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Pharmaceutical Manufacturing and Packing Sourcer

Labelled as Safe

In September 2013, the FDA set out its framework for establishing a unique device identification system to track medical devices through their distribution and use. The system, which is being phased over several years, 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 public and healthcare stakeholders to access and download device information.

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 offer a standard identifier to help manufacturers, distributors and healthcare providers to manage product recalls efficiently
  • To provide a platform for a secure global supply chain that protects against counterfeiting, and can respond effectively in a medical emergency
The complexities of the new system 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 a more holistic label lifecycle management (LLM).

First in Class

The first two phases of UDI implementation are now complete. By September 2014, Class 3 devices, and those licensed under the Public Health Service Act, were obliged to use a UDI and submit their data to GUDID. The second stage required implantable, life-supporting and -sustaining devices to bear a UDI by September 2015. It also mandated that such devices, which are intended to be used more than once, must include a permanent marking on themselves. In all cases, once again, UDI-labelled devices were expected to submit relevant data to GUDID.

As we approach the three-year mark following publication of the FDA’s ruling, the onus will now fall on Class 2 medical devices to comply. So what has been learned from the process so far, and what does this mean for manufacturers facing the September 2016 deadline?

In the final quarter of 2015, a poll was conducted to find out how the new UDI regulations had impacted medical device organisations. The survey sample included companies directly affected by the first two phases of implementation, as well as early adopters not yet mandated by the FDA’s timetable. 41% of respondents had not yet been required to meet UDI requirements, while, interestingly, 8% were unsure whether they had. The overall results provide a good barometer of current feelings regarding UDI across the sector, and highlight some key findings that can inform strategies for organisations yet to make the leap.

As expected, the majority of respondents whose companies had implemented UDI found the process challenging. 58% described implementation as “difficult”, with a further 4% regarding it as “extremely difficult”. Encouragingly, however, just over a third (34%) reported minimal challenges and 4% described the process as “easy”. The challenges were widely anticipated. Almost two thirds of respondents (63%) stated that the impact of UDI implementation on business operations had matched their expectations – though almost a fifth (18%) said it had had a “massive impact”.

Labelling at the Centre

The introduction of UDI capabilities is undoubtedly a cross-functional challenge for all medical device manufacturers. The poll shows 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 poll shows unequivocally that the biggest impact of the introduction of UDI is typically felt in labelling and packaging, with 85% of respondents reporting that labelling, packaging and design were affected the most. This is further underlined by data which reveals that companies experienced more problems around their labelling capabilities than in 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 that getting a UDI onto the device label represents a significant hurdle, while 9% reported complications when adding a UDI to device packaging. This data shows that, when asked to name the most significant issue around UDI compliance, more than half of all respondents cited problems related to labelling.

This is hardly surprising. Making the move to UDI compliance requires manufacturers to ensure device labels not only include a DI, PI and associated barcodes, but also 13 additional pieces of information. These conditions represent a major shift, and necessitate a labelling system that can capture these datasets 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 input of data to GUDID. This separate process needs 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 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 vital if organisations are to meet the regulatory requirements of UDI. However, the survey shows that only 40% of companies polled are confident that they are ready for an FDA inspection that includes UDI activities. A third of the sample does not believe they are ready, while 27% are unsure. More specifically:
  • Around 45% of companies sampled believe they are either unable or uncertain as to whether they could provide any correction or removal reports they have submitted since the UDI rule was introduced
  • Around 36% cannot, or are unsure whether they can, provide DIs, the issuing agency and packaging configurations from the GUDID DI record for each premarket submission number
  • Almost a fifth of companies (19%) cannot provide medical device reports submitted since UDI was introduced, and a further 19% are undecided
  • More than a quarter (26%) of companies cannot, or are uncertain whether they can, provide a sample of devices listed – including the device class, product code and premarket submission number
Perhaps most significantly of all, only 43% of companies believe that their quality system includes the processes and systems used to maintain the data attributes submitted to GUDID in compliance with 21 CFR parts 820 and 11. Almost a fifth (19%) admits that their quality system falls short of requirements, while a further 38% are unsure.

In each of these cases, where a medical device organisation believes their operations may fall short at FDA inspection, an LLM system can help mitigate that risk. Fully integrated LLM solutions allow companies to take a more strategic approach to the management of global data. Moreover, they improve quality control with the use of automated validation systems, and provide comprehensive audit capabilities to ensure all documentation is recorded, stored and quickly accessible whenever required.

Validation is a critical aspect of the labelling process. Companies need to be able to prove that an action has taken place and demonstrate the outcome it yielded. As far as the FDA is concerned, if there is no evidence, it did not happen. This black and white approach to auditing is driving the need for companies to ensure they deploy a fully validated system that can close the gaps, and limit labelling errors that could lead to product recalls.

Ensuring Readiness

It is, therefore, unsurprising 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. This is a smart move for businesses aspiring to achieve zero defect labelling; they are investing a huge amount of time and money to ensure labels are UDI compliant – so why risk an FDA recall or warning letter, by potentially bringing in human error?

The most progressive organisations are deploying end-to-end LLM systems that give them a 360 degree view of all their data via a centralised global platform, which 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 manufacturers of Class 2 devices to ensure they have the optimal labelling solution in place as they approach September’s FDA deadline.

An LLM solution can not only help companies meet the regulatory challenges that lie ahead, but it can also aid in meeting wider strategic goals of efficiency, productivity and, ultimately, profitability.

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Kevin Grygiel, Vice President of US Sales at PRISYM ID, has over 15 years’ experience in software development and implementation, helping to deliver complex and personalised business solutions to life sciences customers. He has a proven ability to focus, align and build effective teams with an uncompromising regard for customer impact. Kevin’s expertise also includes conceptualising, developing and delivering innovative solutions and services that address and resolve enterprise-wide business needs, resulting in a high degree of customer loyalty and retention.
Kevin Grygiel
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