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NOTE FROM THE EDITOR: The following post is a statement from 3M in response to an article Top Class Actions published on August 25, 2015.
Top Class Actions has invited 3M™ to respond to recent coverage of lawsuits filed against 3M regarding its Bair Hugger™ Surgical Warming System.
3M believes strongly that none of these cases have merit and is eager to prove that in court. There is no valid evidence that anyone has ever contracted a surgical site infection from the Bair Hugger system. Likewise, there is no scientific study that has demonstrated a causal link between the use of Bair Hugger therapy and an increase in surgical site infections. The recent Proceedings of the International Consensus Meeting on Periprosthetic Joint Infections determined that “no studies have shown an increase in SSI related to the use of” forced-air warming devices such as Bair Hugger.
There is, however, ample evidence that Bair Hugger warming therapy helps patients. Many clinical and quality studies have shown that maintaining normal body temperature during surgery reduces the risk of surgical-site infections. Patient warming is a recommended practice by leading health care institutions and professional societies – and the Bair Hugger system is a safe, effective and efficient method of doing so.
Independent medical organizations that have examined the studies – even those that suggest that forced-air warming could, in theory, increase the risk of surgical site infections – have concluded that the evidence does not demonstrate an actual risk, and have reconfirmed their recommendations to continue the use of forced-air warming.
In more than 200 million uses of the device, there is not a single verified incident that ties a surgical site infection to the Bair Hugger.
Absent in any of the coverage by Top Class Actions is an important fact: much of the “research’’ raising issues about the Bair Hugger has been supported by a competitor in the warming space, Dr. Scott Augustine. Dr. Augustine speculates that heated air currents carry bacteria into the surgical field. But not one scientific study – not even the studies Dr. Augustine supported – has linked heat from the Bair Hugger to a patient infection. Moreover, there are multiple sources of heat in an operating room, including the surgical staff, the patient, the surgical equipment and monitors, and the bright surgical lights. Independent studies have shown that heat from the Bair Hugger has no clinically meaningful impact on operating room ventilation.
Patients approached by law firms should understand that:
- Attorneys in these cases are relying on the same flawed studies that Augustine cites on his company website.
- A Texas law firm that has represented Augustine brought the first of the pending lawsuits against the Bair Hugger
- Augustine himself has told 3M that he will “gladly teach” the plaintiffs’ law firms what he believes to be “the science of [forced-air warming] waste heat contamination” and that he expects the plaintiffs’ attorneys to call him as a witness and the he “look[s] forward to it.”
The federal cases have been consolidated into a single multidistrict litigation, which 3M supported. 3M is convinced that consolidation of this litigation will provide the fastest and most efficient means of vindicating the Bair Hugger system.
In summary, the Bair Hugger patient warming system does not cause infections, but it can help prevent the often serious consequences of hypothermia during orthopedic and other major surgeries. Given the universally recognized benefits of preventing hypothermia, and the lack of evidence linking the Bair Hugger system to infections, it is not surprising that leading health care organizations continue to recommend Bair Hugger warming therapy as the most effective technology for preventing surgical hypothermia.
Long after this litigation scare subsides, 3M is confident that the Bair Hugger will still be beneficially warming surgical patients worldwide.
One thought on 3M Bair Hugger Warming System is Safe for Patients; No Studies have Shown Increased Infections
If all this is true then why did I get infection that required additional surgerys
to clear it up. Who is responsible for us contacting these infections. If this equipment helps prevent infections well in many cases it failed and we suffered the consequences. Tell is this right that we have procedures to help us and in some cases end up worse than before. Some one should be held responsible.