FDA Updates Heater-Cooler Device Information

PUBLISHED: Mar 29, 2017
Source: Food and Drug Administration
Relevant to: Hospital

The US Food and Drug Administration (FDA) has updated their Heater-Cooler Device information page to streamline the information and resources for patients and clarify the FDA’s recommendations to health care providers and staff at health care facilities to help minimize patient risks of infections associated with all heater-cooler devices.

Heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care. They are especially important tools for surgeries involving the heart and lungs (cardiothoracic surgeries). Heater-Cooler devices include tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits.

The updated FDA web page includes a schematic representation of heater–cooler circuits tested for transmission of Mycobacterium chimaera during cardiac surgery despite an ultraclean air ventilation system. Blue arrows indicate cold water flow, and red arrows indicate hot water flow and patient blood flow. See the FDA update to view the schematic.

Included with today’s notice is an example policy related to infection control precautions for Heater-Cooler Devices.

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