The GS1 Global GDSN Work Group recently completed a Healthcare extension on the GDSN Trade Item Implementation Guide (TIIG). the guide is publicly available (no membership required) and can be accessed over the web at this link (see the Healthcare link):
GDSN Users and those considering participation may find the guide helpful as it it the first document to contain healthcare related examples and illustrations. Lessons from early GDSN implementers in healthcare have been incorporated and definitions have been clarified for retail users. The Extension is a first release and future iterations are planned as feedback is received and additional trading partners and their products join the community of users.
The Guide is an interactive document with links embedded to the main document for those attributes where implementation is similar to those from the retail side and healthcare nuances are minimal. For Healthcare, it is acknowledged in this document that some of the GDSN required fields (as developed by retail members) may not be applicable for the industry at this time and may even be sitting as a barrier to entry for healthcare manufacturers. For these attributes (examples include EACH level dimensions, and certain relationship specific Boolean fields), the Guide points out how “default” data may be published as placeholders until actual data is gathered or necessary.
The Extension is notably device centric in this initial release, but that should be expected due to much of the formal activity and participating companies in the GDSN adoption discussions are coming from device related companies. Fortunately, a healthy amount of feedback was received from the pharmaceutical side when the document was submitted to the GS1 Healthcare membership for review, so future iterations should be more balanced. The definitions shouldn’t change, but expect additional examples and samples focused on pharmaceuticals and their packaging.
Since this is a Global document, it seems likely that the GS1 US Work Groups will have a look and may provide additional guidance for their members based on the recommendations in this document. Since the document was vetted through the GS1 Global Member Organizations (and included input from GS1 US and their members) it appears this document may get some shelf life. Global manufacturers will likely press for adherence to these global recommendations so that they have a single target to focus on.
Heads up on a NEW Attribute…
Just what you want to hear (not), but hang on – this might be a good one…
In the development of this document, there was much discussion around the importance of the Unit of Measure in Healthcare as a key field. As we discovered in our Pilot discussions, many providers rely on the UOM as more than just a key field in their procurement systems. The UOM of today also serves as a de facto advisor to clinicians and others as an indicator of the type of packaging they may be looking for or as confirmation that they have selected the correct product.
As GDSN aficionados well know, the GDSN neutralizes the importance of the UOM to the building of a hierarchy by including parent and child relationship data in the data stream with any given GTIN. In GDSN, if you are a middle level of pack you are described as such without emphasis on the UOM. And in a GTIN world, you will no longer need to rely on the combination of part number and UOM to arrive at an item’s “uniqueness” – the GTIN is unique all by itself.
It was discovered in these discussions that the retail industries have given this issue much thought and have taken a different route than relying on the UOM for anything other than a reference. GDSN includes an attribute called Packaging Type to define the type of container an item is packaged in. The list of available Packaging Types is quite extensive and looks like it could serve healthcare more succinctly than UOM fields (ANSI or otherwise) do today.
In a side note, the Guide points out that the Community may want to consider implementing the Packaging Type field. Before the conversation get too far, manufacturers should look to see if they have the information at their disposal should the industry decide to recommend the field in the future. Providers should review the code list to determine if additional value would be gained for their users from the clarity that the attribute purportedly provides. And at the very least, GS1 Healthcare Community members involved in the standards development process should review the Packaging Type code list to see if it is suitable for healthcare use today, or if maintenance is required to make it more useful.
Still on the table…
The TIIG goes a long way toward putting a Healthcare spin on the GDSN requirements and will assist community members to better understand the GDSN attributes, their definitions and relationships. However, there are ongoing discussions in various GS1 Work Groups regarding “Level Below the Each” potential identification requirements and the implications of regulatory requirements (when they are released) on product identification. Without clear regulatory guidance, it will be difficult for some manufacturers (on some product lines) to determine which products simply need multiple pack levels or if ”virtual GTINs” or “unmarked GTINs” need to be assigned or if the current netContent definitions will suffice for them to define an item.
Depending on who you talk to the possibilities are many. Depending on how regulations are written, individual cotton balls or exam gloves may someday be required to have their own GTIN to maintain their traceability or test kits may be allowed to have a single GTIN assigned with an associated netContent count to describe how many tests are contained in the bottle. Once those discussions are wrung out, the TIIG will likely be revisited and updated to reflect the outcome. Until then, the Healthcare TIIG is extremely useful – but is still incomplete.