable device data. It will elucidate the best practices in exchange of UDI through the supply chain to the point of care. The ePulse project, then, focuses on the point of care and will use industry-standard nomenclature and interoperability profiles, incorporating UDI to capture critical data at the time of device implantation. These granular data will be communicated to EHRs in C-CDA format. The data will then be available for use for patient care, device surveillance, quality improvement and registries such as the NCDR's ICD Registry. The proposal, then, is to build an end to end initiative that would define leading practices for moving medical device data from the point of manufacture through the supply chain to the point of use and to capture clinical data, combine it with device data, and make the integrated data set available to the patient's electronic health record, to databases at the 3 participating health systems, and the CathPCI Registry. The methodology developed by this initiative will be extensible to all implantable medical devices. Finally, the BUILD initiative will create a road map for other health systems to replicate these methods to improve care quality and patient safety. 1
The research performed under the auspices of the BUILD Initiative will have relevance to public health on a couple of levels. First, learnings from this research will provide insights which will be used to strengthen the nation's medical device safety surveillance system. This will enable the FDA and other agencies to better protect U.S. citizens from harm due to faulty or ineffective medical devices. Secondly, the research will create a roadmap for other healthcare entities to follow in implementing unique-device identifier systems for implantable medical devices that will enable them to track device performance and costs and that will also support patient safety through rapid identification of device problems and through improved management of recalls.
