Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic

项目摘要 鉴于医疗设备在卫生保健系统中日益增长的使用和重要性，有广泛的 认识到建立一个有效的医疗设备使用监测系统的重要性 相关的患者结果。为了规范医疗器械，确保它们一次安全有效 它们都在市场上，使用以下工具进行近乎实时的主动监控变得越来越重要 例行公事地收集电子健康信息。医疗设备提出了一组独特的挑战(例如， 重复的医疗设备生命周期，缺乏标准化的识别系统)，阻碍了进展 促进建立健全的国家医疗器械上市后监督系统。美国的食物 药品监督管理局(FDA)于2010年启动了医疗器械流行病学网络(MDEpiNet)， 作为国家战略的一部分，以实现其加强上市后监督系统的愿景，方法是 改进医疗设备安全和理解的方法和基础设施工具 在整个设备生命周期中。 需要解决许多与治理、方法和数据基础设施相关的问题 建立健全全国医疗器械上市后监管体系。这些问题需要投入 来自相关的外部主题专家和协调结构，以使利益攸关方参与制定 短期和长期战略。布鲁金斯学会恩格尔伯格医疗改革中心(ECHCR) 机构建议支持实施全国医疗器械上市后监管 系统，与FDA合作，为广大利益攸关方提供独特的、结构化的方法 参与和项目协调，以支持医疗器械流行病学的持续工作 网络(MDEpiNet)、设备和设备中心的其他长期合作伙伴关系和计划战略 放射健康(CDRH)。ECHCR将组成并支持：1)由主要利益攸关方组成的规划委员会 和内容领域专家，将通过年度战略和 实施计划；2)实施委员会，由FDA、ECHCR、MDEpiNet方法组成 中心、MDEpiNet科学与基础设施中心等中心(S)或组织(S)是 MDEpiNet结构的组成部分，这将促进 三个主要工作流(即治理/战略、方法、数据基础架构)、它们的优先顺序以及 他们的活动。幼儿保育和康复中心将召开专家研讨会，支持工作流的活动 解决新出现的技术问题的外部专业知识。广泛的公共通信，以 年度公开讲习班、圆桌会议网络研讨会和其他材料将通过以下方式加强这一努力 吸引更广泛的受众。

Project Summary Given the growing use and significance of medical devices in the health care system, there is broad recognition of the importance of having an effective system for monitoring medical device use and the associated patient outcomes. In order to regulate medical devices to ensure they are safe and effective once they are on the market, it is becoming increasingly critical to conduct near real-time, active surveillance using routinely collected electronic health information. Medical devices present a unique set of challenges (e.g., iterative medical device lifecycle, lack of standardized identification system) which has hampered progress towards the development of a robust National Medical Device Postmarket Surveillance System. The U.S. Food and Drug Administration (FDA) launched the Medical Device Epidemiology Network (MDEpiNet) in 2010 as part of a national strategy to achieve its vision of an enhanced postmarket surveillance system by exploring methodological and infrastructure tools for the improvement of medical device safety and understanding throughout the device lifecycle. A number of issues related to governance, methodology, and data infrastructure need to be addressed in order to establish a robust National Medical Device Postmarket Surveillance System. These issues require input from relevant external subject matter experts and a coordinated structure for engaging stakeholders to develop short- and long-term strategies. The Engelberg Center for Health Care Reform (ECHCR) at the Brookings Institution proposes to support the implementation of the National Medical Device Postmarket Surveillance System, in collaboration with FDA, by providing a unique, structured approach to broad stakeholder engagement and program coordination to support the ongoing work of the Medical Device Epidemiology Network (MDEpiNet), other long-term partnerships and program strategies of the Center for Devices and Radiologic Health (CDRH). ECHCR will form and support: 1) Planning Board, composed of key stakeholders and content area experts, that will establish the high-level priorities through the Annual Strategy and Implementation Plan; 2) Implementation Council, composed of FDA, ECHCR, the MDEpiNet Methodology Center, the MDEpiNet Science and Infrastructure Center, and other center(s) or organization(s) that are components of the MDEpiNet structure, that will facilitate the ongoing coordination and communication of the three major work streams (i.e., Governance/Strategy, Methodology, Data Infrastructure), their priorities, and their activities. ECHCR will convene expert workshops to support the activities of the work streams to gather external expertise to address emerging technical issues. Broad public communications, in the form of an Annual Public Workshop, roundtable webinars and additional materials, will augment this effort by helping engage broader audiences.