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CDC Advises Hospitals to Alert Patients at Risk from Contaminated Heater-Cooler Devices Used during Cardiac Surgery

October 13, 2016

Summary

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.

Background

In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection of M. chimaera, a species of nontuberculous mycobacterium (NTM) commonly found in soil and water. The infected patients had undergone open-heart surgery that used contaminated heater-cooler devices during extracorporeal circulation (1). In July 2015, a Pennsylvania hospital also identified a cluster of invasive NTM infections among patients who had undergone open-heart surgery. CDC assisted in a field investigation that used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex (including M. chimaera) infections and exposure to contaminated 3T heater-cooler devices, consistent with the Swiss report (2).

The water circuits in these heater-cooler devices that are used to regulate temperature during cardiopulmonary bypass do not come into direct contact with the patient’s circulating blood; however, these reports suggest that M. chimaera can be aerosolized by the devices and result in infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts about the need to follow updated manufacturer’s instructions for maintenance and use of the devices, evaluate the devices for contamination, remain vigilant for new infections, and continue to monitor reports from the United States and overseas (2).

CDC in collaboration with National Jewish Health completed a whole-genome sequencing analysis and results demonstrate that M. chimaera isolates from patients with heater-cooler associated infections and from the 3T heater-cooler devices from several U.S. hospitals (in Pennsylvania and Iowa) are all highly related to each other (3). This evidence for likely point-source contamination of the 3T heater-cooler devices is consistent with recent reports from Europe (http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm504213.htm) that describe matching of M. chimaera sequences from environmental isolates at the device production site in Germany and isolates from patients and devices in Europe.

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