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Procedures allowing medical implant manufacturers to demonstrate compliance with MRI safety regulations

Completed EMPIR project Procedures allowing medical implant manufacturers to demonstrate compliance with MRI safety regulations (17IND01, MIMAS)   has developed the test methods needed to demonstrate implant compatibility with MRI scanning for improved patient safety.

By improving models of human subjects with implants and validating computer modelling by comparison with test implant measurements, the project results will feed into new and existing international standards for MRI safety regulations.

Specific achievements of the project include:

• Project partner Zurich Med Tech (ZMT) has developed the toolset for the automatic extraction of electromagnetic field data from their exposure database, the MRIxVIP library. These tools and the library itself have been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool, the first ever such qualification for a computational tool. The software and database will be applied in the real world, by manufacturers of active implants, resulting in an accelerated development phase for their new products including faster and more predictable regulatory approval.
• In a second step, about 18 months later, FDA even extended its qualification of ZMT’s toolset such that Tier 2 assessments are also included now. This means that passive implanted medical devices can also be covered now which means the tools can be used for a much wider range of applications.
• A Python programme package was developed and made publicly available on Zenodo to help the user to obtain an estimate of the risk associated with the exposure to radio frequencies and gradient fields, during the execution of realistic MR pulse sequences, for a patient carrying an orthopaedic implant. Starting from electromagnetic simulation results, which can be supplied by the user, involving a generic metallic implant placed in a homogeneous phantom, this tool is able to process the data to provide a risk classification for the MR protocol under investigation.
• The very successful MIMAS Implant Safety workshop took place in September 2021 with 200 people attending from across the world. The event provided an opportunity to reflect in detail on the individual achievements of the project partners and the impact of the project as a whole. It also provided the chance to discuss the future direction of the industry from the perspective of the invited workshop speakers, who represented the FDA, relevant IEC and ISO working groups, as well as major Active Implantable Medical Device manufacturers and test houses.

Project Coordinator Bernd Ittermann from PTB said

‘I am glad the MIMAS project went so smoothly and would like to thank all partners who contributed to that. I am particularly happy that our contributions to implant safety in MRI cover such a wide time scale. The new computational tools of our Swiss partner ZMT Zurich MedTech change the way how implant safety is established already today; the project’s comprehensive results on gradient heating of implants, spearheaded by Italian partner INRiM, will enter the test houses and become the new state-of-the-art within a very few years from now, while PTB’s vision of  sensor-equipped ‘smart’ implants communicating directly with the MR scanner has the potential to revolutionize the field, but may take another decade to become reality. To me, this is what an EMPIR project is all about: make an impact today and go for new horizons.’

This EMPIR project is co-funded by the European Union's Horizon 2020 research and innovation programme and the EMPIR Participating States.

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