By Marty Kerluck, Kallik Business Development Manager for North America
As you may know, the rise of the US Food and Drug Administration’s new Unique Device Identification (UDI) system has been closely followed by both Kallik and our many customers in the medical devices markets (see ‘All The Power Of UDI – In A Three Minute Nutshell’ among other blogs on this topic, for example).
We thought you would be interested in an up-close look at UDI’s impact in the US, the country most immediately in the standard’s ‘firing line’ – and where Kallik has an important presence helping companies get ready for UDI
Please extend a warm welcome to Kallik’s Business Development Manager for North America Marty Kerluck, who is well placed to tell us.
Well, what we are finding with customers opening up the Pandora’s Box of UDI is that while a lot of people have put some good thought into dealing with it well ahead of time, that still doesn’t mean it’s not presenting some issues.
For example, companies we speak to in the medical devices market seem to have been planning for it for some time; they are all geared up for putting data on to the new Global UDI Database, the GUDID for instance, they are aware there is a new barcode symbology they need to start working with, and they are gathering data the right way to share with the FDA.
So far so good – what’s to worry about? Well, it’s a problem I have kept seeing again and again in the fifteen years I have been working in this market:
They aren’t doing enough with the data when they’ve collected it – especially when it comes to utilising it for their packaging and labelling requirements.
And I fear that that is going to come back and bite – hard – if they ever get into any kind of issue as a result, such as the horrible expensive nightmare we know as a ‘product recall.’
Data has a central role beyond UDI
The issue is that the data on the label has to be not just accurate and up to date, it has to be available for a third party like an FDA if there is any kind of product problem.
In addition, if the data on the label isn’t exactly the same as the information you gave the FDA or put into GUDID, then you are going to have a big problem when it comes to building out a proper audit trail to explain what has taken place.
The only way to head off both issues is to see that the data on the label always has to be part of the data you give the FDA for your UDI obligation – they are parts of what should be one seamless whole.
What the experience of complying with UDI is showing to me is that companies are missing out on the last part of this process. They have the data, and it’s good data. The problem is that some of it is in their Oracle system, some of it is in their FDA submissions system – it’s there, but not connected up in one place.
To beat a drum that any Kallik customer will have heard us beat: they are failing to build a single source of the truth, a unified view of product data that can be closely followed and tracked.
Which is a bit odd, as the single source idea is no longer just Kallik’s when it comes to medical device data – it’s a core philosophy of the whole UDI move itself.
Kallik is the glue
So the first stirrings of UDI in the US is that people are not doing badly, far from it, there is great work being done – but that bigger data picture, the link between the back end production systems database, the FDA and the packaging and labelling front-end hasn’t quite gelled yet.
That is, of course, potentially a great opportunity for Kallik, as we are ideally placed to be the ‘glue’ to bring all that together.
But first we need to educate the market a bit more in the importance of not just collecting the right data for UDI but in managing it properly so that full integrity and safety can get embedded in the heart of not just the UDI process, but all core labelling, packaging and artwork management processes.
Marty, Kallik’s Business Development Manager for North America, based in Toronto (Canada), has an extensive track record helping companies in the medical devices and regulated industries sectors; we hope this will be the first in a regular series of dispatches from ‘over the Pond’
Please take advantage of the UDI Compliance webinar: (https://www1.gotomeeting.com/register/786791768) on 3 December 2014, at 12 Noon EDT/1700 BST and find out what you need to do to prepare for UDI compliance