UDI: information for healthcare providers

UDI in healthcare

Unique Device Identification (UDI) is a globally harmonised system that can support improved tracking and tracing of medical devices including within the Australian healthcare system.

The UDI is intended to be the key identifier used in administrative and clinical transactions. Examples include:

• in discharge summaries
• patients’ records
• registries
• clinical notes and records
• purchase orders
• reimbursement or claims documentation
• invoices
• inventory maintenance/management.

Benefits of adopting the UDI can contribute to a more reliable and efficient system of tracking and tracing medical device issues, as well as ensuring correct products are used.

A UDI can also be stored within electronic health records and will be required on Patient Implant Cards (PICs), adverse event reporting, device incident reporting and recall notices.

If implemented across the Australian healthcare system, UDI will offer benefits for patients, healthcare facilities, research facilities and the supply chain, such as:

UDI overview

A UDI is a combination of numbers, symbols and letters allocated by the manufacturer to identify the model of device. A UDI will be present on the device label or the device itself, as well as all levels of device packaging. It will not replace any existing labelling.

Manufacturers must use a UDI from a TGA recognised Issuing Agency to ensure the UDI is globally unique and complies with global standards.

A UDI will comprise two elements: the Device Identifier (UDI-DI) and Production Identifier (UDI-PI).

• UDI-Device Identifier (UDI-DI) - the model of medical device which is used as the “access key” to information stored in the Australian UDI database (AusUDID) and will be used for device related information such as adverse events and recalls.
• UDI-Production Identifier (UDI-PI) - production specific information that identifies a specific production run of the device. This could include values such as batch number, lot number or expiry dates. The UDI-PI is on the device and/or labelling but not stored in the AusUDID.

Purpose of UDI

The UDI system is a key pillar for the post-market surveillance and monitoring of medical devices.

The establishment of the UDI system is one of the medical device reforms as outlined in An Action Plan for Medical Devices.

The UDI system will be a key enabler for other reforms designed to improve the effectiveness our pre-market assessments of medical devices and management of post-market safety-related activities. It has the potential to enable specific devices with issues to be identified quick and for action to be taken.

UDI implementation in hospitals and hospital software products

Implementation or adoption of UDI in hospitals and healthcare organisations, or the software products used in a healthcare organisation is a consideration and decision by those facilities.

We are communicating progress to the Australian Commission on Safety and Quality in Health Care, the public and private hospital sectors, procurement teams and software vendors.

An implementation document to support healthcare facilities to better understand UDI and to assist their consideration of adopting the UDI has been published on the UDI Hub. See the Overview of Unique Device Identification for Australian Healthcare.

Devices required to meet UDI requirements

Medical devices and in vitro diagnostic (IVD) devices supplied in Australia will require a UDI, unless otherwise exempt. Compliance with UDI requirements will be according to the device classification.

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

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.

Understanding UDI barcodes

Guidance to help inform healthcare professionals’ understanding of the UDI labelling will be available on the UDI Hub once it is available.

UDI resources for health professionals

Please continue to visit the UDI Hub as it will be updated as the UDI implementation progresses.

Guidance and other resources will be published on the UDI Hub once available, including fact sheets and answers to frequently asked questions.

Adoption of UDI in hospitals and other healthcare organisations is outside our regulatory remit.

UDI reporting by healthcare providers

After the UDI regulations are in effect, if a UDI is available, it must be included on Patient Implant Cards (PICs) and notifications to us including adverse events, incident reports and recalls.

Further information about these reporting requirements will be set out in the regulations and detailed guidance.

UDIs on Patient Implant Cards (PICs)

Patient Implant Cards (PICs) are provided to patients who receive a medical device implantation.

The UDI must be recorded on the PIC for all implantable devices, with the full UDI (UDI-DI and UDI-PI) in machine-readable form, and UDI-DI in human readable form.

PICs currently require the following information to be supplied:

• name of the device
• model of the device
• batch code, lot number or serial number of the device
• manufacturer’s name, address, and website.

The UDI-PI will either being shown as a single field or split into the above data elements.

An example of a PIC with a UDI is shown below.

UDIs will not be required on instructions for use documentation, although some manufacturers may choose to do so.

For more information on PICs visit Patient implant cards and information leaflets.

UDI on adverse events

Where a UDI is available, we will require the UDI to be included in adverse event reports.

UDI on device incident reports

Where a UDI is available, we will require the UDI to be included in device incident reports.

UDI on recall notices

Where a UDI is available, we will require the UDI to be included in recall notices, including mandatory recall procedures and voluntary recalls.

Australian UDI Database (AusUDID)

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

Within the AusUDID, you will be able to search, view and download UDI information using device information such as the device identifier, brand name, manufacturer name, sponsor name, a GMDN code, in addition to the ARTG ID. You will be able to scan the UDI barcodes on a device label and retrieve the data for that specific device.

The AusUDID will also allow you to access documents such as the Patient Information Leaflet for a specific device if the sponsor or manufacturer has attached this information for their device.

Accessing AusUDID

Once available, you will be able to access the public version of the AusUDID via our website.

This will allow you to access all publicly available information on the AusUDID.

Searching AusUDID for device information

You will be able to search for UDI data in the AusUDID in multiple ways.

You can search for data by keyword, such as:

• Brand
• Model
• Manufacturer
• ARTG ID
• GMDN term
• UDI

You can also use the Scan a Barcode feature on the AusUDID, allowing you to scan a barcode on the device’s label with a mobile phone or other device with a camera and barcode scanning capabilities.

Downloading data from AusUDID

You can download individual UDI records, bulk records reflecting specific search criteria, a full copy of the AusUDID database, or periodic downloads based on certain timeframes (such as day, week, or month).

The format of the download is dependent on whether the download is a full record or a search result.

Further guidance on using the AusUDID will be published on the UDI Hub once it is available.

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