Research demonstrates importance of registries for medical devices

FDA-funded research by the Kaiser Permanente and Weill Cornell Medical College highlights the importance of registries and unique device identification implementation for post-market surveillance of medical devices.

The researchers analyzed data from a collaboration among two U.S. registries and registries in Australia, Spain, Italy, Sweden and Norway to examine the performance and safety of hip and knee implants.

The registries, part of the International Consortium of Orthopedic Registries (ICOR), are part of efforts to identify gaps in evidence related to implants, according to Kaiser Permanente. ICOR’s real-world device data for performance in all settings and for all demographics can be identified and provided to surgeons and patients to determine the best implant for the patient, according to the study.

"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 healthcare policy and research at Weill Cornell Medical College, in a statement. "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."

Read Kaiser Permanente's policy brief.