“Bair Hugger” is a trade name of a forced-air warming blanket that has been used now in over 200 million surgeries. There are approximately 4000 people currently suing 3M Co. alleging the unit caused debilitating deep-joint infections. See one mans disaster story here
Two decades ago, Dr. Augustine, an anesthesiologist in Minnesota, helped pioneer the idea that keeping a patient warm during surgery would lower bleeding and improve recovery. Augustine went on to develop a patent that changed surgical practices and made him a good deal of money.
The “Bair Hugger” Controversy
In 2009, Dr. Augustine and Arizant settled a court battle related to Medicare Fraud involving a different device Augustine had created, paid a $2 million fine and barred from participating in federal health care programs
A short time later, Dr. Augustine then turned around and successfully sued Arizant in Minnesota state court for the 2 million in Medicare fines plus 3 million more in unpaid salary, receiving 5 million total.
Dr. Augustine contends that he created the new device, “The Hotdog“, because he came to believe that the accumulation of waste air from the device under the surgical table was changing the sterile airflow dynamics in the surgical room causing higher than normal infections in patients receiving implant devices like artificial heart valves and joints.
Arizant executives have been accused by Dr. Augustine, of covering up the device’s problems. Arizant has sued Augustine’s new company charging that it is distributing information that falsely disparages the “Bair Hugger”.
Is Dr. Augustine an honest whistleblower? Did his findings or concerns about the potential dangers of the “Bair Hugger” cause him to be ousted by his original company, which sought to conceal the danger and retain market share?
Or is Dr. Augustine a malcontent whose difficult personality caused company conflict? Was he irritated enough by his perceived mistreatment that he patented a new product as a direct competitor with the old product while continuing to disparage his original company and product to extract revenge on Arizant?
I am afraid that I can’t answer those questions but all of the studies found at the bottom of this page seem to conclude that the air flow dynamics of the surgical room are being changed by the forced air warmer. What they can not conclude is that this dynamic actually caused the surgical site infections until a broader based study is completed.
Hence, in the meantime, it seems highly prudent to avoid forced air warmers for knee replacement surgery especially when there are other alternatives until more definitive evidence is obtained.
Dr Augustine-In His Own Words
Sometimes it is also helpful to listen directly to the person in question to get to the truth of a matter.
Here is a video of Dr. Augustine being interviewed. He directly answers the question about the problems related to forced air heating devices 3:25 into the video.
Studies Related to Forced Air Heating and Infection
“Until the disruptive effects of forced-air warming on ventilation can be fully evaluated with regard to affecting the sterility of the surgical site, the use of air-free patient warming alternatives might be recommended for procedures involving implants carried out in ultra-clean theatres.”
“This study does not show that forced-air warming increases the risk of infection – only that in certain types of theatre set-up it can significantly disrupt unidirectional airflow and draw particles from the potentially contaminated area below the sterile surgical field. This is a concern.”
“The benefits of maintaining normothermia during the perioperative period are without doubt. Many studies suggest that disruption of UCV airflow by FAW [Forced Air Warmers] is significant but the effect on SSI [Surgical site Infection] rates in implant surgery has yet to be determined by robust level 1 evidence.70 We recommend consideration of the use of alternative patient warming devices when performing orthopaedic hip and knee implant surgery until a definitive trial can be performed, but that some caution in condemning FAW [Forced Air Warmers] should be observed.