The United States Food and Drug Administration (FDA) has issued a safety alert concerning forced air thermal regulating systems.
Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, are devices used to regulate a patient's temperature during surgical procedures. Forced air thermal regulating systems use an electrical blower to circulate filtered, temperature controlled air through a hose into a blanket placed over or under a patient.
The FDA is reminding health care providers that using thermoregulation devices during surgery, including forced air thermal regulating 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.
Therefore, the FDA continues to recommend the use of thermal regulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
As always, health care providers should follow the manufacturer's instructions for use in the operating room/and or the post-operative environment.
For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574053.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm573837.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 31 August 2017