The Unique Device Identification (UDI) system will be an important way of improving the identification and traceability of medical devices. The UDI will be a key enabler for other reforms designed to improve the effectiveness of pre-market assessments of medical devices and management of post-market safety-related activities.
Throughout the broader healthcare system, the UDI is intended to be the identifier used in the context of business and clinical transactions. For example, in discharge summaries, patients’ records, registries, clinical notes and records, purchase orders, invoices, inventory maintenance/ management.
The UDI system is a key pillar of the Australian Government’s response to the Senate Community Affairs References Committee report into the number of women in Australia who have had transvaginal mesh implants and related matters. It underpins the response to four recommendations made by the Senate Committee, relating to post-market surveillance and monitoring throughout the healthcare system.
The Government is also undertaking a significant program of reforms to strengthen the regulation of medical devices in Australia. The establishment of a UDI System is one of the medical device reforms as outlined in An Action Plan for Medical Devices that delivers Strategy 2: Strengthen monitoring and follow up of devices already in use.
What is UDI?
The unique device identifier (UDI) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard, and applied to a specific model of medical device.
It is comprised of both device information and production information, and is applied to the device label and all levels of packaging for that device in both machine readable (such as a barcode) and human readable forms. It allows the unambiguous identification of a specific model of medical device on the market.
It is used as the ‘access key’ to information stored in a UDI database and is the data that allows the linking of device information across other systems such as registries, and in patients’ My Health Record.
When the UDI system is fully implemented, the label of most devices will include a UDI in both a human and machine-readable form (such as a barcode). Globally harmonised, core data about those devices will be publicly available through the Australian UDI Database (AusUDID).
Why this is important
In 2017–18 there were more than 2.8 million devices implanted and funded by private health insurance alone – with many more implanted in the public system. The ability to accurately identify medical implants has been challenging and has hampered contacting specific patients when an issue with their implant has been identified.
Implementing a UDI system aims to facilitate strengthening patient safety and quicker responses to any safety issues that may arise with devices.
For more information about other reforms visit Medical devices reforms.
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Medical Devices Surveillance Branch |