FDA, Encompass recall Thermoflect blankets for MR environments
The FDA and Encompass Group have issued a voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR environment.
The FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached with instructions to remind hospitals that the product line should not be used in the MR environment.
"In the past, we have stated that the Thermoflect product may be used in the MR environment. However, after being informed by the FDA, at this time we will not promote the products for use in the MR Environment,” said Jea R. Gackowski, Encompass’ corporate compliance officer. “However, the product is still safe and effective for use in treating hypothermia.”
The McDonough, Ga.-based company said it has been advised by the FDA that a report has been filed of an injury to an MRI patient. Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one.
There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure Encompass is voluntarily recalling the product line for relabeling, said Gackowski.
Encompass has concluded that there is currently no ASTM International standard to test Thermoflect in the MR environment, although the company has conducted multiple laboratory and field tests. "Until an ASTM standard has been developed by ASTM International, we have removed statements on our Web site and in our product literature that Thermoflect is MR-conditional or MR-compatible,” said Gackowski.
The FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached with instructions to remind hospitals that the product line should not be used in the MR environment.
"In the past, we have stated that the Thermoflect product may be used in the MR environment. However, after being informed by the FDA, at this time we will not promote the products for use in the MR Environment,” said Jea R. Gackowski, Encompass’ corporate compliance officer. “However, the product is still safe and effective for use in treating hypothermia.”
The McDonough, Ga.-based company said it has been advised by the FDA that a report has been filed of an injury to an MRI patient. Several items are under consideration, including all of the blankets used in the MRI environment, of which Thermoflect is one.
There is no evidence that the Thermoflect blanket caused the injury but as a precautionary measure Encompass is voluntarily recalling the product line for relabeling, said Gackowski.
Encompass has concluded that there is currently no ASTM International standard to test Thermoflect in the MR environment, although the company has conducted multiple laboratory and field tests. "Until an ASTM standard has been developed by ASTM International, we have removed statements on our Web site and in our product literature that Thermoflect is MR-conditional or MR-compatible,” said Gackowski.