FDA issues safety reminder on mask use during MRIs; approves new sedation drug in short supply

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FDA issues safety reminder on mask use during MRIs; approves new sedation drug in short supply
tjordan_drupal
Dec 9, 2020

Patients should not wear face masks, such as surgical or non-surgical masks and respirators, with metal parts and coatings during a Magnetic Resonance Imaging exam, because they may become hot and burn the patient, the Food and Drug Administration reminded patients and health care providers this week.

“Some face masks include flexible parts, nose pieces, headband staples, nanoparticles, or antimicrobial coating that may contain metal,” the agency notes. “If the absence of metal cannot be confirmed and it is determined to be appropriate for the patient to wear a face mask, an alternative face mask where the absence of metal can be confirmed should be used. Health care providers who perform MRI exams are encouraged to provide face masks without metal to patients who will undergo an MRI.”

FDA said it received an injury report for a patient who was wearing a face mask with metal during a 3 Tesla MRI scan of the neck, which describes burns to the face consistent with the shape of the face mask. The agency encourages patients and providers to report any adverse events during an MRI to its MedWatch reporting program.

Also this week, FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride, a drug in short supply that is used to sedate intubated and mechanically ventilated intensive care patients and other patients before or during surgery and other procedures. 

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FDA issues safety reminder on mask use during MRIs; approves new sedation drug in short supply
tjordan_drupal
Dec 9, 2020

Patients should not wear face masks, such as surgical or non-surgical masks and respirators, with metal parts and coatings during a Magnetic Resonance Imaging exam, because they may become hot and burn the patient, the Food and Drug Administration reminded patients and health care providers this week.

“Some face masks include flexible parts, nose pieces, headband staples, nanoparticles, or antimicrobial coating that may contain metal,” the agency notes. “If the absence of metal cannot be confirmed and it is determined to be appropriate for the patient to wear a face mask, an alternative face mask where the absence of metal can be confirmed should be used. Health care providers who perform MRI exams are encouraged to provide face masks without metal to patients who will undergo an MRI.”

FDA said it received an injury report for a patient who was wearing a face mask with metal during a 3 Tesla MRI scan of the neck, which describes burns to the face consistent with the shape of the face mask. The agency encourages patients and providers to report any adverse events during an MRI to its MedWatch reporting program.

Also this week, FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride, a drug in short supply that is used to sedate intubated and mechanically ventilated intensive care patients and other patients before or during surgery and other procedures. 

COVID-19: CDC, FDA and CMS Guidance
Regulatory Compliance

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