“We need to do a better job of educating radiologists, rad techs and MR techs to understand when they are faced with a set of conditions that do represent a specific risk and when, even where there are no labeled conditions from the manufacturer, a set of conditions don’t represent a significant risk,” he says.

The problem is complex and exacerbated by the current state of federal guidelines. For instance, providers are unable to contact manufacturers and ask if a specific MR model will correspond well with an implant as manufacturers under FDA rules are prohibited from communicating this information.


Implant manufacturers, meanwhile, are not required by any law to label if an implant is safe for MR procedures unless the device is specifically designed and marketed for that purpose. They also do not have to provide information on what field strengths their products can handle or go back and update their product labeling.

This effectively hinders the ability for FDA guidelines to significantly enhance MR safety while also preventing hospital personnel from making decisions that could help protect or treat patients.

Ferromagnetic detectors: a key piece of the puzzle
Adverse events, though a consequence of MR technology and human decisions, can be largely prevented through the right form of screening.

But even the issue of how to screen patients properly is up for debate, especially regarding the use of ferromagnetic detectors. One particular issue concerns location.

"Many facilities would like to have what they call the last task effort on the magnet room door,” says Keith Kopp, the president and founder of Kopp Development, a manufacturer of ferromagnetic detectors. “And the function of that is if something got missed, if staff comes in that didn't plan on coming into the magnet room and for some reason they have to go in, there's a last ditch scanning.”

But Gilk says detectors by the door can create major safety hazards, and that a more suitable option would be to place the device a few feet away.

“When you do that, you inherently create a number of potential problems,” he says. “One of them is you’re right at the door and so therefore, if the alarm goes off and someone is actually walking forward, they don’t have the opportunity to stop until they’re three to five feet inside the room which may be a little too late, depending on the size of the room and extent of the magnetic field of that MR scanner.”

Another issue involves the features of ferromagnetic detectors. Many detectors are equipped to spatially locate door hinges so they can ignore ferromagnetic signals that come from them. There is, however, a concern that a metal object at the exact height of the hinge, in perhaps a pants pocket, may be ignored as well because of this feature.

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