When the 3M Bair Hugger warming blanket was introduced in 1988, it seemed like a good idea. Under anesthesia, the patient’s body temperature drops. Maintaining the normal body temperature at around 98.6 degrees Fahrenheit reduces bleeding and decreases recovery time. The device has been also effective for the treatment of hypothermia in patients suffering from exposure. However, the heated forced air that comes in contact with the patient’s body also circulates under the table, where bacteria may hitch a ride and wind up in patient incisions. The resulting infections have led to a growing number of lawsuits.
Bair Hugger’s inventor, Dr. Scott Augustine, tried to notify hospitals about the infection risks several years ago. An anesthesiologist practicing in Minnesota, Dr. Augustine was among the first to demonstrate the advantages of keeping a patient warm during surgery. When he realized that his invention was spreading infectious bacteria in operating rooms, he created another device, similar to an electric blanket, eliminating the risks of using forced air. By that time, Augustine had no financial interests in the Bair Hugger. He had resigned as CEO of his company, Augustine Medical, Inc., in 2002 in the wake of a dispute with the Board of Directors. That company changed its name to Arizant and became a subsidiary of 3M.
In April 2010, Dr. Augustine accused his former company of concealing the infection dangers associated with the Bair Hugger. In a letter, he wrote: “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?”
In response, Arizant filed suit against Augustine’s new company, Augustine Biomedical and Design, alleging that it was spreading misleading information about the Bair Hugger. A representative of parent company 3M issued the following statement: “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless.”
Some in the medical community speculated that Dr. Augustine was simply trying to disparage his old invention in order to promote his new one (known as the “Hot Dog”). In the meantime, Dr. Augustine attempted to present data about his concerns and have it evaluated. At the time, the data was found to be “compelling,” but was ruled “inconclusive.” Another study, published in the March 4, 2003 issue of the journal Critical Care, concluded that: “use of this warming system does not lead to increased bacterial contamination of the operating theatre atmosphere, and it is unlikely to affect the surgical field adversely.”
Recently, however, there has been a significant rise in the number of patients coming forward, alleging that their infections and post-surgical complications (including removal of surgical prostheses and amputation) were caused by use of the Bair Hugger. The medical research also is beginning to verify what Dr. Augustine warned. That is, the use of the Bair Hugger unnecessarily increases the risk of severe infections, especially during hip and knee replacement surgeries, and that there are clear alternatives.