Inventor Says Bair Hugger Patient Warming Device Carries Infection Risk

Hospitals are being advised to avoid using a device called the <"">Bair Hugger for certain surgical procedures – by the very doctor who invented the machine. According to a report in The New York Times, Dr. Scott D. Augustine says the Bair Hugger, which is used to keep a patient warm during surgery, poses a danger of bacterial infection in people receiving implant devices like artificial heart valves and joints.

Dr. Augustine helped develop the Bair Hugger about two decades ago, the Times said. It carries warmed air through a hose to a special blanket that is draped over a patient. Studies have shown that keeping patients warm during surgery produces benefits like less bleeding and a faster recovery, according to the Times.

Dr. Augustine made a fortune from the Bair Hugger. But now, according to the Times, he says the device can spread bacteria associated with hospital-acquired infections in patients receiving implanted heart valves and joints. He told the Times that he now has a safer alternative that works more like an electric blanket, and doesn’t used forced air. Dr. Augustine has spoken out against the Bair Hugger at professional medical meetings and has underwritten studies intended to show that it may pose a bacterial threat.

According to the Times, Dr. Augustine’s charges against the Bair Hugger are repeated in a promotional video for his new device, the HotDog. He has also accused the marketer of the Bair Hugger, Arizant. of covering up its problems.

According to the Times, Dr. Augustine’s critics assert he has no clear evidence to back up his claims about the safety of the Bair Hugger, even though an independent testing laboratory sought out by Dr. Augustine reached similar conclusions. One infectious disease expert interviewed by the Times said he found Dr. Augustine’s data on the Bair Hugger “compelling”, but that proving a link between a bacterial threat and the device would require mounting a huge clinical study.

Underlying all of this controversy is an ongoing feud between Dr. Augustine and Arizant, the Times said. He resigned in 2002 as chairman and chief executive of the company, which used to be known as Augustine Medical, after a dispute with other board members. After a 2004 guilty plea to a misdemeanor charge stemming from a Medicare fraud investigation, Dr. Augustine sued Arizant, claiming the company was required to indemnify him. He ultimately received around $5 million in a settlement, the Times said.

Arizant executives refused to be interviewed for the Times article. But in a statement to the Times, 3M, which acquired Arizant this fall, disputed the doctor’s claims about the Bair Hugger. “We believe Mr. Augustine’s allegations against forced-air warming stem from a personal vendetta and are baseless,” the statement said.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.