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Concerns Remain About Bair Hugger Infections, Despite FDA Conclusion

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On August 30, 2017, the FDA issued a letter to health care providers regarding the use of forced-air warming systems like the Bair Hugger warming blankets. These systems have been under scrutiny lately because of concerns that they can increase the risk of serious post-surgical infections, particularly after hip and knee replacement surgery.

The FDA’s letter acknowledged the concern about these thermoregulating devices, but stated that  “[a]fter 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. Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.”

They added that they will continue to actively monitor the situation.

Meanwhile, there are a growing number of lawsuits pending around the country in which plaintiffs bring claims against the manufacturers of the Bair Hugger warming blanket. All federally-filed lawsuits were consolidated in the District of Minnesota in December 2015, where bellwether trials are scheduled to begin in 2018.

What is the Bair Hugger Warming Blanket?

The Bair Hugger warming blanket has a portable heater/blower connected to a flexible hose that inflates a disposable blanket. Surgeons put this blanket over patients during surgery to prevent them from getting too cold. Without some sort of warming system, patients can suffer dangerous temperature drops during surgery, which can increase the risk of bleeding and infections.

The device gently blows warm air through the blanket to keep the patient warm, but several studies have indicated that the warm air blowing can cause convective currents that carry and deposit microorganisms into the surgical area. These can then cause serious infections in the area of the new artificial joint and can lead to septic arthritis.

The original creator of the Bair Hugger blanket, Dr. Scott Augustine, has spoken out about the potential risks of forced air and has created what he says is improved technology in a convective warming blanket.

Over 2,000 Cases Pending

There are currently are over 2,000 Bair Hugger lawsuits pending in court. Plaintiffs allege that after undergoing joint surgery, they developed serious infections that resulted in hospitalization and sometimes necessary and risky revision surgeries.

Plaintiffs who have filed lawsuits claim to have experienced this dangerous effect firsthand, with many of them having to endure multiple corrective surgeries because of complications.

Correction: November 1, 2017

This content has been revised to remove some references to scientific studies and reflect that the August 30, 2017 FDA letter stated that “[a]fter 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.  Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.”

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