The U.S. Food and Drug Administration today issued a letter reminding healthcare providers that it continues to recommend patients be warmed during surgery when clinically warranted.
The FDA specifically mentioned that its recommendation includes the continued use of forced-air warming devices. The 3M™ Bair Hugger™ warming system is the world’s leading forced-air warming product.
The FDA said it recently became aware that some providers and patients are foregoing the use of forced-air warming because of concerns about a possible increased risk of surgical site infections. Those concerns have been driven by a 3M competitor and a group of plaintiffs’ attorneys, who are promoting a theory that forced-air warming devices such as the Bair Hugger system lead to an increased risk of surgical site infections.
The FDA, which regulates medical devices, said it has thoroughly reviewed available data and “has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”
You can read the letter here.
You can read an update from the Minneapolis Star Tribune here.