The Food and Drug Administration (FDA) has issued a communication to health care providers regarding the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices.

The FDA has recently become aware of 3 patients from 1 facility who were infected with Mycobacterium abscessus (a type of NTM) after undergoing cardiothoracic surgery involving the use of a CardioQuip Modular Cooler-Heater (MCH). At this time, the root cause of NTM patient infection and device contamination with use of this device is not known. NTM patient infections, NTM device contamination, and in some cases both issues, have now been reported for all manufacturers of heater-cooler devices in the United States.

FDA recommendations for health care providers include the following:

  • Strictly adhere to the cleaning and disinfection instructions provided in the manufacturer’s heater-cooler device labeling.

  • Ensure you have the most current version of the manufacturer’s instructions for use readily available for staff who interact with these devices.

  • DO NOT use tap water to rinse, fill, refill, or top-off heater-cooler water tanks since this may introduce NTM organisms. Use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns. When making ice needed for use in the heater-cooler, use only sterile water or water that has been passed through a filter of less than or equal to 0.22 microns.

  • Establish regular cleaning, disinfection, and maintenance schedules for heater-cooler devices according to the manufacturer’s instructions to minimize the risk of device contamination and patient infection.

  • Patients suspected of an infection associated with heater-cooler devices or exposed to a contaminated heater-cooler device should be notified and evaluated.

Food and Drug Administration (FDA). Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care Providers [news release] September 30, 2020. Available at: click here. Accessed September 30, 2020.