The FDA issued new federal draft guidance on August 2, 2019, titled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance Environment,” providing an outline about medical devices such as pacemakers, neurostimulators, insulin pumps, artificial heart valves, and cochlear implants that are meant to undergo Magnetic Resonance (MR) environment. The new guidance would supersede the FDA’s 2014 recommendations.
Many medical devices and implants cannot enter a Magnetic Resonance Imaging (MRI) machine as they are metallic and can cause abnormalities to the images or harm the patient. However, manufacturers have started designing MRI compatible medical devices. Pacemakers implanted in 2018 were 70% MRI-compatible as compared to 12% compatibility in 2016.
The guidance explains how to determine the medical devices and implants that are safe to enter a magnetic resonance imaging (MRI) machine, whose exposure to powerful magnetic fields could dangerously affect the patient's body. The guidance states that the devices should also include safety labeling, indicating the device is “MR Safe,” “MR Unsafe,” or “MR Conditional,” according to its compatibility with the MR environment or have special guidance for use in the MRI machine.
The details on how to undertake testing to evaluate the safety and compatibility of medical devices in the MR environment along with a format of MRI was also mentioned in the guidance.
