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

• Improvements to digital/portable health records (accuracy of implants for instance) to general health management
• Increased ability to be advised where an issue has occurred with a product (especially implants)
• Increased ability for medical support teams to be informed of potential issues with a product that the patient/consumer uses to enable proactive, informed and shared decisions around managing any impact
• More data to support value-based approach to healthcare, where data not only empowers the health provider and R&D but also empowers the patient/consumer to make more informed decisions
• Possibly added ability to find quality information about products that they may have implanted, that they may be using, that they might come into contact with etc. This point will be greatly determined by what data

• Being able to easily confirm that a product is approved for use in Australia
• Improved ability to easily record/source data about products used with, on, around or implanted within patients in their care
• UDI-DI and UDI-PI used as keys that enable improved ability to manage recalls using technology and data exchange within these processes
• Less need for manual processes within care settings to find the right information about products or confirm the correct product
• Access to electronic IFU by using data capture from UDI to source information
• Ability to use technology to automate re-ordering processes meaning no manual processes for clinical staff within hospitals
• Possibly easy prompting of alerts or issues with product by scanning product during use

• Optimisation of processes within operating theatres
• Improved ability to easily record data about products used with, on, around or implanted within patients in their care
• Less need for manual processes within care settings to find the right information about products or confirm the correct product
• Access to electronic IFU by using data capture from UDI to source information
• Improved processes to record implants for registries

• Improved management of the products they source, use, wastage, allowed to be used (VMO) – sourcing, inventory, patient records, accuracy for billing purposes, reimbursement claims to private health, patient level costing capability, data for VBHC, collection of data for external reporting, data capture for registries and MyHealthRecord, less clinical time used to ‘manage’ products. The potential benefits to Hospitals are far greater than many expect or understand.
• The caveat here is that for hospitals to be able to gain the benefits they will need to have ‘digital’ capability to utilise a ‘UDI’ meaningfully.
• It should eliminate the need to scope and request (and pay for) the ability to be able to scan all products as it should become a minimum requirement for all software that is sold to health providers of any type in Australia – cutting down on cost and time to implement important changes to technology platforms.
• Ability to use technology to automate re-ordering processes meaning no manual processes for clinical staff within hospitals
• Possibly easy prompting of alerts or issues with product by scanning product during use or where picked from imprest
• Improved patient level cost capture and management of variation through improved data capture capability

• A harmonized UDI regulation, it may allow for device manufacturers a more direct path to compliance with the regulation and the ability to develop a global response for safety and surveillance purposes
• Improved supply chain management and flexibility to use stock that is designated for other markets if UDI related elements are consistent
• Improved post market surveillance
• The benefits will differ greatly between those manufacturers who have products in other markets (international/multi-market) and those that only manufacture for Australia. The benefits will also differ between larger and SME entities as larger organisations may be able to achieve scaled benefits versus a smaller/start up may view UDI requirements as a burden.
• One advantage may also be greater control of product and prevention of counterfeit or substituted product which is of a lower standard entering the market and potentially causing harm to patients.

• Benefits for Manufacturers would be very similar to manufacturers.
• If implemented in line with other UDI systems may enable faster market access

• Improved supply chain management where UDI now become available versus internal codes or no data capture technologies
• Ability to scale/leverage solutions developed for use in other sectors to manage automated and efficient supply chains (where medical device products use GS1 standards)
• Removes challenge of ensuring data capture for products sourced from other markets where no UDI exists – currently these products are not identified unless this is mandated by a trading partner or the products are sold in other more mature markets
• Improved ability to identify, quarantine and action products with recall actions or alerts
• Greater visibility of stock holding, product expiry dates and an improved ability to action redeployment across organisation for short dated items to minimise wastage

• UDI regulation should eliminate the need for identification to be requested within procurement (tenders & contracts) or simplify the requirements and assessment by referring to regulation
• Removal of objections to requirements for identification or data by making at least some of the requirements a regulatory requirement
• As procurement is the start of the supply chain process within health providers UDI should ensure that supply chain processes have unique identification of products for effective management

• Clear minimum requirements for the recording of products within patient systems

