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Whitepaper

Ensure your critical items are protected 24/7 whilst reducing manual interventions.
In the dynamic world of healthcare, efficiency and safety are paramount, especially in surgical environments. One key challenge that persists is the effective tracking and management of surgical instruments. This white paper explores the impact of (Radio Frequency Identification) RFID-enabled surgical instrument tracking systems in healthcare facilities. It also highlights a number of key benefits, these being optimising workflows, improving patient and staff safety, improving efficiencies and compliance, providing insights, reducing hospital-acquired infections (HAIs) and optimising the supply chain.
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Unique Device Identifier

The unique device identifier (UDI) is a unique number on medical devices that identifies a device at the point of distribution and at the point of use. The UDI consists of the following:

Global Trade Item Number (GTIN) + Application Identifier (AI) = UDI

A UDI will comprise two elements: the Device Identifier (DI) and Production Identifier (PI).
Device Identifier (DI) – is the “access key” and this information will be stored in the Australian UDI database (AusUDID). It will be used for device related information such as adverse events and recalls.
Production Identifier (PI) – production specific information that identifies a specific production run of the device. For example, batch number, lot number or expiry dates. The PI is on the device and/or labelling but not stored in the AusUDID.
The UDI is placed on each medical device using direct part marking (DPM) in a 2D data matrix format, where possible. The data matrix is also printed on each product label. Direct part marking requirements are:
DPM must not interfere with the safety or effectiveness of the device
DPM is not required for single use devices
Device has been marked under 21 CFR 801.45(a)
DPM is technologically not feasible.
In the case of our surgical instrument tracking, we apply an UHF RFID tag to your instruments, cords, pouches, containers, trolleys, and any other valuable asset you require tracked. We can encode each tag with:
EPC
UDI
Batch/lot number
Serial number
Expiry
Manufacturer
and any other vital information
Devices Required to Meet UDI Requirements

Medical devices and in vitro diagnostic (IVD) devices will require a UDI, unless otherwise exempt by the TGA. 

UDIs will apply to the following medical devices and IVD devices:

Medical device classes
  • Class III
  • Class IIb
  • Class IIa
  • Class Is – supplied sterile
IVD classes
  • Class 4
  • Class 3
  • Class 2
  • Class 1 categorised as:
    • Instrument/analyser (GMDN Collective Term 943)
    • Software (GMDN Collective Term 944)

Some medical devices already have a UDI on the device, the labelling or packaging due to UDI being implemented globally.

Australian Unique Device Identifier Database (AusUDID)

The TGA has established the Australian UDI Database (AusUDID) as a repository of medical device UDI information for devices supplied in Australia. This data in will link to relevant medical device in the Australian Register of Therapeutic Goods (ARTG).

AusUDID will enable you to search, view and download UDI information.  The information stored in AusUDID will contain:

  • DI
  • Brand name
  • Manufacturer name
  • Sponsor name
  • GMDN
  • ARTG ID
  • Patient information leaflet

Further guidance on using the AusUDID will be published on the UDI Hub in 2024.  Click link here to UDI Hub.  https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/unique-device-identification-udi-hub

UDI Compliance Timeframe

Mandatory compliance will be progressively phased by the TGA based on device classification.  The TGA will begin with high-risk and implantable medical devices, followed by lower risk class devices.

Mandatory compliance will commence at a minimum of 12 months from the date the regulations take effect.  The dates for compliance are yet to be announced.  Please refer to the TGA website for updates.