Home E-Weekly September 12, 2017

FDA Supports Forced-Air Warmers in Letter to Healthcare Providers

Published: September 11, 2017

OK TO USE The FDA said some healthcare providers and patients were avoiding the Bair Hugger forced-air warmer due to concerns over increased SSI risk.

The FDA sent healthcare providers a letter last month saying that forced-air warmers are helpful, not harmful, during surgery — a clear effort to allay fears that the systems spread bacteria capable of causing or contributing to infections, as has been alleged in more than 2,600 patient lawsuits from all 50 states.

"The FDA recently became aware that some healthcare providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery)," William Maisel, MD, acting director of FDA's Office of Device Evaluation, wrote in an August 30 letter to providers.

Saying it has found no "conclusive evidence" between 3M's popular Bair Hugger — which has been used to warm more than 200 million patients — and an increased risk of surgical-site infections, the FDA said the agency has concluded from all the available evidence that surgical facilities and patients should continue to use the system in cases where it is "clinically warranted," such as during joint replacement surgery.

After collected and analyzing data from several sources, the FDA concluded that the benefits of forced-air warmers surpass any perceived risks, as these systems have demonstrated their ability to result in less bleeding, faster recovery times and decreased risk of infection for patients.

Bair Hugger by 3M, the market leader in forced-air warming systems, has been named in multiple lawsuits claiming the systems spread bacteria capable of causing or contributing to infections that, in some cases, have led to patient deaths. 3M has consistently asserted that the claims have no merit.

Bill Donahue

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