Medical Device Barcode Pros and Cons: GS1 versus HIBC

[Sam Lazzara]

The proposed FDA regulations regarding UDI (Unique Device Identification) mentions GS1 and HIBCC data technology as acceptable alternatives.
The rule will establish a UDI system that requires manufacturers to include both a plain-text version of the identifying data and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear/two-dimensional bar codes, RFID tags, etc.

What are the pros and cons surrounding GS1 and HIBC barcode systems?

I have more experience with GS1-128 barcode symbology than the corresponding HIBC. Here are some of my ideas (which could be wrong) from my limited experience. Am I right, am I wrong? Any other input.

1. GS1 barcodes are in a pure numerical format. No alphabetical letter characters are permitted. Many companies have alpha-numeric item/catalog (REF) codes with numerous digits. The HIBC format appears to allow the actual catalog number (alpha, numeric or alpha-numeric) to be directly encoded and in the readable text.

2. For GS1 format, the digits available for the item/catalog (REF) code can be as few as 3 numerical digits depending on how you answer some questions. Maybe you can have 5 numerical digits if you answer "correctly" - saying you have more than 999 items. This seems to require the company to maintain a cross-reference between the barcode item number and the actual item number. Is this what companies do? Then the supply chain customers must have this cross-reference so their databases work properly? Note - HIBC does not appear to have a limit for the number of digits, and alphanumeric characters are permitted.

3. Just looking at "128" symbology, the GS1 format is a single barcode, and it takes up less space than the corresponding HIBC barcode which is actually 2 separate barcodes - one with company identifier and item code, and the second with lot/serial number and use-by-date. Does HIBC have a condensed (single bar) format?

Some Questions
- What are the direct cost differences for company's choosing between GS1 and HIBC? By direct costs, I mean start-up and annual fees due to GS1 or HIBCC to get/maintain company identification code.
- It appears that the upcoming FDA regulation will allow either symbology, but on a worldwide basis, is GS1 the "best" solution?
- Might some companies end up using both symbologies?
- What is up with the 2D "QR" symbology? Can that be a good way to go?
- How are implant manufacturers going to identify implants that are very small? What symbology works best for bone screws and the like? Can microscopic barcodes be read economically? Is it expected that the barcode will be readable after implantation? Yikes!!!

 

[sagai]

I am a wee struggling to see a benefit of having a bar code on implants, where the barcode obviously has little or no use after actually implanted.
Cheers!

 

[pkost]

I would argue it is important on implants - they can be explanted and it can be difficult to identify the batch and in some cases even the ref/manufacturer. In fact if they are being removed they are likely to have failed therefore it is even more important to have traceability.

I used to laser etch bone screws in a previous life, I don't see it being too difficult/challenging to read a barcode that has been etched onto a screw.

Ensuring it is readable after implantation though...as you said...yikes!

 

[Sam Lazzara]

Here are some comments I received from members of the LinkedIn UDI Group:

The real cost difference comes from the move of many customers of Med Device mfgs to require GS-1. A number of large distributors and hospitals have issued an ultimatum that the format is GS-1, or else.
Yes, some companies may be using GS-1 and HIBC simultaneously to satisfy diverse processes and customer requirements. Some implants will be exempt from FDA UDI due to their size or if the act of adding the barcode would compromise the device.

AIM Global has taken the position that for medical devices, Data Matrix 2D bar codes should be used rather than linear bar codes. Data Matrix supports the complete systems of GS1, HIBC and ISBT128 (which the FDA mandated for prescription biologicals in their SNI Initiative). It is far more compact than any linear bar code, and even QR Code, and most importantly, has error correction built in which will increase the probability of a good scan even if the symbol damaged.

Additionally, the 2-D Data Matrix can be directly marked on virtually any substrate such that it will last for the lifetime of the device. It is also scaleable to any extent necessary - I have seen 50 micron IDs on the junction of stents (laser marked).

Direct marking is why the military uses DataMatrix in the IUID program to mark weapons and safety equipment (Labels tend to fall off M-16s and turbine blades!). I think Medtronic is directly marking Data Matrix on pacemakers. About 10 years ago AIM Global led a very successful effort to develop quality guidelines for direct part marking, which had now gone to ISO.

