FDA Warning: Infection Risk Linked to Heater-Cooler Devices

FDA Warning: Infection Risk Linked to Heater-Cooler DevicesOctober 15, 2015 — The FDA has issued a Safety Communication to warn that heater-cooler devices can contribute to serious infections.

Heater-cooler devices are used in open-heart surgeries to keep a patient warm or cool. The system consists of a water tank and tubes that carry water into a warming/cooling blanket or a heat exchanging device.

Water in the circuits does not directly contact the patient. However, contaminated water can aerosolize through the air in the device’s exhaust vent and blow into the environment.

Between January 2010 and August 2015, the FDA received 32 reports of patient infections or bacterial contamination of a device — including 25 reports this year. About half of those reports involved infections, particularly Nontuberculous Mycobacteria (NTM) infections. According to the FDA:

“NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.”

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