MRI System Safety Evaluation

The radio frequency (RF) and gradient coil fields from commercial scanners present a number of potential health risks for the patients. To develop the methodology for assessing MRI risks, IT'IS initiated the EUREKA Project MRI+, and several follow-up projects, with various partners from industry and academia. IT'IS performs customized evaluations of MRI exposure scenarios for a wide range of MR transmit technologies and patient populations. Based on the results, the critical parameters can be identified to improve overall patient safety. IT'IS has cooperated with major MRI manufacturers, including GE, Siemens and Philips, and actively contributes to the IEC 60601-2-33 safety requirements for medical MRI.

The group’s Yellow Submarine Laboratory is equipped with the most advanced tools including a PiX system, MITS-1.5T, -3T, -TT, -HFR, and -Gradient systems, the latest DASY8 RX90L with DASY52NEO licenses, and a wide range of specialized probes for E-field, SAR, H-field and voltage, including hardened probes designed specifically for MRI environments.  With more than 100 Sim4Life licenses, including the Virtual Population 3.x/4.x and multiple animal models, and several High Performance Computers (HPC) ranging from Graphics Processing Unit (GPU) clusters to supercomputers, our interdisciplinary research team can tackle highly specific and complex research tasks with superior innovation and efficiency – while ensuring compliance to national and international standards.

• Collaborated with several major MRI manufacturers to measure full MRI systems with the aid of MRI-hardened acquisition systems developed by IT'IS together with SPEAG;
• Developed benchtop MRI testbeds, the MITS platforms, together with ZMT Zurich MedTech AG and in collaboration with a leading implant manufacturer, to study a range of MRI configurations, exposure conditions and tissue phantoms;
• Developed software tools for design of birdcage coils and parallel transmit coils, as well as an MRI system simulator, together with ZMT Zurich MedTech AG;
• Developed the MRIxViP library of precomputed RF coil exposures on the Virtual Population over a range of exposure conditions for 1.5T and 3T;
• Developed the IMAnalytics shimming tool for benchtop high-throughput exposure assessments;
• Produced morphed phantoms to model morbidly obese patients for new wide-bore MR systems.

As new MRI technologies evolve, risk assessment becomes significantly more complex. As the current methods for demonstrating MR safety are still highly empirical, it is important to continue to protect higher-risk populations, such as patients with medical implants or impaired thermoregulation, without resorting to overly conservative risk estimates which stifle innovation and technological progress. The IT'IS Foundation is committed to expanding its MR safety activities collectively with potential partners.

We look forward to discussing with you how we can best support your R&D initiatives and regulatory submissions – simply call us at +41 44 245 96 96 or send us an email at customized@itis.swiss.