Course Access
Maree,
Yes this is correct.
The TGA ARTG Certificate is the TGA form
used for the classification of Sterilants and Disinfectants.
An "Aust L" on the TGA ARTG Certificate
indicates that the product is only listed with the TGA not registered.
Generally products need to be registered
to make fungicidal, sporicidal, tuberculocidal
and viricidal claims.
regards
Glenys
Glenys Harrington, Infection
Control Consultant |Communicable
Disease Prevention and Control | Public Health
Department of Health | Level 14 50 Lonsdale Street Melbourne Victoria 3000
Australia
t. 03 909 65094 | f. 1300 651 170 | e. glenys.harrington@health.vic.gov.au
| http://www.health.vic.gov.au/ideas
| From: | Maree Sommerville <MSommerville@MERCY.COM.AU> |
| To: | AICALIST@AICALIST.ORG.AU |
| Date: | 18/11/2011 05:41 PM |
| Subject: | Re: Sporicidal wipes |
| Sent by: | AICA Infexion Connexion <AICALIST@AICALIST.ORG.AU> |
Glenys,
The " TGA listed" product
and "TGA registered" product refers to medicines and not to medical
devices. The product mentioned previously meets the criteria under
medical devices. Is there something else on the certificate that
would identify it as appropriate on not appropriate in relation to the
companys claims?
Maree Sommerville
Infection Control Nurse
Consultant
Mercy Hospital for Women
8458 4759
From: AICA Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU]
On Behalf Of Glenys.Harrington@HEALTH.VIC.GOV.AU
Sent: Friday, 18 November 2011 11:59 AM
To: AICALIST@AICALIST.ORG.AU
Subject: Re: Sporicidial wipes
Robert,
Can you be more specific about they type of non lumened medical devices
your mention?
Also in terms of "TGA approval" can you be more specific as the
claims that can be made for TGA Sterilants and Disinfectants for a "
TGA listed" product and "TGA registered" product are
different.
See the TGA "Guidelines for the Evaluation of Sterilants and Disinfectants"
– pages 62-65 for guidance at http://www.tga.gov.au/industry/disinfectants-evaluation-guidelines.htm
regards
Glenys
Glenys Harrington, Infection Control Consultant |Communicable
Disease Prevention and Control | Public Health
Department of Health | Level 14 50 Lonsdale Street Melbourne Victoria 3000
Australia
t. 03 909 65094 | f. 1300 651 170 | e. glenys.harrington@health.vic.gov.au
| http://www.health.vic.gov.au/ideas
| From: |
Robert Robinson <Robert.Robinson@SWAHS.HEALTH.NSW.GOV.AU> |
| To: |
AICALIST@AICALIST.ORG.AU |
| Date: |
18/11/2011 11:37 AM |
| Subject: |
Sporicidial wipes |
| Sent by: |
AICA Infexion Connexion <AICALIST@AICALIST.ORG.AU> |
Hi all
Im interested to hear from the list if anyone uses or has comments on
sporicidial wipes for high level disinfection of non lumened medical devices.
I have heard (but not confirmed) these are being used in some Australian
hospitals. Im only aware of one company that has TGA approval for their
use in Australia.
Your thoughts would be much appreciated.
regards
Robert Robinson
Clinical Nurse Specialist- Infection control
Nepean Hospital
Penrith NSW
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