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.

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.

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 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.

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.

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:

Electronic Medical Record systems have now been widely adopted in Australia and around the world. Possibly the most publicised roll out has been in the United States with the government providing significant fiscal incentives under the Meaningful Use program.

In this blog I use the terms EHR and EMR interchangeably.

In the US for example it's common to use EHR (Electronic Health Record) as the term for a patient’s medical record, whereas in Australia, the personal health record system, MyHealth Record is commonly referred to as an EHR. In Australia, the patient record is generally referred to as an EMR (Electronic Medical Record)