What kinds of MR tests are performed when evaluating safety?

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What kinds of MR tests are performed?

Many virtual and physical tests are used to evaluate the MR safety of passive medical devices. These tests look at numerous aspects of the effect that MR scanning has on devices.

Magnetically induced displacement (ASTM F2052)

Testing can determine the amount of magnetically induced displacement force that an MR scanner exerts on devices. Understanding displacement can prevent devices from migrating under scanning.

Magnetically induced torque (ASTM F2213)

Testing can determine the amount of magnetically induced torque that MR scanning can produce in devices. Similar to displacement, torque can disrupt the placement and performance of devices.

Image artifacts (ASTM F2119)

Testing can determine whether devices create artifacts in the MR image and quantify how large the artifact might be.

RF heating (ASTM F2182)

Testing can determine how much RF-induced heating of tissue occurs under specific scanning conditions. Excessive heating could potentially result in injury to the patient.

MR marking of medical devices (ASTM F2503)

Ultimately, testing helps manufacturers mark or label the device appropriately for MR scanning.

MR testing is only one area of testing that MED Institute performs. MED Institute performs over 200 test methods that are accredited to ISO 17025, including:

  • MRI safety analysis
  • Durability and fatigue testing
  • Corrosion testing
  • Particulate counting and sizing
  • Radiopacity testing

For more information, please visit our website www.medinstitute.com.

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Why is it important to label devices for MR safety?

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If a patient has an implanted medical device that contains metal, then an MR scan can be risky. In an MR environment, the device can pose risks to the patient as well as to the quality of the scan.

The most serious risks to the patient are radio frequency (RF) heating and device migration. The electromagnetic field from an MR scan can heat the device and burn the patient or cause the device to move. The metal in the device can adversely affect the quality of the scan by  distorting the image.

Examples of common implantable metal devices are stents, vena cava filters, and joint implants.

MR safety is a serious issue for patients and physicians, because tens of millions of MR scans are performed each year. If devices aren’t labeled, then patients might undergo—and physicians might perform—MR scans without being aware of the risks.

MED Institute has partnered with the Center for Devices and Radiological Health to analyze the effect of RF heating on passive medical devices. The information from the project will be shared in peer-reviewed manuscripts and other written communications, and will help engineers design new MR safety testing strategies.

For more information, please visit our website www.medinstitute.com.

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