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Are you compliant? Every medical device exported to the US now needs a unique ID

Posted by Zebra EMEA

January 16, 2014 at 8:52 AM

Back in September 2013 the Food and Drug Administration (FDA) issued draft guidance on the Global Unique Device Identification Database (GUDID). GUDID is a publicly searchable database administered by the FDA that will serve as a reference catalogue for every device with an identifier. Under the UDI final rule, the labeller of each medical device labelled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.

Yes, it’s a US compliance guideline – but if you’re thinking you’re outside the US and it doesn’t apply to you, think again. If you’re a medical industry manufacturer and you’re exporting to the US, the guidelines apply to you, too.

You might also be surprised to see what qualifies as a device in GUDID. It isn’t just obvious items such as electronic equipment: it now drills all the way down to products such as catheters, syringes and swabs packs. They’re being absorbed into the guidelines in stages, with higher classes of devices introduced first. With this, there are official deadlines for meeting the compliance requirements, however there appears to be a move within the distributors of this type of material to request compliance well ahead of the official cut off dates.

If GUDID guidelines do apply to you, it’s important not only to know which categories are relevant to your case but to have plans in place to ensure compliance. Here at Zebra, we’re very well placed to help you develop and implement those plans. We have long years of experience in product identification technology, and the expertise and innovation we bring to our solutions make what could be a major undertaking much more straightforward.

For instance, the Link-OS software we use in our reliable and high-quality printers means they can be programmed and monitored to log the fact that an individual barcode has been printed, providing a level of verification to the process that goes beyond what GUDID stipulates.


The bigger picture

The capacity to validate in this way does more than merely tick US federal government boxes. The implications are much broader, because it also introduces additional layers of traceability not just to medical device production but to manufacturing as a whole. With individual products identified, and the issued barcodes logged on the printers that produced them, recall initiatives can be put in place quickly and effectively so corrective actions can be implemented if product problems are identified up or down the supply chain.

It’s about continuous improvement as much as about spotting and solving problems. In factories of the future, there will be a need for greater collaboration between partners at all points in the value chain, and consequently there will need to be much greater ability for manufacturers to interrogate processes. By making this possible there will be scope for better decision making and best-practice approaches in terms of managing items at component or finished goods levels as they make their way through the manufacturing journey.

GUDID may be a requirement for people exporting to the US in one specific market sector – but the implications of a technological solution to that requirement are far broader, and so too are the potential benefits.


Update June 2014:

The first phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry is now available. The first phase includes updates to sections on establishing and using a GUDID account, managing account changes, Global Medical Device Nomenclature (GMDN), and GUDID submissions and part 11 requirements.

This guidance identifies several sections that will be finalised in the second phase, which is expected in the coming months. Until these sections are finalised, users may refer to the Global Unique Device Identification Database (GUDID) Draft Guidance (dated September 24, 2013). 


David Taylor, Business Development Manager – Manufacturing 

Topics: Healthcare, Barcodes, Manufacturing, Link-OS Environment, Identification, APAC, North America, Latin America, EMEA