The federal government and stakeholders interested in device innovation and evaluation should support the creation of a comprehensive partnership on medical devices to monitor the products' performance after they become commercially available, a Food and Drug Administration-initiated and independent national group of experts is recommending in a report. The recommendations call for a master network of data in each clinical area where devices are used.
|Dr. Art Sedrakyan |
Photo credit: Carlos Rene Perez
Information on medical devices does exist — in registries, electronic health records (EHR) and claims data — but the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently. Yet millions of patients undergo surgery each year and require some type of medical device during the procedure.
Knee replacements, for example, are one of the most common implant-based interventional procedures. There are a multitude of different devices available, such as partial knee replacement and total knee replacement, as well as the different manufacturers of those subtypes. The report, a summary of which was published Aug. 24 in the Journal of the American Medical Association, suggests 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.
"The ultimate beneficiary of the CRN is the patient," said author Dr. Art Sedrakyan, director of the Medical Device Epidemiology Network's (MDEpiNet) Science and Infrastructure Center. The FDA Center for Devices and Radiologic Health (CDRN) charged the task force with providing recommendations through MDEpiNet. Dr. Sedrakyan is also a professor of healthcare policy and research and professor of healthcare policy and research in cardiothoracic surgery at Weill Cornell. "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."
"Device manufacturers will also benefit from the CRN because it will enable assessment of information from more diverse groups of patients exposed to devices in more diverse treatment settings, ultimately providing critical information about device benefits and risks," said author Dr. Sharon-Lise Normand, who leads the MDEpiNet Methodology Center and is professor of healthcare policy and of biostatistics at Harvard University.
The JAMA summary of the National Medical Device Registries Task Force report includes eight foundational characteristics for a national medical device evaluation system. It would 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; and 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.
"The recommendations in this report are a significant milestone in improving our approach to designing and evaluating medical devices," said Dr. Mitchell Krucoff, an author of the report and an interventional cardiologist at Duke University, who serves as director of the MDEpiNet Coordinating Center at the Duke Clinical Research Institute. "By building on previous efforts and pooling our knowledge and experiences, we've been able to describe a framework for a national system that can help us understand how medical devices perform in real-world situations, while at the same time speeding up access to safe and effective technologies for the patients who need them."
In addition to this effort, the Agency for Healthcare Research and Quality has supported several innovative 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.
"FDA continues to promote collaborative efforts to create our national medical device evaluation system in order to help the agency strengthen its ability to understand the performance of devices throughout their life cycle," said Dr. Danica Marinac-Dabic, director of the division of epidemiology at CDRH, who contributed to the JAMA paper. "Registries linked to other electronic health information including unique device identification are the core foundation of such a system."
The recommendations will be open to the general public for feedback for the next 60 days.
This story was updated on August 25 with additional information and comment from the FDA.