Kaiser, Weill Cornell show importance of device registries
December 19, 2014 in Medical Technology
Researchers from Kaiser Permanente and Weill Cornell Medical College have pointed to the importance of tracking the effectiveness and safety of medical devices in registries, after they’re in use.
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Billed as an “unprecedented collaboration” among Kaiser and Weill Cornell researchers, the study, sponsored by the FDA, analyzed data from seven registries – all part of the International Consortium of Orthopedic Registries – that track reliability and safety of hip and knee implants.
The findings, researchers say, show the importance of registries and unique device identification for post-market surveillance of medical devices.
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“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 press 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,” he added.
Researchers looked at data from two U.S. registries (Kaiser Permanente and Health East), as well as registries in Australia, Spain, Italy, Sweden, and Norway – offering the chance to collect “real-world” device performance data in all settings, and for all demographics, enabling data to be identified and offered to surgeons and patients to determine the best implant for the patient.
“As an orthopedic surgeon, I have found that our registries have allowed me to help patients make more informed health care choices and they have enhanced the conversations I have with patients,” said Thomas Barber, MD, associate physician-in-chief, at the Permanente Medical Group, in a statement. ?
“Based on the longitudinal data we can track and analyze, we are able to discuss the best implants and surgical techniques for patients based on their individual demographics, preferences, and lifestyles,” he added. “Having robust registries at the national and international level furthers our understanding of how to optimize outcomes for patients.”
Research has shown that very few electronic health record systems can automatically and uniquely identify devices and link them to an individual patient’s outcome data. Registries can, however.
ICOR’s “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,” said Liz Paxton, director of Kaiser Permanente’s Surgical Outcomes and Analysis Unit, in a statement.
The FDA has prioritized development of device registries, and the creation of a UDI system for medical devices. It plans to develop a national medical device registry and will make recommendations for how to maximize the value of registries, along with providing guidelines on governance and other processes. Researchers say incorporating the UDI in electronic health records and medical device registry systems will help improve the efficiency and effectiveness of post-market surveillance activities.