Bair Hugger - Hip & Knee Infection
Legal Options
The FDA first approved the Bair Hugger warming system in 1987 by way of a premarket clearance program, 510(k), which allows a device to hit the market without clinical proof that it is safe as long as it is similar enough to a device already on the market. Originally developed by Dr. Scott D. Augustine and sold by his company Augustine Biomedical and Design, which later changed its name to Arizant and was later purchased by 3M, Bair Hugger Therapy has been used on more than 180 million patients and is employed by and estimated 80 percent of hospitals in the US.
Bair Hugger Therapy uses forced air warming to prevent and or treat hypothermia in patients during surgery. Hypothermia occurs when the body is losing heat faster than it can produce it; almost all surgical patients become hypothermic during surgery which can lead to blood loss and infections. The Bair Hugger units filter the air, and then force warm air through disposable blankets that are covering the patients. In addition to warming the body through the use of warm air, they are designed to help prevent heat loss from evaporation by wicking moisture from the body. In order to reduce patient to patient infection risk the blankets are disposable.
There are several signs that may indicate a possible infected joint replacement:
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Among the side effects patients may be at risk for when undergoing surgery where the Bair Hugger blanket is used are: