MDEpiNet: MCM (Medical Countermeasures)

总结本申请建议创建一个重大的医疗创新计划/项目 医疗器械流行病学网络（MDEPiNet）中的反措施（MCM）。的重点 拟议的倡议是通过以下方式推进监管科学并支持MDEPiNet学术伙伴关系 合作项目。该计划有两个主要组成部分：1）康奈尔大学内部的主要合作 大学通过以患者为中心的比较研究计划;国际联盟的家 骨科登记倡议和MDEPiNet科学和基础设施中心，2）与 外部合作伙伴，如布鲁金斯研究所和MDEpiNet学术机构。我们的使命是 医疗器械评价的证据和基础设施，无论是在MCM的背景下， 我们开发和使用各种数据源，以提高器械的安全性和有效性， 在不断改进的同时，采用全产品生命周期（TPLC）方法。我们的应用程序构建 康奈尔大学在过去十年中积累了丰富的经验，包括AHRQ的设备， MDEpiNet科学和基础设施中心。我们计划与FDA合作满足所有要求 of this project项目.我们计划协助FDA使用各种CBRN事件的“浪涌模型”来提出策略 设备优先级。然后，我们提出了六个额外的目标。在目标1中，我们提出证据审查， 以起搏器为例说明已发表文献对MCM器械评价的贡献， 假体和髋关节植入物。在目标2中，我们使用索赔/管理数据库或注册表来填补空白 作为证据说明性实例包括心脏起搏器、ICD、心室辅助装置、胰岛素泵、 真空辅助闭合装置，手术装置。在目标3中，我们使用电子病历（EMR）或其他 MCM器件评估的电子资源。说明性的例子包括安全性和 心脏起搏器、助听器和设备的有效性。在目标4中，我们提出了TPLC框架， 使用合作开发的最新和新的国际概念框架进行器械评价 与FDA合作，用于器械监管。我们使用这种方法来识别设备在 研究的发展周期，并得出适当的研究设计和分析战略，以进一步推动 TPLC。在目标5中，我们提出了与其他MDEPiNet参与者的合作项目。这些项目 促进MDEPiNet内的创新和协作。最后，在目标6中，我们召集相关利益攸关方 讨论与MCM优先医疗器械相关的关键问题，并传播这些问题的结果 用简短的白色文件进行讨论。我们与布鲁金斯学会和FDA合作， 会议、智囊团和讲习班。通过这一举措，我们将成为一个可靠的，适应性强， 灵活的设备基础设施;不仅是MCM和监管研究的重要资源， 利益相关者和公私合作伙伴，与其他国家计划，如FDA哨兵倡议。

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.