FDA safety alert: Heater-cooler devices linked to infections

Editor's Note

The Food and Drug Administration on October 15 issued a safety alert that heater-cooler devices have been associated with Nontuberculous Mycobacteria infections, primarily in patients undergoing cardiothoracic surgical procedures.

Devices include:

• oxygenator heat exchangers
• cardioplegia heat exchangers
• warming/cooling blankets.

Between January 2010 and August 2015, the FDA received 32 reports of patient infections linked to heater-cooler devices or bacterial heater-cooler device contamination.

The alert provides eight recommendations that facilities using heater-cooler devices should consider implementing to reduce patient risk.

oxygenator heat exchangers, cardioplegia (paralysis of the heart) heat exchangers, and/or warming/cooling blankets. [Posted 10/15/2015] AUDIENCE: Surgery, Infectious Disease, Risk Manager ISSUE: Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.