ScanCARE Blog

Posts about Instrument Level Tracking:

TGA vs AS 5369: Closing the Gap in Surgical Traceability

Michael Stanton 21-May-2025 13:49:03
TGA vs AS 5369: Closing the Gap in Surgical Traceability

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.

QuickShot 2: Improving Surgical Tracking with Naming Rules

Michael Stanton 15-Jun-2023 15:17:26

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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.