Device Identification (UDI): How to avoid redundant info?

[mr.mike]

Trying to re-design some device labels, with the recent FDA Unique Device Identifier (UDI) requirements in mind...

My issue is with redundant information, especially since the label real-estate is severely limited.

In particular:
If the label already has explicit fields for serial number, batch/lot number, expiry-date, etc., what is the value in an additional "human readable" translation of the UDI that gives the exact same info (albeit in an arguably more cryptic manner).

Example:
The label already has the EN980 "LOT" symbol followed by the batch number.
So is it really necessary to translate the batch portion of the UDI into "(10)111234"?

As far as the human-readable portion of the UDI goes (especially given the limited label space), it'd be nice if we could just stick with the data that's NOT already on the label elsewhere (i.e. the GTIN).

Any input or advice much appreciated.
MM.

 

[Ajit Basrur]

Did you refer to

Request for Modification of Unique Device Identifier Labeling Requirements for Devices That Have Small Labels

 

[mr.mike]

Yes, according to final rule:

"FDA does not agree that any additional exception should be provided in the final rule based only on the size of the device label."

You can, however, submit a request for an exception...but by the sounds of it you'd be pretty hard-pressed to get one...
(...I wonder what manufacturers of hearing-aids do...)

 

[mr.mike]

Update:

I think this might be a solution:

Ditch the bounding boxes around EN980 symbols such as "REF", "LOT" or "SN", and place it next to or under the UDI.

Here's an example pulled from the web:

 

[MIREGMGR]

If the label already has explicit fields for serial number, batch/lot number, expiry-date, etc. (...)

I think the usual approach will be to re-design involved labels to eliminate existing content that otherwise would be redundant relative to UDI specified content.

Ditch the bounding boxes around EN980 symbols such as "REF", "LOT" or "SN", and place it next to or under the UDI.

Labeling requirement harmonization gets short shrift among the EU and FDA standards/rules folks, it seems to me. My hope is that EN980 and ISO15223 will be revised ASAP to be coordinated with the FDA UDI requirement so that global (or at least USA/EU) labeling remains practical without too many idiosyncratic "fixes" to specific standards requirements.

 

[dzurn]

I don't see that putting Lot and Use-by data under the barcode is the best solution. (Anyway, the date format in the example is not conforming to ISO 8601, YYYY-MM).

WE have been taking the same tack as Mr. Mike, just putting the GTIN next to the 2D code. The REF and LOT and USE-BY still get their larger print with useful symbols, in expected locations, and adding the GTIN now means that all the same information in the barcode can be gleaned from the human-readable elsewhere.