Abstract
A multi-country outbreak of Mycobacterium chimaera infection associated with contaminated heater-cooler devices (HCDs) has been reported, with more than 70 cases in Europe and the United States and two cases in Canada to date. The epidemiological and microbiological characteristics of this outbreak provide evidence for common-source transmission of M. chimaera from the exhaust air of intrinsically contaminated HCDs to patients during cardiac surgery. To date, all reported cases have been associated with Stöckert 3T HCDs manufactured at one plant by LivaNova prior to September 2014. Implantation of prosthetic material increases the risk of infection. Infections usually present as prosthetic valve endocarditis, vascular graft infection or disseminated infection. Reported mortality rates have varied, but were often over 40%. Several measures are recommended to facilitate case-finding and mitigate risk of exposure. The feasibility of some risk mitigation measures and their effectiveness in reducing the risk of exposure are yet to be determined. Until HCDs are redesigned in a manner that prevents water contamination and aerosolization, separating the HCD exhaust air from the operating room air during surgery may be the most effective risk mitigation strategy. However, possible unintended consequences of this approach should be considered. This overview summarizes findings from peer-reviewed and other relevant national documents on key features of the outbreak, including the source, identified risk factors for infection, signs and symptoms of infection, burden of disease, risk mitigation measures, management challenges and knowledge gaps.
Highlights
Affiliations10 All working group contributors are noted at the end of the paperHealth care–associated infections related to medical device contamination and biofilm formation have been documented in the literature [1]
Fifty-seven articles were excluded for one of several reasons including studies that reported on case(s) already described in detail elsewhere; studies that focused on nontuberculous mycobacteria (NTM) in general; studies that did not discuss patient exposure or transmission; and national guidance documents or safety communications that did not provide additional information to that obtained from similar documents from Canada, the United States (US), Australia and Europe
All cases of M. chimaera infection reported internationally have been associated with Stöckert 3T heater–cooler device (HCD) manufactured in Germany by LivaNova before September 2014 [3,9,13,15,21,22,23]
Summary
Health care–associated infections related to medical device contamination and biofilm formation have been documented in the literature [1]. Heater–cooler devices (HCDs) used during cardiopulmonary bypass (CPB) for cardiac surgeries and during extracorporeal membrane oxygenation (ECMO) have come under scrutiny due to infections linked to contaminated devices [2,3]. Heater-cooler devices have water tanks that pump temperature-controlled water through closed circuits to external heat exchangers that regulate patient body temperature by convection [4]. The device is equipped with a radiator and fan to facilitate constant dissipation of excess heat through grid openings and the stirring of water in the tank results in aerosolization via the exhaust air [4,5]. A biofilm is an aggregate of microorganisms embedded within an extracellular matrix that adhere to each other and to internal surfaces, such as the interior of HCDs
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