Response 1069152288

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Question 1 - What are the benefits of an Australian UDI System across the broader health system?

1. Anticipated benefits of a UDI

Patients and consumers
Ability to more easily find information relating to medical devices, through the AusUDID, ARTG and other similar services and databases
Medical professionals (for example doctors, nurses, surgeons, pharmacists)
Improved ability for medical staff to accurately identify devices and device characteristics to reduce medical errors
Clinical practices, operating theatres
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Hospitals (private and public)
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Manufacturers
When globally harmonized UDI Systems improve inventory management due to automated capture of production information and post-market surveillance due to the ability to unambiguously identify models of devices on a national, regional, and global basis
Sponsors
Improved post-market surveillance due to the ability to unambiguously identify models of devices on a national, regional, and global basis
Distributor / supply chain
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Procurement
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Reduction of the risk of device shortages
Patient management and record systems
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Improved post-market surveillance due to the ability to unambiguously identify models of devices on a national, regional, and global basis
Inventory management, warehousing and stock control
Reduction of the risk of device shortages
Health care administrative systems (e.g. invoicing/billing)
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Registries (e.g. the Australian Breast Registry)
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
Health researchers
Improved ability for data sharing across research organizations
Medical funders (private healthcare)
Improved ability to automatically capture device information, reducing time and risk of data errors and inconsistencies
The Therapeutic Goods Administration (TGA)
Improved ability for data sharing across regulators
Better visibility for recalls, and reduced time and effort to locate and remove recalled devices
Improved ability to detect fraudulent devices through the supply chain
Other regulators
Improved ability for data sharing across regulators
Better visibility for recalls, and reduced time and effort
to locate and remove recalled devices
Improved ability to detect fraudulent devices through
the supply chain

2. Are there any key groups that will also benefit that are not listed above?

Please select one item
Yes
No

3. If you have answered 'Yes' please list those groups here, including the benefits

Retailers will benefit from recognition of the EAN/UPC as the UDI for the devices sold at retail

4. Do you have any suggestions on how we might measure the benefits?

- Error rates in device information shared throughout the supply chain
- Time and effort required to obtain device related statistical data
- Time and effort required to prepare, monitor, and share relevant data related to product recalls

Question 2 - Should the first phase of an Australian implementation be limited to a small number of high-risk devices?

1. Do you think a limited first phase is a good idea?

Please select one item
Yes
No
Not sure

2. What do you see as the benefits of this approach?

Learnings from a first phase limited to certain high-risk devices can be used to improve/optimised system implantation

3. What might the disadvantages be?

While UDI benefits will not be realized as quickly, this is outweighed by a smooth, deliberate implementation process minimizing starts and stops if moving too quickly

4. Do you have suggestions on the scope?

- The staggered UDI implementation should be done in four phases:
1) subset of high-risk devices, 2) remaining high-risk devices, 3) moderate-risk devices, and 4) low-risk devices
- We recommend implementation of the AusUDID occur as a separate phase because database development is incomplete, and publication of data elements is pending.
- A database pilot phase provides a good opportunity to understand and make necessary adjustments to accommodate large volumes of data

5. Who should be involved?

Please select all that apply
Manufacturers/sponsors
Hospitals
Distributors
Procurement
Consumers and patients
Registries
Researchers
Other

7. How long should the first phase run?

Please select one item
6 months
12 months
>12 months
Other

9. How will we measure success?

Finished devices manufactured and labelled after the implementation data of each phase are identified with an UDI on the label and packaging
AusUDID data elements are defined and published prior to establishing an implementation date

10. What would industry participants need to do to prepare?

- Manufacturers need to have procured, tested, and validated printing and scanning equipment to implement UDI on labeling and packaging
- Established procedures and training within the Quality System
- Manufacturers or sponsors, depending on the contractual agreement between each manufacturer and sponsor, should have a plan and procedures in place for entering UDI data into the AusUDID

