The FDA recently issued a Safety Communication to inform about infections associated with heater-cooler devices, which provide heated and/or cooled water to certain medical devices such as heat exchangers or warming/cooling blankets.
These heater-cooler devices are mainly used during cardiothoracic surgeries, as well as during some other medical procedures that require the patient to be warmed or cooled.
Although there is no direct contact with the water in the circuits used to heat or cool the device, there is a possibility for contaminated water to enter other parts of the device or transmit bacteria through the air, ultimately reaching the patient.
Through the FDA's analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. 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."
There have been 32 Medical Device Reports sent to the FDA between January 2010 and August 2015 of patient infections associated with heater-cooler devices.