The International Consortium of Orthopedic Registries data shows how important the unique device identification implementation has been to medical device post-market surveillance to identify issues with implants.
Weill Cornell Medical College, Kaiser Permanente and ICOR partnered to examine data on orthopedics device registries and how they impact surgeon decision making.
"[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 Surgical Outcomes Analyst Unit of Clinical Analysis in San Diego. "We are very excited about the potential of this critical work and its implications for patient safety and affordability in healthcare."
The researchers examined data from the Kaiser Permanente and Health East registries as well as registries in Australia, Spain, Italy, Sweden and Norway. Here are three thoughts from the study:
1. No current electronic health record can identify devices automatically and link them to patient outcomes data. However, registries can.
2. The UDI development is a key priority for the FDA, which plans to develop a national medical device registry and will make recommendations for maximizing the value of registries. The FDA will also provide governance guidelines and guidelines for other processes.
3. The study authors recommend incorporating the UDI in EHR and medical device registry systems to improve the efficiency and effectiveness of postmarket surveillance.
"As an orthopedic surgeon, I have found that our registries have allowed me to help patients make more informed healthcare choices and they have enhanced the conversation I have with patients," said Thomas Baber, MD, associate physician-in-chief at The Permanente Medical Group in Oakland. "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."