Recently, the FDA has published an update to the documentation outlining their recommendations for the testing and labelling of medical devices in MRI. ‘Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment’
For those unfamiliar with the guidance, it outlines a number of interactions that should be considered when foreign objects are introduced into the MR environnement, including (but not limited to): Magnetically Induced Torque, RF heating and Rectification, Gradient Induced Vibrations and Extrinsic Electrical Potentiel, Medical Device Malfunction and Image Artifacts.
For those previously aware of the document, this latest version offers important clarifications and updates that should be reviewed.
Have questions about this update or how it may affect your medical devices? Contact us today and let our team of MRI experts assist you in determining what actions you may need to take.
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