Optimizing Medical Device Post-Market Surveillance for Public Value

项目摘要/摘要 使用预期注册表对医疗设备进行监控理想地提供了关键的 向所有相关利益相关者提供有关设备安全、长期产品性能和 在改善患者预后方面的有效性。然而，有几个挑战必须 成功地采用了基于登记的上市后监督系统 医疗器械涉及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，需要新的方法方法来 管理不良事件和结果的不完全确定以及缺乏标准化 以及定义设备之间的关系的通用方法， 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行业、学术机构、 以及政府合作，每个合作都带来了各自的优势和视角。 此外，这种合作对努力的可信度和完整性很重要。 因此，我们建议美敦力和耶鲁建立产学研合作关系， 目前正在合作开发设备监视注册网络的组织和 基础设施，理想地与其他联邦努力相结合，如医疗设备 流行病学网络倡议(MDEpiNet)。 在这个为期五年的项目过程中，该伙伴关系将召集一系列利益攸关方 会议包括上市后监督方面的方法专家、行业、学者、 政府、临床医生和患者开发所需的关键方法，以主动 监控医疗设备以及定义专家角色和责任的政策 参与医疗器械监测生态系统的各方。这包括政策和 确保工作的完整性的程序、共享设备、临床和质量的策略 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 应用于此类协作，并采用新的数据收集方法 (包括设备跟踪和唯一设备标识合规性)和分析 解决破坏现有医疗器械监测登记系统的缺陷。

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.