Heater-cooler Device News
As of October 15, 2015, the U.S. Food and Drug Administration (FDA) has publically confirmed the association between the surgical use of heater-cooler devices and the spread of Nontuberculous Mycobacteria (NTM) infections. In a five-year span, 32 reports have been filed with the FDA regarding bacterial contamination of heater-cooler devices.
To see the FDA Statement Regarding NTM Infections and Heater-Cooler Devices, visit FDA Safety Communication.
Heater-Cooler Devices
Heater-cooler devices are commonly used to provide heated and/or cooled water to oxygenator heat exchangers, and cardioplegia (paralysis of the heart) heat exchangers, to warm or cool a patient’s blood during cardiac surgical procedures, and in warming/cooling blankets.
Heater-cooler devices work by distributing temperature-controlled water from a water tank to the exchanger or blanket. The concern with this design is that sometimes, if used improperly, contaminated water may, one, seep into other parts of the device and spread bacteria to the patient, or, two, escape from the device’s exhaust vent into the air and infect the patient through the environment.
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Centers for Disease Control and Prevention (CDC) Directive for Doctors and Medical Staff
On October 21, 2015, the CDC also issued a public safety warning, including this warning to healthcare professionals:
“The most important action to protect patients will be to remove contaminated heater-coolers from operating rooms, and ensure that those in service are correctly maintained.”
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Information on Nontuberculous Mycobacteria (NTM) Infections
NTM is a bacteria that can cause a respiratory infection when a person inhales the organism from their environment. The bacteria may then infect the airways or lung tissue, causing inflammation. This inflammation, if left untreated, can develop into a severe lung infection, which may become chronic.
For more information on NTM, visit lung.org
NTM infections related to the use of heater-cooler devices may go undetected because the infection may not develop until months after the patient’s exposure to the NTM, and may not be identified as a NTM infection until years later.
The CDC’s Recommendations for Patients:
“Patients who have recently had cardiac or thoracic surgery should contact their health care provider if they have (a) symptoms of NTM infection, which may include a combination of the following: fever; pain, redness, heat, or pus around a surgical incision; night sweats; joint pain; muscle pain; and fatigue; or (b) questions about possible or exposure to a heater-cooler device. ”
To see the entire CDC Recommendations regarding Non-tuberculous Mycobacterium (NTM) Infections and Heater-Cooler Devices, visit CDC Practical Guidance.
