Re: Sporicidal wipes

21/11/2011 at 1:20 pm #68828 Quote

Anonymous

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Further to this, Scott Pabst the National Sales Manager at AshMed Pty Ltd has confirmed to me this morning that the product is TGA registered as a Class 2B Medical Device.

Regards
Megan

Megan Reilly RN BN Cert IV Assessment & Workplace Training MHlthSc (Inf Control) Immunise Cert RCNA CICP
Director
Hands-On Infection Control
PO Box 233 (Suite 1/46 Angove Street)
NORTH PERTH WA 6906
Tel: 61-8-9227 1132
Fax: 61-8-9227 1134
Mob: 0417 178 935
Email: megan@handsoninfectioncontrol.com.au
Website: http://www.handsoninfectioncontrol.com.au

From: AICA Infexion Connexion [mailto:AICALIST@AICALIST.ORG.AU] On Behalf Of Glenys.Harrington@HEALTH.VIC.GOV.AU
Sent: Monday, 21 November 2011 9:35 AM
To: AICALIST@AICALIST.ORG.AU
Subject: Re: Sporicidal wipes

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.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

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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