Medical Device Safety and Recalls: Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication

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Title: Medical Device Safety and Recalls: Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication

A safety communication has been posted titled, Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices.  Heater-cooler devices are used during cardiothoracic surgeries, as well as other medical and surgical procedures to warm or cool a patient to optimize medical care and improve patient outcomes. Heater-cooler devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. 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.

To read the safety communication, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm466963.htm


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