New research indicates that the Bair Hugger forced-air warming system used during orthopedic surgery may be associated with a high risk of bacterial contamination at the surgical site, allegedly putting patients at risk for MRSA and other infections. As a result, the manufacturers of the Bair Hugger warming device are being sued by patients who suffered deep joint infections after undergoing hip or knee replacement surgery where the forced-air warming blanket was used. If you believe you have been harmed by side effects of Bair Hugger forced-air warming, contact a reputable product liability lawyer to discuss the possibility of filing a Bair Hugger infection injury lawsuit against 3M.
The potential for Bair Hugger to cause deep joint infections in surgical patients is due to the fact that forced-air warming may allow contaminated air contained under the anesthesia drape and on the operating room floor to be blown over top of the patient and into the surgical site. Some possible alternatives to forced-air warming products like Bair Hugger for keeping patients warm during hip and knee replacement surgery include the following:
The Bair Hugger blanket is a forced-air warming blanket designed to help regulate the body temperature of anesthetized patients undergoing surgery, in order to prevent hypothermia and soft-tissue surgical infections. Approved by the FDA in 1998, Bair Hugger is manufactured by medical device maker 3M, and functions by forcing hot air through a hose and into a special blanket that is draped over the patient. When the Bair Hugger blanket first entered the market in the United States nearly two decades ago, it was touted as a breakthrough product for keeping patients warm during surgery, which can help reduce bleeding and promote a faster recovery. However, some say the Bair Hugger device can spread bacteria associated with hospital-acquired infections, like MRSA.
Several studies published in recent years have linked the Bair Hugger warming blanket to joint infection in knee and hip replacement patients, and even the man who invented the medical device, Scott Augustine, warns that it may pose a danger to surgical patients receiving implant devices like artificial heart valves and hip or knee joints. According to a growing body of research, patients kept warm during hip or knee replacement surgery using the Bair Hugger blanket may face a risk of deep joint infections and other injuries. Some of the most common symptoms of an infection during joint replacement include the following:
Despite claims by 3M that Bair Hugger is safe and effective for use during surgery, recent research has indicated that the medical device may actually put patients at risk for joint infections, by sucking bacteria-contaminated air from the operating room floor and depositing it into a patient’s open surgical wounds. According to one study published in Anesthesia & Analgesia in August 2013, “Forced air warming was found to establish convection currents that mobilized resident air from nonsterile areas (under the anesthesia drape) upward and into the surgical site,” posing a serious risk for MRSA and other infections in patients.
A recent study published in the Bone & Joint Journal found that air circulating over the surgical wound in procedures where a forced-air warmer like the Bair Hugger device was used, contained 2,000 times more contaminants than alternative systems, which results in a significantly increased risk of deep joint infections in patient. In an article published in Clinical Quality & Infection Controlin July 2013, the author writes that “recent studies published in medical journals questioning the safety of forced-air patient warming in orthopedic implant and other ultra-clean surgeries could mean a wave of new litigation.”
The alleged risk of infection from the Bair Hugger blanket is of particular concern for patients undergoing heart surgery to implant artificial valves, or for patients receiving hip or knee replacement systems, and a growing number of complaints have been brought against the makers of the Bair Hugger system, on behalf of consumers who believe they have been affected by side effects of Bair Hugger.
March 2013 – A 70-year-old man files a Bair Hugger lawsuit against 3M after suffering a deep joint infection during a hip replacement surgery that caused him to require 15 surgeries, including surgery to remove and replace his artificial hip implant.
March 2014 – A federal lawsuit is filed in Kansas alleging that Bair Hugger caused a man to develop a Methicillin-resistant Staphylococcus aureus (MRSA) infection following knee replacement surgery, leading to the amputation of his leg.
The following are some warnings that have been issued recently regarding the potential risk of infection injuries from Bair Hugger devices:
April 2009 – The inventor of the Bair Hugger device writes a letter to Arizant, the maker of the forced-air warming system, accusing the company of concealing information about the risks associated with the medical product.
June 2010 – The FDA issues a warning letter to the President and CEO of Arizant Inc., detailing the company’s “failure to report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information of any source, that reasonably suggests that a device that you market may have caused or contributed to a serious injury.”
December 2010 – The inventor of the Bair Hugger device advises hospitals to stop using the warming machine due to the risk of MRSA and other deep joint infections.
Nearly two decades after the FDA approved the Bair Hugger warming system through its 510(k) fast-track approval process, researchers have finally begun to examine the possible risk of side effects from the medical device. The following are some of the most recent studies highlighting the potential for Bair Hugger to cause infections and other injuries in patients:
July 2011 – Researchers involved in a study published in The Bone and Joint Journal indicate that “a significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio, was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used.”
March 2013 – The Bone and Joint Journal publishes another study in which researchers found that “waste heat from the poorly insulated forced-air warming blanket increased the air temperature on the surgical side of the drape by > 5˚C. This created convection currents that rose against the downward unidirectional airflow, causing turbulence over the patient.”
August 2013 – A study published in Anesthesia & Analgesia finds that “excess heat from forced air warming resulted in the disruption of ventilation airflows over the surgical site,” and calls for further research into the potential risk of infection from forced-air warming.
The inventor of the Bair Hugger system, Scott Augustine, has been very vocal about his opinion that the surgical device may expose patients to a risk of serious infections, and in April 2009, he wrote a letter to 3M’s Arizant subsidiary, accusing the company of covering up the risks associated with the medical device. Lawsuits brought against 3M recently over infection injuries allegedly caused by Bair Hugger forced-air warming have also accused the company of a number of things, including:
Approximately one in one hundred patients undergoing joint replacement surgery develops an infection, which sometimes requires multiple surgeries to replace the infected implant, followed by ongoing medical care and rehabilitation. If you underwent hip or knee replacement surgery with the Bair Hugger forced-air warming device, and you have since suffered MRSA or another severe joint infection, consult an experienced Bair Hugger attorney today for legal help. You may have grounds to file a Bair Hugger lawsuit against 3M, in order to pursue financial compensation for your injuries, medical expenses, and pain and suffering.