Heater-Cooler Devices Used in Surgeries Associated With NTB Infections, FDA Reports

WASHINGTON, D.C. — The Food and Drug Administration has warned that the use of heater-cooler devices during surgery has been associated with nontuberculous mycobacteria (NTM) infections.

According to an Oct. 15 Safety Communication entitled “Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections,” the agency received 32 Medical Device Reports between January 2010 and August 2015 of patient infections associated with heater-cooler devices or bacterial heater-cooler device contamination.

Included in the agency’s communication are all heater-cooler devices providing heated and/or cooled water to oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers, and/or …