Why the 3m Bair Hugger Failed
The 3m Bair Hugger Developer
Originally the Bair Hugger product was invented by an anesthesiologist out of Minnesota named Dr. Scott D. Augustine. After he invented the product he created a company called Augustine Medical. In 2002 Dr. Augustine resigned and stepped away from his company after a serious dispute with the board. The company then became Arizant Inc. The original founder Dr. Augustine has openly admitted that his product poses a risk and should no longer be used. We know the 3m Bair Hugger shouldn’t be used in hospitals because it can create infections that can be life threatening or even cause long term negative effects.
In the fall of 2010 Arizant inc. was bought out by 3M for 810 million. 3M is a global billion-dollar corporation that invents products for a variety of industries. They don’t specialize in product innovation for one specific industry. If they see an opportunity they will dive into it and when they came across Arizant inc. they saw an opportunity, so bought them. With locations all over the world the company had over 31 billion in sales in 2014 and an estimated 29 billion in sales for 2015.
What Went Wrong
Understanding Heat Loss Because of Surgery
Perioperative hypothermia is a condition where the body’s core temperature will drop below 96.8 degrees Fahrenheit before, during, or after surgery. It’s an added risk to surgery that is well known among professional Doctors, it can be deadly if not treated properly because it has a direct impact on the heart.
The core temperature drops because of multiple factors including the cool surgical room for doctors, anesthesia, intravenous fluids and an open incision can lower a patient’s body temperature by 2 to 4 degrees Fahrenheit. That drop can cause serious heart problems, literally the leading cause of death in patients recovering from surgery. There’s always a high risk with surgery because of this form of hypothermia. Therefore solving this one problem from surgery can save lives and make a significant difference in this world.
How the 3m Bair Hugger Worked
In a way the bair hugger is similar to an electric warming blanket but more advanced. One main difference being its ability to blow clean warm air under the blanket. The second difference – its ability to keep the warm air trapped below the blanket and focused on the patient. The combination of the warm air flow, the trapped air, and the coverage of the blanket help warm up the body and help prevent the core from cooling down. There are even more advanced Bair Huggers that can send warm intravenous fluid into the body. This helps with the problems anesthesiologists and physicians face after a surgery.
The Major Side Effects From This Product
The Bair Hugger wasn’t aggressively tested before launch, it”s not a drug so it falls under the 510(k) program. This program enables the FDA to approve a medical device even if it’s not clinically tested. In 1987 the FDA cleared the device. In fact the FDA has consistently cleared the Bair Hugger, even when Arizant inc. took over in 2002. With the very thin clinical research the side effects were completely missed.
The biggest side effect being its ability to spread bacteria into the air and into the wound, and occasionally deep into the joints. Not all surgeries patch up the wound immediately, leaving the wound exposed to the air. As the Bair Hugger filters air it exhausts that filtered air under the surgery table – this ends up circulating the bad air with bacteria onto the patient. The doctors at one point believed the patient was being exposed to nothing but clean air, however it was contaminated.
Surgery patients would then start getting extremely painful infections, some deep into the joints. In extreme situations the infection would lead to an amputation. What was believed to be helping a person heal was just creating a deeper injury. This has led to many lawsuits. This is why our law firm takes on 3m Bair Hugger lawsuits – we believe victims of this device deserve to be compensated.