--- title: blog | Michael Stanton description: The ScanCARE Blog provides an abundance of information on all things relating to Surgical Instrument Tracking --- # ScanCARE Blog Browse by All AS/NZS4187 Surgical Instruments standards Product Families Paperless Patient Records Medical Records Management cssd Surgical Instrument Tracking Digital Medical Records Medical Assets UDI AS 5369:2023 AS5369 Instrument Level Tracking QuickShot Tray Level Tracking AS 5369 AS/NZS 4187 AS/NZS 4815 Reprocessing medical devices Sterilisation standards Australia TGA ## Posts by Michael Stanton: ![Top 10 Key Differences Between AS/NZS 4815 and AS 5369](https://blog.scancare.com.au/hubfs/Images%202021/Blogs/Differences%20Header.jpg) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) [Surgical Instrument Tracking](https://blog.scancare.com.au/blog/topic/surgical-instrument-tracking) [AS 5369](https://blog.scancare.com.au/blog/topic/as-5369) [AS/NZS 4815](https://blog.scancare.com.au/blog/topic/as-nzs-4815) [Sterilisation standards Australia](https://blog.scancare.com.au/blog/topic/sterilisation-standards-australia) [Reprocessing medical devices](https://blog.scancare.com.au/blog/topic/reprocessing-medical-devices) ### **Introduction** If your clinic or healthcare facility is still using **AS/NZS 4815:2006**, you're working under an outdated framework.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. ![TGA vs AS 5369: Closing the Gap in Surgical Traceability](https://blog.scancare.com.au/hubfs/Images%202021/Blogs/Closing%20the%20Gap%20Header2.jpg) [Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) [UDI](https://blog.scancare.com.au/blog/topic/udi) [Instrument Level Tracking](https://blog.scancare.com.au/blog/topic/instrument-level-tracking) [Surgical Instrument Tracking](https://blog.scancare.com.au/blog/topic/surgical-instrument-tracking) [AS5369](https://blog.scancare.com.au/blog/topic/as5369) [AS 5369:2023](https://blog.scancare.com.au/blog/topic/as-53692023) [TGA](https://blog.scancare.com.au/blog/topic/tga) ### 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. ![Navigating the Changes in Product Families from AS/NZS 4187 to AS 5369](https://blog.scancare.com.au/hubfs/Images%202021/Blogs/Product%20Families%20Fruit.png) [Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [standards](https://blog.scancare.com.au/blog/topic/standards) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [Product Families](https://blog.scancare.com.au/blog/topic/product-families) [Surgical Instrument Tracking](https://blog.scancare.com.au/blog/topic/surgical-instrument-tracking) [AS5369](https://blog.scancare.com.au/blog/topic/as5369) [AS 5369:2023](https://blog.scancare.com.au/blog/topic/as-53692023) 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. [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) [QuickShot](https://blog.scancare.com.au/blog/topic/quickshot) [Tray Level Tracking](https://blog.scancare.com.au/blog/topic/tray-level-tracking) [Instrument Level Tracking](https://blog.scancare.com.au/blog/topic/instrument-level-tracking) [Surgical Instrument Tracking](https://blog.scancare.com.au/blog/topic/surgical-instrument-tracking) ![3_scissors](https://blog.scancare.com.au/hs-fs/hubfs/Images/Images_used_on_scancare_blog/Medical_equipment/3_scissors.png?width=504&height=301&name=3_scissors.png) 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. [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) [QuickShot](https://blog.scancare.com.au/blog/topic/quickshot) [Tray Level Tracking](https://blog.scancare.com.au/blog/topic/tray-level-tracking) [Instrument Level Tracking](https://blog.scancare.com.au/blog/topic/instrument-level-tracking) [Surgical Instrument Tracking](https://blog.scancare.com.au/blog/topic/surgical-instrument-tracking) ![2d-scan](https://blog.scancare.com.au/hs-fs/hubfs/Images%202021/Pillar%201/compressed-resized/2d-scan.jpg?width=500&height=333&name=2d-scan.jpg) What are the benefits and drawbacks of tracking surgical instruments at the tray level and at the instrument level. Which method is more suitable to your facility. [Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [standards](https://blog.scancare.com.au/blog/topic/standards) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) [UDI](https://blog.scancare.com.au/blog/topic/udi) [Product Families](https://blog.scancare.com.au/blog/topic/product-families) [QuickShot](https://blog.scancare.com.au/blog/topic/quickshot) ## ![Busy Nurse](https://blog.scancare.com.au/hs-fs/hubfs/Busy%20Nurse.jpeg?width=720&height=481&name=Busy%20Nurse.jpeg) 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. ![AS 4187 Product Family categorisation - it's only part of the story](https://blog.scancare.com.au/hubfs/AS4187%20label.png) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [Product Families](https://blog.scancare.com.au/blog/topic/product-families) In my last blog, we looked at the complex and confusing nature of Product Families and looked at a way to simplify the categorisation process for assigning instruments and instrument sets to product families. In it we provided a free Product Families Toolkit containing a matrix and a six-part video series, demonstrating how to use it. ![AS 5369:2023 Product Families Online Course](https://blog.scancare.com.au/hubfs/Product%20Families_Blog.jpg) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [Product Families](https://blog.scancare.com.au/blog/topic/product-families) [AS/NZS 4187](https://blog.scancare.com.au/blog/topic/as-nzs-4187) [AS5369](https://blog.scancare.com.au/blog/topic/as5369) [AS 5369:2023](https://blog.scancare.com.au/blog/topic/as-53692023) ## **Introduction** We are proud to announce the Scancare Academy and our very first course, Understanding & Implementing Product Families, is available now and its completely free to enroll. ![Unique Surgical Instrument Identification – AU and NZ update](https://blog.scancare.com.au/hubfs/Should%20I%20track%20to%20tray%20or%20instrument%20level%20(1).png) [Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [UDI](https://blog.scancare.com.au/blog/topic/udi) 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. ![Should I track to tray or instrument level?](https://blog.scancare.com.au/hubfs/Should%20I%20track%20to%20tray%20or%20instrument%20level.png) [Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [AS/NZS4187](https://blog.scancare.com.au/blog/topic/as-nzs4187) [cssd](https://blog.scancare.com.au/blog/topic/cssd) 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: [ Prev ](https://blog.scancare.com.au/blog/author/michael-stanton/page/0) [1](https://blog.scancare.com.au/blog/author/michael-stanton/page/1) [2](https://blog.scancare.com.au/blog/author/michael-stanton/page/2) [3](https://blog.scancare.com.au/blog/author/michael-stanton/page/3) [4](https://blog.scancare.com.au/blog/author/michael-stanton/page/4) [5](https://blog.scancare.com.au/blog/author/michael-stanton/page/5) [ Next ](https://blog.scancare.com.au/blog/author/michael-stanton/page/2)