A news article published in Clinical Quality & Infection Control, a publication of Becker’s ASC Review, stated:
“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 journal did not mention Bair Hugger by name, but the device constitutes more than 90% of the forced-air warming (FAW) systems used by hospitals in the United States. FAW systems blow heated air through a hose into an inflatable “blanket.” The hot air jets through holes in the blanket onto the surgical patient. Most of the heat, however, escapes near the contaminated floor of the operating room. The studies referenced by Clinical Quality & Infection Control show that this waste heat can mobilize floor-level pathogens, lifting them into the sterile field.
At least one lawsuit already has been filed against 3M, the manufacturer of Bair Hugger. The plaintiff, a 70-year-old man from Houston, underwent 15 revisions after the Bair Hugger system allegedly caused an infection during total hip replacement surgery. Although the plaintiff avoided amputation, he remains severely disabled. The Petition claims damages in excess of $1 million.
More than 50,000 Bair Hugger units are currently in use across the country, and Bair Hugger is used in almost all total joint replacement surgeries. According to the Houston plaintiff’s attorney, many more cases are likely to be filed. Several plaintiffs’ firms have begun advertising for patients potentially injured by Bair Hugger. [Firm 1] [Firm 2] [Firm 3]
The studies cited by Clinical Quality & Infection Control all involved Bair Hugger systems. A study published in The Bone & Joint Journal, for example, included a retrospective analysis of 1,437 hip and knee replacements. There was a 76 percent decrease in deep joint infections when FAW was discontinued and replaced with air-free warming.
Clinical Quality & Infection Control wrote:
“Additional peer-reviewed articles established that 1,000-plus watts of rising heat from FAW blowers mobilize contamination from the floor of the operating room that could deposit in the sterile surgical field. Another article from The Bone & Joint Journal showed a 217,000 percent increase in contamination over the wound site with FAW.” (Emphasis added.)
Dr. Scott Augustine, inventor of Bair Hugger warming, defends the device for some uses, claiming that it is “probably safe in soft-tissue surgeries. The risk to patients only occurs with implanted devices,” he says, “ like artificial joints. In those surgeries, a single bacteria landing on the device can secrete a biofilm, making it impervious to antibiotics and antibodies. The infection can erupt weeks later. In those cases, the pathogen usually arrives through the air.
“Orthopedic surgeons and other clinicians do everything possible to protect patients from infectious agents” Dr. Augustine concluded. “There is no protection, however, from the laws of physics. Heat rises…and rising heat can mobilize dirty air from the floor. If forced-air warming is used, the risk cannot be avoided.”
A full version of the article in Clinical Quality & Infection Control can be seen here.
Orthopedic Infection Advisory (OIA) is dedicated to educating healthcare professionals about the risks and consequences of orthopedic infections. OIA monitors scientific publications for research relating to such infections, with particularly emphasis on peri-prosthetic infections. OIA is supported by patient safety advocates. The primarily sponsor is Augustine Temperature Management.