Glenys.Harrington@HEALTH.VIC.GOV.AU Subject: Re: Sporicidal wipes In-Reply-To:'s Replies – ACIPC – Australasian College for Infection Prevention and Control

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21/11/2011 at 12:34 pm in reply to: Re: Sporicidal wipes #68827

Glenys.Harrington@HEALTH.VIC.GOV.AU Subject: Re: Sporicidal wipes In-Reply-To:

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Glenys.Harrington@HEALTH.VIC.GOV.AU Subject: Re: Sporicidal wipes In-Reply-To:

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Maree and Robert,

Further to my comments earlier today. I have contacted the TGA for further
clarification.

The particular product under discussion in this thread is categorised as a
“medical device” as it is “intended to be used on medical devices”.

Such products must be included on the Australian Register of Therapeutic
Goods Devices (ARTG) before they can be supplied in Australia.

The ARTG form will state the following:

“Product type: Medical Device – Class …… – Included”

The key word is “included” which confirms that the product is suitable for
the ” intended purpose” which is also included on the ARTG form. For this
particular products the intended purpose on the ARTG form is as follows:

“Intended purpose: The Tristel disinfecting wipes system is intended to
decontaminate and disinfect non-lumened medical devices that cannot be
fully immersed in liquid disinfectant or sterilant and cannot be
sterilised by heat. It allows high level disinfection of instruments where
automated dishwashers, sinks and water supplies are unavailable. The
system provides high-level disinfection in less than two minutes. The
Tristel system is not intended for high level disinfection of critical
medical devices which must be sterilised prior to use on patients”.

The information above is unclear and ideally should have included
information about semi critical devices (ie contacts mucous membranes,
non-intact skin) in addition to critical devices (ie enters normally
sterile tissue or vascular system). It is also unclear in the intended
purpose statement reference to the use of the product “where ….sinks and
water supplies are unavailable” as such devices would before high level
disinfection need to be meticulously pre-cleaned?

I am providing TGA with additional information (ie Methods of
sterilization and disinfection, [Modified Spaulding classification
system]).

All ARTG forms can be found by searching the ARTG database available on
the TGA web page.

https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuDevices?OpenView

For disinfectants not used on medical devices (ie for general, outbreak or
isolation cleaning and disinfecting purposes) there are 3 categories:

1. Hospital grade and commercial/household grade disinfectants with
specific claims
2. Hospital grade disinfectants without specific claims
3. Household or commercial grade disinfectant without specific claims
(that do not make disinfectant claims)

1 & 2 must be either “listed” or “registered” on the ARTG.

The ARTG form will include an “ARTG identifier” with either “Aust L” or
Aust R” (listed or registered with the TGA). Generally products need to be
registered to make fungicidal, sporicidal, tuberculocidal and viricidal
claims (ie with specific claims).

If a product is not registered in Australia and the manufacturer/supplier
is making fungicidal, sporicidal, tuberculocidal and viricidal claims TGA
have asked that you let them know via their on-line “Report a perceived
breach or questionable practices” at the following link and they will
follow-up.

http://www.tga.gov.au/about/form-breach-tgact.htm

The manufacturer/supplier may not be fully aware of the TGA requirements
as outlined in the TGA “Guidelines for the Evaluation of Sterilants and
Disinfectants”.

Find below additional information provide by the TGA this morning:

Disinfectants are regulated in a variety of ways in Australia, depending
on the claims made in the instructions for use, labelling and promotional
material.

Type of disinfectant
How is it regulated?
Comments
Sterilants and instrument grade disinfectants (all levels) – intended to
be used on medical devices
An accessory to a medical device – Class IIb
Must be included on the ARTG before they can be supplied in Australia.
In Europe are regulated as Class IIa. Sponsors importing these products
need to ensure that the Australian regulatory requirements have been met
by the manufacturer.
Undergo a mandatory Level 2 Application Audit.
Cleaners intended to be used on medical devices

An accessory to a medical device – Class I
Must be included on the ARTG before they can be supplied in Australia.
Hospital grade and commercial/household grade disinfectants with specific
claims*
‘Other Therapeutic Goods’ – registered

Must be registered on the ARTG before they can be supplied in Australia.
Must comply with TGO 54.
Information to be submitted for review includes instructions for use,
promotional material, labels, product specifications, and efficacy,
stability and quality control data.

