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UDI (Unique Device Identification): HIBCC or GS1?

#1
Not wanting to be partial for one nor the other, I recently read an announcement that the Dutch healthcare regulators will be requiring UDI for medical products starting July 2018 (similar in fashion to the FDA requirements).

One note that caught my attention was that they currently use GS1 for their supplies and may follow suit with medical devices.

My request to the sage wise ones in this forum is to offer their opinion given that GS1 (initially designed for retail) is substantially more expensive than HIBCC (initially designed for health care products and devices).

My concern is that the cost of GS1 format will increase unit costs beyond what manufacturers can tolerate in an increasingly expensive endeavor.
 
#3
My concern is that the cost of GS1 format will increase unit costs beyond what manufacturers can tolerate in an increasingly expensive endeavor.
Typical. Unintended consequences of continual regulatory creep... :bonk:
...and people wonder why healthcare costs are so high... :nope:

Rant aside, has there been any petitioning for HIBCC to be adopted as well, given that, presumably, many manufacturers already have such systems in place for the US FDA?
 

Ronen E

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#4
Typical. Unintended consequences of continual regulatory creep... :bonk:
...and people wonder why healthcare costs are so high... :nope:

Rant aside, has there been any petitioning for HIBCC to be adopted as well, given that, presumably, many manufacturers already have such systems in place for the US FDA?
MDR specifically calls out HIBCC (as well as GS1 and ICCBBA) as a default UDI issuing agency until the Commission will officially appoint any. Quite certain they will be included for the long term. I can't see why any Member State would nominate GS1 and not HIBCC.
 
#5
...Quite certain they will be included for the long term. I can't see why any Member State would nominate GS1 and not HIBCC.
Not just the Dutch, the UK NHS expects GS1 barcodes for patient wrist bands, medicines and medical devices.
SteveK: I'm not familiar with regulations in the UK, but are you sure that only GS1 is expected?

My optimistic side agrees with Ronen - that there'd be no reason not to allow HIBCC. However, if it is indeed the case that UK NHS only recognizes GS1, I'd be very interested to know the reason...
 
#7
Thanks for the link. The NHS released this statement in March 2015:
"The NHS as a purchaser of medical devices has decided to require its suppliers to use GS1 standards in preference to HIBCC standards. In time this will mean that products that are not GS1 compliant will not be purchased by the NHS. Medical device suppliers who currently use HIBCC standards and wish to continue to sell to the NHS will need to either convert to GS1 or support GS1 standards in addition to HIBCC."

A quick search reveals that a number of medical equipment manufacturers are using GS1 instead of HIBCC. The difference in costs to the manufacturer is significantly more with GS1.
 
#8
I appreciate that there is a cost difference between HIBCC and GS1 (GS1 requiring an annual payment), however I don't think the cost this cost truly represents any significant investment on the part of the manufacturer.

Costs come from the processes and controls that need to be implemented and maintained and the subsequent costs within the supply chain.

GS1 is widely recognised outside of the device sector and many companies will already be registered with GS1 for this reason, there is no incremental cost in these cases. The recognition and acceptance of GS1 in other industries encourages it's use in devices and drives new companies to use it as well.
 
#9
I have to disagree that the costs between the HIBCC and GS1 doesn't represent a significant cost. For example, HIBCC has a one time cost of $1000+ (based on revenue) for an unlimited number of bar codes. GS1 has an annual cost (also based on revenue) plus an annual cost based on the number of codes that are required (1-10, 1-100, 1-1000). For a company that has a lot of smaller parts where margin is scant to begin with, these added costs may have a larger than expected impact.
 
#10
An update on GS1 and the NHS in the UK.

As part of a discussion on the DoH DH eXchange website today:

The Department of Health has been promoting the use of GS1 standards since the early 2000s and published a document in 2007 called Coding for Success which identifies GS1 as the nominated standard for the NHS. We are aware that the EU has not stipulated GS1 specifically, however the Department of Health has, for all suppliers into the NHS. If you want to continue to use the supplier(s) in question then yes they will need to adopt GS1 coding standards.
Increasingly the NHS are asking for compliance to the NHS eProcurement Strategy (which includes the adoption of GS1 and PEPPOL standards) as part of their tender evaluation process and ultimately this will become a pass/fail criteria. As already stated there is a period of time allowed for transitioning.


Steve
 
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