Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: UDI consultation paper 2

The UDI system could empower patients with device information, so that they can easily access key safety information about their medical devices such as MRI compatibility and whether the device contains latex. Patients would also be able to identify if their device has been subject to a recall or field safety corrective action.

The system could also facilitate reporting and traceability especially if patients have an implant card.

See anticipated benefits for hospitals.

See anticipated benefits for hospitals.

An underpinning UDI system would support patient safety by enabling healthcare institutions to decode UDIs captured in their systems, identifying for example if a device is MRI Compatible or has any critical warnings associated with it.

It could also allow hospitals to identify products that are subject to a product recall to prevent their further use. If this information was linked to patient identifiers it would be possible to identify patients who had received or had such a device implanted.

Reduced wastage is also another potential benefit of the introduction of a UDI system because hospitals could more easily identify products that are due to expire.

Manufacturers would be better equipped to initiate product recalls or Field Safety Corrective Actions (FSCAs). The inclusion of UDIs in manufacturer Field Safety Notices would result in more effective and efficient device recalls.

It would allow for better identification of medical devices through distribution and use.

UDI facilitates eProcurement – for English example see NHS E-procurement Strategy
which defines eProcurement as the “application of technology to automate the exchange of procurement throughout the supply chain.”

Information from a UDI database could feed reference data into registries, allowing them to capture more complete and accurate device information using barcodes etc. It would also facilitate analysis of registry data.

The introduction of a UDI system could facilitate the documentation and longitudinal capture of data on medical devices which will be useful for health researchers.

The introduction of a UDI system will improve the traceability of devices across the regulatory and healthcare system, enabling all parties to confidently identify devices.

UDIs will facilitate the identification of medical devices in adverse incident reports. The introduction of UDIs is also a powerful enabler for signal detection. It will result in better device identification as it leads to the unambiguous identification of devices - all parties will be referring to the same device in the same way.

The introduction of a UDI system will also be beneficial for linkage with other systems which are set up to track and trace devices to safeguard public health.

The introduction of a UDI system could potentially ease the process of adverse incident reporting for clinicians and patients. Clinicians could potentially scan the UDI of a device and the relevant device information could be automatically populated into an adverse incident report. This would also result in the regulator obtaining more accurate information about the device

The 2020 Scan4Safety report highlights some of the proven benefits of introducing point of care scanning in health care provision. UDI is one of the enablers of this, but when used with other enablers such as location identifiers, it can dramatically improve the process of identifying affected products during product recall.
The following benefits were measured:
• Time savings – e.g. for product recalls and clinical time released to care for patients
• Cost savings- inventory management improvements

A limited first phase is a good idea as it enables you to prioritise high risk devices. However, it should not be limited to only those classes of devices, as some manufacturers may be ready to label their UDIs for other classes of devices before they are required to.

It is also important to note that phasing the placement of UDIs on device labels and the allocation and submission of UDI information to the UDI database are two separate issues. A phased approach should be considered for the placement of UDIs on device labels, however the deadline of submission of UDI-DIs (and the surrounding information) to the UDI database should be the same for all devices, irrespective of device class.

It may take longer for lower risk devices to become UDI compliant because some manufacturers may choose only to apply UDIs to their products when it is mandated

You could start with implantable devices. (European risk class III and IIb)

Submissions/allocation same time for all devices. UDI labelling could be introduced in a phased manner – perhaps 2 year intervals which was used for the implementation for the U.S. UDI System and the European UDI system introduced in MDR 2017/745

Compliance rates to UDI timelines.

Manufacturers will need to:
- Select a UDI issuing agency
- Allocate UDIs and ensure they appear on the device label
- Work out how they will submit information to UDI database. (e.g. manual submission/machine to machine)

The TGA will need to:
- Designate one or more UDI issuing agencies in Australia
- Publish a comprehensive data dictionary
- Set up a UDI database and mechanisms for data submission
- Provide educational materials on UDI requirements to industry and other stakeholders.

The first three elements should take into account international recommendations – such as the IMDRF UDI guidance documents.

Adequate consultation with all stakeholders

Interoperability
Sharing of data
May help with international signal detection in the future
Better data exchange

Rules and requirements may differ from region to region.

Ease of access to information for the public is very good in the FDA system and the provision of bulk download of data is another asset of the FDA system.

The introduction of Basic UDI-DI

The legal manufacturer should provide/be responsible for the data, but who submits the data is a different question. Redacted text

Having to contact multiple organisations

HL7 would be useful for global convergence, recommended in the IMDRF UDI guidance.
FHIR could also be considered for the future.

GDSN – currently only GS1 coded products are included in the GDSN. However, there are plans to align the GDSN to the Eudamed model.

TGA could consider interacting with the various companies that can perform data validation services for manufacturers (third parties that check the data).

A flat database does not provide an easy way of grouping device models, however the Basic UDI-DI would facilitate this and help with post market safety analysis.

It is important to have the same Basic UDI-DI definition and structure. We would suggest that the TGA adopt the EU version of Basic UDI-DI.
It would also be useful for IMDRF to adopt the EU concept of Basic UDI-DI.

Cost implications- there are costs associated with assigning and inputting Basic UDI-DIs into systems However, the benefits outweigh the costs
The Basic UDI-DI is not placed on the device labels, so there are no cost implications with regard to product labelling etc.

The GMDN code is captured at device registration in the UK registration system. It is also captured in MHRA’s adverse incident management systems.

We plan to use GMDN codes and collective terms in signal detection.

Regulatory signal detection and compliance functions.

MHRA is currently part of an International Working Group looking to provide a common framework of analysis of post-market data and pooling of data on an international basis (e.g. common taxonomy for breast implant registry data analysis).

International data exchange and consistency will facilitate international signal detection.

At present, some manufacturers may have the view that GMDN does not have sufficient granularity in some device areas e.g. IVDs.

In these circumstances it is MHRA’s opinion that regulators should (where necessary) work with the GMDN Agency to ensure that the codes/terms available are fit for purpose

We are using an in house coding system, this is slowly being phased out as we see GMDN as a better solution.