MIMAS Final Project Meeting and Retrospective

The final meeting of the 3-year EMPIR project MIMAS (Medical Implant Manufacturers' Safety procedures) took place on 22 September, 2021, one week after the very successful MIMAS workshop co-organized by ZMT which was attended by over 100 people. Both events provided an opportunity to reflect in detail on the individual achievements of the project partners and the impact of the project as a whole. They also provided the chance to discuss the future direction of the industry from the perspective of the invited Workshop speakers, who represented the FDA, MT40, ISO 10974 JWG, and major AIMD manufacturers and test houses.

Over the three years, the MIMAS project resulted in a number of successful open-access publications from our project partners Physikalisch-Technische Bundesanstalt (PTB), Istituto Nationale di Ricerca Metrologica (INRIM), National Physical Laboratory (NPL), and Istituto Ortopedico Rizzoli (IOR). On the ZMT side, our achievements include:

the FDA qualification of the Medical Device Development Tool, IMAnalytics with MRIxViP and BCLib, as well as its update to extend its usefulness to ASTM and Tier 2 implant safety assessments;
the introduction of the SAIMD-U validation device, demonstrated in two videos, and its incorporation into an annex of ISO 10974;
comprehensive verification, validation and confidence interval evaluations for the entire ISO 10974 Tier 3 workflow;
the 2019 Thermal Dose workshop hosted by IT’IS;

and the following open-access publications with our research partner, the IT’IS Foundation:

“Induced radiofrequency fields in patients undergoing MR examinations: insights for risk assessment”, Physics in Medicine & Biology
“Radiofrequency-Induced Heating of Broken and Abandoned Implant Leads During Magnetic Resonance Examinations”, Magnetic Resonance in Medicine
“Experimental and Numerical Optimization Modelling to Reduce Radiofrequency-Induced Risks of Magnetic Resonance Examinations on Leaded Implants”, Applied Mathematical Modelling

Our project partners were also very active and published the following articles:

“In silico evaluation of the thermal stress induced by MRI switched gradient fields in patients with metallic hip implant”, INRIM, Physics in Medicine & Biology
“Rapid safety assessment and mitigation of radiofrequency induced implant heating using small root mean square sensors and the sensor matrix Qs”, PTB, Magnetic Resonance in Medicine
“Parallel transmission medical implant safety testbed: Real-time mitigation of RF induced tip heating using time-domain E-field sensors”, PTB, Magnetic Resonance in Medicine
“Letter: RF-induced heating of metallic implants simulated as PEC: Is there something missing?”, INRIM, Magnetic Resonance In Medicine
“MRI-Related Heating of Implants and Devices: A Review”, PTB, Journal of MRI
“Heating of hip joint implants in MRI: the combined effect of radiofrequency and switched-gradient fields”, INRIM, Physics in Medicine and Biology

with seven more works submitted and four more in preparation.

Participating in the MIMAS project has been a challenging and exciting experience. We thank our project partners for the great collaboration, and the industry sponsors, and of course EMPIR and the Horizon member states, for their support. We are looking forward to the next project together!

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ZMT Zurich MedTech Team