Tracking the safety and efficacy of implanted medical devices will be easier for patients and patient advocates in Korea, with the inauguration of a new government-run online information service designed to track and disseminate information about the devices. Foreign device manufacturers need to be aware of this for PMS and adverse event reporting.
Developed by Korea’s Ministry of Food and Drug Safety and unveiled in December, the “Patient Safety Information Check System,” is a publicly accessible repository of key information on such common medical devices as artificial joints, breast implants, artificial blood vessels, and cardiac pacemakers. The goal of the portal is to enable the public to learn of side effects, recalls, and other safety issues in real time. Once registered for the service, patients can receive text messages on a raft of safety issues. The new service is accessible through the ministry’s medical device information portal.