The U.S. Food and Drug Administration (FDA) issued an alert on December 7, 2020, informing patients and healthcare providers that patients may be injured if they wear face masks with metal parts and coatings during magnetic resonance imaging (MRI) exams. Metal parts (e.g., nose pieces, nanoparticles, or antimicrobial coatings that may contain metal such as silver or copper) may become hot and burn patients during MRIs.
Recommendations for Patients and Caregivers
- Do not wear a face mask containing metal parts (e.g., bendable nose piece or staples on the headband, nanoparticles, or antimicrobial coating that may contain metal) when having an MRI. You may not be able to tell whether a mask has metal in it. Ask the person performing the MRI to confirm that the face mask you are wearing does not contain metal parts.
- If patients are burned by a face mask during an MRI, report the event to FDA. Your report, along with data from other sources, can provide information that helps improve patient safety.
Recommendations for Healthcare Providers Who Perform MRI Exams
When patients must wear a face mask during an MRI exam, such as during the COVID-19 public health emergency, ensure that it contains no metal. Some face masks include flexible parts (e.g., nose pieces, headband staples, nanoparticles, antimicrobial coatings) that may contain metal. If the absence of metal cannot be confirmed and the patient must wear a face mask, an alternative face mask with no metal should be used. Healthcare providers who perform MRI must provide face masks without metal to patients who undergo MRI.
- Continue to screen all patients for MRI safety, including looking for metallic objects, prior to MRI exams.
- If a patient experiences an adverse event, such as a burn, while wearing a face mask during MRI, report the event to FDA. Your report, along with data from other sources, can provide information that helps improve patient safety.
Potential for Injury During an MRI While Wearing a Face Mask That Contains Metal
Patients should wear a face mask for an MRI exam during the COVID-19 pandemic. Before beginning an MRI, healthcare providers should confirm that the face mask has no metal. Some face masks have strips to help shape the mask to the user’s face, nanoparticles, or antimicrobial coating, all of which may contain metal (e.g., silver or copper). The metal could result in radio frequency-induced heating, which may be a hazard for MRI during the pandemic.
FDA received an injury report for a patient who was wearing a face mask with metal during a 3 Tesla MRI scan of the neck. The patient had burns to the face consistent with the shape of the face mask. Burns from metal objects worn by a patient during an MRI exam are a known issue, and patients should not wear any metal during an MRI. Given the increased use of face masks during the COVID-19 pandemic, patients and healthcare providers must be aware of the potential risk of face burns related to the use of masks containing metal during an MRI.
FDA is monitoring the issue and will keep the public informed if significant new information becomes available. If patients experience a problem during an MRI, report it through the MedWatch Voluntary Reporting Form. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow those facilities’ reporting procedures. Contact the Division of Industry and Consumer Education at email@example.com or call 800-638-2041 or 301-796-7100 with any questions.