The FDA issued a notice today saying that it is working to evaluate new strategies to mitigate infections associated with heater-cooler devices.
According to the notice, the administration is collaborating with professional societies, public health partners, heater-cooler manufacturers, and experts on the matter surrounding the heater-cooler devices used during medical and surgical procedures to warm or cool a patient. Although fluid in the circuits does not directly contact the patient, there is the potential for contaminated fluid to enter other parts of the device or transmit bacteria through the air through the device’s exhaust vent or other unsealed openings, reaching the environment and the patient.
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