FDA Expands MRI Safety Recommendations in Draft Guidance
Posted August 7, 2019
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health has published draft guidance that proposes updated testing and labeling recommendations to ensure the safety and compatibility of medical devices in the magnetic resonance (MR) environment. In addition, the draft guidance describes the agency’s preferred format for labeling device safety information.
The new guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, which would supersede the FDA’s 2014 recommendations upon approval, expands the range of included devices (e.g., active implants and ancillary medical equipment), as well as broadens the agency’s recommendations on mitigating the safety hazards unique to the MR environment and device labeling.
Magnetic resonance imaging (MRI) devices "are powerful tools for health care professionals to diagnose medical conditions [and] guide certain procedures," the FDA wrote in a tweet, while stating that the updated labeling recommendations are "intended to help health care professionals better consider potential hazards" for devices in the MR environment. In the scope of the draft guidance, the agency clarified that it applies "to all implanted medical devices, external medical devices that are fastened to or carried by a patient (e.g., external insulin pump), and all medical devices that are intended to enter the MR environment."
The draft describes the manner in which a given hazard should be addressed according to device type, as well as provides examples for the format and content of labels for devices in three categories: MR Safe, MR Unsafe, and MR Conditional.
“Appropriate testing and analyses, scientific rationale, and labeling, such as well supported MR conditional labeling ... form the basis of adequate mitigations for the unique safety hazards of the MR environment,” FDA wrote in the guidance.
While including mitigation strategies for hazards described in the 2014 guidance (i.e., magnetically induced displacement force, magnetically induced torque, heating, and image artifact), the new guidance also covers mitigation of additional hazards (i.e., gradient-induced variation and extrinsic electrical potential, rectification of radiofrequency pulses from MR exams, and device malfunctions).
Although implant cards and patient cards have been required for certain device types (e.g., hearing aids, breast implants) for several years, the FDA is recommending in its new draft guidance that patient medical device cards also be included for in-scope implants and external devices fastened to or carried by patients.
"The healthcare provider labeling should clearly and unambiguously identify the medical device, identify the MRI safety status of the medical device (MR Safe, MR Unsafe, or MR Conditional), and if the medical device is MR Conditional, provide the conditions for safe use in the MR environment," the FDA wrote.
In 2017, FDA expressed concerns related to implantable infusion pumps in the MR environment following reports of serious adverse events, including patient injury and death. The EU posted guidance on implant cards in June.
The FDA is accepting feedback on the draft guidance until Oct. 1 at www.regulations.gov (docket FDA-2019-D-2837).