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Has the FDA Taken any Action Against the Makers of the Bair Hugger?

FDA Passage

Has the FDA taken any action against the makers of the Bair Hugger? The United States Food and Drug Administration (FDA) approved the Bair Hugger blanket for use in 1987. It was approved under the 510(k) exemption. This meant that it did not have to be clinically tested because it was substantially similar to another device that was medically tested.

FDA Recalls

To date, the FDA has not placed a recall of the Bair Hugger blanket. However, the prospect of this happening is still in its infancy and it could quite well become a reality. The work that goes into a recall is great and demands countless amounts of research, investigation, and money. With recent studies that have outlined its dangers and its own inventor calling for its removal from the market the Bair Hugger blanket might be a relic of the medical past in the coming years.

Trouble on the Horizon

Putting aside the comments of the medical community, the Bair Hugger blanket has also gathered the suspicion and frustration of the FDA itself. It has reported many adverse events associated with the blanket to the manufacturers themselves. The problems normally revolve around air circulation, burning, and other malfunctions. Here are some sample reports of malfunctions that they sent to the makers:

  • 09/14/06, a Bair Hugger unit caught fire. The failure analysis traced the cause to three failures: (1) the heater wire was touching a tertiary thermostat, resulting in a short circuit; (2) a screw came loose and fell into the unit: (3) the loose screw lodged itself in the blower motor and stopped the motor.
  • 07/30/07, a Bair Hugger unit was applied during abdominal aortic aneurysm surgery. The heater unit in the device was not functioning causing the patient to become hypothermic and inducing Disseminated Intravascular Coagulation (DIC), requiring medical intervention.
  • 01/02/08, a patient treated with a Bair Hugger unit was found to have burns (blistering) on 17% of the body. The temperature of the unit continued to increase after the unit was shut off. The distribution of these burns was consistent with placement of the Bair Hugger blanket.
  • 07/15/08 - A Bair Hugger unit caught fire at the power cord.
  • 08/20/09 - The hose of a Bair Hugger unit partially separated from the blanket hose card resulting in a patient burn.

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