Richard Pether, Rotech, gives an overview of UDI and some practical steps that healthcare suppliers can adopt to implement UDI using offline coding technologies
In the near future, a UDI (unique device identification) number will be required on all pharmaceutical products.
In 2013 the US Food and Drug Administration (FDA) mandated unique device identification (UDI) for most medical devices distributed in the United States.
Supported by the International Medical Device Regulators Forum (IMDRF), regulators in the rest of the world are considering similar legislation.
International guidance on UDI has been developed and this will serve as the basis for the EU’s future identification and traceability infrastucture, building on the pharmaceutical pack serialisation requirements set out by the Falsified Medicines Directive (FMD), which comes into force in 2018.
The aim is that there will be one, globally harmonised system for identification of medical devices - from surgical instruments, inhalers, contact lenses and dressings to diagnostic tests - by healthcare providers such as the NHS.
So, for producers and packers of healthcare products, it’s no longer a question of whether item-level serialisation will become a legislative requirement in the EU. It’s a question of when.
UDI explained
A UDI is a unique number or alphanumeric code that consists of two parts: a UDI-DI (device identifier) and a UDI-PI (production identifier). The DI element of the code identifies the specific version or model of a device, for example, through a GSI global trade item number (GTIN), whilst the PI element gives production data - typically batch code, lot number, expiry date or date of manufacture.
This information must be presented in two formats: human readable and machine-readable.
Although not stipulated by the legislation, the GS1 2D DataMatrix is frequently selected as a machine-readable carrier for UDI data. So, as an example, the UDI could consist of GTIN, batch code and expiry date encrypted in a 2D code, with the same data also presented in human-readable format. The idea is that the creator of the UDI (usually the manufacturer), submits the code to a central database, so that it can be checked at various stages in the supply chain, via a scanner or smart phone. For this purpose, the US FDA has created the Global Unique Device Identification Database (GUDID).
How it works
GS1 is the main accredited issuing agency for UDIs. With the GS1 framework, every party in the supply chain is given a unique global location number (GLN), while every product that enters the supply chain is given a unique global trade item number (GTIN). GTIN and GLN data is shared electronically through a global data synchronisation network (GDSN). The idea is that as products pass through the supply chain, they are scanned by each stakeholder and both GTIN and GLN information is updated automatically.
Why UDI?
UDI will make it quicker and easier to identify and track medical devices in the supply chain, from supplier to patient. This has a number of potential benefits - for patients, heathcare providers and manufacturers. Patient safety should be better safeguarded through a reduction in medical errors, industry and regulatory authorities will be able to identify medical devices involved in adverse events more rapidly and issue more targeted safety alerts and recalls, and the traceabililty provided by UDI should serve as an effective anti-counterfeiting measure. From a business operations and supply chain perspective, UDI should allow for improved procurement, security, inventory management and accounting.
What do I need to do?
Soon, all healthcare suppliers wishing to deal with providers such as the NHS will need to apply UDI identification to their products, at an individual item level. In order to print serialised data and 2D codes, printers will have to be digitally addressable, which means any old embossing kit and the hot foil coders will have to go.
Code quality is crucial for machine-readable codes, and that quality needs to be maintained from the day the code is applied to the day it is scanned by a patient or healthcare provider, which could be a year or two later. Ink fade is a potential problem, and any codes that are slightly fuzzy, blurred or out-of-position might be unreadable further along the supply chain. Whilst most manufacturers will deploy an on-line camera-based system to verify the code, vision system performance will also be influenced by the quality of the code, and rejection and rework of any packs carrying unreadable codes will have serious implications for overall equipment effectiveness (OEE).
Thermal inkjet printers (TIJs) place their pixels more accurately and offer higher resolution printing (typically 300 dpi or above) than CIJ systems. This makes TIJ the obvious print technology of choice for 2D codes.
However, even where manufacturers are using TIJ, print quality is still dependent on the presentation of the product to the printer. DataMatrix barcoding requires near perfect presentation to achieve the highest verification grade. As many medical devices are awkwardly shaped, feeding can be a problem, resulting in mis-coded items that cannot be validated by an online vision system or a scanner further along the supply chain.
Producing high quality serialised codes at the line speeds required by some healthcare operations is no mean feat either, and compromises between quality and speed often have to be made.
Offline coding: a consideration
For many healthcare suppliers, the answer to these issues could lie in taking coding offline. Rotech, for example, has designed a modular system that incorporates printing, labelling, inspection and automatic stack-to-stack feeding technology. This system has already been supplied to a number of pharmaceutical manufacturers in advance of the FMD, and is equally applicable to medical device manufacturers who want to implement UDI without impacting their production lines.
Offline overprinting systems come into their own where a large amount of text is required or the print is required to meet an exacting standard, such as the 2D DataMatrix code on a medical device pouch. By taking this process offline, the packs are brought to the line ready printed and inspected, eliminating any delays due to coding issues. The potential for rejects is massively reduced because the pack can be presented to the printer in the most favourable orientation.
Offline systems can be fitted with either a thermal inkjet or a thermal transfer printer.
Many companies assume that an online system will be faster and more efficient than an offline one, but once you take into account the impact that inline verification, serialised code printing and mis-codes could have on line efficiency and OEE, offline coding starts to look like an attractive option. Speeds of up to 200 packs per minute are well within the capabilities of an offline coder, and a range of packaging formats can be coded offline, including cartons, wallets, pouches, bags, sleeves and crash-lock cartons. In fact, small batches are more efficient and economical coded offline.
Systems can be positioned either near or next to a line to keep it supplied during running or can supply a second line in a central location.
Get ready for UDI
From pharmaceuticals to surgical equipment, every product being manufactured by the healthcare industry will, in the very near future, be required to have a unique device identification (UDI) number. Now is the time for manufacturers of pharmaceuticals and medical devices to get their coding systems UDI ready, and offline coding could just be the best route to compliance.