www.fdanews.com/articles/183400-fda-says-patient-warming-device-is-safe
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FDA Says Patient Warming Device Is Safe
September 7, 2017
The FDA sent a letter to healthcare providers confirming 3M’s Bair Hugger Forced Air Warming Device is safe to use.
The agency issued the letter in the wake of a series of lawsuits claiming the device spread airborne contaminants. The device includes a heater and a plastic blanket draped over the patients during surgery that draws in air from the operating room, heats it, and blows it into the blanket.
According to one suit, the warmed air from the device deposits bacteria from the floor of the surgical room into the surgical site. Some hospitals have stopped using the device to avoid possible risks to patients.