Data registries for implantable medical devices are providing evidence for the importance of unique device identifiers.
- Data registries for implantable medical devices such as hip and knee replacement joints are helping to demonstrate the importance and usefulness of unique device identifiers (UDIs). Research sponsored by the Food and Drug Administration (FDA) and published in the Journal of Bone and Joint Surgery, shows the positive impact of UDI use for collecting standardized electronic data in registries and promoting post-market surveillance and evaluation.
“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.”
The research is the product of collaboration between Kaiser Permanente, Weill Cornell Medical College, and the International Consortium of Orthopedics Registries (ICOR). Researchers examined data on hip and knee implants from several US and international registries. While the vast majority of EHR systems do not have the capability to track and associate a particular medical device with a patient’s experience and outcomes, registries are able to perform these tasks easily. The challenge is ensuring that registries can share their data with other systems while ensuring patient privacy and security.
“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 FDA has made the adoption of unique device identifiers a top priority. In 2013, the FDA issued a ruling requiring UDIs on all medical devices within the next few years. “UDI represents a landmark step in improving patient safety, modernizing our post-market surveillance system for medical devices, and facilitating medical device innovation,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development.”
Providers may begin to collect UDI data at the point of care and record the information in their EHRs, according to the Brookings Institute, which may help to bring data registries like those run by ICOR into closer alignment with health IT systems already in use by the majority of US healthcare providers. UDIs may also find their way into the Stage 3 meaningful use requirements, which would speed adoption of the scheme and ensure that most higher-risk devices would be associated with their own unique identification.