How Hague can take the worry out of Unique Device Identification compliance
Unique Device Identification (UDI) identifies and marks individual medical devices throughout their distribution and product life. Containers like blood sample tubes are now officially recognised as medical devices and their proliferation throughout the healthcare industry highlights how important UDI is to the security and efficiency of the labelling process.
The UDI system was originally developed to make it much simpler to identify and trace devices, which is vital in a regulated industry such as healthcare. Today, as well as speeding up the whole process, it also helps with procurement and reimbursement.
How does it work?
A UDI consists of a Device Identifier (DI) and a Production Identifier (PI). The device is marked with the UDI using Automatic Identification and Data Capture (AIDC) – usually a bar code. This will normally comply with standard GS1, which the NHS authorises for e-business procurement.
What you need to know about UDI compliance
Under EU regulations, all medical devices must be clearly identifiable and compliantly labelled to facilitate easier traceability, reduce medical errors and fight against falsified devices. The use of the UDI system also sets out to improve purchasing and waste disposal policies and stock-management by health institutions and other economic operators.
You can rely on Hague, wherever we sit in the supply chain.
The importance of UDI can’t be overstated. It is used as a global system to support patient safety and the efficiency of supply chains. At Hague, we are specialists in producing pre-printed UDI labels to help our customers meet regulations both easily and efficiently. We provide this in two ways:
• Direct to end-user in a pre-printed format, so that they can be applied to sample bottles, vials etc.
• Direct to medical container manufacturers, so that the label is already applied, saving even more time for hospital and lab staff.
The added security of UDIs with holograms.
In addition to the unique sequential numbering used on UDI labels to ensure devices can be quickly identified, authenticated and traced, we can also take security a step further.
Some of our UDI labels can be hologrammed and integrated with other security technology including barcodes, DME and other technologies that cannot be duplicated. This helps provide additional quality assurance and improves inventory control – a perfect solution for laboratories, chemists, hospitals, dental practices, vets and doctor’s surgeries.
To find out more about Hague’s secure UDI labelling solutions, contact us here.
