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Hard surface disinfectants and instrument grade disinfectants (including sterilants)

Fact sheet no. 28

October 2006

1. Introduction

This Fact Sheet provides information on the regulatory requirements applied to all hard surface disinfectants, instrument grade disinfectants (including sterilants), sanitisers and sanitary preparations except:

  • sterilant gases;
  • antiseptics and skin disinfectants;
  • antibiotics;
  • a disinfectant that is represented to be for antifungal use only;
  • a disinfectant or sanitiser registered under the Agricultural and Veterinary Chemicals Code Act, 1994 for which no claim or representation for disinfectant use is made other than a use which is registered for the disinfectant;
  • a disinfectant or sanitiser that is represented to be suitable for the treatment of water only and;
  • contact lens care products.

Definitions of some of the terms are in Section 7.

Australia has adopted a new regulatory system for medical devices based on the Global Harmonisation Task Force model of device regulation. Under the new system, manufacturers must demonstrate compliance with the regulatory requirements (Essential Principles and Conformity Assessment Procedures) for medical devices. Any product specifically intended to be an accessory to a medical device is subject to the same requirements. For further information on the new regulatory system for medical devices see guidance document 1 <http://www.tga.gov.au/docs/html/devguid1.htm>.

Instrument grade disinfectants (including Sterilants) are to be treated as accessories to medical devices.

Hard surface disinfectants including those defined as Hospital, Household and Commercial Grade Disinfectants will continue to be subject to the requirements that were in place prior to the commencement of the new devices legislation.

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2. Hard surface disinfectants (hospital, household and commercial grade disinfectants)

As a consequence of the introduction of the medical device legislation hard surface disinfectants now form part of the group of products referred to as "other therapeutic goods (OTGs)." OTGs will continue to be subject to the requirements for registered or listed goods, under Chapter 3 of the Act. For guidance on the regulation of OTGs, please refer to DR41 <http://www.tga.gov.au/docs/html/dr4.htm>.

Disinfectants that are OTGs are still subject to Therapeutic Goods Order 54 (Standard for Disinfectants and Sterilants) <http://www.tga.gov.au/docs/html/tgo/tgo54.htm> as a mandatory requirement.

Applications for registration or listing of these products should be made through DEAL2 <http://www.tga.gov.au/devices/dealfaq.htm>.

  1. Medical Device Requirements Version 4 under the Therapeutic Goods Act 1989
  2. DEAL: Device Electronic Application Lodgement system

3. Instrument grade disinfectants (including sterilants) - are they medical devices?

Disinfectants used for sterilisation/disinfection of medical devices (in order to prevent the transmission of communicable diseases between patient and user, or between patients) are considered to be an accessory to a medical device. On that basis, they are regulated under Chapter 4 of the Act.

These disinfectants include all low-level, intermediate level and high level instrument grade disinfectants, as defined in Therapeutic Goods Order (TGO) 54. Sterilants are taken to be a sub-group of disinfectants.

In Australia, these products are regulated as Class IIb, regardless of the level of disinfection of devices claimed, while in Europe they are regulated as Class IIa. Therefore any assessment performed for Europe for the purposes of affixing the CE Mark may not have addressed the requirements for inclusion on the Australian Register of Therapeutic Goods (ARTG). Sponsors who wish to import these products need to ensure that the Australian regulatory requirements have been met by the manufacturer.

4. Compliance with Essential Principles

Since instrument grade disinfectants (including sterilants) are an accessory to a medical device, they must comply with the essential principles for safety and performance.

An internationally recognised harmonised standard for these products does not exist. However, in Australia the testing regimes set out in TGO 54 are considered to be state-of-the-art, and may be used to demonstrate compliance with the essential principles related to performance. The use of TGO 54 is not mandatory and a manufacturer may choose to use other standards, or tests for performance. However, the manufacturer must be able to demonstrate that other tests used deliver an outcome at least equivalent to the testing specified in TGO 54.

If other standards are used, the disinfectant/sterilant must fall within the scope of the standard, the standard must be correctly applied and the manufacturer must be able to show how the standard demonstrates compliance with relevant essential principles. In the case of the manufacturer's own 'standards' any test method, pass criteria or procedure must be verified.

Manufacturers must generate documentary evidence (a technical file) of compliance with the essential principles that are relevant to their disinfectant. This documentation and if necessary, evidence of its assessment, is the first element of the Evidence of Conformity that must be available to an Australian sponsor before the Sponsor can make an application for inclusion of a medical device onto the ARTG.

More information can be obtained by accessing the Guidance document on The Essential Principles <http://www.tga.gov.au/docs/html/devguid22.htm>.

5. What are the conformity assessment procedures to be followed for instrument grade disinfectants (including sterilants)?

