Home E-Weekly October 31, 2017

Bair Hugger Lawsuits Could Be Tough to Prove

Published: October 30, 2017

THE CULPRIT? Is the Bair Hugger really to blame for infection?
When the first of the more than 4,000 Bair Hugger lawsuits goes to trial early next year, the plaintiffs could have a hard time proving that the popular warm-air blower caused their surgical site infections after joint surgery. That's because none of them has definitive physical proof that the blower swept bacteria-laden particles off of the floor and deposited them into their wounds during surgery.

Instead, they hope to rely on expert testimony and computer simulations to try to prove that the Bair Hugger disrupts an operating room's normal downward airflow that's meant to keep bacteria on the floor, according to a Star Tribune report on pretrial arguments in a Minneapolis federal courtroom last week.

3M's lawyers urged the court to exclude the simulation as evidence, saying that the animation is not supported by dozens of studies that show forced-air warming devices effectively warm patients before, during and after surgery and can reduce the risk of surgical site infections.

Even the FDA seems to side with 3M. Concerned that some healthcare providers may be avoiding forced air warmers due to concerns over an increased risk of infection, the FDA released a letter saying that it continues to recommend forced-air warmers.

"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 letter reads. The FDA added that surgical procedures performed without the use of a thermoregulation system like the Bair Hugger "may cause adverse health consequences for patients during the postoperative and recovery process."

Brielle Gregory

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