MDEpiNet: MCM (Medical Countermeasures)

点击翻译按钮获取中文摘要

Summary This application proposes creation of a major innovative initiative/program on medical countermeasures (MCM) within the Medical Device Epidemiology Network (MDEpiNet). The focus of the proposed initiative is advance the regulatory science and support MDEpiNet academic partnership through collaborative projects. The initiative has two major components; 1) A major collaboration within Cornell University through a Patient-Centered Comparative Research program; home of the International Consortium of Orthopedic Registries initiative and MDEpiNet science and infrastructure center, 2) Collaboration with external partners such as Brookings Institution and MDEpiNet academic institutions. The mission is to improve the evidence and infrastructure for medical device evaluation both in the context of MCM and overall regulation, We develop and use various data sources to advance the safety and effectiveness of devices and incorporate a total product life cycle (TPLC) approach while continuously improving it. Our application builds upon the extensive experience accumulated by the Cornell during the past decade including AHRQ 'device center' and MDEpiNet Science and Infrastructure Center. We plan collaboration with FDA for all requirements of this project. We plan to assist FDA by using the 'Surge Model' for various CBRN events to propose strategy for device prioritization. Then we propose six additional aims. In Aim 1 we propose evidence reviews to illustrate the contribution of published literature to MCM device evaluation with examples of pacemakers, defibrillators and hip implants. In Aim 2 we use claims/administrative databases or registries to fill in the gaps in evidence. Illustrative examples include cardiac pacemakers, ICD, ventricular assist devices, insulin pumps, vacuum assisted closure devices, surgical devices. In Aim 3 we use electronic medical records (EMR) or other electronic resources for MCM device evaluation. Illustrative examples include the studies of safety and effectiveness of pacemakers, hearing aids and equipment. In Aim 4 we advance the TPLC framework for device evaluation using a recent and a novel international conceptual framework developed in collaboration with FDA for application in device regulation. We use this approach to recognize the stage of the device in the cycle of its development and derive appropriate study designs and analytical strategies to further advance TPLC. In Aim 5 we propose collaborative projects with other MDEpiNet participants.These projects promote innovation and collaboration within MDEpiNet. Finally, in Aim 6 we convene relevant stakeholders for discussion of key issues related to MCM-priority medical devices and disseminate results of these discussions in brief white papers. We collaborate with the Brookings Institution and FDA to hold stakeholder meetings, think-tanks and workshops. Through this initiative, we will serve as a dependable, adaptable, and flexible device infrastructure; a vital resource not only for MCM and regulatory research, but also for stakeholders and public-private partners, in line with other national programs such as FDA sentinel initiative.