The Bair Hugger Blanket is a device that is used to warm patients before and during surgery. Going under general anesthesia for any type of surgery is risky and dangerous and the warmth of a device can help mitigate some of those risks. Invented by a Minnesota anesthesiologist, the Bair Hugger has been used in millions of surgeries since it first was approved and made available in 1987.
Although the Bair Hugger devices can save lives and reduce risks during surgery by keeping patients warm, there have been numerous reports of adverse events with its use. These include infections, fires that caused burns, and failures that led to patients losing body temperature during surgery. Lawsuits have been filed against the current owner and seller of Bair Huggers, 3M, especially for the serious infections that plaintiffs claim the devices have caused.
The Importance of Warmth During Surgery
Operating rooms are usually kept a little chilly to make sure surgeons are comfortable doing their work. For a patient lying inert on a metal table, though, this can be dangerous. Various factors, including open incisions and anesthesia, conspire to lower the body temperature of patients during surgery by two to four degrees. This can cause heart problems and even fatal heart attacks. Being too cold also increases the risk of excessive bleeding and infections. By keeping patients warm ahead of and during surgery, doctors can reduce these risks significantly.
What is the Bair Hugger Blanket?
The Bair Hugger blanket is designed to warm patients during surgery, or at least to keep the body temperature normal, while the room remains cool for the comfort of surgeons. 3M makes and sells Bair Hugger products and there are 25 different designs featuring different sizes and shapes to meet the needs of individual patients and types of surgery. They are one-use blankets that are disposed of after surgery.
The Bair Hugger is more than a blanket. It is attached to a temperature management unit, which through a hose, delivers warm air to the blanket. The blanket is perforated with small holes on the side that faces the patient’s body so that the warm air is circulated over the body.
The History of Bair Hugger Devices
The Bair Hugger was invented in the 1980s by an anesthesiologist, Dr. Scott D. Augustine, who saw the need for a device that would effectively keep surgical patients warm. Tests with the device showed that patients were kept warmer, had less bleeding, and recovered faster from surgery when it was used during surgical procedures. Dr. Augustine sold his invention as the CEO of Augustine Medical, now called Arizant Inc, and made a fortune.
In 2010, 3M bought Arizant and with it the rights to the Bair Hugger blankets. 3M paid around $800 million for the medical company. Today, 80 percent of hospitals use 3M’s Bair Huggers and more than 200 million surgeries have been performed with the blankets.
Fires, Burns, and Equipment Failures
The FDA’s adverse events reporting system collects information about problems and side effects of medications and medical devices. In 2010, before the sale to 3M, the FDA issued a warning letter to Arizant regarding Bair Huggers and reports of adverse events. The FDA found Arizant at fault for failing to report certain adverse events that occurred with use of the Bair Huggers.
These adverse events included several burns, including severe second and third degree burns. There were reports of the devices catching fire because of faults like loose screws and heater wires as well as short circuits. In one report a patient ended up with blistering burns on 17 percent of the body. In this instance the device had been turned off, but continued to heat and cause the burns.
Other reports included instances in which the Bair Huggers failed and the patients using them ended up with hypothermia. In one such case the patient’s temperature loss resulted in a condition called disseminated intravascular coagulation.
While burns and hypothermia have been serious adverse events connected with the Bair Hugger, even more serious for some patients have been the infections caused by it. Keeping a patient warm is supposed to reduce the risk of infections, but reports and some studies have concluded that the Bair Hugger may actually make patients more vulnerable to serious infections, especially patients having joint surgery.
The problem is thought to be in the way the Bair Hugger circulates warm air. It forces air through the blanket and out through small holes that face the skin of the patient. This moving air, it has been claimed, can pick up contaminants and circulate them over the patient, causing bacteria to get into the surgical incisions, and potentially deep into the joints of patients having joint surgery.
Even the inventor of the Bair Hugger, Dr. Augustine, backs up the claim that the device can cause serious infections. He has accused Arizant, which took over sales of Bair Hugger before 3M bought it, of covering up the known problems with the device. There is some controversy as to whether the risks of infection are valid or whether Dr. Augustine is biased because he has a new product competing with the Bair Hugger.
Regardless of whether or not Dr. Augustine has ulterior motives in criticizing his original invention, the Bair Hugger has caused problems. People have received burns and have become hypothermic when the device failed. People who experienced infections, especially the serious and damaging deep joint infections, claim that the Bair Hugger caused their infections and many have filed lawsuits against 3M.
Over 50 surgical patients have filed suits, claiming infections caused by the Bair Hugger, but 3M is denying that there is any issue with the device and calls the suits unwarranted. Research is mixed, but what is clear is that patients have suffered and they deserve compensation. It is likely that the number of lawsuits will continue to grow and that there will eventually be a resolution. If you have been hurt by a Bair Hugger device, you too could get in on a suit and fight for your compensation.