What is Bair Hugger?
The Bair Hugger is what is known as a forced-air warming system (FAW). It contains a portable heater/blower unit with a flexible hose that is hooked up to a disposable blanket that is positioned over surgical patients.
The Bair Hugger delivers warm air to keep a patient’s temperature stable during surgery by cycling the air under the blanket. This helps to:
- Reduce wound infections (soft tissue)
- Reduce blood loss
- Reduce cardiac events
- Lower mortality rates
- Shorten recovery times
Other common methods of patient warming include: resistive electric warming and water-based systems.
More Than 50,000 Bair Huggers in Use
The Bair Hugger has been used in many orthopedic joint replacement surgeries over the past 30 years. Today, more than 50,000 Bair Huggers are in use and it is estimated they are used in more than 80% of all hip and knee replacement surgeries.
The device, manufactured by 3M, was approved through the FDA’s fast-track approval process, which allows medical devices to enter the market as long as they are sufficiently equivalent to products already available.
What is the issue with the Bair Hugger?
The Bair Hugger has been linked to an increased risk of infection when used in knee and joint replacement surgeries.
Forced-air warming systems have the potential to disrupt the airflow in the operating room, resulting in bacteria and other particles being carried into the sterile area around the patient’s incision. This can result in serious infections known as periprosthetic joint infections (PJIs). Even with additional surgeries and weeks of antibiotics, patients never regain their full capacity after catastrophic PJIs.
Bair Hugger May Increase Risk of Serious Infection After Surgery
A study in Bone & Joint Journal documented over 2,000 times more bacteria in the air over the wound with a forced-air warmer than alternative warming methods.
Other relevant findings identified in studies include:
- Patients were 3.8 times more likely to develop sepsis in the new joint when FAW blankets were used
- Deep joint infections dropped by 74% when an alternative to the device was used
- Three studies have found that FAW blowers are a breeding ground for contaminates.
Serious Infection Problems & Risks
Airborne bacteria and particles can lead to serious deep joint infections. Hip and knee replacement patients where the Bair Hugger has been used have experienced severe infections requiring repeat surgeries and replacement of the artificial joint.
Treatments for knee or hip replacement infections may require:
- Multi-stage revision surgery
- Placement of an antibiotic spacer, which can severely limit mobility
- Lengthy physical therapy
Bacteria entering the surgical area may result in:
- Methicillin-resistant Staphylococcus aureus (MRSA)
- Sepsis or septic hip/knee
- Deep joint infection
- Wrongful death
3M and Arizant Healthcare Facing Product Liability Lawsuits
3M and Arizant Healthcare have been accused of:
- Knowing about the infection risks yet failing to make design changes or provide adequate warnings about the potential risk of joint infections
- Lying to the FDA about the device’s effectiveness in filtering out and trapping bacterial contaminants, saying it meets HEPA standards when it doesn’t
- Failure to issue a Bair Hugger recall after the risk of infection became known
Individuals who have experienced infections or post-surgical complications after hip or knee replacement surgeries in which a Bair Hugger was used are beginning to file product liability lawsuits based on these allegations.
It is anticipated that the number of complaints will continue to rise over the coming years.
Receive a Free Evaluation
If you developed a serious post-operative infection following a hip or knee replacement surgery that involved a 3M Bair Hugger forced-air warming system, we want to talk with you.
Treating a deep joint infection is a painful, lengthy and expensive process. You may be entitled to compensation for medical expenses, lost wages, pain and suffering, and more. Let us help you obtain the compensation you deserve. Contact us for a free, no-obligation review of your case.
Bair Hugger in the News
- Hip Infection Lawsuit Filed Over MRSA Following Joint Replacement Surgery
- Bair Hugger Lawsuits Filed Over Infections from Knee, Hip Surgery Warming Blanket
- Knee and Hip Surgery Infection Lawsuits
- Hip, Knee Replacement Infection Lawsuits Over 3M Bair Hugger Claim HEPA Non-Compliance
- Complaint Filed, Barbara Libby, August 19, 2015
- Complaint Filed, Michael Williams, August 19, 2015
HEPA stands for High Efficiency Particulate Air. These are standards that require an air filter be capable of removing 99.97% of all particles 0.3 microns or larger.
One of the allegations against 3M is that they told the FDA that the Bair Hugger met this standard when it does not.
- Oct 2009: Orthopedic Review: Forced-air warming: a source of airborne contamination in the operating room?
- Dec 2010: New York Times: Doctor Says a Device He Invented Poses Risks
- Nov 2010: American Journal of Infection Control: Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room
- Nov 2011: Journal Bone and Joint Surgery: Forced-air warming and ultra-clean ventilation do not mix
- Feb 2012: Journal of Bone and Joint Surgery: Do forced air patient-warming devices disrupt unidirectional downward airflow?
- Mar 2012: Anaesthesia: Effect of forced air warming on the performance of operating theatre laminar flow ventilation”
- Aug 2013: Anesthesia & Analgesia: Patient warming excess heat: The effects on orthopedic operating room ventilation