A task force convened by the Food & Drug Administration has recommended that the federal government and other stakeholders support the creation of a comprehensive partnership on medical devices to monitor the products' performance after they become commercially available. The recommendations call for a master network of data in each clinical area where devices are used.
Information on medical devices exists in registries, electronic health records and claims data, but the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently.
The report, a summary of which was published Aug. 24 in the Journal of the American Medical Association, suggests the development of a coordinated registries network (CRN) to track the performance of each device for each patient in one integrated location, so that physicians' recommendations would be bolstered by robust evidence.
A description of the task force’s work was published on the web site of the Weill Cornell Medical College in New York, where one of the report’s authors, Art Sedrakyan, M.D., is also a professor of healthcare policy and research.
"The ultimate beneficiary of the CRN is the patient," said Sedrakyan, who is director of the Medical Device Epidemiology Network's (MDEpiNet) Science and Infrastructure Center. The FDA Center for Devices and Radiologic Health charged the task force with providing recommendations through MDEpiNet. "Conceptually, this is the best way for us to make sure that physicians and patients get up-to-date, near real-time information about the performance of medical devices to be able to make informed choices about what works best for individual patients,” Sedrakyan added.
In the JAMA paper, the task force said it recognized that most existing registries, EHRs and data sources do not contain all the elements necessary for device evaluations, including device and procedural details, patient descriptors, or long-term outcomes. But it said that such limitations could be mitigated through interoperability solutions that strategically link complementary registries and data sources to produce networks for which the data composite could support robust device evaluation. The task force termed this structure the strategically coordinated registries network, or CRN—with the recognition that many key elements in such networks (such as EHRs, administrative claims data, or mobile device outputs) are not registries, per se. “The task force recommends strategic CRNs as the foundational architectural construct for the national system that will augment national registry development and unique device identifier implementation rather than replace them,” they wrote.
The JAMA summary report identified eight foundational characteristics for a national medical device evaluation system:
• provide continuously updated data on benefit-risk and safety information;
• offer customized analyses to enable regulators and stakeholders to make decisions;
• organize patient device data into standardized domains such as procedures and outcomes;
• actively engage stakeholders to develop a cohesive, efficient, and collaborative conversation about medical devices;
• identify lessons learned and accompanying solutions;
• demonstrate value to stakeholders to ensure that the system remains sustainable;
• leverage international medical device data efforts;
• promote pilot programs that create momentum for a centralized database.
Duke University School of Medicine, Weill Cornell Medical College, and Harvard T. H. Chan School of Public Health and Harvard Medical School summarized the task force's report in JAMA.
In addition to this effort, the Agency for Healthcare Research and Quality has supported several projects that are enhancing the timely collection and analysis of data in registries and that will support the FDA’s effort to build a CRN. These projects include the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) registry, which is the most comprehensive U.S. database on total hip and knee joint replacement patients and their surgical outcomes, and the Registry of Registries project, which contains registry-specific information intended to promote collaboration, reduce redundancy, and improve transparency among registry holders.