• Improved ability to manage inventory
• Improved ability to automate processes related to procure to pay within supply chain
• Improved consignment stock management
• Improved ability to identify, quarantine and action products with recall actions or alerts
• Greater visibility of stock holding, product expiry dates and an improved ability to action redeployment across organisation for short dated items to minimise wastage

• Improved accuracy of billing where it relates to products used/issued/implanted/loaned
• Improved accuracy of patient and procedure level costing and associated modelling used for funding applications and support of management decisions

• Simpler and more accurate data collection where it relates to products used
• Enable more streamlined (& automated) data collection processes

• More accurate and more real time data availability related to product usage and therefore performance
• Where clinical, product, PREMS and PROMS data is all available it enabled real value-based healthcare research to inform future improvements to health systems

• Greater accuracy related to actual products used for
patients within procedures
• Improved control measures and benchmarking of costs

• Ability to work more collaboratively with other
regulators to ensure speed to market for products
where innovation or other factors dictate expeditious
action
• Ability to have truly unique identification for ALL
regulated healthcare products approved for use within
Australia (if implemented for all types of medical
devices)
• (Hopefully) some streamlining of processes
• (Hopefully) some improvements to up-to-date data
related to products over time
• (Hopefully) more streamlined processes in the sector
enabling improvements to recall processes, enabling
technology to support the management of the physical
recall elements

• Alignment of Australia’s UDI regulation to those of other
countries or regions (content and timeframe) may help
to support the expansion of UDI availability on products
in more markets

• Supply services within hospitals – improving visibility of
products overall and generally improving how products
are managed within facilities through increased use of
technology
• ICT solution providers (supply chain and clinical
solutions) – able to develop solutions that can be
implemented at scale with the knowledge of the actual
detailed requirements (as opposed to assumed
requirements). Expected ability to bring innovations
developed in solutions elsewhere globally (such as EU
or US) to Australian health providers ort supply chain
partners
• Digital Health/Clinical Information teams in health
providers and Hospitals – able to include accurate and
timely information related to products within the data
collected in electronic medical records. Potential
improvements to the development of technology for
clinical support (including AI) in care facilities as well as
pre and post procedures therefore improving
effectiveness of health system
• ADHA/My Health Record – ability for accurate and
timely implant (or similar) to be recorded as data within
records. This in turn has potential to improve patient
contact and longitudinal study to be improved
(depending on future capability of the MHR)
• Public Health Funding agencies/schemes where
‘product’

The measurement will be determined by the scope of the UDI system that is implemented and how it is defined.
Some of the benefits should be able to be quantified, however the ability to properly measure benefits will be based on the accurate measurement of ‘as is’ which may not be well known or well documented in some cases. Engaging with the stakeholder groups will be needed in order to ensure that measurement of possible in the often disparate and complex Australian health system versus reliance on anecdotal assessments which may not be a true reflection of benefit.

There is certainly benefit to a first phase that limits the number and type pf products and there is no doubt that a focus on high-risk devices will provide a great deal of benefit to the patient safety and will also limit risk if timelines are not met for some reason. Our feedback however from stakeholders raises several points which we feel are worthy of consideration.
• Most regulator has made changes after the release of their regulations, often after implementation has started. Whilst limiting the products impacted to high-risk devices may appear to limit the impact in effect this is not necessarily the case.
• Many regulations of this type have seen delayed timelines and adjusted expectations for many reasons.
• Whilst starting with high risk devices alone may appear to allow learnings to be gained in a control way for all stakeholders, it does not include those who manufacture, supply, sponsor lower risk products in these learnings. Therefore, each new tranche that comes with new classes of devices will need time and support to adjust
• Whilst limiting the product mix to only high risk devices may allow for slower implementation for the manufacturer/supplier/sponsor community within the stakeholder community it will mean that for supply chain partners, procurement teams, hospitals and consumers the benefits will be slower whilst investments in capability will be needed from the beginning
• Based on experience our stakeholder community have suggested that pilots of a proposed UDI system be completed to specifically include all stakeholder groups and refine the regulation before it is final

In addition to the disadvantages or additional comments in the advantages section, our stakeholders have provided the following feedback.
• There will be pressure from hospitals and consumers for the data related to the UDI database for all products regardless of class, where data is not available this will lead to some dissatisfaction
• Processes will be needed to ensure that obsolete data is able to be identified or that review processes are in place to ensure currency
• Where the requirements are not in alignment with other markets (which is expected) those not involved in the first phase may not have the understanding of the differences and thus be seen as disadvantaged by comparison to those companies who have been involved in phase 1.

