More bad news came recently for a 3M warming blanket used for hip and knee replacement surgeries that may cause serious infection. FDA issued a Class 2 recall of 165,000 Bair Hugger Forced Air Warming Blankets on Feb. 12, 2018. The blankets were recalled for a design problem that may prevent them from warming up people during surgery, which is the blanket’s sole intent.
3M’s recall notice said health care providers should identify and discard any Bair Hugger underbody blankets affected by the recall. Recalled lot numbers are R10359, R10360, R10361, R10362, R10363, R10364, R10365 and R10366. They represent some 33,108 cases of five units each distributed worldwide.
The Bair Hugger is a single-use blanket that keeps patients warm before surgery. Four out of five hospitals use the single-use device today. The blankets are used in approximately 90 percent of all hip and knee surgeries.
Warming Blanket Lawsuits
3M Co. faces warming blanket lawsuits from more than 4,200 people who claim the company’s popular “Bair Hugger” surgical warming blankets circulate contaminants and cause debilitating deep-joint infections.
The Bair Hugger forced-air warming blanket has been used in more than 200 million surgeries since 1987. Lawyers for the Minnesota-based 3M company say no study has proved the blanket causes surgical infections.
3M company spokeswoman Donna Fleming Runyon told the Star Tribune: “3M will vigorously defend the product and the science against these unwarranted lawsuits. (We) think (plaintiffs’) attorneys are using bad science to blame their clients’ infections on a device that has helped so many people.”
Inventor says Device Creates Infection Risk
Attorneys representing the injured people say research shows the device can spread airborne contaminants while warming up surgical patients. Dr. Scott Augustine, the inventor of the device developed in the 1980s, is expected to testify that it creates infection risk, especially for joint-surgery patients.
“There is no question that it’s a true phenomenon. It’s happening. And it’s easy to show,” said Dr. Augustine, a Minnesota Twin Cities anesthesiologist and entrepreneur who now opposes Bair Hugger use. “With regard to orthopedic infections, a scare is what’s needed. This product should never be [used] on another orthopedic patient.”
Dr. Augustine would be a witness with some baggage. He pleaded guilty to a health care-related misdemeanor in 2004, paid a $2 million fine, and denied any wrongdoing. Today he is chief executive of Eden Prairie’s Augustine Temperature Management, which sells a competing patient-warming device called the HotDog, which uses conductive heat similar to an electric blanket. The Bair Hugger uses forced air.
Dr. Augustine said he regularly lectures to health care professionals about his concerns regarding the Bair Hugger device.
3M sells various disposable Bair Hugger patient-warming blankets that retail from $6 to $24 each. The blankets include rows of inflatable tubes that fill with hot air to warm patients. The goal is to improve surgical outcomes by preventing heat loss from the body’s core and reduce hypothermia risk from anesthesia.
A separate warming unit, connected by a hose, pumps air into the Bair Hugger blanket.
Dr. Augustine says that Arizant “stumbled onto” the discovery that the warming unit can disrupt the carefully designed flow of sterile air inside an operating room. He said waste heat from the unit builds up under the operating table and creates convection currents that can stir up contaminants from the floor and embed them on the surface of a knee or hip implant.
“We studied this extensively for about 18 months. I can tell you with 100 percent certainty that the waste heat rises every single time. This was reported before 3M even bought the company,”said Dr. Augustine. “3M can say that it doesn’t happen. … But when you are going against a basic law of physics, it’s kind of an absurd thing to say.”
Bone and Joint Journal Backs Plaintiff’s Theory
In November 2011, the Bone and Joint Journal in the United Kingdom published a paper from a study of experiments with mannequins and research on past patient records that found the Bair Hugger created a “significant” increased risk for deep-joint infection compared with patients who used the HotDog. The study used statistical regression to report an infection rate of 3.1 percent with forced air, compared with 0.8 percent with the HotDog.
A medical-evidence entity, ECRI Institute, evaluated the Bair Hugger and HotDog data. ECRI concluded in 2014 that there wasn’t sufficient evidence to determine whether one system was better at reducing surgery-related infections.
A systematic review of past studies published in the Journal of Bone and Joint Surgery in Massachusetts last year concluded, “forced air warming can impact [air] flow under certain very specific conditions, but any actual clinical impact on surgical site infections must be considered unproven at this time.”
3M claims the Bair Hugger’s safety is supported by 60 randomized controlled clinical trials since its development in 1987.
One plaintiff’s attorney who represents some people suing 3M said the cases could be tough to prove because no direct evidence shows the Bair Hugger stirring up contaminants, then placing them into any particular patient’s surgical wound.
The burden of proof is on the plaintiffs to prove that the blankets are more likely than not causing infections. The attorney noted that similar indirect evidence on relative risks was the basis for tens of thousands of lawsuits filed against Merck & Co. over its $4 aspirin Vioxx. Merck eventually agreed to pay $4.85 billion to resolve those cases.