Medical Device Barcode Pros and Cons: GS1 versus HIBC

[somashekar]

Our major principle has fixed the GS1 and we are all gearing up to implement in Sept 2016...

 

[SteveK]

If you go to the Smith & Nephew link in my thread about GS1 (https://elsmar.com/elsmarqualityforum/threads/68197/ ) and then click on ‘Labelling and GS1 Standards' on the menu bar, it shows graphically how they are transitioning from HIBCC to GS1.

Steve

 

[dzurn]

I agree with SteveK that GS1 is the way to go for larger companies, but I just wanted to point out that HIBCC is still a valid symbology for UDI and the GUDID database.

Our company has standardized on GS1, but folks aren't required to make the switch for GUDID compatibility.

Darryl Z

 

[Edward Reesor]

I would like to follow-up with this discussion as we initially went with HIBCC when our products were required to be barcoded by the FDA in 2015. We chose HIBCC as it was significantly cheaper than GS1, but we have since learned that GS1 has changed their business model to make it more affordable.

We have two issues to contend with if we decide that the battle isn't worth it and switch to GS1:
1) many countries are asking for GTIN numbers which is a GS1-based number and not applicable to HIBCC registered products. Please correct me in my understanding of this as we do not have a response to my domestic health authority (Health Canada) asks me to provide a GTIN number. I don't lik the idea of my country forcing me to adopt GS1 when HIBCC is working perfectly fine for our markets;

2) How does one switch GUDID barcode information for US markets (say from HIBCC to GS1) when you have several stages of manufacturing and shipping in the pipeline? I can see two barcode values existing simultaneously, one for the products already on the shelf or in transit and another for the next batch of manufacturing. You can't re-register the exact same product but with a new barcode, or can you?

I have asked the FDA twice now and have never received a response.

 

[Malomsoki Gabor]

Hello all, i have a strange situation here, we are using GS1 Data matrix, but a customer wants HIBC Code 128 only on the packaging, can i use both codes, GS1 and HIBC on the same label? to avoid 2 kind of labels for the same product thanks

 

[Edward Reesor]

I will assume the US market as this is what I am familiar with. When you register the device with GUDID, there is a drop down menu that allows you to select the UDI type you are using (GS1, HIBCC or the other one for blood products). The whole point of this system is traceability. Because of the way the system us set up, I don't see how you can register the same product with two different systems. You may want to ask the GUDID info center for a definitive answer.

 

[Malomsoki Gabor]

I will assume the US market as this is what I am familiar with. When you register the device with GUDID, there is a drop down menu that allows you to select the UDI type you are using (GS1, HIBCC or the other one for blood products). The whole point of this system is traceability. Because of the way the system us set up, I don't see how you can register the same product with two different systems. You may want to ask the GUDID info center for a definitive answer.

Thanks Edward, the customer wants HIBC strip code only on the packaging to scan it at the reception, so i can only register with the GS1 code.

 

[Edward Reesor]

Hello all, i have a strange situation here, we are using GS1 Data matrix, but a customer wants HIBC Code 128 only on the packaging, can i use both codes, GS1 and HIBC on the same label? to avoid 2 kind of labels for the same product thanks

The whole system is for traceability, so I might suggest that you verify that the customer will be able to maintain records of all product locations in the event that you or one of your parts supplier initiates a recall. This could also be used as part of your QMS audit regarding traceability (I always use a critical supplier initiating a recall whenever I perform my internal audits, as this tests our system both upstream and downstream of our company).

 

[Malomsoki Gabor]

The whole system is for traceability, so I might suggest that you verify that the customer will be able to maintain records of all product locations in the event that you or one of your parts supplier initiates a recall. This could also be used as part of your QMS audit regarding traceability (I always use a critical supplier initiating a recall whenever I perform my internal audits, as this tests our system both upstream and downstream of our company).

Edward, thank you for the hint. i know that this is for the traceability, but my question is more related to if we can apply both HIBC and GS1 code on the packaging label, is there any rule, directive, regulation in the EU or US against that? i know that this is a very strange question, but we have just introduced GS1 data matrix, now there is new customer in the US who is requesting HIBC. So we have now a few products where we need to use HIBC, so would not start again from the beginning to change everything to HIBC. Just apply the 2 types of codes on the packaging labels for the few products which are sold in the US and also in the EU.