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FDA MR-COMPATIBLE DEVICE REVIEWER GUIDANCE

This article was originally published in The Gray Sheet

Executive Summary

FDA MR-COMPATIBLE DEVICE REVIEWER GUIDANCE will provide instructions for reviewers in all office of device evaluation divisions on how to evaluate claims that devices can be used in conjunction with magnetic resonance imaging systems. The guidance, which is being drafted by a task force from the MR group of ODE's computed imaging devices branch, is intended to improve efficiency of the premarket review of applications that include MR-compatible claims. Under the current system, an application that contains an MR- compatible claim is passed on to the MR group for clearance of the claim. The guidance is intended to eliminate this step by providing the necessary information that will allow reviewers outside of the MR group to clear the claims. The device center also is reviewing labeling of already- cleared devices that generally should not be used with MR systems. FDA will check whether the devices' labeling make claims implying MR compatibility. The guidance development and labeling review were prompted by the autumn 1992 death of a patient with an intracranial aneurysm clip who underwent an MR procedure. Aneurysm clips, which may be made of stainless steel or other metals susceptible to magnetic fields, may move or twist when exposed to active MR machines. In its spring Radiological Health Bulletin, FDA explains that "currently, there is no way to be certain that a patient with one of these clips can be safely scanned." FDA requires that MR labeling contain contraindications against scanning patients implanted with aneurysm clips. The office of compliance and surveillance also has begun its own survey of aneurysm clip labeling claims that may imply MR compatibility. FDA's bulletin says that it is "urging physicians to be especially cautious in ordering or performing MR scans on patients who have these implants." The agency is sending its bulletin to professional societies such as the American College of Radiology, the American Medical Association and societies of x-ray and MR technologists. Aneurysm clips fall into one of several categories of devices that interact unfavorably with MR devices. Other products of concern include stents used in the vascular system and mechanical devices such as carts and holding poles for intravenous equipment that may be pulled into MR machines if brought into the same room with them. MR equipment labeling also contraindicates electronic or mechanical devices like pacemakers or ECG machines, since MR fields tend to interfere with the operation of these devices. Finally, machines containing metallic or electronic parts such as computers may give off small radiofrequency signals, which themselves interfere with MR equipment, adversely affecting the quality of the resulting MR image.

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