Important Answers about 3M™ Bair Hugger™ Therapy
What is the 3M™ Bair Hugger™ patient warming system?
The Bair Hugger warming system is used by more than 80 percent of U.S. hospitals to keep patients warm before, during, and after surgery. The Bair Hugger warming system draws in the filtered air of the operating room, passes it through an internal filter and warms that air to the selected temperature. The warmed air flows to a single-use Bair Hugger warming blanket through an enclosed hose, and is then gently dispersed across the surface of the skin. Contrary to claims from a competitor, the Bair Hugger system does not disrupt the air flow in the operating room.
I’ve seen advertising suggesting that the Bair Hugger warming system caused infections during knee and hip replacement surgery. Are these advertisements true?
No. The advertisements are wrong and misleading. There is no evidence that the Bair Hugger system ever caused an infection in any of more than 200 million patients who have been warmed with it. These advertisements are paid for by lawyers.
Can the Bair Hugger patient warming system cause infections?
No. There is no conclusive evidence that the Bair Hugger system’s forced-air warming causes infections.
In fact, scientific literature suggests that maintaining normal body temperature during surgery can have numerous benefits that include a reduction in the rate of postoperative infections, reduced blood loss, a reduction in the possibility of heart attacks, shorter recovery times and lower mortality rates. The Bair Hugger system is a safe and effective method of maintaining normal body temperature during surgery.
What has caused these concerns now?
A competitor that sells a different type of warming device has waged a decade-long campaign claiming the Bair Hugger system can cause infections. There is absolutely no proof of that. The competitor has worked with plaintiffs’ lawyers to try and blame the Bair Hugger system for infections suffered by patients during surgery.
Have any regulatory agencies looked at the issue?
In August 2017, the U.S. Food and Drug Administration recommended that health-care providers continue to use warming devices, including forced-air devices such as the Bair Hugger system, when clinically warranted. The FDA said it became aware that some health-care providers and patients were not using forced-air warming because of concerns about a possible increased risk of surgical site infections. The FDA, which regulates medical devices, said it “has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”
Have any of these lawsuits been resolved?
Yes. The first case went to trial in May 2018. A federal jury deliberated less than two hours before finding in 3M’s favor. 3M, which makes the Bair Hugger warming system, takes every allegation of patient injury seriously, but does not believe there is merit to any of the lawsuits. 3M is confident that the science shows the Bair Hugger system does not cause surgical-site infections.
How prevalent are surgical site infections?
About one of every 100 patients develops an infection after surgery. Rates will vary depending on the type of surgery and the patient's risk factors.
What causes a surgical site infection?
Many factors can cause a surgical site infection. Everyone has bacteria in their bodies. The majority of surgical site infections come from the patient’s own bacteria. When the skin is opened, bacteria in the body can migrate to the surgical wound. A number
of factors are known to increase the risk of surgical site infections, including having other medical problems or diseases such as diabetes, high blood pressure or heart disease, being elderly, or overweight and smoking. The U.S. Centers for Disease Control discusses surgical site infections here.
What are the benefits of keeping people warm during surgery?
A widely accepted practice for reducing the risk of infection is to maintain a surgical patient’s core body temperature greater than 96.8° F throughout the surgical procedure. Keeping people warm during surgery can, in fact, reduce the risk of infections, reduce the length of hospital stays and improve overall outcomes from surgery.