FDA warns that contaminated heater-cooler devices pose an infection risk

The FDA issued a warning about heater-cooler devices, saying they are associated with nontuberculous mycobacteria infections, especially in patients receiving cardiothoracic surgical procedures. Between January 2010 and August 2015, the agency received 32 Medical Device Reports of infections associated with the devices, included 24 in Western Europe. Heater-cooler devices are used to warm or cool a patient during medical or surgical procedures. They contain tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets. "Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device or transmit bacteria through the air (aerosolize) through the device's exhaust vent into the environment and to the patient," the FDA said. The agency recommended some best practices to minimize the risk and is monitoring the situation, but did not announce any concrete action in the notice. Here's the warning

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