Creating National Surveillance Infrastructure for Priority Medical Devices

FDA新的上市后监督愿景强调了国家注册和联系的重要性

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.