Archive September 2017 XVIII, No. 9

Editor's Page: FDA's Forced Air Letter Seems a Little Forced

The FDA recommends you continue using 3M's forced-arm warmers.

Dan O

Dan O'Connor

BIO

forced-air warmers OK TO USE The FDA sent healthcare providers a letter last month saying that forced-air warmers are helpful, not harmful, during surgery.

It's OK to wheel your Bair Hugger out of the storage closet and start using it again. No, really. The FDA says so.

You weren't the only one who got so spooked by those whispers that the Bair Hugger Forced Air Warming Device spread contaminants and increased infection risk that you stopped using the warming blanket that you and your patients love.

You weren't the only one who'd rather let purple-lipped patients shiver and gnash their teeth than subject their surgical wounds to the contaminated particles the blown air and waste heat allegedly sent swirling.

And you weren't the only one who noticed the more than 2,600 patient lawsuits from all 50 states that allege the devices increase the risk of serious surgical infections.

Apparently a lot of surgical facilities have stopped using forced-air warming blankets over fear of airborne contamination — certainly enough that the FDA took notice and issued what amounted to a plea to start using the product again.

"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 the Bair Hugger 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.

It's not unusual for the FDA to send letters to healthcare providers about safety concerns with medical devices used in healthcare facilities. Also last month, the agency sent an alert about 5 reports of unanticipated deaths in patients with liquid-filled intragastric balloon systems used to treat obesity. What's unusual about the Bair Hugger letter is that the FDA is recommending you continue to use a product, not warning you to stop using one. It's practically an endorsement.

"The FDA is looking strictly at the documented link to infection," says Brent Augustine, president of Augustine Temperature Management, maker of the HotDog air-free conductive fabric warming blanket. "There are 2 retrospective studies showing 74% and 78% reductions in infection rates when forced-air warming was discontinued (HotDog was used as the replacement warming technology). There are zero studies showing that forced-air warming is safe in implant surgery. The agency evidently feels that isn't enough 'conclusive evidence' to initiate FDA action, but it is not an endorsement of the technology."

Maybe not an endorsement, but it's pretty powerful when the FDA grants you permission. OSM

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