Oakland, Calif., and New York, NY — An unprecedented 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.
|Dr. Art Sedrakyan |
Image credit: Carlos Rene Perez
Most Americans will be exposed to a medical device during his or her life and tens of millions will receive an implantable device. However, public health and regulatory agencies in the U.S. and internationally acknowledge there are gaps both in the ability to track these devices and to provide the public 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 (FDA) and published today, researchers analyzed 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 (ICOR), 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 (UDI) implementation for post-market surveillance of medical devices in the United States and worldwide. 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 healthcare 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."
Researchers analyzed data from two U.S. registries (Kaiser Permanente and Health East), and registries in Australia, Spain (Catalonia), Italy (Emilia-Romagna), Sweden (Swedish Knee Arthroplasty Register), and Norway. ICOR's work provides an opportunity to collect real-world device data for performance in all settings and for all demographics, so important information can be identified and provided to surgeons and patients to determine the best implant for the patient.
Prior research found that almost no electronic health record system can automatically and uniquely identify devices and link them to an individual patient's outcome data — but registries can. Similarly, very limited national data exists that can identify medical devices and link them to patient outcomes within claims systems, a process that can benefit from an aligned post-market surveillance system.
To enable these registries to share critical information while protecting patient privacy, researchers developed an innovative methodology. For this article supplement, researchers analyzed the health information of patients as a group, rather than their personal, protected health information — to communicate between registries and learn about individual devices and implants.
The FDA has made the development of device registries and the creation of a UDI system for medical devices a key priority. The FDA 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. Incorporating the UDI in electronic health records and medical device registry systems will help improve the efficiency and effectiveness of post-market surveillance activities.
"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, The Permanente Medical Group, Inc., Oakland, Calif. "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. Having robust registries at the national and international level furthers our understanding of how to optimize outcomes for patients."
The research was conducted jointly by Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, Calif., U.S.A.; Weill Cornell Medical College, Department of Healthcare Policy and Research, New York, U.S.A.; Office of Surveillance and Biometrics, Center for Device and Radiological Health, FDA, Silver Spring, Md., U.S.A.; and seven international registries.
For more information on Kaiser Permanente's data registries, read this policy brief.
About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve approximately 9.5 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.
Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances — including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with Houston Methodist. For more information, visit weill.cornell.edu.