Posted November 10, 2016 | Product Liability
The Bair Hugger Warming Unit is a small medical device which blows hot air through a detachable hose. The air flows through the hose into a surgical blanket, which is used to warm patients while they undergo surgery. Unfortunately, the Bair Hugger blankets may increase the patient’s risk of developing a hip or knee infection. Bair Hugger joint infection lawyer Brent Wieand explains how these products may increase risk of infection for patients.
The Bair Hugger operates by blowing air into a blanket, similar to the way an electric pump inflates an air mattress. The blanket cannot heat up on its own, and therefore relies on a steady supply of warm air from the Bair Hugger Warming Unit, which is manufactured by Arizant Healthcare, a subsidiary of 3M.
People who are under sedation cannot regulate their internal temperature, which is why artificial warming is necessary. However, “forced-air warming,” may increase the rate of infection.
As you already know, it is important that surgeons maintain a sterile environment while operating on a patient. Doctors take a number of safety measures to ensure sterility in the operating room. Autoclaves, for example, sterilize medical instruments by engulfing them in super-heated steam for upwards of 15 minutes. Prior to performing an operation, surgeons also rub their hands and forearms with a powerful iodine solution, which functions as an antiseptic.
Rigorous sterilization is essential, because contamination by bacteria can lead to an increased risk of infection at the site of surgery.
Bair Hugger’s critics – the most notable of whom is its own inventor, Arizant founder Scott Augustine, MD – claim that air currents generated by the Bair Hugger lift contaminants from the floor of the operating theatre. Allegedly, these contaminants then settle inside incisions in the patient, causing infections to develop. In many cases, the sites of infections are hip joints and knee joints.
Several lawsuits claiming that the Bair Hugger is a defective product have been filed against 3M and Arizant. These companies have denied allegations that the Bair Hugger poses any danger. According to a spokesperson for 3M, “There is absolutely no evidence that Bair Hugger warming therapy causes or increases the risk of surgical site infections. Patient warming is a recommended practice by leading health care institutions and professional societies, and the Bair Hugger system is a safe, effective and efficient method of doing so.” However, some studies show forced-air warming devices increase infection odds.
In 2011, the Journal of Bone and Joint Surgery, a peer-reviewed medical journal that publishes research in the field of orthopedics, investigated this issue in a study titled “Forced-Air Warming and Ultra-Clean Ventilation Do Not Mix.” The study compared forced-air products against conductive heat products, which heat up without producing any air currents, similar to an electric blanket.
To conduct the study, the researchers released detergent bubbles at two locations: one near a mannequin’s head, and one at floor-level. The researchers were then able to track and count the bubbles, which were used to simulate contaminants in a surgical setting. Here is what the study concluded:
“A significant increase in deep joint infection, as demonstrated by an elevated infection odds ratio… 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 orthopedic procedures.”
To be more specific, patients treated using forced-air methods had an infection rate of 3.1%, more than three times greater than the 0.8% infection rate observed with conductive heat methods. 11 species of Staphylococcus aureus – a bacterium which can cause conditions ranging in severity from pimples to life-threatening sepsis – were identified in forced-air warming operations. By comparison, none were identified in when conductive warming fabric was used.
The very nature of joint surgery makes the problem even more complicated. According to Dr. Martin Bédard, a Canadian orthopedic surgeon who works at Hôpital de l’Enfant Jésus de Québec, “Once the bacteria is in contact with metal” – for example, an implant – “it is very difficult, if not impossible to eradicate with antibiotics alone. As a surgeon, infection is your worst complication.”
According to a 3M press release issued in 2012, the Bair Hugger “is used in more than 80% of U.S. hospitals and warms more than 50,000 patients each day.” If you are among the millions of patients who have been operated on using a Bair Hugger, you may have been exposed to bacteria.
If you or one of your family members developed a joint infection after undergoing surgery with a Bair Hugger Warming Unit, you may be able to get compensated for your medical bills, your pain and suffering, joint replacement surgery, wage loss and other expenses. Brent Wieand, an experienced Philadelphia product liability attorney who handles claims and lawsuits involving defective medical devices, may be able to help. Call the Wieand Law Firm at (888) 789-3161 to talk about your Bair Hugger claim in a free and confidential consultation today.
*Disclaimer: This article is for informational purposes. It is not legal advice and should not be used as legal advice. The Wieand Law Firm, LLC is based in Philadelphia, PA, and proud to serve clients throughout Pennsylvania and New Jersey.*