Non-tuberculous mycobacterium infections associated with heater-cooler devices

Consumers and health professionals are advised that the TGA has been advised of a possible patient infection with Mycobacterium chimaera following open cardiac surgery in 2015.

Although this is the first reported case in Australia, there have been reports internationally of surgical site infections with Mycobacterium chimaera, a type of non-tuberculous mycobacterium, in patients who have had cardiac surgery.

These infections have been associated with the use of heater-cooler devices which are used within the operating theatre to control the temperature of blood diverted to cardio-pulmonary bypass machines. Heater-cooler devices contain water tanks that provide temperature-controlled water for the operation of the device. This water does not come in contact with the patient.

The TGA has been actively monitoring the issue and published advice for health professionals and facilities issue in the May 2016 issue of Medical Devices Safety Update.

The TGA has also updated its advice for health facilities regarding the management of devices found to test positive for non-tuberculous mycobacteria (see the Information for health professionals and facilities section below for more details).

Since May two device sponsors have undertaken recall actions to make safety-related changes to their heater-cooler devices, in addition to one sponsor issuing a safety alert to enhance the safe use of its device.

The TGA is currently liaising with specialists from the hospital and the Australian medical device sponsor regarding the reported infection.

As only a small number of cases have been identified globally to date, the risk to individual patients of non-tuberculous mycobacteria infections is thought to be very low.

Information for consumers

If you, or somebody your provide care for, has had open cardiac surgery and you are concerned about this issue, consult your doctor.

Information for health professionals

Health professionals and health facilities are advised to be alert to this issue.

The TGA's updated advice if your facility has a heater-cooler device that tests positive for non-tuberculous mycobacteria is:

• Consult your infection control unit, infectious diseases unit and clinical teams to determine the most appropriate action for your hospital.
• Implement the appropriate protocol for decontamination of the device.
• In some circumstances, a loan device may be available through the Australian sponsor.
• Report the positive result according to the protocols of your health facility.
• Report the positive result to the TGA and the Australian sponsor of the device.

Further information and up-to-date advice is provided in Medical Devices Safety Update.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.