Heater-cooler device contamination

The use of heater-cooler devices (HCD) to control the temperature of the patient’s blood during open cardiac surgery has been associated with the risk of infection likely to arise from contamination of the HCD.

The organism concerned is a bacterium called Mycobacterium chimaera, which is a member of the non-tuberculous mycobacteria (NTM) group. These organisms can be found widely in the environment in soil and water, but rarely cause infection.

There have been a number of infections identified in cardiac surgery patients overseas, with 11 confirmed cases in Australia.

All patient infections reported to the Therapeutic Goods Administration (TGA) as at 31st March 2023 have been associated with Stöckert 3T heater-cooler devices manufactured prior to September 2014. These Stöckert 3T heater-cooler devices were potentially contaminated during manufacture.

What has SA Health done to address this issue?

Following the identification of the problem in 2016, SA Health alerted all hospitals and cardiac surgeons of the possibility of contamination of implicated HCDs. A range of response measures were undertaken including testing of HCDs; changes to the use of HCDs; and notification and evaluation of patients identified as potentially affected by contaminated devices.

Healthcare services are required to follow national advice and have systems and processes in place to address risks associated with the use of HCDs.

Information for healthcare services and clinicians

The SA Health information for clinicians Information for clinicians fact sheet (PDF 258KB) provides guidance for clinicians on assessment and management of patients potentially exposed to Stöckert 3T heater-cooler devices (HCD) made by Sorin/LivaNova prior to September 2014.

The Australian Commission for Safety and Quality in Health Care (ACSQHC) National infection control guidance for clinicians and Therapeutic Goods Administration (TGA) Infections associated with heater-cooler devices webpages provide national guidance for all healthcare facilities where heater-cooler devices are used.

Guidelines and recommendations include the processes and systems that should be in place to mitigate the risks of NTM infection associated with the use of these devices.

Information for patients

The SA Health Mycobacterium chimaera in heater-cooler devices fact sheet (PDF 344KB) provides information for patients containing answers to some commonly asked questions.

Further information

For further information, email Health.ics@sa.gov.au