---
title: blog | UDI
description: UDI | 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 about UDI:

![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.

[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.

![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.

![Get ready for Unique Surgical Instrument Identification.](https://blog.scancare.com.au/hubfs/UDI%20Instrument-1.png)

[Surgical Instruments](https://blog.scancare.com.au/blog/topic/surgical-instruments) [UDI](https://blog.scancare.com.au/blog/topic/udi)

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.