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.

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.

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:

The advances in surgical procedures and surgical instrumentation, over the past 10-20 years has been astounding. Once upon a time, just about every surgical procedure was open surgery and involved simple pivot based stainless steel instruments. These days, surgical instruments are highly complex hybrid material devices.

This has led to a quiet revolution in sterilizing departments around the world. Instruments were once simple and tray assembly straightforward.