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Safety alert: Bacterial infections associated with heater-cooler devices
Last month, the FDA and Centers for Disease Control and Prevention (CDC) released a safety communication concerning Nontuberculous mycobacterium (NTM) infections related to heater-cooler devices.
Heater-cooler devices are commonly used during cardiac surgical procedures to warm and cool a patient's blood during cardiopulmonary bypass. The FDA received 25 medical device reports in 2015 about patient infections associated with heater-cooler devices. In some of these cases, patients developed infections several months to years after the surgical procedure. Typically, surgical site infections are typically observed 30?90 days after surgery.
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