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FDA Issues Infection Warning from Surgical Heater-Coolers

Frank Hoffman1 year ago

The U.S. Food and Drug Administration (FDA) issued a warning about medical heater-cooler devices due to instances of infection which have arisen from their use during surgical procedures.

Details of the FDA Warning

According to MassDevice, heater-cooler devices are utilized in medical facilities to maintain temperature control of patients during surgery. Although the devices maintain a separation of their water from the patient via water tanks, the FDA warns that contaminated water can potentially come into contact with patients through other parts of the machine.

Most notably, the FDA warns that bacteria within the water can enter the surgical environment through the exhaust ports of the devices.

Over 30 infections due to the use of these devices have been reported to the FDA, 25 of these incidents occurred this year. The FDA has released new guidelines regarding the use of these devices, mainly recommending that hospitals take greater care in the cleaning and maintenance.

Healthcare-Associated Infection Statistics

The following information was provided by the U.S. Centers for Disease Control and Prevention (CDC):

  • On any given day, 1 in 25 hospital patients have at least one healthcare-associated infection (HAI)
  • In 2011, roughly 75,000 patients with HAIs died while in the hospital.
  • Among the most common HAIs are:
    • Pneumonia
    • Gastrointestinal illness
    • Urinary tract infection
    • Primary bloodstream infection
    • Surgical site infection


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