During the August meeting of the GHX Global Data Standards User Group, Joseph Drozda, Jr., M.D., FACC, director of Outcomes Research for Mercy Center for Innovative Care, described how his organization is collaborating with other healthcare systems, manufacturers, government agencies and academic institutions on the FDA’s Medical Device Epidemiology Network (MDEpiNet) project.

Harvard Medical School is leading the Methodology Center Project, which includes a UDI Demonstration Project to develop a system to track products from purchase through consumption and to utilize electronic health records (EHRs) and clinical registries to assess the safety and effectiveness of medical devices after they are marketed.

A corresponding Infrastructure project, led by Cornell Weill Medical College, will leverage the UDI to integrate orthopedic device outcomes data from multiple U.S. and international registries into the International Consortium of Orthopaedic Registries (ICOR), which can then be used for better adverse event reporting and comparative effectiveness research.

The Mercy Center for Innovative Care is serving as subcontractor to Harvard Medical School on the device tracking system, which Dr. Drozda says is supported by groundwork already completed as a result of a strong partnership between the clinical, supply chain and information technology (IT) teams at Mercy. Specifically, Mercy has implemented an EHR system in all of its hospitals and laid the infrastructure to integrate UDIs into the EHR and link the EHRs with its enterprise resource planning (ERP) system and clinical software. The next step will be to create data sets that can be analyzed and shared with the FDA and partnering health systems. To increase the data available for analysis, the larger scale plan calls for linkages with national registries, including the American College of Cardiology’s (ACC) CathPCI Registry. Initially the demonstration project will focus on coronary artery stents, but will expand to implantable cardiac defibrillators (ICDs).

"What I find most exciting about this project is the ability to access many different data sources that, when combined, can yield robust information on the long-term effectiveness of devices," said Dr. Drozda. "We need to come up with a methodology to access these data in a meaningful way both from a patient safety and comparative effectiveness standpoint. We can then share these data with other likeminded health systems to improve patient care across the board."

"We believe this system will improve patient care by giving all clinicians, including primary care physicians, emergency room staff and specialists, access to the same device information," said Dr. Drozda. "This will make it easier for us to track patients when there are device warnings and recalls."

Dr. Drozda says success depends upon extensive collaboration across a number of stakeholders, including other healthcare systems, coronary stent suppliers, professional physician societies, national registries and the FDA itself.

"We need to identify the benefits for each stakeholder and get everyone involved," said Dr. Drozda. "If one party is just along for the ride, then this probably isn’t going to work."

Mercy is currently collaborating with three coronary stent suppliers that will provide the organization with UDIs for their products, as well as 10 key UDI attributes for each product. The ACC and the Society for Cardiovascular Angiography and Interventions (SCA&I) will define additional clinically relevant product attributes moving forward.

"We hope the system will help suppliers with their obligations to the FDA for post market reporting and surveillance," added Dr. Drozda.

Members of the Healthcare Transformation Group, which in addition to Mercy includes Mayo Clinic, Kaiser Permanente, Intermountain Healthcare and Geisinger Health System, will provide guidance on the final design, monitoring and maintenance of the project.

According to Dr. Drozda, the MDEpiNet initiative is part of a much larger strategy to leverage the FDA’s proposed UDI system.

"No one is going to have the secret sauce coming right out of the gate," said Dr. Drozda. "We are encouraging other healthcare providers, manufacturers, regulators, researchers and others to work with us in an experimental way so that we can come up with a mutually beneficial solution. This requires everyone to be as open as possible and trust each other, knowing that our work is for the greater good. Working together and delivering an industry-wide roadmap for how the FDA’s UDI system can be used for a variety of purposes, versus having individual organizations come up with their own proprietary solutions, will save everyone a great deal of time, money and effort and ultimately result in a more effective and efficient system for device documentation, tracking and reporting."