FDA Draft guidance on Medical Device’s Safety in MRI Environment

FDA Draft guidance on Medical Device’s Safety in MRI Environment

A new draft guidance namely Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment has been issued by the U.S. Food and Drug Administration (FDA).

Unique safety hazards are faced by the patients and other persons in the MR environment. After finalization, the draft guidance intends to provide suggestions for testing the medical device’s safety in the MR environment, identification of testing methods for specific hazards and provide information related to MRI’s safety in medical device labeling.

The guidance is meant for all kind of medical devices intended to enter the MR environment but does not apply to the MRI scanner systems themselves. Suggestions related to MR safety and compatibility assessments are there in the draft guidance.

It also suggests that all the medical devices should be assessed for their safety and performance while they are exposed to different magnetic field strengths.

Few potential safety issues included in the document are unwanted movement of the device, the device and surrounding tissue getting heated, gradient induced vibrations, image artifacts and medical device malfunctioning.

All devices must be labeled as either MR-conditional, MR safe or MR unsafe.