title: 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.
authors.affiliation: Department for Infectious Disease Epidemiology, Robert Koch Institute (RKI), Berlin, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Haller
authors.forename: Christiane
authors.initials: C
authors.lastname: Höller
authors.forename: Anja
authors.initials: A
authors.lastname: Jacobshagen
authors.forename: Osamah
authors.initials: O
authors.lastname: Hamouda
authors.forename: Muna
authors.initials: M
authors.lastname: Abu Sin
authors.forename: Dominique L
authors.initials: DL
authors.lastname: Monnet
authors.forename: Diamantis
authors.initials: D
authors.lastname: Plachouras
authors.forename: Tim
authors.initials: T
authors.lastname: Eckmanns
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000295:instrumentation; D015897:Comorbidity; D004196:Disease Outbreaks / Q000706:statistics & numerical data; D004866:Equipment Contamination / Q000706:statistics & numerical data*; D005112:Extracorporeal Circulation / Q000295:instrumentation*; D005858:Germany / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium / Q000302:isolation & purification; D009164:Mycobacterium Infections / Q000453:epidemiology / Q000382:microbiology*; D009205:Myocarditis / Q000453:epidemiology / Q000382:microbiology*; D011159:Population Surveillance; D015995:Prevalence; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000382:microbiology*; D014657:Vasculitis / Q000453:epidemiology / Q000382:microbiology*
keywords: Heater-Cooler Units; Mycobacterium chimaera; international; outbreak