Optimizing Medical Device Post-Market Surveillance for Public Value

项目总结/摘要 理想情况下，使用前瞻性登记对医疗器械进行监督， 向所有相关利益相关者提供有关器械安全性、长期产品性能的信息，以及 改善患者预后的有效性。然而，有几个挑战必须 成功采用基于注册表的上市后监督系统， 医疗器械相关医疗器械的多样性和复杂性，迭代性 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，还需要新的方法， 管理不良事件和结局的不完全确定以及缺乏标准化 端点定义，以及定义设备之间关系的常用方法， 或机器、故障和临床事件。 这些挑战的解决方案最有可能来自工业界、学术机构， 和政府合作，各自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也很重要。 因此，我们建议美敦力和耶鲁大学建立行业-学术合作伙伴关系， 目前正在合作开发设备监督注册网络的组织， 基础设施，理想地与其他联邦努力，如医疗器械 流行病学网络倡议（MDEPiNet）。 在这个为期五年的项目中，该伙伴关系将召集一系列利益攸关方， 包括上市后监督方法学专家、行业、学者， 政府，临床医生和患者制定积极主动的关键方法， 监测医疗器械以及规定专家角色和职责的政策 参与医疗器械监管生态系统的各方。这包括政策和 确保工作完整性的程序、设备共享策略、临床和质量 临床研究者和其他人之间的数据，促进透明度的政策， 以及数据收集的新方法 （包括器械随访和器械唯一标识合规性）和分析， 解决损害现有医疗器械监督注册系统的缺陷。

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.