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Medical Industry Moves to Tighten MRI Safety Rules

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image Patient in MRI scanner

MRI is a safe imaging technique proven to be much less hazardous than ionizing radiation (X-ray) methods. Yet there has been talk that some insurance companies plan to limit their reimbursements only to MRI examinations performed by accredited MRI providers.

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In an unrelated report, the U.S. FDA’s database on industry experience using facility devices has shown a huge increase of 140% in reported accidents involving MRI, for a one-year period that ended in mid-2006. Because MRI-related accidents are not usually reported to the FDA, this statistic has been interpreted to mean that the risk factors to MRI safety have increased.

In the U.S., about 20 million MRI examinations are taken annually. The superior imaging and diagnostic benefits of MRI have encouraged wider utilization in many medical cases. These alone serve to increase the chances of accidents. That is compounded by the increasing number of people using implants and other medical devices which contain metals that can be affected by magnets used in MRI.

The main hazards of MRI are the projectile effect it has on ferromagnetic objects that may be medically or accidentally implanted in your body and the heat that is generated by its radiofrequency waves in the body and on metal parts of implants and of instrument electrodes. In the projectile effect, loose ferromagnetic objects are attracted toward the center of the magnet and can acquire high velocities, posing a danger to equipment and persons in their path. Radiofrequency fields during MRI can heat cables, ECG leads, or non-removable metallic implants and burn the skin. RF burns form the majority of MRI-related accidents.

The serious, even fatal injuries inflicted on patients during MRI procedures are still happening, yet nearly all MR accidents can be avoided. The safety issues become more urgent with the increased use of more powerful 3.0T units. To address these concerns, the American College of Radiology (ACR) has issued a 2007 update on its guide to acceptable MR practices. These guidelines will also be used as the basis for MR site accreditation.

You should know that as of this writing, there are no uniform standards for safety for MR practices at the site-provider level which are integrated into state or federal regulations, national accreditation and payer accreditation programs. The ACR 2007 Updates may change all that. And, if the reports on insurance company plans are accurate, it would seem that insurance companies want some way to compel MR providers to get ACR accreditation.

Many other organizations are closely following the development of the ACR guidance and regulation system for MR safety issues, including hospital building design groups and the U.S. Veterans Administration. Perhaps these will soon result in uniform national standards for the profession. Let us hope so.

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That is compounded by the increasing number of people using implants and other medical devices which contain metals that can be affected by magnets used in MRI.
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These alone serve to increase the chances of accidents. That is compounded by the increasing number of people using implants and other medical devices which contain metals that can be affected by magnets used in MRI.



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