Forced-air warming blankets such as 3M’s Bair Hugger, are designed to “promote post-surgical healing and cut down on infections by maintaining a patient’s body temperature in surgery,” the FDA states.
However, they have been under review further to reports that they may actually be causing infections. A number of 3M Bair Hugger injury lawsuits have been filed by patients who had hip or knee replacements and allege they developed Deep Joint Infections due to forced air warming blanket use. One patient who filed a Bair Hugger defective medical device lawsuit needed his leg amputated after developing infection following surgery.
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In a letter dated August 30, 2017, the agency states that it became aware that “some health care 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). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.”