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Bair Hugger warming blanket consists of a portable heater/blower connected by a flexible hose to a blanket that blows warm air on a patient's skin. The purpose of a warming blanket is to help maintain a patient's body temperature during surgery. Studies have shown that keeping a patient warm during surgery produces benefits including less bleeding and faster recovery times. The Bair Hugger was invented by Scott Augustine, MD, and approved by the U.S. Food & Drug Administration (FDA) in 1988. Since resigning from his positions as chairman and chief executive of Arizant Healthcare Inc. in 2002, Dr. Scott D. Augustine has campaigned against his invention. He claims Bair Hugger therapy can cause infectious bacteria to spread during orthopedic surgery. 3M (Minnesota Mining and Manufacturing Company) bought Arizant in 2010. 3M and Arizant continue to market Bair Hugger products.
Surgical warming blankets, such as Bair Hugger, work like a forced-air heater, pushing warm air through a hose into a blanket covering a patient. The device releases warm air over a patient's body, but also releases air under the surgical table. The air released under the table can cause germs and bacteria to spread throughout the room, landing on a patient's surgical site. This can cause an infection in the patient's hip or knee, such as sepsis and Methicillin-resistant Staphylococcus aureus (MRSA). Unfortunately, these infections are very difficult to treat when they occur deep in a patient's joint.
Since Augustine's warning, a number of lawsuits have been filed over the Bair Hugger Warming System's alleged link to MRSA and other hospital-acquired infections. These complaints allege that the device can suck up and recirculate contaminated air near the floor of operating rooms. Any bacteria present on the floor may come in contact with the patient and land on the hip or knee implant, leading to adverse health complications including deep joint infections and other hospital-acquired infections.
Patients who developed infections after surgeries involving Bair Hugger temperature management systems filed lawsuits claiming the device's manufacturer, 3M, was negligent, failed to warn of risks and misrepresented its products as safe.
Bair Hugger Complications
Potential treatments that may be needed to address deep joint infections caused by a Bair Hugger blanket may include:
- Physical therapy
- Removal of implant
- Amputation of the affected limb if the infection cannot be cured
- Insertion of antibiotic spacers in the infected joint
- IV antibiotic therapy
Bair Hugger lawsuits pending against 3M accuse the company of:
- 1. Knowing about the risks associated with using the warming blanket during orthopedic surgery;
- 2. Not attempting to redesign the system despite understanding the risks;
- 3. Failing to warn the public and medical communities of the risk of deep infection during hip and knee replacement surgery, and
- 4. Attempting to conceal and discredit and scientific data that identified potential risks associated with the device.
Objective points to look for
Orthopedic surgeries, especially hip or knee replacement surgery complicated with serious joint infections
- Anesthesia records of the surgery
- Perioperative temperature management records
- Surgical Care Improvement Project Data (SCIP)
- Operative report to treat postoperative infections.
Medical Record Review and claim validation of Bair Hugger case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.