FDA's Pro-Thermoregulation Device Sends An Official Notice

  • FDA Notice

The FDA has released a letter to the health care providers according to which the use of thermoregulatory devices during surgeries are advised as research shows patients have shown less bleeding that has lead to a faster recovery and decreased risk of infections. The study was taken up when it was noticed that forced air thermal regulating systems were being avoided by health care providers during surgeries to bypass the chances of increased risk of surgical site infection. Moreover, it reported that the avoidance could lead to the development of adverse health consequences for patients during the post-operative and recovery process. The letter stated clearly that the FDA was unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection. This is surely a good news for manufacturers of forced air thermal regulating systems like the 3M's Bair Hugger System who is currently facing thousands of lawsuits in the U.S. District Court, District of Minnesota under MDL No. 2666.

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