MRI-related FDA adverse event reports: A 10-yr review.

PURPOSE

To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US FDA) for magnetic resonance (MR) systems over a 10-yr period.

METHODS

Two reviewers independently reviewed adverse events reported to FDA for MR systems from 1 January 2008 to 31 December 2017 and manually categorized events into eight event types. Thermal events were further subcategorized by probable cause. Objects that became projectiles were also categorized.

RESULTS

FDA received 1568 adverse event reports for MR systems between 1 January 2008 and 31 December 2017. This analysis included 1548 reports. Thermal events were the most commonly reported serious injury (59% of analyzed reports). Mechanical events - defined as slips, falls, crush injuries, broken bones, and cuts; musculoskeletal injuries from lifting or movement of the device - (11%), projectile events (9%), and acoustic events (6%) were also observed.

CONCLUSIONS

Adverse events related to MR systems consistent with the known hazards of the MR environment continue to be reported to FDA. Increased awareness of the types of adverse events occurring for MR imaging systems is important for prevention.