Bair Hugger Blankets
TRUTH: Orthopedic patients have developed infections from air-forced warming blankets being used, namely 3M’s Bair Hugger Blanket.
TRUTH: The inventor, Dr. Scott D. Augustine, has warned the public that the design puts patients at risk of infections.
TRUTH: Some healthcare providers and patients are avoiding the use of forced air thermal regulating systems, due to this increased risk of infection.
The manufacturer of the device 3M has stated publicly: “there is no evidence that the 3M Bair Hugger warming system causes infections.” Yet thousands of lawsuits have been filed by victims, claiming 3M’s device used with their orthopedic surgery was the cause of their post-surgery infections.
The allegations stem for the device blowing contaminated air onto the patient to warm or cool them
In February 2018, the FDA announced 3M has commenced a voluntary recall of two models, totaling 165,000 warming blankets worldwide. This recall is not connected to claims the product causes infections in patients, but a design flaw that prevents the blankets from functioning properly.
The Bair Hugger system is designed to maintain patients’ body temperatures before, during, and after surgeries. Its purpose is to prevent hypothermia in surgical patients. However, there have been reports of the Bair Hugger warming system trapping contaminated air and causing infections, especially in orthopedic patients.
What are Bair Hugger Blankets?
Bair Hugger warming system is made up of two parts: a reusable warming unit and single-use blankets. The system is meant to prevent hypothermia in patients by keeping their body temperature stable during all stages of surgery. The blankets can vary in size and shape so that they only warm the areas of the body that will not be operated on.
How Do Bair Hugger Blankets Work?
The warming unit connects to the disposable blanket using a flexible hose, which passes warm air from the warming unit into the blanket. The air then exits the blanket through perforations on the blanket’s underside to warm the patient’s skin. It uses convective heating, or the transfer of heat due to the movement of molecules in a gas or liquid, to maintain normothermia, or the normal human body temperature.
Who Invented the Bair Hugger System?
The Bair Hugger system was invented by an anesthesiologist named Scott Augustine. He helped to introduce the idea of keeping patients warm for surgery, which can help lessen bleeding and hasten recovery. The Bair Hugger system was cleared by the FDA for use beginning in 1987.
Who Makes the Bair Hugger System?
The Bair Hugger system was originally produced by Arizant, which used to be called Augustine Medical, after Scott Augustine. Dr. Augustine resigned from Arizant in 2002 after disagreeing with board members and experienced some legal difficulties with Arizant over fraud investigations. In 2009, Arizant was purchased by 3M.
What Are Bair Hugger Blankets Used For?
The primary use of Bair Hugger Blankets is to prevent hypothermia in surgical patients by maintaining normothermia, or a patient’s normal body temperature. The area of the body that will be operated on should not be exposed to the warm air from the blankets, so blankets are shaped to warm the other parts of the body.
What Is Hypothermia?
Hypothermia is a lower than normal body temperature that occurs when the human body releases more heat than it can absorb. Humans experience hypothermia when the body temperature is below 95 °F (or 35 °C).
What Causes Hypothermia?
In surgical patients, perioperative hypothermia, or hypothermia that occurs during surgery, can be caused by disruptions to the body’s normal ability to regulate its own temperature by anesthesia. Other factors include cooler temperatures in an operating room and exposure to cleansing and sanitizing products.
Symptoms of Hypothermia
Hypothermia is divided into three primary stages: mild, moderate, and severe. Each stage has different symptoms.
- High blood pressure
- Fast heart rate
- Fast respiratory rate
- Contraction of blood vessels
- Increased urine production
- Mental confusion
- Hyperglycemia (high blood sugar)
- More violent shivering
- Muscle miscoordination
- Mild confusion
- Slow and labored movement
- Stumbling pace
- Pale skin
- Lips, fingers, toes, and ears may turn blue
- Decreased heart rate
- Decreased respiratory rate
- Decreased blood pressure
- Difficulty speaking
- Sluggish thinking
- Inability to use hands
- Blue and puffy skin
- Very poor muscle coordination (walking almost impossible)
- Incoherent and irrational behavior
- Major organs shut down
- Possible death
Paradoxical undressing, which is when a person suffering from hypothermia removes clothing, occurs in the moderate to severe stages of hypothermia. It is thought to be caused by both confusion and by blood vessels rushing to the person’s extremities, causing them to feel overheated.
Terminal burrowing occurs only in the final stages of hypothermia and involves the person hiding in small, enclosed spaces. This is thought to be caused by an autonomous function of the brain that triggers primitive hibernating behaviors in an attempt to protect the body.
