Australian UDI Database release notes

HL7 SPL Machine to Machine (M2M)

• Added timestamp in M2M error messages
• Amendments to Restricted number of uses field
• Amendments to DI and GMDN Codes
• Improvements to Author, OIDs and document effective time
• Removed reference to PrimaryDI when reusing SetID
• Enforce document root
• Fix incorrect error when brand name is left blank
• Improvements to validation rules for PrimaryDI, SecondaryDI and Direct Marking fields
• Fix validation error messages for Single Use
• Fix error message when providing more than one PreviousDI
• Fix error messages for Manufacturer Commercial Distribution End Date field
• Fix error message for Device Size Text Clinical Size
• Creation of AusUDID XSD. Added API enforcement of schema
• SetID/Version number feature
• Validate PackageDI Issuing Agency matches the Primary
• Disallow complete removal of ARTG IDs during Grace Period
• Fix to Author section of M2M message
• Disallow use of Correction reason in non-correction requests
• Changes will directly impact users. 

National Product Catalogue (NPC) submission method

• Minor fix for NPC numeric fields
• Fix for reference data for Device Classes 
• Minor fix with UOM error messages
• Improvements to corrections when organisation has multiple agents
• Improved validation of Information Provider section. 
• Changes will directly impact users. 

Supporting Documents

• ARTG Centric Supporting Documents Search on Manage Documents page
• Fix validation issues for Supporting Document dates, use AEST for validation purposes
• M2M: If existing documents are not included after Grace Period, they are removed
• Changes will directly impact users. 

Grace Period

• Change Grace Period to 1 day
• Amendment to make records within Grace Period visible to the public
• Changes will directly impact users. 

Data field

• Complete removal of ContainsDEHP field
• Changes will directly impact users. 

Portal

• Disallow manually entering past dates to be used as future publish dates
• Fix issue with undesirable table sorting after correction request
• Update to About/Confidentiality UDI Page
• Updated Microsoft Excel Bulk Upload template
• Fix issue of filtering of content for the delta download files not being applied
• Changes will directly impact users. 

Industry impact notes

• The UDI Data model has been revised to completely remove the ‘ContainsDEHP’ field
• Submissions via the Bulk Upload channel will need to use the latest updated template file
• The UDI records initial Grace Period has now been changed from 7 days to one day in Pre-Production to facilitate testing
• Records still within the initial Grace Period are now immediately publicly visible to facilitate testing. They will still require an ARTG to be associated with them to be visible
• A new AusUDID.xsd schema file has been developed for use in the testing and validation of M2M submissions. This will be provided to end users by the UDI Support Team
• Upon submission, M2M messages are now validated against this new AusUDID schema file by the UDI API
• Additional code system validation checks have been added
• Development on the M2M channel has continued to close existing gaps with the implementation spec. Including among others, use of AU Codes for Device Class, Author Handling and SetID/Version Number
• The search tools on the Manage Supporting Documents section of the portal now filters the results to be ARTG specific
• The time zone used when validating if the start date of the supporting document has been reached is now Canberra/AEST 
• If you reuse an existing SetID with a different PrimaryDI, we now no longer show that other PrimaryDI in the error message.
• An issue with NPC Device Class codes has been resolved. Class Im and Class Is are now mapped to NPC values “Class I - measuring" and “Class I - sterile"
• Fixed up several validation issues with Supporting Documents on the M2M channel. For example, not including an existing supporting document you own after the initial Grace Period now removes it from the device. 

UDI platform architecture 

• Upgraded to improve security and resilience. 
• Changes will not directly impact users.  

Bulk Upload template

• Updated to version 1.7. 
• Updated template incorporates the latest reference value changes and a new Direct Marked DI Issuer column. 
• The number of UDI records per file increased to 200. 
• Changes will directly impact users.

Direct Marking DI Issuing Agency

• Direct Marked DI is not allowed to contain a value if “Device Subject to Direct Marking (DM) but Exempt” is True. 
• If Direct Marked DI is provided, Direct Marked DI Issuing Agency must also be provided as it may or may not be the same as the Primary DI Issuing Agency. 
• Changes will directly impact users. 

Corrections functionality

• Users may now request a correction via the portal for the Machine to Machine (M2M) and National Product Catalogue (NPC) channels. 
• Once a correction request is submitted, the next record update on the selected channel sent by the requestor organisation will automatically be treated as a correction. 
• Changes will directly impact users.

Unit of Use DI and Direct Marking DI

• If Device Count is greater than one, then either a Unit of Use DI or Direct Marking DI can be provided, but not both. 
• Changes will directly impact users.

Data field

• “Software in a Medical Device” renamed to “Medical Device incorporating software”.
• Changes will directly impact users.

Data field

• “Restricted number of uses” renamed “Restricted Number of Reuses” and validation amended to “Must be a number between 1 and 999999 if Single Use is No, else leave blank”.
• Changes will directly impact users.

Data field

• “Commercial Distribution End Date” renamed “Manufacturer Commercial Distribution End Date”.
• Changes will directly impact users.

Data field

• “Package Commercial Distribution End Date” renamed “Manufacturer Package Commercial Distribution End Date”.
• Changes will directly impact users.

Data field

• “Contains DEHP?” renamed as “Device labelled as contains DEHP?”
• Changes will directly impact users.

Corrections functionality

• Introduction of Corrections functionality via the Online Portal. 
• Users now able to use ‘Make a Correction’ functionality via the Online Portal.
• Changes will directly impact users.  

Grace Period functionality

• Any data submitted in to AusUDID Pre-Production will now have a 7-day window in which changes can be applied before the trigger rules apply.  
• Changes will directly impact users. 

Feedback module

• Feedback module removed. Users now unable to submit feedback via the module. 
• Changes will directly impact users. 

Machine to Machine HL7 SPL

• Introduction of Machine to Machine HL7 SPL to the platform. Users now able to submit data via this channel. 
• Changes will directly impact users. 

Manufacturer Editor

• Updated to provide clearer user experience.
• Changes will directly impact users.

ARTG Editor

• Updated to provide clearer user experience.
• Changes will directly impact users. 

ARTG

• Changes to device records to require an ARTG to be present on the record for the record to appear in public search results. 
• Changes will directly impact users. 

Latex validation rule

• Additional validation error if both “Device contains Latex” and “Device does not contain Latex” are selected.
• Changes will directly impact users.

Supporting Documents

• Introduction of dedicated Supporting Documents section in the Device Creator and Editor.
• Documents can be accessed via the Find Supporting Documents tab in the menu bar. 
• Changes will directly impact users.

About AusUDID page

• Updated to reflect Pre-Production environment.
• Changes will not directly impact users. 

Confidentiality Undertaking page

• Updated to reflect Pre-Production environment.
• Changes will not directly impact users. 

ARTG editor

• Updated the Device Create/Edit screens to relocate the ARTG Editor. ARTG Editor now in its own dedicated section which appears prior to the manufacturer linking screen. 
• Changes will directly impact users. 

ARTG Editor

• Added validation rule to make ARTG required for sponsor/manufacturer organisations who enter a different manufacturer to their own organisation. 
• Changes will directly impact users.

AusUDID Pre-Production environment

• Platform cleared of test data in preparation for external use. 
• Changes will not directly impact users.