11. What would be required from the TGA in order for industry participants to prepare?

The TGA guidance on UDI would have to provide clear
direction on the following aspects:
• Adoption of GS1 standards for UDI
• Exemptions from the requirement to bear an UDI,
e.g., for parts and components and investigational
use devices
• EAN/UPC recognized as an appropriate device
identifier for devices sold in the retail space
• Clarification of date of manufacture as a production
identifier only when it is the only production identifier
• A procedure for applying for exemptions or
alternatives from UDI requirements
• Handling UDI for special device categories such as
procedure kits
• Proposed timelines for a staggered implementation,
that allows for a time lag after the AusUDID
database requirements have been established
• Provision to permit inventory depletion of finished
devices manufactured and labeled prior to UDI
compliance date, including medical devices in
distribution channels and allowances for continued
use of reusable medical devices (not directly
marked) currently in use
• Specific requirements for placing UDI-carriers on
devices, their labeling and packaging, including for
reprocessed devices requiring UDI permanent
marking
• Development and piloting of the AuSUDID and
advanced publication of database elements before
establishing AuSUDID compliance dates
• If following EU procedures, allow a 12- month
implementation period from the EU compliance date

12. What lead-time might be required before the start of the first phase?

Please select one item
6 months
12 months
>12 months
Other

14. What oversight should be in place (i.e. across all participants)?

Please select all that apply
Working group
Steering committee
Other

16. Would you be interested in being involved?

Please select one item
Yes
No

17. If so, in what capacity?

Member of the Working Group and the Steering Committe

Question 3 - If the Australian implementation fully aligns with the IMDRF guidance, what will the impact be?

1. What do you see as the benefits from a globally aligned system?

Consistency of product information across jurisdictions and operating environments

2. What do you see as the disadvantages from a globally aligned system?

No disadvantages

3. If the IMDRF is taken as the foundational model, what is the potential impact for your organisation in complying with the additional requirements of multiple jurisdictions?

Please select all that apply
Complexity in IT systems
Complexity in business processes
Requirement for additional staff
Cost
Need to purchase equipment
Other

5. What are the potential impacts on organisations that span multiple international markets and are therefore required to comply with multiple jurisdictions?

More complexity, e.g. due to different UDI requirements in major markets such as U.S. and EU, results typically in more costs. The aim should be to harmonize as much as possible the UDI requirements in the U.S, EU via the IMDRF.

6. Are there any data elements or other aspects of the U.S. FDA implementation (outside the IMDRF requirements) that we should consider?

Please select one item
Yes
No

8. Are there any data elements or other aspects of the EU implementation implementation (outside the IMDRF requirements) that we should consider?

Please select one item
Yes
No

10. Are there any gaps in the IMDRF guidance you think we should be aware of?

Please select one item
Yes
No

12. Would there be any requirement/do you plan to use UDIs unique to each country or market?

Please select one item
Yes
No
Not sure

14. How many markets do you sell in (or plan to sell in)?

Please select one item
1
2-5
>5
Prefer not to answer

15. How many of those markets either have already implemented, are in the process of implementing or are planning to implement UDI?

Please select one item
0
1
2-5
>5
Prefer not to answer

16. Please list those countries

China, South Korea, India, US, Saudi Arabia, Australia, Singapore, EU

Question 4 - What mechanisms should be considered for submitting data to the TGA?

1. Who is best placed to provide the data to the AusUDID?

Please select all that apply
Sponsor
Manufacturer
Brand owner
Other

2. Please provide any comments to support your response

The manufacturer is best situated to provide the UDI information in the AusUDID because this is where the UD information resides with the highest level of accuracy

3. What mechanisms might need to be in place to enable the provision of data?

Please select all that apply
Machine to machine bulk upload
Web interface
Other

4. If you have selected 'Other' please provide more details

Specifically allow for use of the GDSN (Global Data Synchronization Network) and a certified GDSN data pool to transmit data.

5. Do you foresee any complexities we might need to take into account where more than one sponsor holds pre-market authorisation for the same device?

Please select one item
Yes
No
Not sure

6. If you have selected 'Yes' please provide more details

Generally, the manufacturer is best placed to provide the UDI information in the AusUDID. However, there may be unique circumstances where an alternate approach is preferred, which can be addressed contractually among the respective parties.

