Optimizing Medical Device Post-Market Surveillance for Public Value

优化医疗器械上市后监管以实现公共价值

• 批准号: 8921829
• 负责人: Harlan Marc Krumholz
• 金额: $ 5万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2017-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8921829
• 关键词: Optimizing; Medical; Device; Post; Market

PROJECT SUMMARY/ABSTRACT The surveillance of medical devices using prospective registries ideally provides critical information to all relevant stakeholders about device safety, long-term product performance, and effectiveness in improving patient outcomes. However, there are several challenges that must be overcome to successfully employ a registry-based post-market surveillance system for medical devices related to the diversity and complexity of medical devices, the iterative nature of product development, the learning curve associated with technology adoption, and the relatively short product life-cycle. Furthermore, novel methodological approaches are needed to manage incomplete ascertainment of adverse events and outcomes and lack of standardization of endpoint definitions, as well as a common method to define the relationship between device, or machine, failure and clinical events. Solutions to these challenges are most likely to emerge from industry, academic institutions, and government collaborations, each bringing their respective strengths and perspectives. Moreover, such collaborations are important for the credibility and integrity of the effort. Accordingly, we propose an industry-academic partnership between Medtronic and Yale, organizations currently collaborating to develop a device surveillance registry network and infrastructure, ideally integrated with other federal efforts such as the Medical Device Epidemiology Network Initiative (MDEpiNet). Over the course of the five-year project, the partnership will convene a series of stakeholder meetings that include methodological experts in post-market surveillance, industry, academics, government, clinicians, and patients to develop the critical methods needed to proactively monitor medical devices as well as the policies that define roles and responsibilities of expert parties engaged in the medical device surveillance ecosystem. This includes policies and procedures to assure integrity of the effort, strategies for sharing of device, clinical and quality data among clinical investigators and others, policies to promote transparency that can be applied to such collaborations, and novel methodological approaches to data collection (including device follow-up and Unique Device Identification compliance) and analysis that address the deficiencies that undermine existing medical device surveillance registry systems.

项目摘要/摘要 使用潜在注册机构对医疗设备进行监视，理想地提供了关键 向所有相关利益相关者提供有关设备安全，长期产品性能以及 改善患者预后的有效性。但是，必须有几个挑战 要克服成功采用基于注册表的后市场监视系统 与医疗设备的多样性和复杂性有关的医疗设备，迭代性质 产品开发，与技术采用相关的学习曲线以及 产品生命周期相对较短。此外，还需要新颖的方法论方法 管理不完整的不良事件和结果，以及缺乏标准化 端点定义以及定义设备之间关系的常见方法， 或机器，失败和临床事件。 解决这些挑战的解决方案最有可能来自行业，学术机构， 和政府合作，每个人都带来各自的优势和观点。 此外，这种合作对于努力的可信度和完整性很重要。 因此，我们提出了Medtronic和Yale之间的行业学术伙伴关系 目前正在合作开发设备监视注册表网络和 基础设施，理想地与其他联邦努力（例如医疗设备）融为一体 流行病学网络倡议（MDEPINET）。 在五年项目的过程中，合伙企业将召集一系列利益相关者 包括市场后监视，行业，学者的方法论专家的会议， 政府，临床医生和患者开发主动的关键方法 监视医疗设备以及定义专家角色和责任的政策 从事医疗设备监视生态系统的各方。这包括政策和 确保努力完整性的程序，设备共享的策略，临床和质量 临床研究人员和其他人之间的数据，促进透明度的政策可以是 应用于此类合作以及新颖的方法学方法来收集数据 （包括设备随访和唯一的设备标识合规性）和分析 解决破坏现有医疗设备监视注册机构系统的缺陷。