Advancing Medical Device Postmarket Surveillance Infrastructure and Epidemiologic

项目摘要 鉴于医疗器械在医疗保健系统中的使用和重要性日益增加， 认识到拥有有效的医疗器械使用监测系统的重要性， 相关患者结局。为了规范医疗器械，以确保它们安全有效， 由于市场上的这些设备，使用这些设备进行近实时主动监视变得越来越重要， 定期收集电子健康信息。医疗设备提出了一系列独特的挑战（例如， 重复的医疗器械生命周期，缺乏标准化的识别系统），这阻碍了进展 建立健全的国家医疗器械上市后监督体系。美国食品 美国食品药品监督管理局（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，通过探索 用于提高医疗器械安全性和理解的方法和基础设施工具 在整个设备生命周期中。 需要解决与治理、方法和数据基础设施相关的许多问题， 建立健全国家医疗器械上市后监督体系。这些问题需要投入 来自相关外部主题专家的意见，以及让利益攸关方参与制定 短期和长期战略。布鲁金斯的恩格尔伯格医疗保健改革中心（ECHCR） 机构建议支持实施国家医疗器械上市后监督 与FDA合作，通过向广泛的利益相关者提供独特的结构化方法， 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），其他长期合作伙伴关系和中心的计划战略， 放射健康（CDRH）。ECHCR将成立并支持：1）规划委员会，由主要利益相关者组成 和内容领域专家，将通过年度战略确定高级别优先事项， 实施计划; 2）实施理事会，由FDA、ECHCR、MDEPiNet方法组成 中心，MDEPiNet科学和基础设施中心，以及其他中心或组织， MDEpiNet结构的组成部分，这将有助于正在进行的协调和沟通， 三个主要的工作流（即，治理/战略、方法论、数据基础架构）、其优先级，以及 他们的活动。ECHCR将召开专家研讨会，以支持工作流的活动， 利用外部专门知识解决新出现的技术问题。广泛的公共宣传， 年度公共研讨会、圆桌会议网络研讨会和其他材料将通过帮助 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.