The U.S. FDA published safety information regarding heater-cooler devices

August 16, 2016    |   By: Eunice Halverson, MA, CPPS

The U.S. Food and Drug Administration (FDA) published safety information to heighten awareness about infections associated with heater-cooler devices used during open-chest cardiac surgical procedures that utilize an extracorporeal bypass circuit. There is the potential for nontuberculous mycobacteria (NTM) organisms to grow in the water tanks of the heater-cooler device. While the water in the heater-cooler device is not intended to come into direct contact with the patient, if water within the heater-cooler tanks is contaminated with NTM, there is the potential for it to become aerosolized into the operating room and enter the sterile field (e.g., open-chest cavity and/or a sterile implant). NTM infections may cause serious illness or death. NTM infections are difficult to detect because patients infected may not develop signs and symptoms of infection for months to years after initial exposure. For more information about FDA’s understanding of the issue and recommendations to reduce risk of infection to patients, please visit: The FDA’s Web page on heater-cooler devices.


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