COVID-19 Alerts: U.S. FDA Issues Safety Warnings To Hospitals, Doctors And Radiologists That Face Masks With Metal Can Burn During MRI Procedures
: The US Food and Drug Administration (FDA) has cautioned all medical staff and hospitals that protective face masks containing metal can heat to unsafe temperatures during Magnetic Resonance Imaging (MRI) scanning.
Magnetic Resonance Imaging (MRI) uses strong magnets and radio waves (radiofrequency energy) to make pictures of the inside of the body. MRIs help health care providers diagnose a disease or injury, and monitor medical treatment.
The warning was issued after a patient's face was burned in the outline of a mask that the individual wore during a 3-Tesla MRI neck scan.
Typically, clinicians, radiologists and imaging technicians have known for years to ask patients to remove all metal jewelry and other objects prior to an MRI.
However, many never really paid attention to face mask due to the widespread wearing of face masks during the COVID-19 pandemic.
The U.S. FDA new guidelines suggested, “It is appropriate for a patient to wear a face mask for an MRI exam during the COVID-19 pandemic. Before the MRI begins, health care providers who perform MRI exams should confirm the face mask has no metal. Some face masks have metal strips to help shape the mask to the face of the user, nanoparticles, or antimicrobial coating, which may contain metal (for example, silver or copper). The metal could result in radio frequency (RF)-induced heating. This may represent a hazard for MR imaging during the COVID-19 pandemic.”
This incident however, adds one more consideration to the list.
The U.S. FDA's December 7th safety communication applies to all surgical and nonsurgical face masks and respirators. https://www.fda.gov/medical-devices/safety-communications/wear-face-masks-no-metal-during-mri-exams-fda-safety-communication?utm_medium=email&utm_source=govdelivery
The potential injury risk relates to rapid heating of metal components. Many face masks contain a nose wire or metal clip that helps the product conform to the face.
Many face masks these days contain metal nanoparticles, while others feature antimicrobial coatings with silver or copper. Each of these products should be avoided during MRI scanning. Also watch out for staples on headbands, the American FDA warned.
Should the metal content of a face mask be unknown, the American drug and medical device regulatory agency suggests providing the patient with a facial covering that is known not to contain any metal.
Dr Robert E. Watson Jr, MD, PhD, chair of the American College of Radiology (ACR) Committee on MR Safety, agreed. Dr Watson recommended that facilities "provide patients with masks known to be MRI-safe and not permit patient-owned masks in the MRI."
Dr Watson also suggested this strategy at a time when face masks are required.
He told media, "COVID-19 safety protocols require that patients wear masks when being scanned, to decrease infection risk to MRI staff, decrease risk of contaminating the MRI scanner, and to protect themselves from infection. Any conducting metal that enters the MRI machine is at risk of heating due
to the radiofrequency fields inherent to image generation."
Adverse events related to the metal components of a face mask should be reported to the U.S.FDA using the MedWatch voluntary reporting form. In addition, healthcare providers subject to the FDA user facility reporting requirements should follow procedures at their facilities to report such events. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Hospitals are advised to put up posters and notices warning and reminding patients, MRI technicians and radiologist about safety protocols involving face mask.
For more COVID-19 Alerts
, keep on logging to Thailand Medical News.