It’s nearly three years since the original publication of UDI and the industry is well on track to achieving compliance. Indeed, April 2016 saw GUDID Labeler Accounts rise from 240 in October 2014 to 1275* only a year and a half later.
For many, this has been a process more challenging and complex than first expected, and it almost goes without saying that those organisations that haven’t started thinking about UDI yet, really should be doing so now.
We’ve recently attended the FDA’s UDI Conference 2016 and what became very clear throughout the two-day event is the collaborative way in which the FDA is engaging with the industry. This means that, rather than simply meeting the requirement to get information on to a device because they have to, manufacturers and hospitals are now talking in terms of the value they can get from UDI.
For the FDA, but also manufacturers, the main benefit of UDI is the ability to pinpoint an individual item; in the event of any problems, a particular device can be quickly identified and recalled. The implications of this include not only significant time savings, but also the very evident cost savings.
Likewise, hospitals are recognising the value that UDI brings in managing consignment stock and inventory down to the individual device: the ability to identify the patient associated with a unique device has dramatic positive impact on patient care and safety – not to mention cost savings, which is something all hospitals internationally are tasked with addressing.
Our labeling systems enable not only UDI compliance labeling but also the realisation of the benefits around traceability, transparency, visibility and ultimately patient safety. Centralised label lifecycle management solutions allow the joining up of systems and processes to remove duplicate checks and data inputs, improve efficiency and auditability.
The largest medical device organisations have recognised this and have taken great steps towards establishing a single, central system that places data at the heart of the process. With UDI, there is now a unique opportunity for all medical device organisations to reap these benefits of what is, ultimately, a single version of the truth.
About the author:
Vince Postill is the SVP of Global Product & Business Development at PRISYM ID.
At PRISYM ID, Vince has been tasked with building strategic relationships with key partners to increase market share in a variety of sectors by building compelling joint value propositions with our enterprise solutions. He believes that these partnerships have one fundamental principle – increased business success for our customers, our partners and for PRISYM ID.