Building UDI into Longitudinal Data for Medical Device Evaluation (BUILD) – Point of Care Capture of UDI for Implantable Devices Final Summary Report & Roadmap (June 28, 2019). Author: Natalia Wilson, M.D. MPH.
MDEpiNet has been championing international collaborations since our launch in 2010. The International Registry Consortia is one of the founding pillars of the MDEpiNet infrastructure with major successes of the International Consortium of Orthopedic Registries and International Consortium of Vascular Registries initiatives. In the past two years, MDEpiNet’s multi-stakeholder focused international chapters have developed as a driving and unifying force for building the device research discipline.
This chapter of MDEpiNet was founded at the University of New South Wales Big Data Centre in January 2018. In December 2018, the Chapter hosted a major stakeholder meeting in Sydney. The focus of this meeting was engaging regulators, major payers and manufacturers to develop data infrastructure and implement unique device identifiers. Another objective was to highlight the role of real world evidence in active surveillance of health technologies. Specific examples from registries and a growing number of administrative databases worldwide were discussed. The meeting also included leaders from the International Medical Device Regulators Forum that focus on big data to start a dialogue about potential maturity models and their application in the claims environment.
Developing Japan Chapter:
In January 2019, MDEpiNet organized a real world evidence workshop and summit in Japan for clinicians and regulators. There were advanced conversations with clinicians and regulators to launch a Chapter at the National Center for Global Health and Medicine, which is one of three major clinical and research centers in Japan that receives government funding for research. The Chapter will have access to insurance claims data in Japan to develop its data model. The national surgical registry of Japan is also interested in collaborative infrastructure development through a novel partnership. Major meetings are planned for fall 2019 to kick start the developmental work for chapter creation.
Developing German Chapter:
The German Chapter of MDEpiNet will be founded at the University Medical Center Hamburg-Eppendorf Research Group GermanVasc at the University of Hamburg, Germany. A nationwide Summit on Real-World-Evidence in cardiovascular medicine is planned for November 1, 2019 to kick start the developmental work for chapter creation. The GermanVasc group is well-experienced in the scientific utilization of health insurance claims and registry data and deeply involved in various national and international collaborations in cardiovascular medicine. Beginning with the development in Hamburg, Germany, public and private stakeholders as well as representatives from different medical specialties are currently invited to join the multidisciplinary task force developing the German Chapter of MDEpiNet.
2019 MDEpiNet Priorities
MDEpiNet’s priorities for 2019 were determined in collaboration with stakeholders at the 2018 MDEpiNet Annual Meeting.
Surveillance is one of the core areas of activity within MDEpiNet, and we are the main international educational and research organization dedicated to device outcomes research and epidemiology. We plan to launch an international task force on surveillance within MDEpiNet to clarify both the growing role of real world evidence and what it means to conduct ‘surveillance’ from our perspective. This activity will likely be conducted within the MDEpiNet Scientific Oversight Committee which oversees, facilitates, and coordinates the proposals, progress, and deliverables of our many disease-based working groups. Additionally, the National Evaluation System for health Technology Coordinating Center is developing national guidance which will inform our work.
MDEpiNet’s vision for data linkage is to join together device registries (which contain information about device attributes, clinical information, and short-term follow-up) with Administrative/Claims/Electronic Health Record data (which contain long-term follow-up, cross-institution follow-up, and additional procedure/medication). These data linkages are an important component of strengthening Coordinated Registry Networks and creating value among learning communities by enabling long-term device evaluation, active surveillance, and quality improvement. A key priority area for MDEpiNet is to consider making investments in computing and data access in order to address strategic, priority questions.
Unique device identifiers are globally unique numbers for devices that are assigned by manufacturers, linked to the FDA AccessGUDID (Access to Global Unique Device Identification Database), and scanned and stored at the point of care to provide better safety and outcomes information. Unique device identifiers are a standard identifier for improving real world evidence. As a result, MDEpiNet has identified a need to determine barriers to device identification integration and adoption as well as establish action plans to engage stakeholder groups to address the current barriers to device identification adoption.
Mercy recently announced a data sharing partnership with Johnson and Johnson that received significant coverage in the health business press. Our intent is to collaborate with J&J to continue the development of methods for using EHR and other health system data in the evaluation of a variety of medical devices. We, of course, began this work in the MDEpiNet Mercy UDI Demonstration Project and are continuing it in the MDEpiNet BUILD initiative. We announced a similar relationship with Medtronic last year and continue to work with them on one of the initial NEST demonstration pilots. We hope to establish similar arrangements with other manufacturers in the future. Our ability to form these significant strategic partnerships stems directly from our MDEpiNet work and the atmosphere of trust engendered by the public private partnership.
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Review the FDA’s recent Guidance document regarding RWE supporting regulatory decision making for medical devices here (PDF).