MR conditional safety assessment of implanted medical devices: advantages of computational human phantoms

Abstract

Until recently, patients with active implantable medical devices (AIMDs) have been contraindicated for magnetic resonance imaging (MRI). Current efforts to demonstrate safety of these devices separate the interaction of the device and MRI into several hazards. For several of these hazards, computational human phantoms (CHPs) are used to provide conservative conditions for a risk-based analysis. This use of CHPs for the identification of conservative conditions provides a substantial benefit to the assessment of MR conditional safety over experimental techniques, as the evaluation of millions of test cases is possible in simulation, but impractical (due to economic constraints) and, in some cases, unethical for an experimental effort.