New Insights into MR Safety for Implantable Medical Devices

Abstract

Over the last two decades, the status of MR safety has dramatically changed. In particular, ever since the MR-conditional cardiac device was approved by the Food and Drug Administration (FDA) in 2008 and by the Pharmaceuticals and Medical Devices Agency (PMDA) in 2012, the safety of patients with an implantable medical device (IMD) has been one of the most important issues in terms of MR use. In conjunction with the regulatory approvals for various IMDs, standards, technical specifications, and guidelines have also been rapidly created and developed. Many invaluable papers investigating and reviewing the history and status of MR use in the presence of IMDs already exist. As such, this review paper seeks to bridge the gap between clinical practice and the information that is obtained by standard-based tests and provided by an IMD’s package insert or instructions for use. Interpretation of the gradient of the magnetic flux density intensity of the static magnetic field with respect to the magnetic displacement force is discussed, along with the physical background of RF field. The relationship between specific absorption rate (SAR) and B_1+RMS, and their effects on image quality are described. In addition, insofar as providing new directions for future research and practice, the feasibility of safety test methods for RF-induced heating of IMDs using MR thermometry, evaluation of tissue heat damage, and challenges in cardiac IMDs will be discussed.