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ARTICLE |

The Safety of MRI FREE

Frank G. Shellock, PhD; Howard Bierman, MD
JAMA. 1989;261(23):3412-3412. doi:10.1001/jama.1989.03420230064024
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To the Editor. —  The Food and Drug Administration1 recently reclassified the magnetic resonance imaging (MRI) scanner from a class III to a class II device and issued revised guidelines for the safe clinical use of this imaging modality. Along with the reclassification, the previously recommended conservative levels of exposure to the electromagnetic fields required for MRI were relaxed significantly.The new recommended safe levels of exposure are as follows: static magnetic fields, 2 T; gradient magnetic fields, 6 T/s or less; and radiofrequency magnetic fields, exposure should not produce a core temperature increase in excess of 1°C or localized heating to greater than 38°C in the head, 39°C in the trunk, or 40°C in the extremities.No long-lasting, hazardous biologic effects have been observed, and none are anticipated from acute or short-term exposures of humans to the static magnetic fields currently used in commercially available MRI scanners.2-4

REFERENCES

Food and Drug Administration.  Magnetic resonance diagnostic device: panel recommendation and report on petitions for MR reclassification . Federal Register . 1988;; 53:7575-7579.
Shellock FG.  Biological effects of MRI . Diagn Imaging . 1987;;9:96-101.
Gangarosa RE, Minnis JE, Nobbe J, Praschan D, Genberg RW.  Operational safety issues in MRI . Magn Reson Imaging . 1987;;5:287-292.
Shellock FG, Crues JV.  MRI: potential adverse effects and safety considerations . MRI Decis. 1988;;2:25-30.
Shellock FG, Gordon CJ, Schaefer DJ.  Thermoregulatory responses to clinical magnetic resonance imaging of the head at 1.5 Tesla: lack of evidence for direct effects on the hypothalamus . Acta Radiol Suppl. 1986;;369:514-516.
Shellock FG, Crues JV.  Temperature, heart rate, and blood pressure changes associated with clinical magnetic resonance imaging at 1.5 T . Radiology . 1987;;163:259-262.
Shellock FG, Crues JV.  Corneal temperature changes associated with high-field MR imaging of the brain with a head coil . Radiology . 1988;;167:809-811.
Shellock FG, Schaefer DJ, Crues JV.  Alterations in body and skin temperatures caused by MR imaging: is the recommended exposure for radiofrequency radiation too conservative? Br J Radiol. In press.
Shellock FG.  MR imaging of metallic implants and materials: a compilation of the literature . AJR . 1988;;15:811-814.

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Food and Drug Administration.  Magnetic resonance diagnostic device: panel recommendation and report on petitions for MR reclassification . Federal Register . 1988;; 53:7575-7579.
Shellock FG.  Biological effects of MRI . Diagn Imaging . 1987;;9:96-101.
Gangarosa RE, Minnis JE, Nobbe J, Praschan D, Genberg RW.  Operational safety issues in MRI . Magn Reson Imaging . 1987;;5:287-292.
Shellock FG, Crues JV.  MRI: potential adverse effects and safety considerations . MRI Decis. 1988;;2:25-30.
Shellock FG, Gordon CJ, Schaefer DJ.  Thermoregulatory responses to clinical magnetic resonance imaging of the head at 1.5 Tesla: lack of evidence for direct effects on the hypothalamus . Acta Radiol Suppl. 1986;;369:514-516.
Shellock FG, Crues JV.  Temperature, heart rate, and blood pressure changes associated with clinical magnetic resonance imaging at 1.5 T . Radiology . 1987;;163:259-262.
Shellock FG, Crues JV.  Corneal temperature changes associated with high-field MR imaging of the brain with a head coil . Radiology . 1988;;167:809-811.
Shellock FG, Schaefer DJ, Crues JV.  Alterations in body and skin temperatures caused by MR imaging: is the recommended exposure for radiofrequency radiation too conservative? Br J Radiol. In press.
Shellock FG.  MR imaging of metallic implants and materials: a compilation of the literature . AJR . 1988;;15:811-814.
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