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Standards and specifications

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Queensland Health is committed to protecting frontline workers and the community with quality products that meet a minimum set of requirements.

For each phase of procurement for the critical supply reserve, information will be provided to suppliers with the requirements they must meet for each product category.

A supplier may be asked to provide several details and items before Queensland Health proceeds to purchase a product.

As an example, if a company is supplying PPE to Queensland Health, the below process will include:

Diagram showing an example of the process for establishing an standard and specification - content is the same as in the webpage.

Example of process to supply PPE

Step 1

A supplier will be asked to provide details about their organisation and products they intend to supply

Step 2

Queensland Health will review the information and ask the supplier to provide the following information as a minimum:

  1. Provide TGA certification per product (this is different to an ARTG Public Summary)
    Queensland Health will verify:
    1. The manufacturer
    2. Product category and Global Medical Device Nomenclature (GMDN)
    3. Sponsor—if the business is not listed as the sponsor on the TGA certification, the supplier will be asked to send through a copy of the Distribution Agreement to support their businesses’ affiliation with the TGA sponsor.
  2. Provide independent testing certificates
    Queensland Health will verify: 
    1. Accredited lab (i.e. lab certificate number)
    2. Standards the product has been tested against (i.e. AS:4381).
      *Compliance to TGA and Australian and/or International Standards is a mandatory requirement.
  3. A supplier will be asked to provide images of the product.
    Images should show:
    1. Product packaging showing the product code as listed on the testing documentation
    2. Brand name listed on product packaging

Step 3

The organisation and products may be evaluated against other evaluation criteria and further information may be requested.

Step 4

A sample of the product may be requested for clinical evaluation.

PPE use in healthcare settings

Appendix 5 to the Interim infection prevention and control guidelines for the management of COVID-19 in healthcare settings describes the properties of different types of personal protective equipment (PPE).

Therapeutic Goods Association (TGA)

Products that may be used for therapeutic purposes should be registered on the Australian Register of Therapeutic Goods (ARTG).

The TGA regulates personal protective equipment (PPE) that may be used for therapeutic purposes, including face masks, gowns and gloves. Find this information here Regulation of Personal Protective Equipment and COVID-19.

View the latest TGA information about medicines and medical devices as related to COVID-19.

Guidance on Testing Requirements

Compliance with the relevant Standard, as described in Appendix 5, should be evidenced through provision of a test report or certificate from an independent laboratory accredited to undertake the relevant test.

All test reports or certificates received by Queensland Health will be verified for authenticity through direct contact with the issuing laboratory, and the accreditation scope will be confirmed with the relevant accreditation body.

Testing standards

Standards Australia has provided guidance on the relevant Australian and International Standards that PPE must meet, including the details of relevant test method standards.

For specific guidance on testing view the Standards Australia and the National Association of Testing Authorities (NATA) websites.

A number of laboratories within Australia are currently seeking NATA accreditation for testing under AS 4381:2015 (single-use face masks used in healthcare) and AS/NZS 1716:2012 (respiratory protective devices).

In the interim, laboratories with self-declared testing capabilities have been identified on the Department of Industry, Science, Energy and Resources website.

Picture of face mask and had sanitiser with legend: Standards

International laboratories

As guidance for manufacturers and suppliers, if testing reports or certificates are sourced from international laboratories, the accreditation scope will be checked by searching the accredited laboratories for the relevant accreditation body in that country.

You can identify the accreditation body for the relevant country on the International Laboratory Accreditation Cooperation (ILAC) website. ILAC is the international organisation for accreditation bodies operating in accordance with a range of international calibration and testing standards including laboratories using ISO/IEC 17025.

The website for the accreditation body enables access to the listing of laboratories accredited with the relevant accreditation body, and the scope each laboratory is accredited for.

Compliance

Suppliers and manufacturers are encouraged to understand their obligations in relation to supply of products and services, under the suite of applicable State and Commonwealth legislation and regulations to avoid the potential range of criminal offences and civil penalties that may apply.

Supplying or offering to supply services in relation to which there is a prescribed safety standard, without complying with that safety standard, carries a fine for a body corporate or individuals.

See the Fair Trading Act 1989 for more information and view the TGA’s information on the consequences of breaking the law.

Last updated: 30 September 2020