FDA Gets Reports Of Post-Surgical Infections Tied To Heater-Coolers

(October 28, 2015, 1:53 PM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Oct. 15 issued a safety communication stating that it is aware that the use of heater-cooler devices has been associated with nontuberculous mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic procedures.

Heater-cooler devices are using during surgeries to warm or cool patients. The FDA said the devices include water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through a closed circuit.

Although water circulating through the patient-facing components does not come into...
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