The scope of the UDI system should be all medical devices including invitro diagnostics, however as mentioned above our stakeholder community suggest strongly that before the decision is made to proceed with only one class of products pilots including all classes should be carried out in order to streamline the eventual implementation. This obviously adds some complexity but the choice of some representative products from all classes and some specific types such as SaMD will assist in ensuring clear regulation and quality guidance documents to assist with implementation.

All stakeholders who are impacted (positively
and negatively) by the implementation of a
new UDI system should be included in any
‘piloting’ or first phase and some of these
may not be currently visible. Currently our
other whom stakeholders feel are missing
include:
• Supply Chain organisations and supply
chain practitioners within healthcare
organisations (these are separate to
procurement)
• All parts of the TGA that will be impacted
or potentially benefit from the new
regulation being in place (Recalls, Post
Market Surveillance)
• All parts of the Federal Health system
where the change to regulation will have
impact/benefit (including Funding, Quality
& Safety, Digital Health/MyHealthRecord)
• Reimbursement/Funders
• Solution providers – supply chain and
clinical
• Non-Hospital health providers such as
Radiology/Imaging, Pathology services
• If future intention is to include devices
that may be sold in retail pharmacy or
similar ‘retail’ then they should be
included

The time required for phase one will be
determined by its final scope, what is
included in it, how well it is prepared for,
how well understood the regulation is and
how effective the guidance and what the
metrics are to assess it.
The timeframe is also directly dependent
upon the TGA readiness to support the
implementation including IT infrastructure,
human resourcing and whether other related
processes will also be impacted

The measurements are again determined largely by the final scope; however, our stakeholders have several suggestions including:
• Actual user adoption and whether the data provided is both able to be and is actively used by the identified groups of stakeholders
• How actively and effectively the elements of the system are used within federal health to help to remove duplication of data and processes
• Commitment from all key agencies to use the data (Federal, State & Territory)
• Inclusion of UDI within the Digital Health eco-system to ensure active use within processes
• Vast improvement in the ability for health providers to scan barcodes and capture data

Industry participants is possibly not a clear term as often this term is used to refer to the manufacturing/sponsor community, but the preparations would be needed across all stakeholders. Specific details for each stakeholder group would be helped by a pilot phase involving the cross section of all.
From the perspective of the manufacturers/sponsor the following are some of the activities that would need to be undertake.
• Evaluating the state of products on the market in Australia
• Assessment of which products will remain in the market following the change to the regulation (as some may be removed as a result of cost v benefit analysis) and whether there is any retrospective action needed for legacy products
• Detailed review, assessment and understanding of the regulatory requirements
• Comparison of Australian UDI requirements with those of other countries or markets (US, EU, etc..) to determine whether labelling can be used, whether data required is available, what processes may need to be added for regulated products sold in Australia (both direct or via separate distribution channels)
• Internal system readiness for the collection and submission of data to and from the UDI database
• Ensure 100% clarity of all data elements/attributes
• Data preparation and evaluation internally prior to submission
• Assess data submission processes to determine best method – manual, bulk load, automated Machine to Machine processes, leverage GDSN connections – and prepare test files

