The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have published safety alerts regarding potential risk of Non-Tuberculosis Mycobacteria infections associated with the use of heater-cooler devices in patient care. Some of the adverse events reported have been related to cardiothoracic surgery, although other reports did not specify the procedure the patient was undergoing.
The alerts do not specify a product recall or recommend discontinuance of heater-cooler devices, but they recommend additional measures clinicians should take to reduce potential infection risk to patients.
For the recommended measures and additional resource information, please review the following communications:
- FDA notice
- CDC outbreak page (updates under “Heater-Cooler Devices” in “Safety Alerts” section)
- CDC notice