At 3M’s request, the federal court overseeing litigation involving the Bair Hugger Patient Warming System hosted a Science Day session on May 19, designed to allow the parties an early opportunity to educate the Court on their respective views of the science.
At Science Day, 3M’s experts outlined the safety and benefits of the Bair Hugger’s system and pointed to the lack of any scientific proof that the device causes or increases the risk of surgical site infections. As 3M explained to the jurists, the Bair Hugger system is the most scientifically tested patient warming device in the world, and no peer-reviewed clinical study has ever concluded that the Bair Hugger system causes or increases the risk of surgical site infections.
Lawyers for the plaintiffs did not present a single scientific study that supports their claims. In their lawsuits, plaintiff attorneys have relied on a handful of studies – promoted heavily by a competitor – that purport to show the Bair Hugger system disrupts airflow in the operating room and causes bacteria to enter the surgical site.
3M experts methodically dismantled the wobbly science of those studies and the claims against the Bair Hugger system. In addition, the judges were shown key passages from each of the plaintiff lawyers’ studies that specifically acknowledge that there is no proof the Bair Hugger causes surgical site infections.
In contrast, an overwhelming number of studies and leading medical organizations continue to recommend the Bair Hugger system because it can provide valuable benefits to surgical patients, including reduced blood loss, lower chances of infection, faster recovery times and a reduced risk of surgical site infections. ECRI, a widely respected nonprofit that assesses the quality and effectiveness of medical devices, reviewed more than 180 studies about patient warming and surgical site infections. ECRI concluded that there is insufficient evidence to establish that the use of forced air warming, like the Bair Hugger system, leads to an increase in surgical site infections compared to other warming methods. Based on its review, the ECRI Institute’s recommendation was not to discontinue the use of forced air warming during surgery.
Science Day was an off-the-record session intended to educate the court about the variety of issues related to the Bair Hugger system and its technology of forced-air warming.