Experience has shown that the more opportunity there is for stakeholders to prepare and ask questions or participate in drafting guidance the better the implementation and the sooner benefits might be realised. Some of the specific suggestions for the TGA to consider include:
• Creation of groups containing all the identified stakeholders listed (and designated issuing agencies where relevant) to discuss and brainstorm together with the TGA
• As mentioned previously the formation of a pilot (or several pilots) to clarify areas of the system and its impact or benefits
• Clear guidance, explanations and expectations need to be provided regarding what is to be done and applicable timelines for each part of the system and each phase. This clarity is needed for the largely multinationals and for the smaller or local organisations.
• Creation of a helpdesk before anything starts to be implemented to answer the preparatory questions that invariably occur
• Clearly defined exceptions and a clear process submission and assessment of any additional exceptions/exemptions should they be required
• A ‘sandpit’ environment of the database for manufacturers/sponsors to test loading and potentially help to refine their own processes or provide feedback to the TGA before the database is ‘live’. It can also help to ensure that data will meet validation requirements and ensure a consistent environment for User Acceptance Testing to be completed. A ‘sandpit’ should be available for all manufacturers/sponsors permanently to support all implementation phases and BAU processes for new sponsors that may enter the market in future. IMPORTANT NOTE: this should be totally separate from the live environment and any data entered into the test system should not ever feed into live system.
• Ensure that a clear ‘data dictionary’ is provided for all key terms used within the regulation and especially for any attributes or data elements within the UDI database. In order to ensure that implementation is smooth, and the data is of the expected quality unambiguous explanations and potentially examples of data are needed.
• Ensure that the database is ready for go live so that projects can be effectively managed

The lead time really is determined by the
TGA readiness to proceed.
It may also be worth noting that as many
other UDI regulations are also ramping up
globally this may impact the timelines for
any Australian regulation if the requirements
are too cumbersome or differ greatly from
those of other regulations.

There may be the need for the other oversight to assist in monitoring of readiness of stakeholder groups such as hospitals

A clearly defined and collaborative approach
that taps into the knowledge gained from
experience with previous regulations will
certainly help Australia in its UDI system
scoping, preparation and implementation.

There are many benefits, however these are the benefits that were deemed by our stakeholders to the most significant.
• For manufacturers/sponsors there are significant benefits as a result of reducing the efforts that may be needed to comply.
• For manufactures it enables them to have products that are able to be supplied across multiple markets – which in turn benefits the Australian health system by making products more easily available in supply chain
• For solution providers consistency means that can develop supply chain or clinical solutions that support UDI in their ‘off the shelf’ applications versus needing tailoring to ensure they can store, scan and use the data the UDI labels contain
• The ability to have a globally labelled product is a significant benefit but so is the management of data. Though thus far the data elements are not the same, even harmonisation of the core elements eliminates significant additional work. Note: This is dependent upon the definitions, structure and format of these same data elements being exactly the same.

The only disadvantage of a globally aligned system would be if Australia decided to adopt parts of other systems which are confusing or where other systems are not aligned. In some cases, data elements with the same labels have slightly different definitions for instance or elements of the system are incredibly complex.

If the Australian UDI system is aligned, then the impact at each point is reduced (though may not be eliminated entirely). Where elements are not aligned there will invariably be impact in greater.

Managing multiple requirements, especially
where they differ, increases costs and
complexity for many of the organisations
involved – whether multiple national based
overseas, local Australian organisations
selling internationally or even solution
providers who are trying to support the
complex UDI needs across many markets.
One of the impacts that has been highlighted
specifically by our stakeholders relates to
data. With added complexity to the data
requirements or where data definitions are
not consistent, there is an increased risk that
the wrong data may be provided to a
database, having the potential to impact
patient safety.

There are several key areas where our
stakeholders feel the US FDA UDI
implementation was successful and would be
worthwhile considering in Australia.
• The US FDA helpdesk capability including
access via email, phone etc. The helpdesk
function had two streams one for
technical aspects and the other related to
the regulation itself.
• The US FDA allowed for the possibility to
correct legitimate data errors in the
GUDID which was helpful especially in
early implementation phases where
definitions were not as clear
• The US FDA defined a clear process for
requested for exemptions and how these
would be assessed
• The use of GMDN as the nomenclature for
UDI was consistent with what has been
used in regulation for many years so
minimised rework. As this is the
nomenclature used in Australia currently
this could have similar benefit
• The US FDA regularly publish updates to
further clarify GUDID data element to
ensure that all new and existing users
continue to improve their data. There is
always clear reference to what has been
changed
• Compliance dates by devices class
allowed for progressive implementation
(also encouraged manufacturers to think
about their devices according to the risk
posed to patients).

