Heated Debate

Patient Safety

By: Matthew Nojiri

Published: 4/15/2019

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Scott Augustine, MD, the inventor of the Bair Hugger patient warming device, claims it causes SSIs. The manufacturer, and the courts, so far have disagreed.


Scott Augustine, MD, begins an hourlong pitch about the dangers of the Bair Hugger forced-air patient warming system he invented — and is now campaigning against because, he asserts, it can cause infections in joint implant patients — with a simple scientific statement.

"Heat always rises," says Dr. Augustine, an anesthesiologist and CEO of Augustine Surgical in Eden Prairie, Minn. "It has to. It's physics."

For 30 years, Dr. Augustine has been at the frontier of patient warming, and he's spent much of the last decade warning about the dangers of the Bair Hugger. He claims the forced-air warming blanket system, which 3M acquired for $810 million in 2010 from Arizant Medical (Dr. Augustine resigned in 2002 as Arizant's chairman and CEO), disrupts the OR's natural air flow, forcing hot air up while stirring contaminated particles from the floor and into the sterile field.

Those deep-joint surgical site infections (SSIs) that plague thousands of hip and knee patients every year? Dr. Augustine says the signs point to the Bair Hugger. Dr. Augustine's claims come with the ultimate caveat. His company sells the HotDog Patient Warming System, an air-free warming method that uses a conductive fabric to warm the patient from above and below. And there's another fact that complicates matters even further: Dr. Augustine is not only the world's leading critic of the Bair Hugger. He's also the one who invented it in 1987.

"I got on a crusade to tell the world about a problem that technically I created," he says.

The stakes for 3M, for Dr. Augustine and for patients and surgical facilities couldn't be higher. 3M says its device warms 50,000 patients each day. By some estimates, patient warming is more than a $1 billion global industry. Here's where things stand in the debate about the Bair Hugger.

The lawsuits

A rash of lawsuits followed Dr. Augustine's Bair Hugger claims. About 5,000 orthopedic patients across the country have sued 3M, making the same argument about the supposed link between the forced-air warmer and SSIs. Dr. Augustine downplays his role in the lawsuits, but he also admits to advising the lawyers who set off the wave of litigation.

"We had no role other than doing the initial education that got things rolling," he says. "3M would like to make this into a conspiracy."

Dr. Augustine says he's on a crusade for patient safety. 3M says he has financial motives in mind. Augustine Surgical sold the Bair Hugger to Arizant in 2003, and now it's selling a competing product, says 3M. Dr. Augustine has also tried to sell the HotDog system to 3M, saying "it would clean up their mess" to have an air-free warming product for implant patients.

"Augustine created a "problem' with the Bair Hugger system, then helped create the research that attempts — but fails — to prove such a problem exists," says 3M on its website defending the Bair Hugger. "Working with a Texas law firm, he helped develop the "research' to support the litigation now under way in Minnesota federal court."

Thus far, the courts have sided with 3M, but the legal process is still unfolding. One bellwether case went to trial last year, and 3M prevailed after a couple hours of jury deliberation. In January, the Minnesota Court of Appeals upheld a decision to dismiss dozens of state cases against the company, writing "that the relevant scientific community has not accepted the novel scientific opinion that (forced-air warming devices) cause an increased risk of SSIs." 3M says more than 600 cases have been dismissed.

"Our case is strong because the science is on our side," says 3M in a statement to Outpatient Surgery.

Dr. Augustine says that doctors shouldn't wait for the courts to determine that forced-air warming is safe. At the same time, he knows a 3M loss in court could mean big things for his business.

"I think there's no question that forced-air is going to go away," he says. "There's 5,000 suits. All they have to do is lose one, and it's game over."

He adds: "The world is moving to electric (warming). We happen to have the best electric system."

What the research says

NOTHING PERSONAL "I don't have a vendetta against 3M," says Dr. Augustine. "I just want them to stop using my invention to stop causing infections."   |  Pamela Bevelhymer, RN, BSN, CNOR

The research into the Bair Hugger's role in SSIs is a minefield of conflicts and competing interests. Both sides can point to research that bolsters their point of view, but it's important to read the fine print.

In a November 2011 study published in The Journal of Bone & Joint Surgery, researchers found that forced-air warming had "significant and disruptive impact on the clean airflow patterns over the surgical site compared to conductive fabric warming, which had no noticeable effect." The study, often called the McGovern study, was co-authored by Mark Albrecht, who worked as a statistician for Dr. Augustine's company at the time.

"It's unfortunate, if you want to call them research studies, that they ever saw the light of day," says Victoria M. Steelman, PhD, RN, CNOR, FAAN, an associate professor at the University of Iowa College of Nursing in Iowa City, who disclosed that she has received payment from 3M for patient warming presentations.

Dr. Augustine concedes there are some inherent conflicts in the research process, but he bristles at 3M's notion that he's pushing junk science.

"There is no such thing as impartiality when it comes to who's doing the study and who's doing the funding," he says. He also claims 3M doesn't have any independent, randomized controlled trials or studies proving their product is safe, either.

"The onus isn't on us to show there are risks here," says Dr. Augustine. "It's on them to show forced-air warming is safe."

Thus far, a few independent agencies have looked at the available research and data, and have not found anything to discontinue the Bair Hugger.

The FDA addressed the issue in a 2017 letter, writing: "After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection." The nonprofit ECRI Institute, in Plymouth Meeting, Pa., reached a similar conclusion from its 2013 review of the medical literature, writing there is "insufficient evidence to establish that the use of [forced-air warming] systems leads to an increase in SSIs compared to other warming methods."

Dr. Augustine has his own take on the FDA and ECRI's reviews. He says the groups aren't ready to make the link between contamination of the sterile field and SSIs. "They're just being conservative," he says. "If we're being asked, "Does this cause infections?' They're saying, "We're not sure.'"

What's next

HOT DOG VENDOR Scott Augustine, MD, says he's tried to sell his HotDog warming system to 3M, suggesting "it would clean up their mess" to have an air-free warming product for implant patients.

For surgical teams, the Bair Hugger cases could have profound impact. The device has become a fixture in many ORs to prevent patient hypothermia. For some, a lawsuit on its own is not enough to change practice. T. Andrew Bowdle, MD, PhD, FASE, professor of anesthesiology and pharmaceutics at the University of Washington in Seattle, Wash., says you need to weigh the hypothetical risks of the Bair Hugger against the well-known risks of hypothermia, which include increased bleeding, SSIs and impaired wound healing.

"When the Bair Hugger came along, it was really transformational," says Dr. Bowdle, "because it was the first time you could prevent serious hypothermia in virtually all surgical patients."

Still proud

Despite his very public campaign against the Bair Hugger, Dr. Augustine says he's still proud of his invention and that it helped put patient warming on the map. As far as his ongoing challenge to 3M, he says it's nothing personal. He says his lab is working on 20 different projects and his life "doesn't revolve around Bair Hugger or HotDog."

"I don't have a vendetta against 3M," he says. "I just want them to stop using my invention to stop causing infections." OSM

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