International Effort to Improve Safety of Orthopedic Devices

ICOR is developing a collaborative process for improving the safety of orthopedic devices, using outcomes registries from the United States and other countries, despite the fact the US national registry is currently under development, and the midterm follow up data will likely take several years to complete. For the moment, the most reliable data on devices come from large private registries in the US, such the Kaiser Permanente Implant Registries (KPIR) and international registries such as those in Australia, the United Kingdom, and Scandinavian countries that track 100% of devices implanted in those countries. However, while these data are complete, each registry takes a unique approach to monitoring safety.

Medical devices have a different path of approval than drugs that may not require conduct of clinical trials in the United States. Furthermore, reporting adverse outcomes for devices is on a voluntary basis, and the resulting data are often incomplete or inaccurate. ICOR was established by the US Food and Drug Administration (FDA, Silver Spring, MD, USA) in October 2010 to address these issues, with the combined ICOR registries projected to include data on millions of orthopedic surgical procedures and all implantable devices on the market. The outline of the ICOR mandate and guidelines was published as a special online supplement on December 21, 2011, in the Journal of Bone and Joint Surgery.

“The result will allow us to find important differences between implants and thus provide important evidence to inform decision making by physicians, hospitals, and patients,” said ICOR supplement coauthor Elizabeth Paxton, director of the Kaiser Permanente (Oakland, CA, USA) KPIR, which includes more than 300,000 registered implants. “This collaboration provides a unique opportunity to improve patient safety worldwide by identifying the best implants for our patients.”

More than 700,000 joint replacement devices are implanted in patients in the United States every year, and this volume is projected to increase twofold for hip-joint replacements and sevenfold for knee-joint replacements, reaching a total of more than three million devices implanted annually during the upcoming 20 years.

Related Links:
US Food and Drug Administration
Kaiser Permanente