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Medical Devices

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

Copies of the ASTM standards may be purchased from ASTM at  **

Copies of the IEC standard may be purchased from ANSI at  **

 **Any reference to a commercial product, process, service, or company is not an endorsement or recommendation by the U.S. government, the Department of Health and Human Services, FDA or any of its components. FDA is not responsible for the contents of any off-site Internet information referenced by or linked to the agency's internet site.

Page Last Updated: 10/06/2014
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