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The U.S. Food and Drug Administration (FDA) is providing updated information about heater-cooler devices used during surgeries to warm or cool patients as part of their care.
Through ongoing efforts by the FDA and industry to bring to market innovative devices that can help mitigate the risk of Nontuberculous mycobacteria (NTM) infections, the FDA has cleared a system that utilizes a glycol-based heat transfer fluid (HTF) instead of water.
The FDA continues to:
- monitor the risk of NTM infections in patients who have undergone cardiothoracic surgery using water-based heater-cooler devices.
- encourage health care providers and users to report any adverse events or suspected adverse events experienced with any heater-cooler devices, including patient infection, device contamination, or difficulty following manufacturer instructions for use.
- engage with manufacturers, health care facilities, and public health experts in evaluating new design features for heater-cooler devices.
Questions?
If you have questions Heater-Cooler Devices, contact the Division of Industry and Consumer Education.
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