Washington, D.C. – The Medical Imaging & Technology Alliance (MITA), the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators, and product developers, today released the following statement in response to a U.S. Food and Drug Administration- issued safety notification on mask wearing during MRI examinations:
"The COVID19 pandemic impacts the way diagnostic imaging examinations are performed. Particularly, patients may need to wear masks during the examination, which may impose hazards in the MR environment. The U.S. FDA issued a safety notification (https://www.fda.gov/medical-devices/safety-communications/wear-face-masks-no-metal-during-mri-exams-fda-safety-communication) to remind patients and providers not to wear any metal during the MR examination. MITA fully supports this reminder and reinforces the instructions for use with MR systems:
Check clothing for the presence of metal pieces, strips, or woven micro fabric
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Recommend use of hospital supplied gowns and masks (for which safety is established by the hospital) in all cases
Check with the mask manufacturer that no metallic nano particles or fabric is included in any of the layers of the mask"
MITA is a Division of the National Electrical Manufacturers Association.
Tobias Gilk
Masks and MRI Risks
February 08, 2021 08:54
I find it odd that the FDA appears to have issued an alert based on a single adverse event report with so little specific information. Yes, we should take steps to avoid electrically conductive materials on the patient during MRI (including the mask), but during a global pandemic when mask usage is both recommended / mandated and when PPE is often in very short supply, having specific evidence-supported guidance on the risk factors seems to me to be the minimum expectation... one that I feel the FDA alert does not meet.
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