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Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United
Abstract:
In the spring of 2015, investigators in Switzerland reported a cluster of six patients with invasive infection with Mycobacterium chimaera, a species of nontuberculous mycobacterium ubiquitous 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 nontuberculous mycobacterial infections among open-heart surgery patients. Similar to the Swiss report, a field investigation by the Pennsylvania Department of Health, with assistance from CDC, used both epidemiologic and laboratory evidence to identify an association between invasive Mycobacterium avium complex, including M. chimaera, infections and exposure to contaminated Stöckert 3T heater-cooler devices, all manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) (2). M. chimaera was described as a distinct species of M. avium complex in 2004 (3). The results of the field investigation prompted notification of approximately 1,300 potentially exposed patients.* Although heater-cooler devices are used to regulate patients' blood temperature during cardiopulmonary bypass through water circuits that are closed, these reports suggest that aerosolized M. chimaera from the devices resulted in the invasive infections (1,2). The Food and Drug Administration (FDA) and CDC have issued alerts regarding the need to follow updated manufacturer's instructions for 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).
Insights
Nontuberculous mycobacterial infections, including Mycobacterium chimaera, have been linked to contaminated heater-cooler devices used during open-heart surgery. These infections may result from aerosolized bacteria from the devices.
Area of Science:
- Infectious Diseases
- Medical Devices
- Public Health
Background:
- Nontuberculous mycobacterial (NTM) infections, specifically Mycobacterium chimaera, have been identified in patients undergoing open-heart surgery.
- Clusters of invasive M. chimaera infections were reported in Switzerland and Pennsylvania, associated with heater-cooler (HC) devices.
Purpose of the Study:
- To investigate the link between invasive NTM infections and contaminated HC devices used in open-heart surgery.
- To alert healthcare providers and manufacturers about potential risks associated with HC devices.
Main Methods:
- Epidemiologic and laboratory investigations were conducted to identify the source of infections.
- Analysis of patient data and environmental samples from healthcare facilities.
Main Results:
- A strong association was found between invasive M. chimaera infections and exposure to contaminated Stöckert 3T HC devices.
- Contaminated HC devices, manufactured by LivaNova PLC, were identified as the likely source of M. chimaera transmission.
- Aerosolization of M. chimaera from HC devices is the suspected route of infection, despite closed water circuits.
Conclusions:
- Contaminated HC devices pose a significant risk for invasive M. chimaera infections in cardiac surgery patients.
- Updated manufacturer instructions, device evaluation, and vigilance are crucial to prevent future infections.
- Public health alerts have been issued by the FDA and CDC to address this emerging threat.
