FDA Safety Alert: Nontuberculous Mycobacteria Infections Associated With Heater-Cooler Devices

By on 6:03 AM

The U.S. Food and Drug Administration (FDA) has released a safety alert for healthcare professionals regarding reports of patient infection after use of oxygenator heat exchangers, cardioplegia heat exchangers and warming/cooling blankets. 

Nontuberculous Mycobacteria (NTM) appears to have been associated with these devices, particularly in patients undergoing cardiothoracic surgical procedures.

NTM are ubiquitous in nature, and are found mainly in water and soil. They are typically not harmful, but may cause infections in very ill patients or in individuals with compromised immune systems.

For further information regarding the FDA findings relating to these infections, as well as FDA recommendations, click here.


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