A collaboration among researchers from Kaiser Permanente, Weill Cornell Medical College, and worldwide registries demonstrates the importance of tracking medical devices' effectiveness and safety – specifically of hip and knee implants – after they are in use.
Public health and regulatory agencies have acknowledged there are gaps both in the ability to track devices and to supply the public with the accurate, evidence-based information consumers need to improve their health and make informed care decisions.
In a series of research articles, sponsored by the Food and Drug Administration, researchers analysed data from a collaboration among seven national and regional registries to examine the performance and safety of hip and knee implants. The registries are part of the International Consortium of Orthopedic Registries, an initiative that aims to address major gaps in evidence related to implants, as well as demonstrate the importance of registries and international collaboration for evaluation performance and patient safety worldwide.
Their findings demonstrate the importance of registries and unique device identification implementation for post-market surveillance of medical devices. Post-market surveillance is a collection of processes and activities the FDA uses to monitor the safety and effectiveness of medical devices once they are on the market.
"In orthopedics, large registries or networks of registries capture device information on a very detailed level and can become particularly important for active surveillance and post-market evaluation," said Art Sedrakyan, the principal investigator of the FDA contract and associate professor of health care policy and research at Weill Cornell Medical College. "Comparative studies of hip and knee devices illustrate the ability of a registry consortium to determine real-world evidence for various classes of devices and help surgeons and patients to make evidence-based choices."
"ICOR's achievements to date have enormous implications for medical device post-market surveillance system development in the United States and worldwide," said Liz Paxton, director of Kaiser Permanente's Surgical Outcomes and Analysis Unit of Clinical Analysis, San Diego, Calif. "Its ability to create an international, distributed research network in the field of medical devices opens a new door for evidence development and device-safety investigations. We are very excited about the potential of this critical work and its implications for patient safety and affordability in health care."