The Bair Hugger system is a temperature control device that is intended to maintain a patient's core body temperature. Thousands of patients have used the Bair Hugger system in hospitals and surgery centers since the 1980s. However, many patients have suffered joint infections caused by the use of the Bair Hugger system, causing injury or even death.
What is the Bair Hugger?
The Bair Hugger is a normothermia system that is used on patients to maintain their core body temperature. It is also known as a forced air warming blanket. The system surrounds the patient to prevent or treat hypothermia. The Bair Hugger is able to monitor, prevent, and treat hypothermia in surgical patients.
The reusable warming unit takes in ambient air from the room, passing it through a filter, and warming the air to a specified temperature. The warmed air then flows into the Bair Hugger blanket, warming the patient. Bair Hugger systems are commonly used in post anesthesia care units (PACU), recovery rooms, operating rooms, emergency departments, obstetrical suites, and intensive care units.
History of the Bair Hugger Device
The Bair Hugger system was developed by Dr. Scott Augustine, an anesthesiologist in Minnesota. The device was introduced in 1987 and quickly became one of the most common devices to prevent and treat hypothermia in surgical patients.
The device was sold by Arizant, Inc. Dr. Augustine was a chairman and the chief executive officer of the company, which began as Augustine Medical. After a dispute, Augustine left the company in 2002. In 2010, Arizant was acquired by 3M.
In recent years, Dr. Augustine has spoken out against using the device he invented, stating the device poses a risk to patients, e.g., surgical patients receiving implant devices like artificial joints or heart valves. The forced air can spread bacteria commonly associated with hospital-acquired infections.
FDA Approval of Bair Hugger Equipment
In 1987, the Food and Drug Administration (FDA) approved the first Bair Hugger system through the 510(k) premarket clearance system. Class I, II, and III devices intended for human use must submit a 510(k) to the FDA unless the device is exempt. This requires demonstrating substantial equivalence to another device legally marketed in the U.S. Since that time, additional models of the Bair Hugger system have been approved for human use as being substantially equivalent to other models, or at least as safe and effective as the predicate.
The Intended Use of the Bair Hugger
According to the FDA, “The Bair Hugger temperature management system is indicated for hyper- or hypothermic patients or normothermic patients for whom induced hyper- or hypothermia or localized temperature therapy is clinically indicated. In addition, the Bair Hugger temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The Bair Hugger temperature management system can be used with adult and pediatric patients.”
The system is often used in a surgical setting. Most people (60% to 80%) lose body heat during surgery, generally leading to mild hypothermia. Contributing factors to hypothermia include:
- Cold operating rooms
- Effects of anesthetic
- Administration of cold intravenous fluids
- Body cavity opening releasing body heat
- Cold exposure
- Spinal trauma
- Geriatric thermoregulatory processes.
Even mild hypothermia can cause adverse effects on the patient. Consequences of hypothermia include:
- Coagulopathy (impaired blood clotting)
- Hemodynamic instability
- Immunodepression increasing the risk of infection
- Patient discomfort and shivering
- Altered drug effect
- Postoperative nitrogen wasting
- Cardiac dysfunction.
Bair Hugger Manufacturer
The Bair Hugger system is currently manufactured by 3M. Models include the Bair Hugger Normothermia System models 505, 750, and 775. 3M also manufactures disposable Bair Hugger blankets.
Adverse Events Involving the Bair Hugger System
The FDA maintains a database of medical device reports of adverse events. Since 1987, a number of adverse events have been reported involving the Bair Hugger system. Some of the adverse events reported with the use of the Bair Hugger system include:
- Prosthetic joint infections
- Burn injuries to patients
- Thermal burns causing blisters and lesions
- Epidermal necrosis and blister formation
- Overheating warning devices
- A burning smell coming from the warming blanket
- Smoke coming from the warming blanket
- Scorching and overheating of the warming blanket
- Uneven heating and dangerous hot spots
- Cooling air on high heat setting
- Adhesive abrasion.
Risk of Infection from Using the Bair Hugger
The use of forced air warming blankets like the Bair Hugger system has been connected to a risk of infection. There may be an increased risk of airborne contamination of the surgical field when using a Bair Hugger system. This includes perio-prosthetic joint infections involving artificial joint surgery, or infections involving artificial heart valve surgery.
Some patients have a higher risk factor for contracting an airborne infection related to forced air warming blankets, including patients with:
- Immunodeficiency disorders (such as AIDS or Leukemia)
- Immunosuppressive treatments (such as chemotherapy)
- Peripheral vascular disease
- Elderly patients
- Obese patients
Signs and symptoms of an infected joint replacement include pain, swelling, redness around the wound, fever, wound drainage, and fatigue. Deep joint infections, including methicillin-resistant Staphylococcus aureus (MRSA), can cause sepsis, pneumonia, bloodstream infections, and even death. Infected joint replacements often require surgery to remove the infected joint and cure the infection.
