FDA Clears Bair Hugger Patient Warming Device for Use

What do you get when you blow hot air around a surgical patient?

If you’re 3M Co., the maker of the Bair Hugger Forced Air Warming Device, you get over 2,600 lawsuits. You also get a letter from the FDA telling healthcare providers that the device is actually cleared for use. The Bair Hugger was designed to “promote post-surgical healing and cut down on infections by maintaining a patient’s body temperature in surgery.”

The device is basically a heater and a plastic “blanket.” The “blanket” is draped over the patient, and the heater draws in room air from the OR, heats it, and blows it into the “blanket.” The Bair Hugger is designed to counteract patients’ inability to regulate body temperature while under general anesthesia. According to Dr. Joe Jackson at Anesthesia Myths, “Your body is a finely tuned machine that normally regulates its temperature within several tenths of a degree. Anesthetics can expand this range to be about 2 to 4 degrees wide.”

That’s a significant range, especially since operating rooms are always cold. This is due to the fact that OR personnel are gloved, gowned, and under high-powered (and heat-generating) lamps. Studies cited by 3M have shown that such unintentional hypothermia may increase recovery time, chances of infection, and even chances of death.

It would seem that the Bair Hugger would be a brilliant device that would be heralded as a lifesaver. It may have actually done that, but according to court records, it’s also caused a lot of problems.

According to one lawsuit, “The hot air produced by Bair Hugger accumulates under the surgical drape covering the patient and escapes from under the surgical drape below the level of the surgical table or at the head end of the surgical table. This escaped air creates airflow currents that flow against the downward airflow of the operating room. As this warmed air rises, it deposits bacteria from the floor of the surgical room into the surgical site.”

Now, that sounds like a cause for concern. And, for over 2,600 patients, including the Michigan man in the suit mentioned above, the concern is real.