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FDA wants materials tested for MR-scan energy fields.(Washington roundup)(magnetic resonance)(Food and Drug Administration)
Magnetic fields are powerful things and magnetic resonance imaging scanners are growing more powerful every year. Recent reports of unanticipated events involving MRI equipment have surfaced over the years since the introduction of the technology, and FDA has responded with a guidance suggesting that makers of passive implants test those devices against MR energy before going to market.
Perhaps the most conspicuous of these is an incident in 2001 in which six-year-old Michael Colombini of Croton, New York, lost his life when a metal oxygen tank was accelerated from its resting place in an imaging lab, inducing a fatal head injury. However, other incidents have made the news, including burns.
The Aug. 21 guidance refers to testing only for devices that are the subjects of a PMA, 510(k) or investigational device exemption filing, and FDA states that the point of interest is "the safety and compatibility of passive implants in the MR environment" due to the possibility of "magnetically induced displacement force and torque, radio-frequency heating, and image artifacts."
The agency says sponsors of passive implant devices should conduct tests that "encompass the range of sizes you intend to market" or test for "a combination of sizes that represents the worst-case scenario for each test."
Some devices apparently will not need testing. "A scientifically based rationale rather than test data may be sufficient to support identifying an implant as 'MR Safe,'" the guidance states. For implants that fall into the categories of "MR Conditional" or "MR Unsafe," sponsors should test for the four effects mentioned previously. FDA also points out that MRI units generating fields of three Teslas or more "are becoming more common," so a field of 1.5 Teslas will not satisfy worst-case requirements.
As for labeling, FDA states that product labels "should indicate the device was tested under non-clinical conditions and list the conditions under which the device can be safely scanned." Among the parameters of interest are the static magnetic field in terms of Teslas and "the maximum whole body averaged specific absorption" for a given duration of scanning.
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Source: HighBeam Research, FDA wants materials tested for MR-scan energy fields.(Washington...