ScanCARE Blog

Introduction

If your clinic or healthcare facility is still using AS/NZS 4815:2006, you're working under an outdated framework. The newly introduced AS 5369:2023 is a modernised, risk-based standard designed to enhance infection control and sterilisation practices in Australia. Below, we compare the top 10 differences between AS/NZS 4815 and AS 5369, with a focus on documentation compliance, staff training, and reprocessing protocols.

Read on to discover the Top 10 differences between the standards.

Introduction

In the modern healthcare environment, where safety, traceability, and compliance are paramount, Australia’s regulatory framework for reusable surgical instruments presents a perplexing disconnect. On one hand, the recently published AS 5369:2023 sets a clear expectation for tracking surgical instruments from sterilization through to patient use. On the other, the Therapeutic Goods Administration (TGA) — Australia's national regulator — does not currently require direct part marking or Unique Device Identification (UDI) for Class I reusable surgical instruments, which make up the bulk of surgical tools used in clinical practice.

This divergence between clinical best practice and regulatory requirements is more than just an academic discrepancy — it has real-world implications for patient safety, operational efficiency, and the traceability of critical medical assets. In this article, we explore the current landscape, compare global standards, and ask whether the TGA is overdue for an update.

The shift from AS/NZS 4187:2014 to AS 5369:2023 introduces notable changes in the implementation of Product Families, especially with the detailed guidance presented in section A.5.2 of Appendix A.

In contrast to AS/NZS 4187:2014, AS 5369:2023 offers comprehensive guidance along with a supporting flowchart.

This blog aims to explore the guidance provided and highlight the differences in managing product family classifications between these two standards, making it easier to understand the adjustments required.

Transitioning to an Electronic Tracking system often involves importing your existing CSSD Check Sheets and Surgical Devices data, currently maintained in MS Word or Excel. A common challenge is the varied naming of the same type of surgical instruments. 

For instance, Mayo Forceps for example, might be named in several ways:

• 15cm Curved Mayo Forceps
• Mayo Forceps 15cm Curved
• Curved 15cm Mayo Forceps
• Forceps Mayo  Curved 15cm
•  6" Mayo Curved Forcep

Let's explore five tips on establishing a consistent naming convention for surgical instruments to simplify this process.

The latest version of AS/NZS 4187 released on the 15^th December 2014  brought some very significant changes to the previous standard. One of the most significant changes is the standards reference to Product Families.

In my blog "Here's how to make sense of the AS4187 categorisation of instrument product families", I provided an overview of ISO/TS 17665-3:2013 - Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization.

In today's post I will get into the specifics of how to apply the standard to a dental assessment tray.