ABSTRACT
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.
