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Safety Information Concerning Infections Associated with Heater-Cooler Devices

Office of Health and Constituent Affairs
Food and Drug Administration
U.S. Department of Health and Human Services

The U.S. Food and Drug Administration has published safety information to heighten awareness about infections associated with heater-cooler devices and steps health care providers and health facilities can take to mitigate risks to patients.

There is the potential for nontuberculous mycobacteria (NTM) organisms found in water to grow in the water tanks of the heater-cooler device. Contaminated water from the heater-cooler device has the potential to aerosolize into the operating room during surgery, and this may lead to infection primarily in cardiovascular patients undergoing open-chest surgical procedures.

The FDA recommends that health care providers and facilities using heater-cooler devices perform appropriate maintenance, adhere to the cleaning and disinfection instructions, and establish a regular cleaning, disinfection and maintenance schedule on these devices. Health care facilities and staff should not use tap water to rinse, fill, refill or top-off water tanks, and should always direct the heater-cooler's vent exhaust away from the surgical field to mitigate the risk of aerosolizing heater-cooler tank water into the sterile field and exposing the patient. Below you will find links to FDA communication products about our understanding of the issue and recommendations to reduce risk of infection to patients.

The FDA is asking that you share this information with members of your organization. For more information, please visit:

If you have questions about these communications, please contact the Emergency Preparedness/Operations & Medical Countermeasures (EMCM) at CDRHEMCM@fda.hhs.gov. If you suspect heater-cooler devices have led to patient infections, please submit a report to the manufacturer and to the FDA via MedWatch. ■

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