Dangers of Hypothermia in Surgery
There are many adverse side effects in patients who experience hypothermia during surgery. These include:
- Prolonged effects of anesthesia and neuromuscular drugs
- Delayed recovery
- Increased perioperative (during surgery) blood loss
- Tripled incidence of infections in surgical wounds
- Decreased immune system
- Increased risk of heart attack
- Increased duration of hospital stay
Dangers of the Bair Hugger System
Dr. Scott Augustine, the inventor of the Bair Hugger system, has claimed that there are risks to using the device, especially in patients who are having an implant of a medical device, including artificial joints and heart valves. The risk Augustine described was that the Bair Hugger system could spread bacteria that is involved in infections acquired in hospitals.
Augustine claimed that the Bair Hugger system produced waste heat that would then warm contaminated air near the floor. Due to convection, that air would then rise and contaminate the sterile air being used around the patient. In a study done by Augustine, it was found that when forced-air warming systems, such as Bair Hugger, stopped being used in favor of other types of warming systems, the infection rate dropped by 78%.
Bair Hugger and Joint Replacement
Augustine believed that the Bair Hugger forced-air warming system was of particular risk to patients undergoing surgery for arthroplasty, or joint replacement. These patients were at a higher risk for deep joint infections. He claimed that this infection risk came from bacteria in contaminated air from near the floor that would, through convection, rise and mix with the sterile air used by the Bair Hugger system.
McGovern’s study focused on hip replacement surgeries and concluded that there was a risk of infection and that it was, therefore, safer to use an air-free warming system than a forced-air warming system such as Bair Hugger.
Bair Hugger Controversy
Dr. Augustine had made the claims of Bair Hugger risks in arthroplasty (joint replacement) patients after he had left his company, Arizant, amidst disagreements with board members. His opinion has been doubted because he no longer had a financial stake in Bair Hugger and had also invented another type of medical warmer that functioned similarly to electric blankets, rather than using forced air like Bair Hugger.
3M, the manufacturer of Bair Hugger, stated that the claims by Dr. Augustine were fabricated in order to discredit Bair Hugger so that Augustine could drive sales of his new warming system. However, Augustine was not the only source of claims that the forced-air method of warming used by Bair Hugger could cause a higher risk of infections. A study by McGovern, P.D., arrived at the same conclusion as Augustine and supported the claim that the forced-air warming system could be contaminated with non-sterile air.
Risks of Deep-Joint Infection
According to the American Academy of Orthopaedic Surgeons, about 1 in 100 patients undergoing a knee or hip replacement surgery experiences an infection. The infection can be caused by bacteria entering the joint through the wound during the arthroplasty or other surgical procedure, or through cuts in the skin.
The following factors increase the risk of deep-joint infection:
- Diabetes mellitus
- Immune deficiencies
- Immunosuppressive treatments (such as chemotherapy)
- Peripheral vascular disease
Symptoms of Infection
The symptoms of a deep-joint infection include the following:
- Pain and stiffness in the joint
- Wound drainage
- Night sweats
- Warmth and redness around the joint
Treatment for an Infection
Treatment for a deep-joint infection involves first a doctor’s examination. If the infection is caught early, some infections can be treated with antibiotics, but many infections require further surgery to cure. Patients who develop infections are thus responsible for the costs of antibiotics, doctor’s visits, and potentially further surgeries and hospital stays.
Litigation Against 3M
A lawsuit was filed in 2017 in Minnesota against 3M, alleging that the deep-joint infections sustained by the plaintiffs were caused by the Bair Hugger forced-air warming system. More than 4,000 cases were consolidated into the one lawsuit. The litigation claimed that the bacteria that caused the plaintiffs’ deep-joint infections could have been either from dead skin cells that contaminated the air or from within the hose that connected the Bair Hugger Blanket to the warming unit.
Bair Hugger and the FDA
There have been recalls of the Bair Hugger system, but not because of the claims of the lawsuit. The recall was due to a design change that had affected the air flow of the device. Another recall was over faulty seals on the device that could shift the patient’s position. In general, however, the FDA continued to maintain that the Bair Hugger system was safe for use.
Have You Been Injured by Bair Hugger Blankets?
If you have a deep-joint infection or other infection from a surgery, the first step is to visit a doctor. After a thorough examination, the doctor can help you determine what the cause of the infection could be. If Bair Hugger was used during your surgery, you may have a case.
Should You Consider a Lawsuit Against 3M?
If you have experienced an infection from your surgery and believe that it was caused by the Bair Hugger System, contact Farah and Farah now for a free case evaluation. One of our experienced attorneys can help with the following steps to determine if you may benefit from legal action:
- Identify the Bair Hugger Blanket used during your operation or hospital stay.
- Identify whether your case is against a specific doctor or surgeon, a medical facility, the manufacturer, or warrants a claim against several groups.
- Check eligibility of your claim against manufacturers.
- Determine the amount of medical and personal damage caused by the defective Bair Hugger Blanket.
There will be no cost to you unless your case is successful.
Co-counsel will be associated on these cases.