Bair Hugger

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.

Bair Hugger Warming Blankets History & Infection Risk

The Bair Hugger Normothermia System is a forced-air warming, or FAW, system designed to prevent hypothermia and keep patients at a normal core body temperature during all three phases of orthopedic surgery — preoperative, intraoperative and postoperative.

Hospitals have used Bair Hugger devices on more than 200 million patients since 1987 and continue to do so today. More than 50,000 units are installed in the 80 percent of hospitals in the U.S. that use FAW therapy.

The warming blankets stabilize core temperature ahead of surgery, then maintain it during the procedure and immediately afterward as the patient recovers.

The current Bair Hugger warming units include models 505, 750 and 775. Model 500 is no longer in production. 3M, the company that manufactures the devices, also makes disposable Bair Hugger blankets and gowns.

How Bair Hugger Therapy Works
Bair Hugger warming units filter air and then force warm air through Bair Hugger disposable blankets, which cover patients before, during and after surgery. Bair Hugger blankets are designed to use pressure points on the patient’s body to prevent heat from reaching areas at risk for pressure sores or burns. The blankets also include drain holes where fluid passes through the surface of the blanket to linen underneath, which is supposed to reduce the risk of skin softening and reduce the risk of unintended cooling because of heat loss from evaporation.

Bair Hugger Warming Blanket Inventor Warns of Infection Risk

The inventor of Bair Hugger warming blankets, also called forced air warming blankets (FAW), is warning of the risk for infections the device could cause when used during orthopedic surgeries.

Dr. Scott D. Augustine invented the Bair Hugger warming blanket and introduced it in 1988. The blankets were a success, but now he is claiming the blankets have an increased risk of spreading infection during surgery.

“I am very proud of the old technology,” Augustine told the New York Times. “But I am also proud to spread the word that there is a problem.”

Doctors use the warming blankets in millions of surgeries every year to prevent hypothermia – a condition where the body loses heat quicker than it can produce it.

Augustine marketed warming blankets through his company Augustine Medical which later changed its name to Arizant. Augustine resigned from his positions as chairman of the board and chief executive of Arizant in 2002, and 3M purchased Arizant in 2010.

In a statement, 3M responded to Augustine’s claims: “We believe Mr. Augustine’s allegations against forced-air warming (FAW) stem from a personal vendetta and are baseless,” according to the Times.

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