Thermoflect Blanket Linked to Injury During MRI
The manufacturer of Thermoflect heat reflecting blankets has recalled the product line for relabeling after the FDA received a report that a patient wearing a Thermoflect blanket was injured while undergoing magnetic resonance imaging (MRI).
Encompass Group, the manufacturer, said that the Thermoflect blanket recall is being issued as a precaution due to the injury. The FDA has not determined that the blanket caused the patient’s injury. There were several other items used in the procedure, including other blankets, which are still being examined for their role in the injury. However, the agency has recommended that Thermoflect products no longer be considered safe for MRI use.
Thermoflect Reflective Heat Technology products are available in a variety of forms, such as blankets, caps, gowns, jackets, pants and vests. They are designed for use by medical facilities and EMS to prevent hypothermia.
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The recall, announced December 26, states that Encompass Group will send labels to customers to be attached to Thermoflect products. The labels will indicate that the products, which are used to protect against hypothermia, are not to be used in magnetic resonance environments.
Encompass Group’s press release says the company previously stated that the products were safe for use in MRI procedures. After the FDA recommendations, the company says it has determined that there are currently no recognized international standards that can effectively be used to test whether Thermoflect blankets can be safely used during an MRI, although the company says it conducted a number of its own tests.
Encompass Group is notifying customers, hospitals and doctors in radiology about the change in safety recommendations, and says it will follow up with training and verification surveys.
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