Houston, TXNo doubt, the Bair Hugger warming blanket has made a valuable contribution to medicine. It is standard equipment in almost every operating room in the United States. An electric heater blows warm air through tubes in a disposable blanket draped over the patient during surgery. It prevents patients from slipping into a hypothermic state.
The problem is that when the Bair Hugger Forced Air Warming (FAW) Blanket is used during surgeries involving orthopedic implants such as hip or knee surgery, critics say the system can actually cause deep joint infections, more properly described as “periprosthetic infections.”
Perhaps the biggest critic of the Bair Hugger FAW Blanket is Scott Augustine, MD, the doctor who invented it some 25 years ago.
“I am not proud of this because I am the inventor,” says Dr. Augustine. “But, the 3M Company, which currently owns the Bair Hugger product, refuses to tell the people that the product has a problem. Better yet, 3M should take this product off the market. In the meantime, I am on a mission to tell the world about this problem.”
Dr. Augustine sold the Bair Hugger system in 2004 and turned his attention to inventing other medical devices. One day, several years later while working in his lab, he discovered a flaw in the Bair Hugger system. Heat pushed to the floor by the Bair Hugger system gathered up a storm of bacteria on the operating room floor and would then start rising toward the surgical area.
“It actually heats the contaminated air down by the floor and causes bacteria to rise, bringing those contaminants up and puts them into the sterile field,” says Dr. Augustine.
Implants must be kept absolutely sterile and bacteria free during surgery. Just “one germ” on a knee replacement or hip implant can become a patient’s worst nightmare.
“These are horrendous complications,” says Dr. Augustine.
“They are different than regular surgical infections, which are easy to treat. You pop out a couple of sutures, add a handful of antibiotics and you are on your way,” says Dr. Augustine.
“With implant surgery, a biofilm develops around that bacteria and becomes indestructible. You have to remove the artificial joint and start over,” says Dr. Augustine.
“There is good orthopedic research that shows none of these patients ever get back to normal,” says Dr. Augustine. “They are all permanently disabled. Twelve percent describe their post-survival life as worse than death. I have no idea what worse than death is like but it doesn’t sound good to me. These are really, really serious injuries,” he says.
There is no suggestion that the Bair Hugger is inappropriate for soft tissue surgeries such as breast surgeries, colon surgeries, gallbladder surgeries, etc. The problem is with orthopedic implant surgeries that require absolutely sterile conditions.
“I take no delight in this, but I am on a mission to get the Bair Hugger out of orthopedics. It is a great product, I am not dissing my product, it is a great product and it has changed medicine. But it should not be used in orthopedic surgery,” says Dr. Augustine.
There are now some 170 civil suits filed against The 3M Company related to periprosthetic infections in patients. Those suits are now consolidated in an MDL in Minnesota.
The 3M Company and Arizant Healthcare deny there is a problem with the Bair Hugger system and are vigorously fighting the claims.
Dr. Scott Augustine is the Founder, Chief Medical Officer and CEO of Augustine Temperature Management and Augustine Biomedical + Design.
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