Hospital grade disinfectants without specific claims*
‘Other Therapeutic Goods’ – listed
Must be listed on the ARTG before they can be supplied in Australia.
Must comply with TGO 54.
Information to be submitted for review includes instructions for use,
promotional material and labels.

Household or commercial grade disinfectant without specific claims*
‘Other Therapeutic Goods’ – exempt from listing or registration
Exempt disinfectants are not required to be entered on the ARTG however
they still must comply with certain parts of TGO 54, including the
labelling requirements, and are expected to comply with performance
requirements.
Antibacterial cleaning wipes
Sanitisers
Sanitary fluids/powders
(that do not make disinfectant claims)
Exempt or excluded depending on claims
Claims determine if exempt from entry on the ARTG or excluded from the
Therapeutic Goods Act 1989.
* ‘specific claims’ cover virucidal, sporicidal, tuberculocidal,
fungicidal or other biocidal activity. Except where claims of activity
against fungi (yeast and mould) for excluded products are concerned, these
claims mean a product is registered.
http://www.tga.gov.au/industry/disinfectants-regulation.htm
http://www.tga.gov.au/industry/disinfectants-hard-surface.htm

A hospital grade disinfectant with non-specific claims is a listable
product
A hospital grade disinfectant with specific claims is a registerable
product
A “non-specific claim” is a claim which includes general antibacterial
action or activity against bacteria covered by the battery of test
organisms included in the specified test, or bacteria of the same family.
Claims for bacteria other than these are allowable and do not cause the
product to become registerable, but the specific organism against which
activity is claimed must be included as an extra organism in the test
battery e.g. E. coli O157, Salmonella spp, Streptococcus spp, etc.
A “specific claim” is one which covers virucidal, sporicidal,
tuberculocidal, fungicidal or other biocidal activity. Except where claims
of activity against fungi (yeast and mould) for excluded products are
concerned, such claims lift a product into the registerable category of
goods.

For information on disinfectants:

Please see TGO 54/54A/54B, which can be accessed at
http://www.comlaw.gov.au/Details/F2009C00327
Please see the “Guidelines for evaluation of sterilants and
disinfectants”, which can be accessed at
http://www.tga.gov.au/industry/disinfectants-evaluation-guidelines.htm.
These guidelines describe the information to be supplied to the TGA for
the registration or listing of disinfectants on the ARTG.

Yours sincerely,

Medical Devices Information Line

Telephone: 1 800 141 144
Fax: 02 6232 8785

Websites:
Information http://www.tga.gov.au/devices/devices.htm
e-Business http://www.ebs.tga.gov.au

Hope this clarifies further.

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:
Glenys.Harrington@HEALTH.VIC.GOV.AU
To:
AICALIST@AICALIST.ORG.AU
Date:
21/11/2011 09:38 AM
Subject:
Re: Sporicidal wipes
Sent by:
AICA Infexion Connexion

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
To:
AICALIST@AICALIST.ORG.AU
Date:
18/11/2011 05:41 PM
Subject:
Re: Sporicidal wipes
Sent by:
AICA Infexion Connexion

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

From:
Robert Robinson
To:
AICALIST@AICALIST.ORG.AU
Date:
18/11/2011 11:37 AM
Subject:
Sporicidial wipes
Sent by:
AICA Infexion Connexion

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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11/18/11 – 10:41:12
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j[^vOn{B{^j{z’rbMaree and Robert,

Further to my comments earlier today. I have
contacted the TGA for further clarification.

The particular product under discussion in
this thread is categorised as a "medical device" as it is "intended
to be used on medical devices".

