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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.

In the letter, the FDA acknowledged the concern about these systems, but stated that after a review of the available data, they were unable to identify a “consistently reported association between the use of forced air thermal regulating systems and surgical site infection.” 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.

Forced-Air Warming May Increase Risk of Infections

The FDA stated that they collected and analyzed data from medical device reports they received for the forced-air warming devices, as well as information from hospitals and available medical studies. They could find no consistent evidence of infection risk, and are therefore continuing to recommend doctors use these types of products “when clinically warranted.”

The FDA typically requires an overwhelming amount of evidence before taking action on established products like the Bair Hugger warming blanket. The data review did not directly address several studies indicating that forced-air warming does increase the risk of surgical site contamination.

In 2009, for example, researchers tested forced-air warming systems and found that 24 percent of them emitted significant levels of internally generated contamination. In 2010, they tested intake filters from the Bair Hugger and from other forced-air warming systems and found that 58 percent of them were internally generating and emitting contaminants.

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. Later studies compared forced-air blankets with convective blankets and found that forced air created currents that moved contaminated floor air into the surgical site area.

 

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.

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.

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