7. Are there any interfaces (such as Health Level 7 Structured Product Labeling (HL7 SPL)) that you use now or plan to use in the future that the TGA should consider/be aware of?

Please select one item
Yes
No
Not sure

9. Do you see a requirement for the ability to download data you have submitted to the AusUDID for validation or other purposes?

Please select one item
Yes
No
Not sure

10. If you have selected 'Yes' please provide additional details

We recommend the AusUDID have the capability to download data without volume constraints, potentially managing high data volume by refining queries by subsets.

11. Are there additional aspects the TGA should consider? For example are there other data stores or sources the TGA should take into consideration as potential means of providing data into the AusUDID?

Specifically allow for use of the GDSN (Global Data Synchronization Network) and a certified GDSN data pool to transmit data.
The AusUDID should be able to transfer data securely to validated recipients. A helpdesk would be beneficial as well as mechanism to correct legitimate data error in AusUDID.

Question 5 - What might the benefits be for implementing the EU Basic UDI-DI in Australia?

1. Are there any potential benefits for Australia in introducing the Basic UDI-DI

Please select one item
Yes
No
Not sure

3. If you have selected 'No' can you please provide further information

We recommend the TGA provide further information as to how a Basic UDI-DI would be used and the benefits. Introduction of a Basic UDI-DI adds a level of complexity and burden for both TGA and industry. Unless a specific reason exists to incorporate a Basic
UDI-DI, we believe it is unnecessary.

4. If Australia was to implement the Basic UDI-DI what might the potential impacts be on organisations that span multiple international markets (including the EU), and therefore have to comply with multiple jurisdictions' requirements?

It would diverge from most other markets. As it pertains to the EU, it does not appear that the Basic UDI-DI under the EU and Australian systems would be the same. Thus, it would require creating another system for Australia.

5. Are there any potential negative impacts in Australia introducing the Basic UDI-DI?

Please select one item
Yes
No

6. If you have selected 'Yes' can you please provide further information

It may create extra work, such as requiring the re-issuance of certificates

7. If there are other aspects of the Basic UDI-DI you believe we should explore further or consider, please provide any additional information here

Yes, we believe the TGA should consider the purpose served but the Basic-UDI and whether it is a necessary component of an effective UDI system in Australia

Question 6 - What are the benefits of the Global Medical Device Nomenclature (GMDN) and how is it currently being used?

1. Are you currently using GMDN Terms?

Please select one item
Yes
No
Not sure

2. If you have selected 'Yes', please indicate how you are using them

Please select all that apply
As mandatory information for procurement
Identify issues related to devices or device use
Identify products to use in a clinical setting
Identify the most effective devices
Identify suppliers (for example compare volumes of products supplied by each supplier)
Identify supply changes or bottlenecks
Identify devices that have specific training needs
Identify devices that require servicing to help establish maintenance cycles
Identify devices that require utilities (such as electricity or compressed air for example)
Identify and manage hazardous materials and waste
Include in patient records for improved post-operative follow-up
For research or academic study
Manage inventory
To meet regulatory requirements
Other

3. If you have checked any of the above boxes can you please provide more information and/or examples on how you are using the GMDN Terms

In addition to the inclusion in the ARTG, we comply with US FDA UDID database expectations to include the GMDN

4. If you are using the GMDN, please provide more information on the benefits

Please select all that apply
Benefits for patient safety in identifying best devices for use and identifying device issues
Facilitate analysis through the ability to identify and group devices
Improved inventory management
Improved supply management
Improved device management
Reduced wastage
Other

6. If you are using the GMDN are there any particular issues or challenges?

Changes in GMDN codes/ terms are a known challenge. Some codes/ terms are made obsolete, some are modified, and new ones are introduced, which affects ARTG entries. Because GMDN codes and terms are currently a mandatory field in the ARTG, sponsors must submit a variation to the TGA every time ARTG information changes. Note that the FDA only uses the GMDN terms, not the codes, in the GUDID.