GS1 developed a 14-character numeric data structure called the GTIN-14 which is a globally unique product ID precisely to support multinational manufacturing, distribution and sales. The GS1 system is the most widely used system in the world for medical products. Aside from EHIBC Europe, HIBC is not widely used outside the US. With most major device companies selling their products multinationally, I think you will see major support of GS1 over HIBC.

 

[gramaley]

The Health Industry barcode was designed to be used for supporting patient record keeping. What I find really bizarre is that it is claimed GS1 is used more by healthcare, but this may be misleading. I can argue that pencils are more often used than computers in hospitals, but that doesn't make them better. I can argue that ISO 9001 is better than ISO 13485, because most of China prefers ISO 9001. MORE is not better, it is just...more.

I saw the UDI presentation by GE Healthcare in Kuala Lampur this last week. They provided a very interesting study on GS1 and HIBBC, and RFID and UPC as well, since they are all accepted by all countries, now and IMDRF members. Clearly you can put more on a HIBBC label, and on a smaller size.

GE also indicate that the proliferation of GS1 codes, accross so many different products (6 billion transactions a day for GS1) is actually a liability. It appeared, in at at least one case, the GS1 barcode indicated three different manufacturers. Was this a one-off incident? I don't think they would have made a slide of this in their presentation, unless it was a foreseeable complication.

I think this is a debate very much worth having, but from what I saw in KL, it would seem that using a barcoding system that has a lot fewer users (just medical products) is more of a benefit than a liability. HIBCC was designed for use by Health Information Technology environment from the get-go, so any hospital that doesn't accept HIBBC codes should have been more careful in selecting their HIT sysems. Future HIT system should adapt to the UDI regulation, because reality is, users will provide all kinds of codes, and hospitals need to adapt, or risk losing much needed technologies to treat their patients. What if that life-saving innovation is only got UPC or RFID, do you abandon using it! No - You may have to hand-type in the identification into the patient record, but the care of the patient is the priority, not the convenience to the HIT technology. All HIT technologies can handle hand-entry, when needed, right?

 

[Sam Lazzara]

I noticed that Johnson & Johnson is switching from HIBC to GS1, and so is Boston Scientific.
I also saw that Zimmer and Smith & Nephew are moving to GS1.
This must mean something...

HIBC is punching back. Check out the attached publication.

This article from Dec 2012 provides some perspective.
.

 

[gramaley]

I can very well imagine that a company like Johnson and Johnson or GE etc, would have a lot of other factors to consider. A manufacturer that has 10,000 or 100,000 employees worldwide, with so many different types of products that are NOT medical, it would seem wise to ensure compatibility within the organization, and avoid using a sector specific technology, regardless of its other benefits.

If GS1 will get it done, and as it works accross both medical and non-medical products. I would probably adopt GS1 too if I were them. If you only make medical devices, than it would seem HiBC would have the edge. I don't know enough about the cost differences though, and that certainly matters too.

 

[dzurn]

I don't see how you can fit more data into a same-sized HIBC barcodes than the GS1 symbology: HIBC is not restricted to numeric-only data when possible, as is GS1, and any numeric-only data can be encoded twice as compactly as regular ASCII data in Code 128 barcodes.

As someone who had to create both HIBC and GS1 barcodes using desktop labeling software, the GS1 system is far better from an error-proofing, space-conserving, readability and overall usefulness compared to HIBC. The GS1 system is also much better for items which have to cross the retail barrier (as opposed to just pharmacies/hospitals etc) since the GS1 system is used for every UPC barcode on the planet.

It doesn't seem to me that a small user base is more valuable when it comes to global standards.

If you are a US-only manufacturer, and only make medical devices, then it might be cheaper short-term to use HIBC, but once you step outside that walled garden you'll be much better served if your barcodes are already globally recognized.

 

[Marc]

Just a quick "Thanks" to Sam for this thread and the valuable information. Your time in writing this here is appreciated.

Now that it's 2016, does anyone have anything new to add? Has anything significant changed over the last 2 years?

 

[SteveK]

I’ve touched on this in another thread, but basically for a UDI you need GS1 and associated 1D or 2D barcoding. All the input for the FDA’s GUDID database (https://accessgudid.nlm.nih.gov/) is in GS1 format (GS1 allocated GTINs). In the UK the NHS is going all out GS1 – it just appears to be the ‘Standard’.

Steve