Creating National Surveillance Infrastructure for Priority Medical Devices

FDA新的上市后监督愿景强调了国家登记和联系的重要性 使用电子健康记录(EHR)、管理索赔数据以及以患者为中心的结果 研究所(PCORI)临床数据研究网络(CDRN)为后评估创建国家基础 市场监控。骨科和血管植入物的研究尤为重要。骨性关节炎和 血管疾病是一种常见的渐进性衰弱疾病，在美国老年人中发病率很高。 在过去的20年里，基于设备的髋关节和膝关节手术成为了 晚期疾病，导致每年数百万美国人使用整形外科和血管设备。 然而，存在着设备性能方面的重大证据差距，这促使国际监控努力联合 由FDA和威尔·康奈尔医学院。其中包括国际整形外科联盟 注册中心(ICOR)和国际血管注册联盟(ICVR)建立的名称为 分布式研究和监视网络，专注于与了解设备安全相关的问题， 和有效性。虽然这些财团提供了巨大的价值，但每个财团都需要加强自己的国家 系统。对于美国人来说，国际上使用的设备往往与美国使用的设备不相似，这创造了一种 有关设备优势和风险的关键知识差距。此外，美国的注册机构并不总是高效的； 几乎没有一家公司利用自动化流程进行数据捕获、存储和导出。利用 国家不断增加对电子人力资源的投资，以实现现有登记程序的自动化，可节省成本， 提高效率，提高质量。 在这项提案中，我们将利用FDA医疗器械流行病学中的一种新的合作伙伴关系 网络(MDEpiNet)建设国家基础设施。我们将把登记处与联邦医疗保险、商业和 州排放账单索赔和CDRN数据，以开发支持售后的创新基础设施 监测整形外科和血管设备。此外，通过使用EHR数据，我们将展示 在注册表创建中进行自动化试点，并向利益攸关方提供工具，以成功创建高效的 注册处。最后，我们将开发、实施和分发解决关键问题的新的方法方法 大型链接数据库中出现的数据问题。虽然网络是独立的、集中的知识 共享将支持跨专业和技术学习。因此，我们有几个目标：1)开发一种 全国整形外科器械监测网络，2)建立全国器械监测网络 对于血管设备，3)试验一种方法，使用全自动的EHR创建有效的注册表 流程，4)开发和实施新的方法，以应对创建 注册处。通过这一计划，我们利用国家对各种数据资产的投资来创建 创新的、可扩展的、可持续和动态的上市后监控系统模式。

The FDA's new post-market surveillance vision highlights the importance of national registries and linkages with electronic health records (EHRs), administrative claims data, and with the Patient-Centered Outcomes Research Institute's (PCORI) Clinical Data Research Networks (CDRN) to create national basis for post- market surveillance. Orthopedic and vascular implants are particularly important to study. Osteoarthritis and vascular disease are common, progressively debilitating diseases with a high prevalence in older Americans. During the past 20 years, device-based hip and knee surgeries became the main treatment options for advanced disease, leading to the use of orthopedic and vascular devices in millions of Americans annually. Major evidence gaps in device performance exist, however, prompting international surveillance efforts jointly by the FDA and the Weill Cornell Medical College. These include International Consortium of Orthopedic Registries (ICOR) and International Consortium of Vascular Registries (ICVR) that are established as distributed research and surveillance networks focusing on questions related to understanding device safety, and effectiveness. While these consortia provide enormous value, each needs to strengthen their own national systems. For Americans, devices used internationally are often not similar to those used in the U.S., creating a critical knowledge gap about device benefits and risks. Moreover, U.S. registries are not always efficient; virtually none capitalize on automated processes for data capture, storage, and export. Taking advantage of growing national investments in EHRs to automate existing registry processes could result in costs savings, gains in efficiency, and quality improvement. In this proposal, we will capitalize on a novel partnership within the FDA's Medical Device Epidemiology Network (MDEpiNet) to build national infrastructure. We will link registries with Medicare, commercial, and state discharge billing claims, and CDRN data to develop an innovative infrastructure enabling post-market surveillance for orthopedic and vascular devices. In addition, through the use of EHRs data, we will showcase pilots for automation in registry creation and provide tools to stakeholders for successful creation of efficient registries. Finally, we will develop, implement, and distribute new methodological approaches that address key data issues emerging from the large linked databases. While the networks are separate, centralized knowledge sharing will support cross-specialty and technology learning. Hence, we have several aims: 1) Develop a national device surveillance network for orthopedic devices, 2) Develop a national device surveillance network for vascular devices, 3) Pilot an approach to create efficient registries using EHRs using fully automated processes, 4) Develop and implement novel methodology to address challenges emerging from creation of registries. Through this initiative, we leverage national investments in variety of data assets to create innovative, scalable models for post-market surveillance system that are sustainable and dynamic.