Such products must be included on the Australian
Register of Therapeutic Goods Devices (ARTG) before they can be supplied
in Australia.

The ARTG form will state the following:

"Product type: Medical Device – Class
…… – Included"

The key word is "included" which
confirms that the product is suitable for the " intended purpose"
which is also included on the ARTG form. For this particular products
the intended purpose on the ARTG form is as follows:

"Intended purpose: The Tristel disinfecting
wipes system is intended to decontaminate and disinfect non-lumened medical
devices that cannot be fully immersed in liquid disinfectant or sterilant
and cannot be sterilised by heat. It allows high level disinfection of
instruments where automated dishwashers, sinks and water supplies are unavailable.
The system provides high-level disinfection in less than two minutes. The
Tristel system is not intended for high level disinfection of critical
medical devices which must be sterilised prior to use on patients".

The information above is unclear and ideally
should have included information about semi critical devices (ie contacts
mucous membranes, non-intact skin) in addition to critical devices (ie
enters normally sterile tissue or vascular system). It is also unclear
in the intended purpose statement reference to the use of the product "where
….sinks and water supplies are unavailable" as such devices would
before high level disinfection need to be meticulously pre-cleaned?

I am providing TGA with additional information
(ie Methods of sterilization and disinfection, [Modified Spaulding classification
system]).

All ARTG forms can be found by searching
the ARTG database available on the TGA web page.

https://www.ebs.tga.gov.au/ebs/ANZTPAR/PublicWeb.nsf/cuDevices?OpenView

For disinfectants not used on medical devices
(ie for general, outbreak or isolation cleaning and disinfecting purposes)
there are 3 categories:

1. Hospital grade and commercial/household
grade disinfectants with specific claims

2. Hospital grade disinfectants without specific
claims

3. Household or commercial grade disinfectant
without specific claims (that do not make disinfectant claims)

1 & 2 must be either "listed"
or "registered" on the ARTG.

The ARTG form will include an "ARTG
identifier" with either "Aust L" or Aust R" (listed
or registered with the TGA). Generally products need to be registered to
make fungicidal, sporicidal, tuberculocidal and viricidal claims (ie with
specific claims).

If a product is not registered in Australia
and the manufacturer/supplier is making fungicidal, sporicidal, tuberculocidal
and viricidal claims TGA have asked that you let them know via their on-line
"Report a perceived breach or questionable practices" at the
following link and they will follow-up.

http://www.tga.gov.au/about/form-breach-tgact.htm

The manufacturer/supplier may not be fully
aware of the TGA requirements as outlined in the TGA "Guidelines for
the Evaluation of Sterilants and Disinfectants".

Find below additional information provide
by the TGA this morning:

Disinfectants are regulated in a variety
of ways in Australia, depending on the claims made in the instructions
for use, labelling and promotional material.

Type of disinfectant	How is it regulated?	Comments
Sterilants and instrument grade disinfectants (all levels) – intended to be used on medical devices	An accessory to a medical device – Class IIb	Must be included on the ARTG before they can be supplied in Australia. In Europe are regulated as Class IIa. Sponsors importing these products need to ensure that the Australian regulatory requirements have been met by the manufacturer. Undergo a mandatory Level 2 Application Audit.
Cleaners intended to be used on medical devices	An accessory to a medical device – Class I	Must be included on the ARTG before they can be supplied in Australia.
Hospital grade and commercial/household grade disinfectants with specific claims*	‘Other Therapeutic Goods’ – registered	Must be registered on the ARTG before they can be supplied in Australia. Must comply with TGO 54. Information to be submitted for review includes instructions for use, promotional material, labels, product specifications, and efficacy, stability and quality control data.
Hospital grade disinfectants without specific claims*	‘Other Therapeutic Goods’ – listed	Must be listed on the ARTG before they can be supplied in Australia. Must comply with TGO 54. Information to be submitted for review includes instructions for use, promotional material and labels.
Household or commercial grade disinfectant without specific claims*	‘Other Therapeutic Goods’ – exempt from listing or registration	Exempt disinfectants are not required to be entered on the ARTG however they still must comply with certain parts of TGO 54, including the labelling requirements, and are expected to comply with performance requirements.
Antibacterial cleaning wipes Sanitisers Sanitary fluids/powders (that do not make disinfectant claims)	Exempt or excluded depending on claims	Claims determine if exempt from entry on the ARTG or excluded from the Therapeutic Goods Act 1989.
* ‘specific claims’ cover virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity. Except where claims of activity against fungi (yeast and mould) for excluded products are concerned, these claims mean a product is registered. http://www.tga.gov.au/industry/disinfectants-regulation.htmhttp://www.tga.gov.au/industry/disinfectants-hard-surface.htm

