FDA: Forced Air Warmers Helpful, Not Harmful, During Surgery
The US Food and Drug Administration (FDA) is reminding healthcare providers that use of thermoregulation devices during surgery, including forced air thermoregulating systems, result in less bleeding, faster recovery times, and decreased risk for infection for patients.
Forced air thermal regulating systems, also called forced air warmers or forced air warming systems, help regulate a patient's temperature during surgery. Forced air 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 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)," William Maisel, MD, acting director of FDA's Office of Device Evaluation, wrote in an August 30 letter to providers.
In their assessment of potential risk for surgical site infection with forced air thermal regulating systems, the FDA collected and analyzed the latest data available from multiple sources, including medical device reports, information from manufacturers and hospitals, publicly available medical literature, operating room guidelines, and ventilation requirements.
"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," Dr Maisel wrote.
"Therefore, the FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted. Surgical procedures performed without the use of a thermoregulation system may cause adverse health consequences for patients during the postoperative and recovery process," he said.
Healthcare providers should follow the manufacturer's instructions for use in the operating room/and or the postoperative environment, the FDA said.
Adverse events or side effects related to the use of these products should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Veritas Capital and Evergreen Coast Capital have signed a deal to buy the electronic health record a
Healthcare regulations aren’t keeping up with medicine’s digital transformation, and that’s a proble