Consumers and health professionals are advised that a total of nine Australians have been confirmed with Mycobacterium chimaera infections following heart surgery involving heater-cooler devices. NSW Health has reported six Mycobacterium chimaera patient infections, Victoria has reported two and Queensland has one reported case. There have been two confirmed reports of death related to the infection in NSW.
The TGA has been conducting a product safety review into all heater-cooler devices supplied in Australia. Information about the progress of this review can be found in the table below.
The above confirmed cases of infection are associated with contaminated Stöckert Heater-Cooler 3T heater-cooler units that were manufactured before September 2014. See the section below – Contamination found in devices‘ – for more details.
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 (see below) regarding the potential for water within heater-cooler units to become contaminated with bacteria, in particular, non-tuberculous mycobacterium (NTM). There is evidence to suggest that patients are infected when bacteria in the device’s water tank becomes airborne in the operating room during surgery.
The latest recall for product correction by LivaNova, the Sponsor of the Stöckert 3T devices in Australia, was published on the TGA Recall actions web site on 27 October 2017, (see table below). The correction was to install a modification that reduces the risk of potential patient infection by preventing dispersion of contaminated aerosols in the operating room. This correction was implemented by onsite modification of units currently in hospital use. The servicing was undertaken in the field by LivaNova service personnel or a local agent. Although the potential for infection is less likely when the 3T device’s water system is maintained according to the current Instructions for Use (IFU), the disinfectant required to undertake the maintenance was not included in the appropriate category of the Australian Register of Therapeutic Goods (ARTG). Therefore, the TGA suspended the supply of new 3T devices until the disinfectant could be suitably accessed to ensure adequate maintenance; and the instructions for use were updated to reflect the disinfectant use and the physical changes to the device. The disinfectant was included in the ARTG on 9 August 2018. The suspension of the 3T device from the ARTG entry did not preclude LivaNova from undertaking the modifications to existing 3T devices. Additionally, any remaining 1T devices were replaced with 3T devices as the 1T devices were unable to be modified to prevent aerosol dispersion.
There are more than 100 patients worldwide identified as being infected with one species of NTM, Mycobacterium chimaera, following cardiac surgery. These cases of infection with Mycobacterium chimaera have been identified between three months and five years postoperatively.
An article published in The Lancet
