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

• It provides patients and consumers with an additional source of consolidated information in relation to medical devices.
• Patients will potentially benefit from reduction in medical errors through accurate identification of medical devices before use.
• Improved recall process

• Reduction of medical errors through accurate identification of medical devices and their characteristics.
• If used, scanning of UDI compliant barcodes or RFID tags will also allow for improved efficiency and accuracy in completing patient records, thereby allowing more time for patient care.

• If used, it could be a standardise method for identification of medical devices reducing medical errors and facilitating adverse event reporting.
• Scanning of UDI compliant barcodes or RFID tags will also allow for improved efficiency and accuracy in completing patient records, thereby allowing more time for patient care and a more efficient practice.
• Comprehensive UDI scanning at the point of care can also result in improved revenue/reimbursement capture.
• The use of a UDI database such as AUSUDID further supports a healthcare provider’s ability to confirm the correct and authentic device is being used, and can also serve as a data source for healthcare provider item data systems.

• If used, it could be a standardise method for identification of medical devices reducing medical errors and facilitating adverse event reporting.
• Scanning of UDI compliant barcodes or RFID tags will also allow for improved efficiency and accuracy in completing patient records, thereby allowing more time for patient care and a more efficient practice.
• Comprehensive UDI scanning at the point of care can also result in improved revenue/reimbursement capture.
• The use of a UDI database such as AUSUDID further supports a healthcare provider’s ability to confirm the correct and authentic device is being used, and can also serve as a data source for healthcare provider item data systems.
• The use of UDI and analysis of resulting data could allow hospitals to perform their own health outcomes analyses to understand the effectiveness of devices and methodologies.

• Additional method to identify medical devices and to capture and analyse data for post-market surveillance.
• In addition to surveillance, effective UDI implementation will provide the opportunity to analyse device outcomes and effectiveness, support product development and business decision-making.
• Improved recall process

• Additional method to identify medical devices and to capture and analyse data for post-market surveillance.
• In addition to surveillance, effective UDI implementation will provide the opportunity to analyse device outcomes and effectiveness, support product development and business decision-making.
• Improved recall process

Standardised identification of medical devices and their data that may reduce data errors and improve processing time. Improved recall process

Standardised identification of medical devices and their data that may reduce data errors and improve processing time. Improved recall process

• If used, it could be a standardise method for identification of medical devices reducing medical errors and facilitating adverse event reporting.
• Scanning of UDI compliant barcodes or RFID tags will also allow for improved efficiency and accuracy in completing patient records, thereby allowing more time for patient care and a more efficient practice.
• Comprehensive UDI scanning at the point of care can also result in improved revenue/reimbursement capture.
• The use of a UDI database such as AUSUDID further supports a healthcare provider’s ability to confirm the correct and authentic device is being used, and can also serve as a data source for healthcare provider item data systems.

• Standardised identification of medical devices and their data that may reduce data errors and improve processing time.
• Comprehensive UDI capture at the point of care will result in accurate utilization records, thus supporting optimization of inventory levels.

Standardised identification of medical devices and their data that may reduce data errors and improve processing time. Improved recall process

Additional method to identify medical devices and to capture and analyse data for post-market surveillance.

Standardized data capture from UDI and UDI databases can support health outcomes analysis and product development. Improved ability to measure longitudinal benefit of product use.

Standardised identification of medical devices and their data that may reduce data errors and improve processing time.

• Enhanced ability for collaboration and data sharing with other global regulators.
• Accurate and efficient identification, traceability and management of medical devices in adverse event reporting, field safety corrective actions and recalls.

N/A

Comparative analysis (pre and post implementation of Australian UDI system) of different health outcomes such as inventory turnover, medical error rates, efficiency and accuracy of patient record completion, procedural outcome.

Initial phase should be limited to high-risk medical devices to identify issues during the implementation of the Australian UDI system.
Consider a mic of high risk and low risk devise to ensure benefits / impact can be fully assessed.

Staggered implementation will be required over at least two years.

The Australian UDI system should be implemented in three phases:
1. High-risk Medical devices
2. Medium-risk devices
3. Low-risk devices

N/A

N/A

Success would be achieved when:
• Complete information for all high-risk medical devices currently registered in the ARTG is loaded into the UDI system within the time frame provided for this phase.
• Accuracy of the final data contained/displayed in the database for medical devices is verified by the manufacturers/sponsors.
• Production and implementation of UDI labelling requirements on all phase 1 medical devices sold in the Australian market.

Manufacturers and sponsors will need to implement plans and procedures to input the data into the Australian UDI database based on guidance and timeline provided by the TGA.
Manufacturers will need to implement plans and procedures to include the Australian UDI carriers to the labelling for existing and new medical devices supplied to the Australian market.

• Implementation of regulatory/legislative changes required for the UDI to apply to medical devices supplied in Australia
• Proposed timeline for each phase of implementation of the Australian UDI system, including transition periods for medical devices already available in the Australian market non-UDI compliant.
• Clear guideline detailing all specific requirements for the Australian UDI system, including but not limited to sponsor/manufacturers responsibilities, data entry procedures, labelling requirements, exemptions, etc.
• Clear guidance on UDI changes
• Successful testing of machine to machine bulk upload/web interface tools for data submission to the Australian UDI database and/or training platform for manufacturers/sponsors to allow understanding of the system and therefore improved submissions before deadline.

• Provides more efficient and accurate data on medical devices along the global supply chain.
• Global visibility of adverse events, recalls and facilitates post-market surveillance globally.
• Allows data sharing and collaboration between global regulators.
• Cost-reduction to manufacturers from having to implement country-specific identifiers, labels and inventory.

None

Increased complexity and room for data errors when different markets have different requirements. Increased cost in having systems and resources that can manage multiple jurisdictional requirements.
Existing use of global standards for product identification (e.g. GS1) across global markets will mitigate impact.

US, Europe, China, Saudi Arabia, South Korea plus other countries such as Australia looking to implement.

Manufacturers hold the all the information required to register medical devices into the Australian UDI database/system and have ultimate responsibility for the data.

The TGA needs to ensure there are mechanisms to avoid discrepancies/errors in the data entered by different sponsors to ensure accuracy/reliability from the information recorded in the Australian UDI system.

HL7 SPL for submission to US FDA GUDID. GDSN for supply chain data provision and potentially UDI database submission.

It would be ideal if data could be transferred from EUDAMED, GUDID OR National Product Catalogue into the AusUDID system.

It allows to create and identify groups of products that share the same intended purpose, risk class, essential design and manufacturing characteristics, which could be registered under a single ARTG.
However it is important to closely monitor any issues that the EU rules are causing.
B-UDI is not globally harmonised, which should also be a factor to consider – EU does not use GMDN therefore there may be misalignment between EU and AU.

As stated above, B-UDI is not globally harmonised. EU does not use GMDN therefore there may be misalignment between EU and AU. The B-UDI is not required on labelling however, therefore the impact on global markets would not be expected to be significant.

Not sure, potential negative impacts related manufacturers having to implement a separate AU B-UDI system while EU MDR projects are underway could be a potential threat to continued supply of product to AU market.

GMDN codes are present in regulatory documentation such as Declaration of Conformity, Technical files and registration certificates. GMDN codes are also used in post-market surveillance to determine issues with similar types of devices.

It is difficult to keep track of when GMDN codes become obsolete and it becomes challenging finding a replacement GMDN code from the available list. This causes issues with registration of medical devices.

The Australian UDI system should be a globally harmonised system and therefore the TGA should avoid using Australian-specific nomenclature to avoid complexities in attempting to meet the requirements of multiple country-specific nomenclatures for global manufacturers.