Active Surveillance of Cardiovascular Devices: The Multi-Registry DELTA Network

与传统的被动监测相比，医疗器械的前瞻性、主动性安全监测具有显著的优势 事件报告策略，用于识别由设备故障风险或 化学、生物、辐射或核(CBRN)事件造成的损害/破坏。然而，从方法论上讲， 数据可用性，以及数据所有者对用于监控安全性的有效工具的访问，都对 制定一种协调一致的国家主动医疗器械监测方法。这项建议旨在 扩展我们在开发和验证主动医疗设备安全监控系统方面的先前工作， 通过开发解决学习效应的方法并实施简化的风险调整模型 发展。这些努力将使主动监控工具在非常广泛的领域得到广泛应用 针对传统上市后需求或医疗保健服务的医疗产品安全监控工作范围 反制措施。该提案以MDEpiNet之间的多个利益相关者合作为中心 方法学中心与三个具有代表性的大型心血管设备登记所有者合作： 马萨诸塞州美国心脏病学会国家心血管设备登记(NCDR) 数据分析中心(MAS-DAC)和退伍军人事务部。 我们建议研究15种新的心血管装置的安全性，这些装置是最近推出的或预计将使用的 在接下来的5年内可用于临床。这些监测研究将采用预期风险- 调整了队列和顺序分析方法，根据设备学习的影响进行了调整。此外， 研究将评估高级自动变量选择方法的性能，将其与 领域专家知情模型开发。三个心血管登记处都在合作这一点 建议书在地理表示、数据质量、与电子产品的集成方面具有独特的属性 健康记录系统，以及链接到纵向行政和临床健康记录的能力。这些 临床数据范围、规模和深度的差异，将通过以下方式实现独特的主动设备安全监控 建立预先指定的信号验证分析，在发生安全警报时触发 通过对其他登记处的信号进行快速评估，在一个数据集中识别。 最后，完整的安全监控系统将作为开源软件通过 现有的国家生物医学计算中心，以促进这一领域的合作。该软件将是 免费提供，可用于任何公共卫生或学术领域的积极医疗产品安全应用 监视系统。这些经过验证的工具的可用性将允许数据所有者监控其临床医疗 独立的设备数据集，或通过FDA、MDEpiNet计划或 其他公共和私人利益攸关方，以支持新兴的国家医疗器械安全监督 网络。

Prospective, active safety surveillance of medical devices offers significant advantages over traditional passive event reporting strategies in identifying previously unexpected safety risks arising from device failure risks or damage/sabotage from chemical, biologic, radiologic or nuclear (CBRN) events. However, methodological, data availability, and access of data owners to validated tools with which to monitor safety all challenge the development of a coordinated national approach to active medical device surveillance. This proposal seeks to extend our prior work in the development and validation of an active medical device safety surveillance system, by developing methodologies to address learning effects and to implement simplify risk adjustment model development. These efforts will permit generalized application of the active surveillance tools to a very broad range of medical product safety monitoring efforts for traditional post-market needs or for Medical Countermeasure efforts. The proposal centers on the multi-stakeholder collaboration among MDEpiNet methodology center in cooperation with three large and representative cardiovascular device registry owners: The American College of Cardiology National Cardiovascular Device Registry (NCDR), the Massachusetts Data Analysis Center (Mass-DAC), and the Department of Veterans Affairs. We propose to study the safety of 15 new cardiovascular devices, recently introduced, or anticipated to become available for clinical use over the next 5 years. These monitoring studies will employ prospective risk- adjusted cohort and sequential analytic methods, adjusted for impacts of device learning. In addition, the studies will evaluate the performance of advanced automated variable selection methods, as compared with domain-expert informed model development. Each of the three cardiovascular registries collaborating on this proposal have unique attributes regarding geographic representation, data quality, integration with electronic health record systems, and ability to link to longitudinal administrative and clinical health records. These differences in clinical data scope, scale and depth, will permit unique active device safety surveillance, through the establishment of pre-specified signal-verification analyses that will be triggered when a safety alert is identified in one dataset, through rapid assessment of the signal in the other registries. Finally, the complete safety surveillance system will be released as open-source software through an existing National Center for Biomedical Computing to foster collaboration in this field. The software will be available for free, to be used for any public health or academic application toward active medical product safety surveillance. The availability of these validated tools will permit data owners to monitor their clinical medical device datasets independently, or through programs coordinated through the FDA, the MDEpiNet program or other public and private stakeholders, to support the emerging national medical device safety surveillance network.