The Standards Australia journey in Sterilisation – By Greg S Whiteley

The first major Australian and New Zealand Standard on Sterilisation was released as AS/NZS 4187:1994 entitled as “Code of practice for cleaning, disinfecting, and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments in healthcare facilities. “, developed by Standards Australia (SA) committee HE002. 

A later revision in 1998, AS 4187:1998 “Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities” published in January 1998 by SA via the new HE023 technical committee and its impact was almost immediate.

A major problem identified by the stakeholders now included in HE-023, was that the second 1998 edition was not appropriate for application in the smaller end of the broader healthcare market, particularly for smaller and office-based practices.

It was agreed that a separate standard – not a lesser in standard of care, but more lightweight and less onerous in terms of documentation and traceability than what was expected from larger public hospitals is required.

The Australian Dental Association (ADA), the Australian Dental Industry Association (ADIA) and the Royal Australian College of General Practitioners (RACGP) were able to present the case for a second standard aimed particularly at the Office Based Practices. This standard was released in 2001 and AS/NZS 4815:2001 titled as; “Office-based health care facilities not involved in complex patient procedures and processes—Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment, and maintenance of the associated environment”.

A second edition of AS/NZS 4815:2006 was than published with the new and revised title as “Office-based health care facilities— Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment”. The title change was to remove the qualification over “…complex medical procedures…” as the public hospital advocates and representatives of the government agency represented on the committee strongly positioned that in fact any surgical procedure was complex.

Changes to practices and technology required further revision to AS/NZS 4187:2003. This was finally released after an enormous amount of public consultation over the proposals. The third edition was released in 2014 titled as; “AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations”.

Subsequently the HE-023 committee were working on a new standard. This standard, AS 5369:2003 Reprocessing of medical devices and other devices in health and non-health related facilities”, was finally published the month before the prior standard (AS/NZ 4187:2014) was due to come into full effect in December 2023.

Dental practices were always going to be covered by the requirements of a standard for sterilisation. It is also of note that the stakeholder group for the standard has also expanded to include additional health professionals (sonographers, podiatrists etc) as well as non-medical organisations such as tattooists and cosmetic piercing.

For any medical or non-health related facilities for which this standard will apply, the first step for compliance is to conduct a risk assessment and gap analysis. This will allow those involved in sterilisation practice to identify areas for improvement. This might also include capacity building and capital cost for new equipment. 

For assistance on understanding the new requirements, we strongly recommend contacting your relevant trade association or a technical advisory group.