First featured in Med-Tech Innovation: Warren Stacey of labelling specialist Prisym ID examines unique device identification implementation to date, and offers best practice guidance for compliance.
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Nearly four years after the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use, implementation is well over halfway and there is little time remaining before its compulsory introduction.
The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.
UDI fig 1
The implications for medical device companies are significant. Assuring UDI compliance requires a major review not only of an organisation’s labelling capabilities but also how it connects with all the other divisions that impact supply chain operations. Furthermore, the journey towards UDI compliance requires an enterprise-wide programme of change management to ensure the requisite infrastructure is in place. It’s a journey that for many manufacturers has proved to be a challenging one.
So what lessons have been learned to date, and what best practice can we give to medical device manufacturers yet to implement UDI?
UDI: its meaning and purpose?
The FDA’s introduction of the UDI system has a number of goals:
- To drive more accurate reporting and analysis of adverse events, ensuring problem devices can be quickly identified and rectified
- To reduce medical errors by giving healthcare professionals key information about specific devices
- To enhance market analysis with access to real-world data on device usage
- To provide a standard identifier to help manufacturers, distributors and healthcare providers to manage product recalls efficiently
The FDA’s definition of a UDI and guidelines are complex and mean that, for many companies, managing the transition to UDI compliance can be a challenging process that touches all parts of the organisation. Critically, the implications for labelling operations are significant and require all medical device manufacturers to examine their current infrastructure and, in many cases, adapt it to enable more holistic label lifecycle management.
Labelling at the centre
The introduction of UDI capabilities is a cross-functional challenge for all medical device manufacturers. A survey conducted last year by PRISYM ID highlighted that UDI implementation caused reverberations in manufacturing, quality, operations and distribution. Likewise, UDI projects also tend to involve IT and regulatory teams, meaning that they permeate almost every department and system within an organisation. This naturally dictates a collaborative approach where implementation decisions cannot be made or managed in isolation.
However, the biggest impact of UDI implementation is typically felt in Labelling and Packaging. 85% of respondents reported that Labelling, Packaging & Design were affected the most. This is further underlined by data which reveals that companies experienced more issues around their labelling capabilities than any other area.
Building and implementing an appropriate labelling system was cited as the single biggest issue, with 23% of respondents encountering difficulties. Alongside this, almost a fifth (19%) found getting a UDI onto the device label their biggest challenge, while 9% reported issues adding a UDI to device packaging. This data shows that, when asked to name their biggest issue around UDI compliance, more than half of all respondents cited issues related to labelling.
Making the move to UDI compliance requires manufacturers to ensure device labels not only include a device identifier (DI), production identifier (PI) and associated barcodes, but also include 13 additional pieces of information. These requirements represent a major shift and necessitate a labelling system that can capture these data sets accurately and efficiently and configure them to the appropriate label design. Ideally, the labelling system would be able to communicate seamlessly with systems that support the submission of data to GUDID. This separate process requires the submission of data covering a total of 62 fields – with data not only coming from the label itself but from various locations right across the organisation.
Label lifecycle management
The impact of UDI regulations on labelling operations is a major reason why Label Lifecycle Management (LLM) is now regarded as a must-have capability for global medical device manufacturers. LLM encompasses the full range of disciplines, processes and controls that go into the preparation, production and audit of every single label. Unlike traditional labelling systems that focus purely on the final output – the label itself – an LLM system focuses on data, supporting the end-to-end management of labelling across its entire lifecycle. It gives companies full visibility of all their data assets as well as editing tools and vision control to help maintain data integrity. Crucially, an LLM system assures robust data validation and reinforces it with transparent audit tools that can supply objective evidence in the event of internal or regulatory inspection.
These capabilities are crucial if organisations are to meet the regulatory requirements of UDI.
Conclusion
It’s therefore no surprise that medical device companies are increasingly looking to improve their labelling systems to ensure operations are UDI compliant. There is a growing trend towards the implementation of ‘vision’ systems that automate label inspection, post-print.
Indeed, the most progressive organisations are deploying end-to-end LLM systems that give them a 360° view of all their data via a centralised global platform that interoperates with existing systems right across the enterprise. LLM solutions give manufacturers the reassurance of complete label integrity – a single version of the truth – across the entire label lifecycle. Moreover, they provide a secure, reliable and scalable platform for efficient UDI-compliant labelling.
With more than half of all survey respondents citing label-related issues as the biggest challenge in the journey towards UDI implementation, it makes sense for the remaining medical device manufacturers who have yet to implement UDI to ensure they have the optimal labelling solution in place as they approach the final 2020 FDA deadline.