Nontuberculous Mycobacterium Infections Associated With Heater-Cooler Devices.

BACKGROUND: Disseminated nontuberculous mycobacterium infections have occurred following surgical procedures involving extracorporeal circulation; contaminated water from heater-cooler devices (HCDs) has been implicated as the source. The purpose of this review was to evaluate the public health concern and to educate physicians who care for this patient population. METHODS: The Food and Drug Administration Medical Device Reporting (MDR) database was queried for reports received between January 2010 and August 2016 for patient infections and device contaminations associated with the use of HCDs. Reports were reviewed for type of infection, patient demographics or outcome, reporting country, HCD manufacturer, and the time to event occurrence. RESULTS: A total of 339 MDR reports involving 99 facilities and 5 HCD manufacturers were found. MDR reports originated within (n = 154) and outside the United States (n = 185), and included 107 MDR reports describing patient infections involving at least 86 patients and 232 MDR reports describing HCD contamination without known patient infections. The MDR reports identified the surgical procedure in 94 reports and infection location in 83 reports. The time from surgical procedure using an HCD to infection diagnosis was calculable in 67 reports and was reported up to 60 months following the initial surgery. Nontuberculous mycobacterium was the most frequent organism identified, with M. chimaera being the predominate isolate. CONCLUSIONS: Nontuberculous mycobacterium infections associated with HCDs used during cardiothoracic surgery may have a long latency period and may be lethal. Cardiothoracic surgeon awareness or involvement in this issue is critical in helping to mitigate this emerging public health concern.

Notes from the Field: Mycobacterium chimaera Contamination of Heater-Cooler Devices Used in Cardiac Surgery - United States.

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).