FDA Warning: Heart Infection Risk from Heater-CoolersAugust 2, 2016 — Health officials in Australia have reported an NTM infection in a patient who had open heart surgery in which a heater-cooler device was used.

The Australian Therapeutics Goods Administration (TGA) reported that the patient was infected with Mycobacterium chimaera, which is a type of non-tuberculosis mycobacterium (NTM) that is commonly found in soil and water.

The infection occurred after the patient had open cardiac surgery in 2015. It is the first reported case in Australia, but dozens of cases have been reported internationally.

In the United States, the FDA has issued several Safety Warnings after receiving 32 reports of NTM infections. Infections are hard to detect because they may not cause symptoms for months or years after the patient is exposed.

Heater-cooler devices are used in the operating room to control the temperature of blood diverted to cardio-pulmonary bypass machines. Heater-cooler devices have water tanks that provide temperature-controlled water.

The water does not directly contact the patient, but bacteria in the water can aerosolize through the exhaust vents and land on the patient undergoing surgery.

Earlier this year, a hospital in Iowa warned 1,500 patients that they may have been exposed to NTM after undergoing open heart surgery. Two hospitals in Pennsylvania have also reported infection outbreaks, including one hospital where eight people were infected and five died.

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