FDA Tells Hospitals the 3M Bair Hugger Surgical Warming Blanket is Fine to Use

During a recent investigation, the FDA found no "conclusive evidence" between the BairHuggerFacts.com device and a higher surgical infection risk

Information released from the Food and Drug Administration (FDA) recently showed that doctors and hospitals could safely continue to use the 3M forced-air warming blanket during surgery. This announcement comes after thousands of lawsuits being filed stating the devices increased the potential for serious surgical infections.

The Bair Hugger device is manufactured by the 3M Co., which is based in Maplewood and is a widely used system that was designed to help promote post-surgical healing while reducing the risk of infections. It did this by keeping a patient’s body a consistent temperature during surgery.

In addition to spreading the information about the FDA’s findings, Bair Hugger has also created the Truth About Bair Hugger website. Here patients, doctors, and others can learn the facts about this medical device that has been used without issue for more than 25 years. It offers many advantages and has helped to reduce serious issues for many patients who may experience body temperature issues while undergoing surgery.

The 3M™ Bair Hugger™ warming blanket system is the most used and studied method of surgical warming in the country, with its clinical benefits, efficacy and safety well documented in more than 170 studies and more than 60 randomized controlled clinical trials.

In fact, according to U.S. News & World Report, Best Hospitals 2015-16, the Bair Hugger warming blanket system is the preferred patient warming device of U.S. healthcare facilities (and 8 of the top 10 orthopedic hospitals) and is supported by numerous healthcare organizations because of its proven safety and effectiveness. The Bair Hugger warming blanket system has become an indispensable component in the care of surgical patients, providing safe and effective warming therapy to patients across the globe.

Additional information about the findings by the FDA and more information about the Bair Hugger is available on the manufacturer’s website.


When a patient is given general anesthesia, it may compromise the ability the body has to regulate its temperature, especially when undergoing any type of major surgery where the internal tissues are open and exposed to the air for extended periods of time. This type of unintended hypothermia during a surgical procedure can increase the rate of infection, as well as recovery times. As a result, over 80 percent of hospitals in the US actively use the Bair Hugger warming system.

FDA tells hospitals that 3M Bair Hugger surgical warming blanket is OK for use

Contact Info:
Name: Joe Carlson
Email: Send Email
Organization: 3M Bair Hugger
Phone: 612-673-4414
Website: http://www.startribune.com/fda-tells-hospitals-that-3m-surgical-warming-blanket-ok-for-use/442296163/

Release ID: 236465