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Thanks Glenys, very useful.
According to one of our perfusionists, Minncare has been available in Australia as a ‘cleaner’ (not TGA registered) for dialysis machines and HCUs for years now. It seems LivaNova is now getting TGA approval for its use as a disinfectant in their machines, so it has been withdrawn from the market until approval is obtained.
Cheers
Michael
Michael Wishart
Infection Control Coordinator
A 627 Rode Road, Chermside QLD 4032
P (07) 3326 3068 | F (07) 3607 2226 | E michael.wishart@svha.org.au | W http://www.hsnph.org.au
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P Please consider the environment before printing this email
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Dear All,
Find below a link to the TGA update on Infections associated with heater-cooler devices
https://www.tga.gov.au/alert/infections-associated-heater-cooler-devices
In summary:
A total of six Australians have been confirmed with Mycobacterium chimaera infections following heart surgery involving heater-cooler devices
The confirmed cases of infection are associated with contaminated Stckert Heater-Cooler 3T heater-cooler units that were manufactured before September 2014
Testing of Stckert 3T Heater-Cooler System (3T) devices by hospitals in Australia has identified that 25% of these devices have tested positive for the Mycobacterium chimaera organism or other organisms. All devices that tested positive were manufactured prior to September 2014
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
The latest recall for production correction by LivaNova, published on the TGA Recall actions web site on 27 October 2017, is to install a modification that reduces the risk of potential patient infection by preventing dispersion of contaminated aerosols in the operating room:
o This correction will be implemented by onsite modification of units currently in use
o The servicing will be 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 is not currently included in the appropriate category of the Austrlian Register of therapeutic Goods (ARTG)
Therefore, the TGA has suspended the supply of new 3T devices until the disinfectant can be suitably accessed to ensure adequate maintenance
o The suspension of the 3T’s device’s ARTG entry does not preclude LivaNova from undertaking the modifications to existing 3T devices
o The 1T devices will be replaced with 3T devices as the 1T devices are unable to be modified to prevent aerosol dispersion
I contacted Livanova PTY LTD who advised that the disinfectant going through the assessment process for registration with the TGA is a product called Minncare Cold Sterilant (22% Hydrogen peroxide w/w, Peracetic acid 4.5%). I have attached the safety data sheet.
The registration assessment process may take some months.
If you need more information you can contact Livanova PTY LTD and ask for the Service Department
https://www.whitepages.com.au/livanova-australia-pty-limited-11933816/toowong-qld-11933814B
regards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
E: infexion@ozemail.com.au
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