Survey on the Number and Percentage of MR Safety Labeling Changed for Implantable Medical Devices

Abstract

The purposes of this study were to investigate the number and percentage of items that changed magnetic resonance (MR) safety information labeling for implantable medical devices (IMDs) and to confirm the importance of checking the latest MR safety information database (117 types and 10031 items). We investigated the number and percentage of MR safety labeling changed for IMDs in the MR safety information database as of December 2021 and August 2022. IMDs of MR Safety Unlabeled decreased from 4116 items (41.1%) to 859 items (8.6%). IMDs of MR Conditional increased from 4141 items (41.3%) to 5896 items (58.8%). Since there have been changes in the MR safety labeling for many IMDs, this study shows that it is important to confirm the latest MR safety information for IMDs.