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 facili-
ties. Also last month, the agency sent an alert about 5 reports of unan-
ticipated deaths in patients with liquid-filled intragastric balloon sys-
tems used to treat obesity. What's unusual about the Bair Hugger let-
ter 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 discontin-
ued (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 'conclu-
sive 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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