The FDA has published a new guidance document focused on making improvements to the overall safety of MR environments and MRI-related medical device labeling.
The guidance, “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” can be read in full on the FDA’s 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 document. “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 reviews the various hazards associated with medical devices brought into an MR environment, including magnetically induced displacement force, magnetically induced torque and the heating of any tissue adjacent to a medical device. Another key safety issue covered within the guidance is that metallic implants and other devices can have a direct impact on how providers diagnose and treat a patient.
“The operation of an active medical device may lead to artifacts or corruption of the acquired MR images,” according to the document. “Both can lead to uninterpretable or non-diagnostic images or disease-mimicking artifacts. This hazard should be addressed for all medical devices intended to enter the MR environment.”
When testing for such issues, the FDA recommends imaging providers provide summaries of their test reports. The hazard being addressed by the test in question and the equipment being tested should both be listed in any test summaries.
The FDA also explored the issue of MRI safety labeling. Devices should be labeled “MR Safe,” “MR Unsafe” or “MR Conditional.” MR Safe devices can be brought into the MR environment, but MR Unsafe devices should always remain outside the MRI scanner room.
Detailed labeling information for all three designations is included in the draft guidance.
Public comments on this new document are being accepted until Oct. 1, 2019. Once finalized, the information will supersede what is noted in the FDA’s current guidance from December 2014.