Heater-cooler device contamination

It has recently been determined that there is a risk to cardiac surgery patients from potential contamination of one type of heater-cooler device (manufactured in Germany by LivaNova [formerly Sorin]) used to control the temperature of the patient’s blood during certain cardiac procedures.

The organism concerned is a bacterium called Mycobacterium chimaera, and is a member of the non-tuberculous mycobacteria (NTM) group. These organisms can be found widely in the environment in soil and water, and rarely cause infection. However, there have been a small number of infections identified in cardiac surgery patients overseas, and nine confirmed cases in Australia.

Therapeutic Goods Authority latest advice:Update, dated 16 April 2019

What has SA Health done to address this issue?

SA Health has alerted all hospitals and cardiac surgeons to the possibility of contamination of these devices, requesting that all devices be tested and results reported to the Communicable Disease Control Branch and the Therapeutic Goods Administration.

In South Australia, two devices were located at Flinders Medical Centre, with additional affected units at Flinders Private and Ashford Hospital.

SA Health has determined that it is prudent to notify all potentially exposed patients of the very small risk that exists, and to provide them with appropriate information.

Information for patients

SA Health has developed a fact sheet (PDF 289KB) for patients containing the answers to some commonly asked questions.

Information for clinicians

The Therapeutic Goods Administration has issued a Safety Alert and a Medical Devices Update in recent months to alert clinicians of the problem and outline actions that should be taken to reduce the risk of post-operative infection.

The Australian Commission for Safety and Quality in Health Care has issued national guidance for clinicians on the decontamination, testing and ongoing management of heater-cooler devices.

SA Health has developed a fact sheet for clinicians (PDF 420KB) that summarises the issue and the mitigation strategies.

Further information

For further information, contact the Infection Control Service via e-mail Health.ics@sa.gov.au