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

Area of Science:

• Medical Imaging Safety
• Biomedical Engineering
• Regulatory Science

Background:

• Magnetic resonance (MR) imaging is a vital diagnostic tool.
• Potential hazards exist within the MR environment, necessitating ongoing safety monitoring.
• Understanding adverse event types is crucial for risk mitigation.

Purpose of the Study:

• To analyze the types of adverse events reported to the US Food and Drug Administration (FDA) for MR systems.
• To provide a comprehensive overview of MR system-related adverse events over a decade (2008-2017).

Main Methods:

• Independent review of adverse event reports submitted to the FDA.
• Manual categorization of events into eight distinct types.
• Subcategorization of thermal events by probable cause and projectile events.

Main Results:

• 1548 adverse event reports for MR systems were analyzed from 2008-2017.
• Thermal events constituted the majority (59%) of serious reported injuries.
• Other reported events included mechanical (11%), projectile (9%), and acoustic (6%) incidents.

Conclusions:

• Adverse events associated with MR systems persist and align with known environmental hazards.
• Enhanced awareness of specific adverse event types in MR imaging is essential for improving patient and operator safety.
• Continued vigilance and reporting are necessary to prevent MR-related incidents.