A hospital grade disinfectant with non-specific claims is a listable product

A hospital grade disinfectant with specific claims is a registerable product

A "non-specific claim" is a claim which includes general
antibacterial action or activity against bacteria covered by the battery
of test organisms included in the specified test, or bacteria of the same
family. Claims for bacteria other than these are allowable and do not cause
the product to become registerable, but the specific organism against which
activity is claimed must be included as an extra organism in the test battery
e.g. E. coli O157, Salmonella spp, Streptococcus spp, etc.
A "specific claim" is one which covers virucidal, sporicidal,
tuberculocidal, fungicidal or other biocidal activity. Except where claims
of activity against fungi (yeast and mould) for excluded products are concerned,
such claims lift a product into the registerable category of goods.

For information on disinfectants:

Please see TGO 54/54A/54B, which can be accessed at http://www.comlaw.gov.au/Details/F2009C00327

Please see the "Guidelines for evaluation of sterilants and disinfectants",
which can be accessed at http://www.tga.gov.au/industry/disinfectants-evaluation-guidelines.htm.
These guidelines describe the information to be supplied to the TGA for
the registration or listing of disinfectants on the ARTG.

Yours sincerely,

Medical Devices Information Line

Telephone: 1 800 141 144
Fax: 02 6232 8785

Websites:
Information http://www.tga.gov.au/devices/devices.htm
e-Business http://www.ebs.tga.gov.au

Hope this clarifies further.

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:	Glenys.Harrington@HEALTH.VIC.GOV.AU
To:	AICALIST@AICALIST.ORG.AU
Date:	21/11/2011 09:38 AM
Subject:	Re: Sporicidal wipes
Sent by:	AICA Infexion Connexion <AICALIST@AICALIST.ORG.AU>

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

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

___________________________________

IMPORTANT: The information contained in this e-mail message (including
attachments) may be confidential and may also be subject to legal professional
privilege.

Unless you are the intended recipient any unauthorised use, dissemination,further
distribution or reproduction of this communication in any form whatsoever,
is strictly prohibited.

If this communication has been sent to you in error, please notify the
sender by return e-mail and delete and/or destroy your copy of this communication
(including attachments).

Any views expressed in this communication are those of the individual sender,
except where the sender states them to be the views of the Nepean Blue
Mountains Local Health District/Western Sydney Local Health District.

11/18/11 – 10:41:12
Messages posted to this list are solely the opinion of the authors, and
do not represent the opinion of AICA.

Archive of all messages are available
at http://aicalist.org.au/archives
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DISCLAIMER This email and any files transmitted with it may be confidential and intended solely for the use of the individual or entity to whom they are addressed. If you have received this email in error please notify the sender immediately by return email and delete or destroy this message and its attachments. While this email any any attachments have been cleared by Mercy Healths virus protection systems, recipients should use their own systems to detect computer viruses or other materials that may corrupt files or systems. Find out more about Mercy Health athttp://www.mercyhealth.com.au

Messages posted to this list are solely the opinion of the authors, and
do not represent the opinion of AICA.

Archive of all messages are available
at http://aicalist.org.au/archives
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Replies to this message will be
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Glenys.Harrington@HEALTH.VIC.GOV.AU Subject: Re: Sporicidal wipes In-Reply-To:

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