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Surgeons in Operating Room

Heater-Cooler Devices

In 2016, the Centers for Disease Control and Prevention (CDC) warned healthcare providers and patients about the potential risk of nontuberculous mycobacterium (NTM) infection from certain heater-cooler devices used during open-heart (open-chest) surgery.

In a Sept. 30, 2020, letter to providers, the U.S. Food and Drug Administration (FDA) is again warning about the potential risk for NTM during cardiac surgery using heater-cooler devices. While infections were at first associated with devices from a single manufacturer, at this point, infections due to device contamination have been reported for all five manufacturers of heater-cooler devices used in the U.S.

More than 250,000 heart bypass procedures using heater-cooler devices are performed in the U.S. every year. Heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedure. Approximately 60 percent of heart bypass procedures performed in the U.S. utilize the devices that have been associated with these infections. CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000. While these infections can be severe, and some patients in this investigation have died, it is unclear whether the infection was a direct cause of death. Available information suggests that patients who had valves or prosthetic products implanted are at higher risk of these infections.

Patients who have had open-heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue or unexplained fever.

Healthcare providers should report infections associated with heater-cooler devices via the FDA’s Medical Device Reporting (MDR) process.

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