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Dear ACIPC Members
I am seeking information and responses to a series of questions regarding UV disinfection. I am not sure what the TGA’s regulatory requirements are and would be grateful for any advice.
Advance thanks.
When does a device require TGA approval?
What are the TGA requirement for UV disinfection?
Can a disinfection device be used outside of healthcare facilities without TGA approval?
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, AustraliaE: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.auMESSAGES POSTED TO THIS LIST ARE SOLELY THE OPINION OF THE AUTHOR, AND DO NOT REPRESENT THE OPINION OF ACIPC.
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Hi Cath,
Have you seen the Aus Gov Advisory Statement regarding UVC published in July 2017?
CheersCath Wade
Clinical Nurse Consultant | Infection Prevention and Control
Level 1, 67 Holden Street Gosford Hospital
Catherine.Wade@health.nsw.gov.au or CCLHD-IPAC@health.nsw.gov.au
[cid:image005.jpg@01D35956.FB112260][cid:image006.jpg@01D35956.FB112260]Dear ACIPC Members
I am seeking information and responses to a series of questions regarding UV disinfection. I am not sure what the TGA’s regulatory requirements are and would be grateful for any advice.
Advance thanks.
When does a device require TGA approval?
What are the TGA requirement for UV disinfection?
Can a disinfection device be used outside of healthcare facilities without TGA approval?
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, AustraliaE: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.auMESSAGES 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.
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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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Hi Cath
You have to ask the question “is this a therapeutic good?” to decide if it needs to be listed on the ARTG by TGA. For disinfectants, it’s about claims made about the disinfectant.
See the TGA website here: https://www.tga.gov.au/regulation-disinfectants-and-sterilants
In my opinion this is a bit of a minefield in which the actual disinfectant sponsors and manufacturers get confused in, so that makes it hard for health professionals to determine what is necessary.
Any disinfectant with claims should be TGA approved for any application, but there are some exclusions at the bottom of the page (refer to the actual regulation for completeness).
Hope this helps in some way. If in doubt, best advice is to contact the TGA.
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 ACIPC Members
I am seeking information and responses to a series of questions regarding UV disinfection. I am not sure what the TGA’s regulatory requirements are and would be grateful for any advice.
Advance thanks.
When does a device require TGA approval?
What are the TGA requirement for UV disinfection?
Can a disinfection device be used outside of healthcare facilities without TGA approval?
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, AustraliaE: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.au______________________________________________________________________
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
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
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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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Thanks Michael
That is a very interesting link. As you suggest it seems difficult or perhaps tricky to distinguish between instrument and surface disinfection. The site has a lot of helpful info but it doesn’t seem to address the use of surface disinfectants in non-clinical settings let’s say for example in theme parks, gyms or other community settings.
Cheers
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, AustraliaE: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.auHi Cath
You have to ask the question “is this a therapeutic good?” to decide if it needs to be listed on the ARTG by TGA. For disinfectants, it’s about claims made about the disinfectant.
See the TGA website here: https://www.tga.gov.au/regulation-disinfectants-and-sterilants
In my opinion this is a bit of a minefield in which the actual disinfectant sponsors and manufacturers get confused in, so that makes it hard for health professionals to determine what is necessary.
Any disinfectant with claims should be TGA approved for any application, but there are some exclusions at the bottom of the page (refer to the actual regulation for completeness).
Hope this helps in some way. If in doubt, best advice is to contact the TGA.
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 ACIPC Members
I am seeking information and responses to a series of questions regarding UV disinfection. I am not sure what the TGA’s regulatory requirements are and would be grateful for any advice.
Advance thanks.
When does a device require TGA approval?
What are the TGA requirement for UV disinfection?
Can a disinfection device be used outside of healthcare facilities without TGA approval?
Cath
Cathryn Murphy RN B. Photog MPH PhD CIC
Chief Executive Officer & Creative Director
Infection Control Plus Pty Ltd
QLD, AustraliaE: Cath@infectioncontrolplus.com.au
M: +61 428 154154
W:http://www.infectioncontrolplus.com.au______________________________________________________________________
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
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
______________________________________________________________________
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
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
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
To send a message to the list administrator send an email to aicalist-request@aicalist.org.au.
You can unsubscribe from this list be sending ‘signoff aicalist’ (without the quotes) to listserv@aicalist.org.au
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