The answer here is possibly it is too early to
say as the implementation of the EU data
requirements has yet to commence. We are
sure that there will be some parts of their
process that may provide positive lessons for
Australia’s UDI system.
At present the EU Commission has still to
clearly define many of the data elements and
some parts of the system have changed
several times.
They have provided a vast number of
guidelines for implementation of the various
aspects of the MDR/IVDR which have been
very useful, however there are still many
more to be developed

It may be better to say that are their
elements of the IMDRF Guidance that our
stakeholders feel should be adopted as some
parts of the IMDRF guidance is very clear but
has not been adopted in other UDI
regulations. These elements include
configurable devices and software as medical
device.

Though explanation is not requested, we
have been asked to stress that one of the
most important aspects of UDI as defined by
the IMDRF is to be able to get consistency
across all markets and the benefits that
come with this, to use different UDI for each
market eliminates the ability to gain these
benefits.

Countries/Regions where this kind of
regulation is already in place or in
development include US, Europe, South
Korea, Saudi Arabia, China

Our stakeholders were of two minds as to whom should be responsible for providing the data, so this is reflected in the response here. The sponsor has the responsibility for the product within the market, but the manufacturer would be the original source of truth related to the product data. It becomes even more critical that the sponsor ensures that they have the correct data from the manufacturers. Consideration may need to be given for manufacturers to be able to review data related to their products depending upon the intended use to ensure that it is correct.
We have some other suggestions/comments related to this question from our stakeholders that we hope are potentially helpful in informing this process.
• There may be a difference between who is providing the data and who is responsible for the quality of the data. There may also be a difference between who is providing the data and who is responsible for the product within the Australian market – these need to be considered in defining who provides the data
• Regardless of which entity provides the data it is important to ensure audit processes and validation are in place to help ensure its quality

• Some flexibility should be allowed in the
loading method to ensure that
organisations of all sizes and capabilities
are able to find a method that will suit
them and ensure they can meet the
requirements of the system.
• Our stakeholders using GDSN (known
locally as the National Product Catalogue)
have asked that we request that this be
considered as a method for providing data
to the AusUDID as a validated machine to
machine interface.
• Regardless of the interface options it will
be important for responses from the
AusUDID to be produced to verify success
or failure of the load of data.

The complexity would depend on which party is providing the product data to the AusUDID

• Given the increased use of technology in
the sector and the need for greater
accuracy in the data that is used, allowance
for technology and interfaces should be
made. There also needs to be consideration
given to technology changes so that such
interfaces can move with the technology in
market that will allow for secure, accurate
and efficient data processes.
• Whilst HL7 SPL was chosen by the US FDA
it is not necessarily the most commonly
used language used in Australia and we
would suggest that consideration be given
to other options including API (REST, FHIR,
JSON), structured XML such as that used
within standards such as GDSN.
• Wherever possible the suggestion from
stakeholders is to allow for flexibility with
regard to interfaces and for technology to
be able to progress unhindered to enable
process improvement overtime. We raise
this as what we define today in preparing
the regulations and guidance may not be
relevant in a few years’ time given the
speed of technology.
• Whenever possible, the machine-tomachine
interfaces provided by the TGA
should support full end-to-end data
processing. Our stakeholders asked to
include separate acknowledgements for the
acceptance of data by the AusUDID and
that accepted data has been data published
by AusUDID (made externally available).

Our stakeholders held varying views on this question thus the unsure response.
• They agreed that validation for instance and ongoing audit/review would require for all data to be able to be extracted/downloaded by the entity that provided it.
• They agreed that the data could be made available as a download for other entities but for this to be possible there is a critical need to ensure that the data is of the highest quality and that is it fit for purpose. This is especially the case where it might be used by a health provider.
• It was agreed that it would be helpful if the data were able to be integrated or linked in some way across the many and varied systems managed by the regulator and other parts of health.
• They felt it was important to ensure that the validation was a controlled process

• As mentioned above, our stakeholders support the use of validated sources of product data to assist with the sourcing or further validation of data in the future AusUDID.
• We would assume that there will be some linkage to the ARTG to enable some validation.
• Where data within the National Product Catalogue (or other GDSN databases) is entered into that platform by the same party responsible for the data in the AusUDID it may provide a validated source, this would need to be determined.
• Feedback provided is that we should not recommend use of other regulators databases at this stage – this may however change in the future as they also mature.
• As other UDI databases may not be aligned to the AusUDID, we would recommend that data not be sourced from other UDI databases and that caution is applied if it is used to check or clean any data. The responsibility for the accuracy of the data should rest with the defined party (yet to be determined).
• In addition to previous points, the TGA is urged to ensure that any database includes validation rules within it to ensure best quality and completeness of the data that is entered, starting but not limited to the UDI-DI that is entered.

