Consumers and health professionals are advised that a total of five Australians have been confirmed with Mycobacterium chimaera infections following heart surgery.
There have been no deaths reported.
The latest case to be confirmed is in Victoria.
As a result, the TGA is conducting a product safety review into all heater-cooler devices supplied in Australia.
Heater-cooler devices are used within operating theatres and intensive care units to control the temperature of blood during procedures where heating or cooling of blood is required. The devices contain water tanks that provide temperature-controlled water for the operation of the device. This water is not intended to come in contact with the patient or their blood.
The focus of the review is those heater-cooler devices intended to be used for cardiac bypass surgery and extracorporeal membrane oxygenation (ECMO).
The TGA previously published advice regarding the potential for water within heater-cooler units to become contaminated with bacteria, most commonly non-tuberculous mycobacterium (NTM). There is evidence to suggest that patients are infected when bacteria in the device’s water tank becomes airborne.
Approximately 100 patients worldwide have been identified as being infected with one species of NTM, Mycobacterium chimaera, following cardiac surgery. Cases of infection with Mycobacterium chimaera have been identified between three months and five years postoperatively.
The risk of Mycobacterium chimaera infection in patients undergoing open-heart surgery has been estimated as 0.4-16 per 10,000 patient-years. Given a background risk of 1.2% for surgical site infection in the first year after cardiac valve operations, and a cumulative 5-year incidence of prosthetic valve endocarditis of 3.2-5.7%, the risk of infection by Mycobacterium chimaera is low.