On the basis that disinfectants/sterilants are Class IIb medical devices, any one of the following conformity assessment procedures ( see Schedule 3 of the Medical Devices Regulations) can be followed:

  • Full quality assurance procedure (except Clause 1.6);
  • Type examination and verification procedures;
  • Type examination and production quality assurance procedures; or
  • Type examination and product quality assurance procedures.

For specific information on the requirements of each procedure, please refer to the Conformity Assessment Procedures Guidance Document <http://www.tga.gov.au/docs/html/devguid3.htm>.

Note: The TGA must conduct the conformity assessment for product manufactured in Australia.

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6. What are the transition arrangements for instrument grade disinfectants (including sterilants) that are currently in the ARTG?

Sponsors of instrument grade disinfectants that where already on the ARTG as registered devices on 4 October 2002, have a period of five years, until October 2007, to make application for inclusion under the new device legislation. There will be no "grandfathering" process.

At the time the sponsor makes an application to include the device the following will apply:

  • An instrument grade disinfectant will be deemed to be in compliance with the Medical Device Standard for performance aspects.
  • Test reports and the evidence of compliance with TGO54 presented at the time of registration should be included in the Technical File for the product.
  • Re-testing will not be required.
  • Sponsors should ensure before making an application to included that the manufacturer has addressed all of the requirements of the relevant conformity assessment procedure.

For a new inclusion, the manufacturer must show that an applicable conformity assessment procedure has been applied to demonstrate conformity with the Essential Principles. The sponsor must ensure that the manufacturer has met this obligation before an application is made. However, if the new product is the same kind as one already on the ARTG, further assessment is not required. Assuming these products are Class IIb, instrument grade disinfectants are considered to be of the same kind if they have the same sponsor, manufacturer, classification and device nomenclature code, see Section 41BE of the Act.

Entries for instrument grade disinfectants (including Sterilants) in the Registrable part of the ARTG will be cancelled on 4 October 2007. Supply of the product will become illegal after this date, unless the product is entered in the part of the ARTG for Included goods prior to that date.

7. Definitions

Accessory
means an article that its manufacturer specifically intended to be used together with a medical device to enable the device to be used as the manufacturer of the device intended.

Disinfectant
A substance:

  1. that is recommended by its manufacturer for application to an inanimate object to kill a range of micro-organisms; and
  2. is not represented by the manufacturer to be suitable for internal use.

Hospital grade disinfectant
A disinfectant that is suitable for general purpose disinfection of building and fitting surfaces, and purposes not involving instruments or surfaces likely to come into contact with broken skin:

  1. in premises used for:
    1. the investigation or treatment of a disease, ailment or injury; or
    2. procedures that are carried out involving the penetration of the human skin; or,
  2. in connection with:
    1. the business of beauty therapy or hairdressing; or
    2. the practice of podiatry;

but does not include:

  1. instrument grade disinfectants; or
  2. sterilant; or
  3. an antibacterial clothes preparation; or
  4. a sanitary fluid; or
  5. a sanitary powder; or
  6. a sanitiser.

Household/commercial grade disinfectant
A disinfectant that is suitable for general purpose disinfection of building or fitting surfaces, and for other purposes, in premises or involving procedures other than those specified for a hospital grade disinfectant, but is not:

  1. an antibacterial clothes preparation; or
  2. a sanitary fluid; or
  3. a sanitary powder; or
  4. a sanitiser.

Instrument grade disinfectant
A disinfectant which is used to reprocess reusable medical devices.

Kind of medical device
Medical devices are considered to be of the same kind if they:

  1. have the same sponsor
  2. have the same manufacturer
  3. have the same GMDNS code
  4. have the same medical device classification; and
  5. are the same in relation to such other characteristics as the regulations prescribe, either generally or in relation to medical devices of the kind in question.

Medical device

  1. any instrument, apparatus, appliance, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following:
    1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
    2. diagnosis, monitoring treatment, alleviation of or compensation for an injury or handicap;
    3. investigation, replacement or modification of the anatomy or of a physiological process;
    4. control of contraception;
    5. and that does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, but that may be assisted in its function by such means; or
  2. an accessory to such an instrument, apparatus, appliance, material or other article.

Sterilant
A chemical agent which kills all micro-organisms with the result that the sterility assurance level of a microbial survivor is less than 10-6.

Disclaimer

This document is provided for guidance only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 for legislative requirements.

Further information

The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the Therapeutic Goods Administration (TGA) can be contacted by:

Telephone: 1800 141 144
Facsimile: 02 6232 8299
Email:
Website: http://www.tga.gov.au/devices/devices.htm
Mail: PO Box 100, Woden ACT 2606

© Commonwealth of Australia 2006

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