Thermoflect blankets and other Thermoflect products have been recalled by Encompass Group for relabeling because they may not be safe for use in the Magnetic Resonance (MR) environment, such as during Magnetic Resonance Imaging (MRI). The Thermoflect recall was prompted by a report to the Food and Drug Administration (FDA) of an injury to an MRI patient. A Thermoflect blanket may or may not have caused the injury.
Thermoflect Products
Thermoflect blankets and other Thermoflect products are used in treating hypothermia. Hypothermia is dangerous lowering of core body temperature. Hypothermia can lead to many serious, acute health issues and complications when it happens in conjunction with other health events.
Thermoflect products help to maintain a patient’s core body temperature both by acting as a regular blanket in preventing heat loss to passing air, and by reflecting the heat coming off of the person’s body back to them. Thermoflect technology is based on NASA pioneered alternatives to electric means of preventing or treating hypothermia.
Thermoflect products do not conduct electricity and do not obstruct X-rays.
The Reason for the Thermoflect Recall
In the past, Encompass Group said that Thermoflect products were safe for use in the MR environment. It says that the product line may indeed be safe in the MR environment, but since an injury linked to the use of a Thermoflect blanket during MRI has been reported, they are going to re-label the products as inappropriate for use in the MR environment and have sent letters to hospitals, doctors, and others warning of the potential danger.
Encompass Group has conducted its own testing of the products, but the American Society for Testing and Materials (ASTM) has not established a standard for testing the products. Encompass Groups says it will not promote Thermoflect products for use in the MR environment until the ASTM establishes a standard and the products are proven safe.
Encompass Groups says that Thermoflect products are still safe and effective for hypothermia treatment outside of the MR environment.
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