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Bair Hugger Complications

Bair Hugger forced-air patient warming device is used during surgery to keep patients warm but may stir up contaminants in the surgical suite and increase the risk for serious infection.

medical devicesThe Bair Hugger warming system is a medical device used to keep surgical patients warm during surgery. It is intended to improve patient outcomes by preventing hypothermia which can occur during surgery. It may, however, increase the risk for serious infection when contaminants from the operating room floor are stirred up and deposited into the surgical site.

Pathogens, including antibiotic resistant bacteria spread in this matter can lead to serious infection during joint surgery and may result in amputation. Surgical site infection may also be more common in patients whose surgery used the Bair Hugger rather than another warming device.

The Bair Hugger device is manufactured by Arizant Healthcare, a subsidiary of 3M who may be facing a number of lawsuits due to infection risk associated with the device.

What Does the Bair Hugger Do?

Operating rooms and suites are often kept at lower than normal temperatures to reduce infection risk and compensate for surgical personnel who work in layers of clothing. Bair Hugger blankets use forced, heated air to keep patients warmed during certain types of surgery.

Warming the patient is intended to compensate for the excessively cool environment, cooled medications, and unclothed patient with open wounds and also to improve patient outcomes and prevent hypothermia-related complications. Hypothermia can contribute to complications, inability to recover, cardiac problems and other serious conditions.

Surgical warming devices which help to maintain proper physiologic temperature can include warm IV fluids, circulated water devices, warming blankets and forced air warming such as the Bair Hugger.

The Bair Hugger is a 2-part device which uses a portable heater-blower unit and a disposable blanket. The blanket portion contains rows of perforated inflation tubes intended to be placed over or under the patient while the heated air is forced through the tubes and across the patient.

Inadequate Filter

Unfortunately, the blower unit on the Bair Hugger may stir up contaminants in the operating room environment and force them into open wounds, particularly joint incisions. The waste heat may also collect in areas under the operating table or other surfaces and form a whirlpool like circulation where contaminants may be captured and concentrated.

Further complicating the contaminant issue, is an accusation that the Bair Hugger may not contain an adequate filtration system. Though the devices were marketed as containing a “High Efficiency Particulate Air (HEPA) filter which are widely believed to adhere to standards indicating that 99.7% of particulates should be removed, the filter in the Bair Hugger is only capable of removing 65% or less of particles.

Research Supports Problems with Bair Hugger

The inventor of the Bair Hugger device has indicated that it should not be used for certain kinds of surgery. This has reportedly not been communicated adequately by manufacturer, 3M, to the surgical community and not at all to the public, patients who may be undergoing joint surgery.

A number of research studies support the claims of inadequate filtration. Articles published in American Journal of Infection Control, Orthopedic Review, Journal of Bone and Joint Surgery and other medical journals indicate that the design and filtration units are both inadequate and may introduce pathogens into open wounds.

The forced air may drive antibiotic resistant bacteria or other disease-causing microbes deep into joint tissue and result in a serious infection which is difficult to treat. As many of these infections cannot easily be cured with antibiotic use, some patients are forced to undergo amputation.

Injuries and Complications Associated with Bair Hugger

Serious complications developed after surgery using the Bair Hugger forced-air warming blanket device have included:

  • Deep joint infections of hip and knee
  • Antibiotic resistant infections
  • Sepsis
  • Need for revision surgery to remove and replace device
  • Need for surgical cleaning and debridement
  • Permanent disability
  • Amputation of affected limb

Bair Hugger Lawsuits

The 3M company and its subsidiary Arizant, are facing hundreds of lawsuits filed by patients who were injured due to surgery with a Bair Hugger system. Lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota.

People or loved ones of those who had surgery using a Bair Hugger warming device and who developed post-surgical infection, required revision surgery, required amputation or experienced other serious complications should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

Sources:

Forced-air warming: a source of airborne contamination in the operating room?, Orthopedic Review (10/2009)

Forced-air patient warming blankets disrupt unidirectional airflow, The Bone & Joint Journal (3/2013)

Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room, American Journal of Infection Control (5/2011)

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