The Bair Hugger is a warming device used to keep body temperatures from dropping dangerously low during surgery. The three-part system stops the development of hypothermia, allows for a quicker recovery and helps prevent complications such as blood loss.
The skin surface warming system forces air through a hose, which is then distributed over a patient’s body. The device has become a standard component in medical facility inventory. But after more than two decades on the market, Bair Hugger’s creator is speaking out against his own invention.
Recent studies show the Bair Hugger, a class II device, can increase the spread of bacteria and subsequently lead to infection. Dr. Scott D. Augustine, the inventor of the device, now works to spread awareness about its potential dangers.
Studies + Science
The Bair Hugger is designed to protect against hypothermia, which occurs when the body cannot replenish the heat at the same rate it is lost. A hypothermic temperature is anything below 95 F.
Hypothermia affects the nervous system and organ functioning. Complications from hypothermia during surgery can be mild to severe, resulting in blood loss, heart failure, or even death.
How the Bair Hugger Works
The Bair Hugger Therapy system includes different sized and shaped blankets, a warming unit, a warming unit filter, and fluid warming set. The multi-piece system filters warm air into the blanket, which evenly distributes heat over the patient. The device is meant to recognize pressure points in order to avoid leaving burns or causing a sore.
Dr. Augustine runs a website explaining the faults of the Bair Hugger system. He cites the reuse of certain components of the Bair Hugger, in addition to wasted heat, as the main causes of contamination.
Because the blower and hose are reused time and again, the Bair Hugger is only partially disposable. The reuse can expose patients, and health professionals, to lingering germs.
"One published study showed that 92 percent of FAW blowers are contaminated with bacteria, and 58 percent internally generated and emitted germ-sized particles. The contamination is significant because high-velocity air blows across the germ colonies.”
— Dr. Augustine
Another cause of surgical site contamination is wasted heat, according to Augustine. The Bair Hugger alters the temperature and flow of the air, affecting ventilation and convection. The disruption could create turbulence that brings surgical drape bacteria near the patient.
"Only about 15 percent of the 1000 watts of heat produced by the Bair Hugger blower is actually transferred to the patient. The excess heat then escapes into the OR and mobilizes contaminants.”
Risk of Infection
Despite the fact that the blankets are disposable, studies found that the Bair Hugger might make patients more likely to get an infection. In comparison to other warming devices, some contaminants may linger.
People undergoing orthopedic surgeries, like knee or hip replacements, are particularly at risk. The introduction of metal plates or implants confuses the body’s immune system, which makes it more difficult to target the infection. Infections at orthopedic surgery sites can lead to swelling, severe pain, or even death.
A study published in the U.S. National Library of Medicine discovered “a significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio, was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used.”
Risk of Burning
Bair Hugger units can cause burns, blistering and potentially catch fire. The FDA discovered multiple incidences where the device malfunctioned and injured patients. The number of more recent fire-related incidences is currently known.
Invented by anesthesiologist Dr. Augustine, the Bair Hugger was the first device that could prevent hypothermia during surgery. After being approved by the FDA through the expedited 501 (k) clearance program, it was introduced into hospitals in 1988.
Bair Hugger was initially sold through Augustine Biomedical and Design, before the company changed its name to Arizant. It was later sold again to 3M, in 2010, for around $800 million.
Statistics show that 80 percent of hospitals use the Bair Hugger Therapy system, with over 180 million Americans having been treated with it in the last few decades.
In 2010, the FDA sent a warning letter to Arizant failing to properly document and report dangerous life-threatening malfunctions. The warning letter mentions a female patient who suffered 2nd-degree burns on her breasts and a 21-month-old child who received 2nd to 3rd-degree burns.
Criticism from Bair Hugger’s Inventor
Dr. Scott D. Augustine now acts as an advocate, spearheading campaigns to inform people about the infection risks of his invention. He argues the forced air method brings bacteria from the hospital setting into contact with the patient.
He has since invented a new warming system that doesn’t utilize a forced-air method called the HotDog, which is more like a blanket than a blowing system, or an air-free electric blanket.
Dr. Jeffrey P. Gumprecht, an infectious disease expert in New York, said that he was hired by Dr. Augustine’s company to review its data. He said he found the inventor’s theory about the potential dangers of forced-air warming compelling, but added that proving such a link might be impossible because it would require mounting a huge clinical study.
“The question for you to answer is the following; is Bair Hugger going to be replaced quickly and catastrophically by a mandatory recall, or do you survive a voluntary recall and live to fight another day?” he wrote.
Studies led the inventor to believe that the Bair Hugger can cause an increased risk of infection. In addition, patients affected by the device have filed adverse event reports with the FDA. The regulatory agency hasn’t issued a recall for the devices, which continues to be used on millions of patients.
The Next Steps
The Bair Hugger exists in nearly every U.S. medical facility. If you’ve had a surgical procedure and developed an infection, it’s possible that the Bair Hugger could have been at fault.