When a patient is under anesthesia, they need to have a regulated body temperature. If the patient gets too cold, there could be complications during the surgery. The Bair Hugger Forced Air-Warming (FAW) blanket was created as a solution to that problem, but it has caused complications of its own.
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During the procedure, the surgeon drapes a Bair Hugger blanket over the patient’s anesthetized area. The blanket has a system that circulates warm air through its components to control the patient’s body temperature. Keeping the patient warm is essential during surgery because the danger of hypothermia in the anesthetic area is raised. This process is especially important during knee or hip replacement surgeries.
The Bair Hugger blanket itself has two parts: the blanket and the hose attachment. The first is a disposable blanket that wraps around the patient. This covering should only be used once before it is discarded. The hose attachment connects to a warming unit, which heats the air before pumping it through the blanket to keep the patient warm. The small perforations in the blanket enable the warm air to pass safely onto the patient, and the cover traps the heat to keep the temperature regulated.
The FDA approved the first air-warming blanket manufactured by Augustine Medical, Inc., in 1987. Eventually, the company changed its name to Arizant, but in 2009, GM acquired Arizant as a subsidiary. However, 3M began to market and sell Bair Hugger blankets under their own name in 2010, making them the manufacturer and distributor of these medical devices.
Without conducting any clinical trials, the FDA originally approved the Bair Hugger Forced Air Warming (FAW) system in 1987. According to an FDA precedent, if a piece of medical equipment is sufficiently comparable to previous devices that have already been approved, it can be cleared without a trial.
Unfortunately, the risks of this device were not documented before its FDA approval and subsequent release. Most notably, there is an increased risk of infection due to the device’s interference with the airflow present in operating rooms.
Because of the sterilized nature of an operating room, airflow is a critical part of maintaining filtration. By circulating air continuously, bacteria are prevented from settling in any of the patient’s exposed wounds. The Bair Hugger FAW blanket interrupts this critical airflow by producing air warmer than the rest of the room, thereby settling in the room and enabling bacteria to be carried to the operating table.
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3M has not made any public statements concerning the hazards associated with its products. However, a public study released in 2011 discussed the potential risks of using FAW systems in the sterile conditions of an operating room.
The original creator of the Bair Hugger also wrote a letter to company executives at Arizant after he departed, outlining his concerns for the product. Despite these warnings, 3M has declined to take steps to address the issues with the product.
Although the FDA has not issued a formal recall on Bair Hugger products, 3M did issue a voluntary recall in 2018, removing 165,000 products from use. 3M stated that a change in the Bair Hugger’s design caused some devices not to properly inflate. Patients developed hypothermia as a result of the device’s failure to regulate patients’ body temperatures adequately due to this product flaw. The voluntary recall only dealt with faulty equipment that could cause hypothermia and did not deal with complaints about infection.
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