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U.S. Department of Health and Human Services

About FDA

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Research Project: MR Compatible Devices

MRI is one of the most highly used imaging modalities and is the method of choice for imaging soft tissues (60 million scans in 2008 in the U.S. with a 15% annual growth rate). MRI has no ionizing radiation dose. Three out of four pacing/defibrillation patients will need an MRI during their device lifetime. However, pacemaker, defibrillator and neurostimulator patients are currently not allowed to undergo an MRI scan.

New MR compatible (MR conditional)  devices are being developed by the medical device industry to avoid RF heating, and the unintended stimulation of patients’ cardiac tissues and nerves where implanted wires are inserted. The FDA labs developed a new method to assess gradient stimulation near lead tips. The FDA labs assessed heating due to RF in implants using computer modeling of the MR coil and the implant.  Uncertainty assessments of implanted lead heating during MRI were performed for each measurement.

 


An FDA engineer measures the magnetic fields emitted by a
magnetic resonance imaging simulator used in testing MRI compatible medical devices.