ScanCARE Blog

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.

ScanCARE QuickShots offer a condensed version of our in-depth blog posts, summarising the key takeaways and presenting them in a quick, easy-to-read format. Each QuickShots blog will cover essential information on surgical instrument tracking, sterilization, and management, helping you stay up to date on industry best practices and innovations.

In July 2018 I published a blog about being ready for unique surgical instrument identification (UDI) and its implications for Australia and New Zealand.

Since then, the therapeutic goods administration (TGA) in Australia has released a consultation paper relating to the implementation of UDI.

The purpose of this blog is to look at the document and provide an update on what’s happening with the implementation of UDI in Australia.

When people ask me about instrument tracking, there are are number of things I need to find out from them so that I get an idea of what they want to track. So I begin by asking them what they would like to track:

By far the most perplexing issue for customers and delegates I talk to at conferences is Product Families.

This topic is the most read on my blog and our free guide to product family categorisation is by far the most downloaded resource on our web site.

The purpose of this post is to challenge the methodology used in the ISO/TS 17665-3 (ISO) standard by asking ‘Why does it need to be that way?’

I recently wrote about new regulations being implemented in Eurpope and the US that require manufacturers to uniquely mark surgical devices at the time manufacture.

Effectively, all reusable surgical devices that are destined for the EU and US markets will need to be marked with a GS1 Data matrix barcode .

In September 2013 the US Food & Drug Administration (FDA) implemented regulations establishing a system to identify surgical devices through distribution and use. Under this rule, each medical device must be labelled with a Unique Device Identifier (UDI).

The UDI needs to be directly marked on the device itself if the device is intended to be used more than once and to be reprocessed before each use.

I recently attended the 37th Annual Dental Congress in Melbourne and it was fantastic to catch up with the dental community and talk about the infection control issues that affect them. We had many visitors to our booth and had several enriching discussions with progressive thinking delegates who were passionate about infection control.

One discussion in particular caught my interest, as the delegate had very interesting views regarding the Spaulding Classification and how it was applied in dentistry. Our discussion centred around whether the classification and AS4815 were still relevant and whether AS4187 should be the "go to" standard for office based dental practices instead.

Blog posts and downloads related to product families blogs are by far the most accessed content on our website. By a long way.

And it’s with good reason. The concept of product families can be extremely complicated and confusing.