Deaths Using the Bair Hugger
A lawsuit filed in the Eastern District of Texas has alleged a Bair Hugger warming blanket caused a surgical patient's death. The widower of the patient claims the Bair Hugger blanket caused an infection after his wife's surgery. The surgical site infection ultimately led to the patient's death. The family has filed a wrongful death lawsuit against 3M, claiming it failed to warn patients of the dangerous risks of infection associated with the Bair Hugger system.
Academic Review and Clinical Studies on the Bair Hugger
Forced-air warming and ultra-clean ventilation do not mix.
A study titled, “Forced-air warming and ultra-clean ventilation do not mix,” was published in the Journal of Bone and Joint Surgery in 2011. The researchers compared the effects of forced-air patient warming systems (like the Bair Hugger) to conductive fabric warming systems during simulated hip replacement and lumbar spinal procedures. The researchers reviewed infection data to determine whether infection rates were associated with the type of warming system.
According to the abstract, “a significant increase in deep joint infection [...] was identified during a period when forced-air warming was used compared to a period when conductive fabric warming was used. Air-free warming is, therefore, recommended over forced-air warming for orthopaedic procedures.”
Do forced air patient-warming devices disrupt unidirectional downward airflow?
A study titled, “Do forced air patient-warming devices disrupt unidirectional downward airflow?” was published in the Journal of Bone and Joint Surgery in 2012. According to the abstract, “patient warming significantly decreases the risk of surgical site infection. Recently there have been concerns that forced air warming may interfere with unidirectional airflow, potentially posing an increased risk of infection. ”
The researchers discovered when compared with radiant warming, forced air warming resulted in a significantly higher temperature increase and the number of particles over the surgical site, which increases the concern for bacterial infections.
Forced-air patient warming blankets disrupt unidirectional airflow.
A study titled, “Forced-air patient warming blankets disrupt unidirectional airflow,” was published in the Bone and Joint Journal in 2013. According to the abstract, “we have recently shown that waste heat from forced-air warming blankets can increase the temperature and concentration of airborne particles over the surgical site. ”
Patient warming excess heat: The effects on orthopedic operating room ventilation performance
An article titled “Patient warming excess heat: The effects on orthopedic operating room ventilation performance,” was published in Anesthesia & Analgesia in 2012. According to the study's conclusion, “excess heat from forced air warming resulted in the disruption of ventilation airflows over the surgical site, whereas conductive patient warming devices had no noticeable effect on ventilation airflows. These findings warrant future research into the effects of forced air warming excess heat on clinical outcomes during contamination-sensitive surgery.”
Bair Hugger Warnings and Recall Notices
On March 11, 2005, Arizant, Inc. issued a recall of almost 90,000 Bair Hugger Temperature Management Blankets. According to the manufacturer, the reason for the recall was that the air channel seals could separate when inflated with air. Separation from the underbody blankets could create bulging areas in the blanket's air channels that could shift the patient's position.
Patients Legal Rights
There are many ways that medical devices and medical products may be considered defective and dangerous. This could include a design defect where the product is not safe for the product's intended use. It may involve a failure to warn where the manufacturer failed to properly warn patients and doctors about dangers involved with using the dangerous medical device.
Patients who are injured by defective medical products may be able to seek damages from the manufacturing company. Damages can include medical costs, income loss, and pain and suffering. Individuals who lose a loved one because of a defect may be able to file a wrongful death claim against the medical device manufacturing company.
Current Bair Hugger Lawsuits
Over 2,000 lawsuits have been filed against 3M alleging the Bair Hugger warming system caused surgical infections. A number of federal Bair Hugger lawsuits pending in U.S. District Courts have been centralized in multidistrict litigation in the District of Minnesota. The lawsuits are still ongoing, with additional victims continuing to file lawsuits against 3M.
In general, the lawsuits have alleged 3M knew about the risks of infection involved with the Bair Hugger warming system and did not disclose those risks to patients or doctors. As a result of the infections, patients suffered serious injuries, additional surgeries, pain and suffering, and other damages. The first Bair Hugger trials are scheduled for early 2018.
Bair Hugger Defect Lawyers Gilman & Bedigian
If you were injured after using a Bair Hugger system, you may have a legal claim for medical bills, lost wages, and other damages. If a loved one died as the result of a Bair Hugger defect, you should talk to experienced medical device defect attorneys about your claim. You should not have to suffer due to the medical device company's negligence.
At Gilman & Bedigian, we will use our experience, knowledge, and dedication to fight for you so that you receive the compensation you and your family deserve. Our aggressive trial lawyers have helped our clients recover millions of dollars in compensation related to defective medical devices and defective drug injuries. Contact us online or call our law office at (800) 529-6162 for a free consultation.