The Food and Drug Administration released a new advisory on Aug. 1 that addresses the testing and labeling of medical devices for safety in the magnetic resonance environment. The document is available for review on the FDA website.
“The MR environment presents unique safety hazards for patients and other persons with medical devices near or inside an MR system,” according to the draft guidance. “Ensuring safety and effectiveness for implants and other medical devices intended to enter the MR environment should be an integral part of the medical device risk management.”
The guidance document addresses a number of serious hazards associated with medical devices brought into an MR environment. Another key safety issue covered within the document is that metallic implants and other devices can have a direct impact on how providers diagnose and treat a patient.
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In addition, the recommendations include establishing three designations for MRI safety labeling: MR Safe, MR Unsafe and MR Conditional.
Public comments on the new guidance document are open until Oct. 1, 2019.