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

Author:

Haller Sebastian1,Höller Christiane2,Jacobshagen Anja3,Hamouda Osamah1,Abu Sin Muna1,Monnet Dominique L.4,Plachouras Diamantis4,Eckmanns Tim1

Affiliation:

1. Department for Infectious Disease Epidemiology, Robert Koch Institute (RKI), Berlin, Germany

2. Bavarian Health and Food Safety Authority (LGL), Oberschleißheim, Germany

3. Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany

4. European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden

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.

Publisher

European Centre for Disease Control and Prevention (ECDC)

Subject

Virology,Public Health, Environmental and Occupational Health,Epidemiology

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