FDA Guidance

Breaking News - FDA endorses Air Warming in Surgery for Better Outcomes

Many, if not most, veterinary surgeons have raised the question of the safety of convective air (or ‘forced air’) warming during surgery,

especially on joint surgery. Many have prohibited use of air at the risk of patient hypothermia.

Finally, the US Food and Drug Administration has now released its definitive position not only on the safety of convective air warming during surgery, but also it’s position to the benefits of warming. Even on total joint surgery! Here’s an excerpt and a link to the FDA position:

ISSUE: The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermoregulating systems, have been demonstrated to result in less bleeding, faster recovery times, and decreased risk of infection for patients.

The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection (e.g., following joint replacement surgery). After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection.

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574053.htm

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