Contamination during production of heater-cooler units by Mycobacterium chimaera potential cause for invasive cardiovascular infections: results of an outbreak investigation in Germany, April 2015 to February 2016

Abstract

Invasive infections with Mycobacterium chimaera were reported in patients with previous open chest surgery and exposure to contaminated heater-cooler units (HCUs). We present results of the surveillance of clinical cases and of contaminated HCUs as well as environmental investigations in Germany up until February 2016. Clinical infections occurred in five male German cases over 50 years of age (range 53-80). Cases had been exposed to HCUs from one single manufacturer during open chest surgery up to five years prior to onset of symptoms. During environmental investigations, M. chimaera was detected in samples from used HCUs from three different countries and samples from new HCUs as well as in the environment at the manufacturing site of one manufacturer in Germany. Our investigation suggests that at least some of the M. chimaera infections may have been caused by contamination of HCUs at manufacturing site. We recommend that until sustainable measures for safe use of HCUs in operation theatres are implemented, users continue to adhere to instructions for use of HCUs and Field Safety Notices issued by the manufacturer, implement local monitoring for bacterial contamination and continuously check the websites of national and European authorities for current recommendations for the safe operation of HCUs.

Microbiological problems and biofilms associated with Mycobacterium chimaera in heater–cooler units used for cardiopulmonary bypass

“…that the LivaNova 3T units were contaminated within the manufacturing site 2,4 . Preliminary data from Haller et al supports this hypothesis 54 . However, Svensson et al, 2017 provided evidence that HCUs from other manufacturers (e.g.…”

“…Chand et al, sampled 45 HCUs across 12 different UK hospitals and nineteen (42%) were positive for M. chimaera. The results of these and other studies suggest that M. chimaera is a common contaminant of HCUs and that contaminated water within a HCU could be the source of M. chimaera infections 2,3,49,54 .…”

“…Such contamination implies a systemic failure of the decontamination regimen resulting in the formation of biofilms. The environmental conditions and usage of the HCU favours the growth of a wide range of microorganisms 4,49,54 . In operating theatres, the HCU is set up and connected to allow water to circulate through the unit, tubing, cardioplegia equipment and oxygenator some hours prior to the entry of the patient.…”

Mycobacterium chimaera Spread from Heating and Cooling Units in Heart Surgery

“…[1][2][3] Infections have been publicly reported in five countries, and it has been noted that these infections developed after the Stöckert 3T heating and cooling unit manufactured by Sorin Group Deutschland (now LivaNova) had been used to regulate the body temperature of patients during coronaryartery bypass grafting. [1][2][3][4][5] Infections are presumed to be acquired through airborne transmission of aerosolized bacteria from water tanks. 1 After these reports in the Northern Hemisphere of infections associated with heating and cooling units, health care institutions in Australia and .…”

“…[1][2][3][4][5] Infections are presumed to be acquired through airborne transmission of aerosolized bacteria from water tanks. 1 After these reports in the Northern Hemisphere of infections associated with heating and cooling units, health care institutions in Australia and . Taxa are shaded according to the three sublineages (G1, G2, and G3) identified by population structure analysis, with the use of filtered alignment of 1562 variable nucleotides as input.…”