FDA's warning- Wear Face Masks with No Metal During MRI

After a shocking incident during a 3-tesla MRI scan wherein a patient experienced severe face burns from the metal in a mask, the U.S. Food and Drug Administration (FDA) issued a guidance circulated to all patients and healthcare providers on the usage of metal during routine MRI exams. This notification was rolled out on December 7.

During the current pandemic scenario, all patients are advised to wear masks when then enter any healthcare facility to prevent the rapid spread of the COVID-19 virus. Therefore, "the [FDA] is informing patients and healthcare providers that patients may be injured if they wear face masks (such as surgical or nonsurgical masks and respirators) with metal parts and coatings during an MRI exam," the agency said. "The FDA reminds patients and providers that patients should not wear any metal during an MRI."

The report stated that the patient who was injured after undergoing a 3-tesla MRI exam of the neck experienced the face burn consistent with the outline of the mask.

"Given the increased use of face masks during the COVID-19 pandemic, the FDA wants patients and healthcare providers to be aware of the potential risk of face burns related to the use of patient face masks containing metal during an MRI," the agency said. "Metal parts ... [in a face mask] may become hot and burn the patient during an MRI."

Although it is a necessity to wear face masks now during an MRI exam due to the COVID-19 pandemic, but some masks have nose clips or wires, nanoparticles, or antimicrobial coatings in them which constitutes the metal part either silver or copper. Hence, before the MRI scan begins, it is the duty of the healthcare professional to ensure that the scans are performed with no metal component in the facemasks.

"The metal could result in radio frequency (RF)-induced heating," the agency said. "This may represent a hazard for MR imaging during the COVID-19 pandemic."

The FDA found a solution to this problem. "Don't allow patients to wear their own masks during an MR exam", said Tobias Gilk, senior vice president of Radiology-Planning, founder of Gilk Radiology Consultants, and an MRI safety advocate.

"The staples holding the elastic to the mask are too small to conduct heat, and since the COVID-19 pandemic, patients have been imaged in masks that have nose bridges without injury," he said. "But antimicrobial treated fabric can heat up. So, to be safe, patients should be provided with disposable surgical masks before their MRI."

The FDA asks any patients who are burned by a face mask during an MRI scan to report such an event immediately.