Medical Devices

Magnetic Resonance Imaging (MRI) Safety

Contact

Sunder Rajan, Ph.D

Summary

Magnetic resonance imaging (MRI) is a widely used diagnostic modality with an excess of 30 million scans being performed every year in the U.S. Although MRI is considered an exceedingly safe modality, there is an underlying potential for injury to patients due to the strong electromagnetic (EM) fields used in MR scanning. In addition, the rapid increase in the number of patients with medical implants who require MRI scans has spawned a new dimension in the field of MRI safety, due to the interactions of medical implants with EM fields used during MR scanning. As a result, this has led to a surge of premarket submissions for medical devices that are compatible with the MR environment.

This research area mainly centers on understanding the safety aspects of medical implants; therefore, here are some of regulatory science areas covered by this group:

  • Development of underlying tools for studying interactions leading to thermal injury
    • Computational, laboratory measurements, thermometry
  • Retrospective evaluation and comparison of testing data to understand trends and effects
    • Passive implants
  • Testing of selected devices in a MRI environment to gain further insights or guide policy
    • Stents, devices with magnets
  • Studying the physiological responses of thermal dosing
    • Perfusion imaging
Virtual model of Body RF coil

3D view of the computational model of a radiofrequency (RF) coil system at 64 MHz used in magnetic resonance imaging (MRI). Computational modeling of coils is extensively used in the evaluation of RF-induced heating during MRI.


Actual Body RF coil

3D view of the physical radiofrequency (RF) coil system at 64 MHz used in magnetic resonance imaging (MRI) available in our laboratory.


Coronal E-field map

Geometry of the 16-rod high pass birdcage coil with loaded Ella model taking a coronal cut plane of the electric field (E-Field).

This group supports the agency’s regulatory and guidance role by advancing knowledge on the complex interactions between electromagnetic fields and human body. These projects are conducted with active collaborations with several researchers within the FDA as well as at leading academic research institutes and industry organizations worldwide. Research is funded by internal (Critical Path, Office of Women’s Health) and external (CRADA) support. Additionally, we are currently leading the MDIC working group on Computational Modeling and Simulations – RF heating in MRI.

Current funding sources

FDA Critical Path Initiative
FDA Office of Women’s Health
Cooperative Research and Development Agreement (CRADA), Imricor Inc.

Personnel

FDA Staff:
Sunder Rajan, Ph.D.
Leonardo Angelone, Ph.D.
Howard Bassen
Maria Ida Iacono, Ph.D.
Wolfgang Kainz, Ph.D.

Research Fellows:
Kyoko Fujimoto, PhD
Peter Serano

External collaborators

Resource facilities

Relevant standards & guidances

Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

Selected peer review publications

Page Last Updated: 05/25/2017
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