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MRI Safety: FDA Safety Communication
A six year old boy undergoing an MRI (Magnetic Resonance Imaging) scan was killed by a ferromagnetic oxygen tank that was pulled into the MR scanner. Although MRI can provide important diagnostic information, medical practitioners and patients should be aware that there are several hazards associated with MRI.
The references below give more information on safety in MR environments.
ECRI Hazard Report: "Patient Death Illustrates the Importance of Adhering to Safety Precautions in Magnetic Resonance Environments"
CDRH Draft Document: "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems"
Standards that address MR safety and compatibility: "CDRH Guidance for Testing MR Interaction with Aneurysm Clips, Draft Document"
- ASTM F2052-00 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Passive Implants in the Magnetic Resonance Environment
- ASTM F2119-01 Standard Test Method for Evaluation of MR Image Artifacts From Passive Implants
- IEC 601-2-33 - Medical Electrical Equipment - Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
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