There are distinct advantages in being able
to group products from within a ‘family’
where post market surveillance or
reimbursement coding at that level may be
desirable, however it needs to be clearly
defined in a way that is not overly
complicated or prescriptive making it too
hard to manage. It also needs to be clearly
defined regarding its relationship to the
product ‘UDI’.
A number of our stakeholders have raised
concerns at the complexity of the Basic UDIDI
concept as it is now within the EU. It no
longer focussed on an aggregated identifier
for a family of product and is much more
complicated.
A note also is that the definition between
why a GMDN and Basic UDI-DI is needed
(i.e.: GMDN is common to all products of the
same type from all legal manufacturers
where Basic UDI-DI was originally a method
of identifying the distinct grouping from one
entity)

Our stakeholders have expressed concern
that it would be difficult for TGA to reuse
exactly the same “grouping” as in the EU as
it would require that all the different aspects
of the MDR/IVDR are also included in the
TGA requirements. If these other elements
were not implemented it could not be
implemented, but if they are then it becomes
a very complicated solution as it has evolved
to become more than a simple “grouping” of
a family of products in the EU. It has been
highlighted that though products may have
the same conformity, because they are
produced by different legal manufacturers
they are not able to have the same Basic
UDI-DI under the EU MDR which may in fact
lead to confusion versus improvements to
processes.
There was also concern expressed that the
portfolio of product sold in the EU may not
be the exact same as those sold in Australia
or some other differences may exist in the
regulations making it problematic to
implement in exactly the same way.

In order to answer this question fully there is
a need to understand how it is planned to be
used within Australia – it the purpose that
this identifier be used as the single market
ID for all devices that have the same premarket
approval/conformity processes, same
reimbursement processes etc..
The hope expressed by some stakeholders
was that if this is implemented it is done in a
more simple fashion than the way it has
been used within the EU and if necessary a
different term for the logical and globally
unique grouping of products with a shared
conformity should be used.
One aspect that was reinforced is that it
should only be an element within a database
and not be physically present upon a
product. The only identifier for the physical
product should be the UDI.

We have provided response to this in the
details above. In order to answer this
question most accurately the intention of the
use of the Basic UDI-DI is required.

In order to answer this question in a
meaningful way our stakeholders would like
to understand more of the intention for such
an identifier being introduced.

Our stakeholders provide GMDN as part of
their regulatory processes in Australia and
many other countries.
There is sometimes a request for GMDN as
part of tender requirements with health
providers.
Some health providers use GMDN to group
products of similar type as part of their
cataloguing process, but less so as they are
cataloguing all products using UNSPSC
primarily so GMDN has become more of a
secondary reference point

Please refer to above response for details

The only issue that had been identified by health provider stakeholders is that GMDN for products when they had been approved for Australia may be different to the GMDN that applies to these products today so the use of this nomenclature needs to take into account the changes that occur over time. These changes would also need to be managed within the AusUDID
Our manufacturer stakeholders agreed with the health providers, identifying that one of the challenges with GMDN is that it is dynamic so what is valid at a point in time will need maintenance as the codes may become invalid in future – this is the same for many nomenclatures and classification systems.
One concern raised by the manufacturer stakeholder was ensuring that if over time the GMDN change did occur, this should not necessitate a UDI-DI change, as the GMDN is a grouping of products but does not change the product itself.
Another concern raised also related to the use of GMDN with IVD products due to some other terminology used with these products (Collective terms versus Preferred terms), we suggest in any pilot process that looking at the specific application for IVD should be reviewed in detail.

We do not have any recommendations for alternatives

Our stakeholders have strongly suggested that Australia does not divert from existing and well understood nomenclature to develop its own as this will add further complexity to an already complex process.