CDC issues Health Advisory on contaminated heater-cooler devices
The Centers for Disease Control and Prevention (CDC) is advising hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing. Hospitals should advise potentially exposed patients to seek medical care if they are experiencing symptoms such as night sweats, muscle aches, unexplained weight loss, fatigue, or unexplained fever. In addition, hospitals that use or have used this device are strongly encouraged to make and execute a plan to communicate with potentially exposed patients and to increase awareness among healthcare providers.
Link to CDC sample notification letters. (see “Heater-Cooler Notification Toolkit” at bottom)