Tuesday, April 9, 2013

Some UDI Thoughts...

I recently responded to an industry member's question around the use of GTINs for purposes of meeting UDI compliance... As is true with any requirement and regulation everything is up for interpretation.... but I felt others may find this information helpful so I decided to post.  

The question mainly centered around the proper allocation of GTINs to devices in a few different situations- specifically devices that are sold as part of kits, identical devices with different internal SKUs, and proper use of the GTIN-14 'indicator digit'.

My two cents below:

The first key is to evaluate whether the devices in question fall under the requirements defined for 'Combination' or 'convenience' kits. As the UDI rule states all devices in a convenience kit, except single use devices, must bear its own UDI in addition to the UDI assigned to the entire kit. I'll assume for now that [the] device in question either falls under this rule or that you simply prefer to mark your device to improve identification and tracking.

As for the proper GTIN to use on an implantable device- the first step is to take your GS1 assigned company prefix. I'll use 1234567 for purposes of this example The next step is to assign an 'item reference' number which is completely up to you. Med device is fortunate in that it doesn't have to deal with the issues the pharma industry encountered in having to encode the pre-assigned NDC into the GTINs for all of their products. In your situation the recommended approach is to assign GTINs sequentially, thus a valid GTIN-12 that could be assigned to an implantable device would be 123456700017 (the 7 is the check digit). To convert the GTIN-12 into a GTIN-14 which would be encoded in the 2D barcode and stored in any IT system you simply add '00'.

The next key point is that the GTIN assigned to the implantable part does not have to link in any way to the SKU used internally at [your company] to identify that part. A common best practice that I recommend to companies is to utilize the GS1 field AI(240) which represents your legacy SKU. Many companies will continue to encode the legacy SKU into the barcode using this GS1 field to help minimize the impact to exiting IT systems which are based off the legacy SKU. This should only be used temporarily however as IT systems should be converted to use the GTIN as the primary identifier for the device.

Using the logic above you should not have identical parts that have different GTINs because the mapping between your legacy SKUs and GTIN will not be 1 to 1. In the case you assign a different legacy SKU to a device because of its manufacturing location, going forward the device should use the same GTIN regardless of mfg location. Again you can utilize a GS1 field for mfg location (AI 422) in the 2D barcode to minimize impact on IT systems which may need to map the now common GTIN to its legacy SKU based on mfg location.

Finally your question around indicator digit. For all unit-level items the indicator digit will always be '0'. You can not use the indicator digit to differentiate one device type from another. Indicator digit is only used to portray some level of packaging hierarchy. In the case you describe you would have two different GTINs for the two different devices included in the kit (e.g 00123456700017 and 00123456700024). Additionally you would have a 3rd GTIN assigned to the kit as a whole. this GTIN would still use an indicator digit of '0' since the kit itself is a sellable-unit. (e.g. 00123456700031)

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