Revisiting the opportunities for Health providers as a result of some proposed regulatory changes

At the time of writing, the Therapeutic Goods Administration has just closed its third and final consultation related to the implementation of a ‘UDI System’ in Australia — UDI being Unique Device Identification. It seems worthwhile then to revisit the article from Spring 2020 to ensure that Australian health providers and those providing solutions to them are considering and planning for the opportunities that this regulatory change may bring.

Australian healthcare is underpinned by a wide variety of standards. The many standards have been defined or chosen to improve how our health systems operate, ensure the highest quality and safety of care and enable a more digitised health system. These standards are often supported by regulations or similar frameworks. In the case of ‘UDI’, the proposed regulation related to a UDI System provides the framework for the use of several global standards underpinned by a new regulatory database for the specific purpose of improving how Medical Devices are managed across our health system.

The initial concept of UDI was developed as a mechanism to support increased harmonisation of how medical devices are regulated and managed globally. Most importantly, was the proposal for UDI systems as a change for regulators, it also focussed on greater consistency, availability and collection of data related to these products to support ongoing improvements to safety for patients and consumers. For more detail, refer to the International Medical Device Regulators Forum (IMDRF).

What is UDI exactly?

Each country that is implementing a UDI system is doing so whilst balancing local needs with a harmonised global approach. All UDI systems have an identification layer and a data capture layer utilising global standards (such as those defined and managed by GS1) and a database.

The original IMDRF UDI guidance document from 2013, calls out that the purpose of a UDI system is to optimise patient care by improving five elements:

a. traceability of medical devices, especially for field safety corrective actions,

b. adequate identification of medical devices through distribution and use,

c. identification of medical devices in adverse events,

d. reduction of medical errors,

e. documenting and longitudinal capture of data on medical devices.


To find out more about the specific plans for Australia you are encouraged to visit their website or attend the ongoing webinar series.

UDI is about the regulation of products, so how does this relate to a health provider?

Although the most impacted part of the sector with the introduction of UDI will be the manufacturer or product sponsors in each market, one of the areas with the greatest potential benefit is the health provider community and the patients that they serve. Whilst this is the case, in many instances health providers have not looked into what their benefits could be. Thankfully Australia is later to the implementation of these regulations so our health provider community can learn from their international peers.

As a result of other countries already adopting UDI, we can already identify some of the benefits for health providers as a result of these regulations. Amongst the benefits found these include Unambiguous Identification of Medical Devices; More efficient product recalls; Improved ability to verify the legitimacy of medical devices; Improved product data available for patient records; More accurate reports of adverse events; Optimisation of Supply chains; Improved cost management; and Improved reimbursement processes.

There are a large number of case studies available to assist Australian Health Providers in understanding what their potential benefits may be. A few examples are:

  • St Josephs Hospital, Chinese Taipei — reported a 50% reduction in time to process an order, a 96% scanning rate after only two months, increased patient safety with the implementation of traceability and auto alert functionality and significant improvements in inventory management
  • Rigshospitalet Region Cardiac Catheterisation Laboratory, Denmark — reported zero cancelled procedures, reduction in stock items needed, freeing of the equivalent of 3 nurses (FTE) to focus on providing care to patients
  • Franciscan Missionaries of our Lady Health System (FMOLHS), United States — reported improved inventory management, increased patient safety by implementing barcode scanning across care processes, improved cost of care/cost per case information available, better outcome bases information available for analysis of physicians, products and procedures that could be linked to more value-based approaches to care.


These and many similar stories can be found in the GS1 Global Reference Book 2020/21

The Scan4Safety program in the UK, whilst not being based on ‘UDI’ also provides some insights into how standards-based identification and data capture can fundamentally improve patient care and safety so the evidence report is also a worthy reference.

What steps should Health Providers be undertaking to prepare for the benefits that UDI will bring to them?

There are probably four main steps that will ensure that Australian Health providers can gain benefits from this planned regulatory change.

  1. Assess your existing capability for capturing and using global standard identifiers, such as the Global Trade Item Number (GTIN) within the systems that are used to order products, manage inventory and track products used with/on patients. As these standards are the identifiers used within UDI.
  2. Assess your existing capability to scan standardised barcodes, including 2D Barcodes like the GS1 Datamatrix, as these are the barcodes and data formats that are commonly used by suppliers when implementing UDI data capture.
  3. Understand what processes could benefit from increased standardised identification, barcoding and data to start to create your plan for how your organisation can start increasing capability in normal BAU system upgrades.
  4. Engage in the process of developing the UDI system for Australia by contacting the TGA UDI team and watching for updates from the TGA. Your peak bodies may also have further information on their responses to the consultation they can share with you.

For any additional information about GS1 standards, please do not hesitate to contact the GS1 Australia Healthcare team

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