FDA Clears Bair Hugger for Post-Surgical Use

Washington, DC3M’s , Bair Hugger, the subject of some 2600 defective products lawsuits across the US, has received clearance for use from the US Food and Drug Administration (FDA). According to a spokesperson for the FDA, the agency has no conclusive evidence to establish an association between use of a forced air thermal regulating systems and an increased risk of surgical-site infections.

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.

In determining if there is an increased risk of surgical site infection when forced air thermal regulating systems are used during surgery, the FDA collected and analyzed data available to date from several sources, including medical device reports received by the agency, information from manufacturers and hospitals, publically available medical literature, operating room guidelines, and ventilation requirements.

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.”