Bad Product or Bad Science? 5 Things to Know About the Bair Hugger System

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While Bair Hugger forced air warming (FAW) blankets aren’t new technology, they are new to the headlines. Recently, you may have seen articles about pending lawsuits against Bair Hugger’s parent company, 3M, based on information from the device’s original inventor, Dr. Scott Augustine.*

So, what’s true, what’s not, and what does it mean for patients at your hospital?

The Lumere research team has identified the 5 things that supply chain leaders need to know about the Bair Hugger controversy:

  1. How it helps patients: The Bair Hugger system, developed in the late 1980’s, was the first of its kind, and is now standard equipment in operating rooms across the country. The device blows warm air over patients during and after surgery to prevent their body temperature from dropping to dangerously low levels—a very important purpose since numerous studies have shown that hypothermia significantly increases the risk of poor clinical outcomes.
  1. The inventor’s claims: Augustine has been campaigning against the use of his device in surgical procedures where prosthetic devices are implanted. Dr. Augustine’s claims are primarily based on a single study that reported a higher risk of infection associated with the Bair Hugger in knee and hip replacement procedures.
  1. The evidence says: The Bair Hugger’s safety is supported by over 60 randomized controlled clinical trials since its development in 1987. Only one study, cited by Dr. Augustine, found a higher risk of infection associated with the device. However, that study was poorly designed because the antibacterial regimen that patients were given changed throughout the study and some data necessary for evaluating risk of infection was not available. It’s also noteworthy that while the study did show an increased rate of infection when the Bair Hugger was used, it did not establish a cause and effect relationship between the two.
  1. Professional societies weigh in: Because of the incomplete and inadequate body of evidence, professional societies like the Association of Perioperative Registered Nurses (AORN), which conducted a systematic evidence review, still recommends using devices, like the Bair Hugger, to keep patients warm. This recommendation is based on the abundance of evidence showing that the Bair Hugger benefits patients and the fact that the severe complications from hypothermia outweigh the risk of surgical site infection.
  1. If your hospital uses the Bair Hugger: To be clear, despite the claims, the Bair Hugger hasn’t been recalled and until February 2016, only one adverse event for the product was due to infection. It’s safe to continue using it, or similar devices with FAW technology, until clinical evidence clearly shows an increased risk of infection associated with its use – which doesn’t appear to be happening anytime soon.

Interested in learning more about the Bair Hugger or other devices? Contact us at for a complimentary research sample.

*Correction: An earlier version of this post said that Dr. Augustine “spearheaded” the lawsuits against 3M. Dr. Augustine is not affiliated with those suits.

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