FDA Issues Medical Device Safety Guidance for MRI Facilities

May 20, 2021 | Eric D. Fader | FDA | Hospitals | Legislation and Public Policy

On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms, but not to MRI machines or components themselves.

The FDA points out that “the MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system bore.” Devices may be affected by electromagnetic interference due to strong emissions from the MR system and, conversely, the MR system may be sensitive to radiofrequency (RF) noise from active devices. Implanted devices may heat up or vibrate, potentially causing device malfunction or tissue damage. Furthermore, external devices that are used inside the scanner room should be permanently secured so that they don’t become projectiles when the magnet is turned on.

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