A medical device used in 80 percent of hospitals recently linked to catastrophic and fatal surgical site infections is now facing 14 lawsuits.
Some jokingly say it’s signing your life away. Signatures- they hold more power than most people think about while signing the back of a check or their child’s permission slip. It’s the be all end all (unless there’s an almighty lawyer in your back pocket) and often not truly a choice for things we really need. For example, surgeries.
You or your loved one sign the consent form and are wheeled off into an operating room. It’s possible you scanned it, not fully aware of the complexities behind the sentences, and signed on the line. But it’s just a routine surgery for this surgeon – you would never volunteer to be the first patient – so what are the chances anything goes seriously wrong?
One in 25 patients will get a hospital acquired infection (HAI), meaning they were originally admitted to the hospital for another reason. In 2011, 722,000 people contracted one with 75,000 ending in death, according to the CDC. And as of 2013, infections from surgeries are the most common HAIs.
These surprising numbers means sometimes there’s no laughter after “signing your life away”. One of the most current and serious surgical site infections are affecting knee and hip replacement and heart surgery patients due to a problem with a medical device commonly used in these operations, the Bair Hugger Warming System.
The Bair Hugger is designed to help keep a patient’s body temperature normal while under anesthesia, typically causing body temps to drop. The system forces warm air into disposable blankets that cover patients at all times during a surgery. The blankets use the patient’s pressure points to avoid overheating certain areas therefore preventing sores or burns while also allowing fluid to pass through the blanket and into the linen underneath, preventing skin softening. Keeping patients warm helps reduce bleeding during surgery, risk of infections and recovery time. Today, the Bair Hugger Warming Blanket is used in more than 80 percent of hospitals, according to Drugwatch.
The device is dominating the operating rooms, and now it’s making headlines for being the cause of something it set out to prevent, infections, leading to a wave of Bair Hugger lawsuits. But the most surprising part? The source behind the news attention is the Bair Hugger inventor himself, Dr. Scott Augustine, who made millions off this one product.
“I am very proud of the old technology,” Augustine said to The New York Times. “But I am also proud to spread the word that there is a problem.”
The doctor claims the forced air allows bacteria into the device’s air hose, directing the bacteria straight into the surgical site causing dangerous and potentially catastrophic infections. Orthopedic patients in particular are reporting deep joint infections resulting in more surgeries, sepsis and, in some cases, amputation or death.
Adverse reports of the warming blankets are on record with the FDA, but the agency has not issued a recall. This fact seemingly does not sit well with the inventor.
“The question for you to answer is the following; is Bair Hugger going to be replaced quickly and catastrophically by a mandatory recall, or do you survive a voluntary recall and live to fight another day?” Dr. Augustine wrote.
“You” is referring to Arizant and 3M, the current owner and manufacturers of the Bair Hugger systems. In 2010, Dr. Augustine wrote the current owners a letter, which he later shared with The New York Times, expressing his concern for his past invention. The doctor no longer has a financial stake in the product after resigning as chief executive from his company in 2002 for disputes with his board members. He is, however, currently promoting a new electric warming blanket.
Many people harmed by infections from the warming blankets after knee replacement, hip replacement and heart surgeries are now contacting attorneys to help file lawsuits against Bair Hugger, Arizant and/or 3M. Prominent lawyer Brian White explains the root of these suits are in product liabilities including defective design and failure to warn against possible dangers. Currently, there are 14 different lawsuits pending in five different federal courts against 3M and Arizant with the collective financial compensation sought totaling in the millions.
Attorneys are helpful in the aftermath of botched surgeries and HAIs, but don’t be afraid to voice any medical concerns to your doctor prior to an operation. Asking questions, like which warming device they prefer to use, may help you or a loved one avoid facing any type of aftermath at all.