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Spangenberg Shibley & Liber LLP | Oct 10, 2015

Doctor Who Invented Forced-Air Warmer Now Says Device Poses Risks

Categories: Product Liability

The inventor of a widely-used item of surgical equipment is now asking hospitals to discontinue the use of the Bair Hugger forced-air warmer. The Bair Hugger is a blanket-like device which covers a patient during surgery, keeping their body at a constant temperature. Unfortunately, recent studies have found that the forced-air warming system creates convection currents which take air from nonsterile areas (such as the floor), sending them up and into the surgical site. In short, the Bair Hugger can mobilize contaminants, preventing the ventilation system from removing those contaminants from the surgical site. Smaller free-floating bacteria and microscopic skin cell fragments appear to be the highest contaminant concern.

Study Compares Bair Hugger to HotDog Conductive Fabric Warming Device

One study compared the Bair Hugger forced-air warmer to the HotDog conductive fabric warming device, which is air-free. When the HotDog was used, no convective currents were detected, yet when the Bair Hugger was used, there was a substantial disruptive impact on the flow of clean air. Dr. Scott D. Augustine invented the Bair Hugger more than two decades ago, yet now asserts the device can pose serious risks to patients. Dr. Augustine pioneered the idea of keeping patients warm during surgical procedures, and subsequent studies have shown patients who are kept warm during surgery experience less bleeding and experience quicker recovery times.

How Deep Joint Infection Can Occur When the Bair Hugger is Used

The Bair Hugger forces warm air through a hose to a special blanket which covers the patient. It is that forced-air which appears to create a high risk of infection, particularly among those receiving an artificial knee or hip or an artificial heart valve. Dr. Augustine theorizes that in joint surgeries, a single bacteria landing on the device can secrete a biofilm which makes the joint impermeable by either antibodies or antibiotics. While Dr. Augustine notes the Bair Hugger is probably safe when used in soft joint surgical procedures, he reiterates that the law of physics dictates heat rises and rising heat can stir up contaminants on the operating room floor.

Dr. Augustine Develops a Safer Alternative to the Bair Hugger

Although Dr. Augustine no longer has a financial stake in the Bair Hugger, he has developed what he considers to be a safer alternative which works more like an electric blanket, rather than using forced-air. Dr. Augustine wrote a letter to Arizant executives, accusing them of a cover-up regarding the potential risks of the Bair Hugger. Arizant executives declined to answer questions regarding Dr. Augustine’s accusations.

AORN Journal Reviews Forced-Air Warmer Studies

According to drugwatch.com, Bair Hugger warming blankets have been used on more than 180 million patients since their introduction in 1988, with more than 80 percent of all U.S. hospitals using the Bair Hugger brand warming blankets today1. A blogspot.com article asserts Bair Hugger makes up at least 90 percent of the warming blankets in use today.2 If these numbers, are, in fact, accurate, it would appear any research on “forced-air warming blankets,” would certainly include the Bair Hugger brand. A 2009 study by Albrecht, Gauthier and Leaper found that of the 25 forced-air warming devices examined, 17 tested positive for bacteria on the intake and output hoses, and 9 of the forced-air warming systems had 89 percent positive cultures from the liquid rinsed from the inside of the output hose3.

In the interest of fairness, while a significant number of the studies done on forced-air warmers have concluded there is a risk of joint infection to patients, an issue of ECRI deems it a “theoretical concern” which could be “particularly worrisome…during orthopedic surgeries,” concluding insufficient evidence to definitively say forced-air warmers result in an increase in SSIs.

Deep Joint Infection Traumatic for Patients and Can Lead to Amputation

The bottom line is that virtually every joint infection is traumatic for the patient. When a deep joint infection occurs, the implant must be removed and the patient is likely to undergo 6-8 weeks of IV antibiotics, necessitating a lengthy hospital stay. This is assuming the patient does not lose his or her limb to amputation. Eventually the artificial joint will be re-implanted. The patient could potentially be left with medical bills well over $100,000 as well as losing a limb as a result of the design of the Bair Hugger forced-air warmer. Those who have suffered this kind of traumatic injury from a Bair Hugger should consider speaking to an experienced product liability attorney who is knowledgeable about the Bair Hugger forced-air warmer.

1. http://www.drugwatch.com/bair-hugger/

2. http://heat-rises.blogspot.com/2013/07/wave-of-bair-hugger-litigation.html

3. http://www.aornjournal.org/article/S0001-2092(13)00840-5/fulltext