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Dear All,
Find below a link to the TGA update on Infections associated with
heater-cooler deviceshttps://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 devicesThe confirmed cases of infection are associated with contaminated
Stckert Heater-Cooler 3T heater-cooler units that were manufactured before
September 2014Testing 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 2014The 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
airborneThe 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 useo The servicing will be undertaken in the field by LivaNova service
personnel or a local agentAlthough the potential for infection is less likely when the 3T
devices 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
maintenanceo The suspension of the 3Ts devices ARTG entry does not preclude
LivaNova from undertaking the modifications to existing 3T deviceso The 1T devices will be replaced with 3T devices as the 1T devices are
unable to be modified to prevent aerosol dispersionI 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 Departmenthttps://www.whitepages.com.au/livanova-australia-pty-limited-11933816/toowon
g-qld-11933814Bregards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
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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
MichaelMichael Wishart
Infection Control CoordinatorA 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
[cid:image001.png@01D01926.61F1C2B0]
P Please consider the environment before printing this email
[https://www.safetyandquality.gov.au/wp-content/uploads/2017/11/AAW-2017-Signature-block.jpg]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-11933814Bregards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
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MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
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______________________________________________________________________
This email and any attachments to it (the “Email”) is confidential and is for the use only of the intended recipient, and may not be duplicated or used by any other party without the express consent of the sender. If you are not the intended recipient of the Email, please notify the sender immediately by return email, delete the Email, and do not copy, print, retransmit, store or act in reliance on the Email. St Vincent’s Health Australia (“SVHA”) does not guarantee that the Email is free from errors, viruses or interference. Emails to and from SVHA or its related entities may be scanned and filtered in locations outside Australia.MESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
The use of trade/product/commercial brand names through the list is discouraged by ACIPC. If you wish to discuss specific reference to products or services by brand or commercial names, please do this outside the list.
Archive of all messages are available at http://aicalist.org.au/archives – registration and login required.
Replies to this message will be directed back to the list. To create a new message send an email to aicalist@aicalist.org.au
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