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PSNet: Patient Safety Network

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. May 20, 2021.

Magnetic resonance imaging (MRI) suites harbor unique hazards that can harm patients, should process missteps occur. This report shares assessment steps to assure that medical devices are labeled appropriately to support their safe use in the MRI environment and encourages organizational reporting of problems encountered when testing device use.