We’re all familiar with Einstein’s definition of insanity: doing the same thing over and over and expecting different results. It’s a logic that translates beautifully to medical device labeling, where companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls. In 2018, 9% of all medical device recall events – and the return of over a million units – were due to labeling issues.
It’s an expensive business, with organisations known to spend as much as $350,000 for every global label change. And yet, despite opportunities to de-risk the process through automated technologies, many persist with archaic methodologies that leave them vulnerable to human error. It’s an insanity that’s as unsustainable as it is avoidable.
As global regulations stiffen and the cost of non-compliance climbs, manufacturers must find a method to end the madness. Those that do will not only remove risk from their business – they’ll unlock the potential for additional cost-savings that could transform the bottom line.
Common causes of labeling recall
Labeling errors are a recurring reality for medical devices. The scale of the problem has barely shifted since 2012 when – just like now – around 10% of product recalls were label-related. However, as label content becomes more complex with the introduction of new regulations, this figure will only increase if companies don’t proactively review and strengthen their labeling infrastructure. The tell-tale signs of sub-optimal operations are evident in the most prevalent causes of labelling recalls. There are four common scenarios:
Wrong label on the wrong product – or IFU placed in incorrect package
It only takes one stray label or IFU to cause a product recall. However, an over-reliance on manual processes and weak SOPs leave many companies exposed to the risk. It’s not unusual for labels to be printed in batches and spread across the shop floor during a works order process, increasing the risk of reconciling the wrong label or IFU with the wrong product. When this occurs, recall is the only viable option.
The right labeling software with the right tools can help eliminate the problem. One option is to deploy ‘just in time’ labeling and IFU printing at the point of packaging. Alternatively, the use of an integrated solution that pulls label-specific information from other business systems to enable Master Data Management, can give organisations greater control. These rules-based, automated systems can be configured to utilise barcode scanning of the box, label and IFU to ensure reconciliation is correct.
Labels with printing errors
Sometimes, despite label content being accurate and approved, unexpected hardware or software failure can trigger dangerous printing errors. A trivial issue like a faulty print ribbon can lead to missing, unreadable or misinterpreted content. When this goes undetected and products reach the supply chain, regulations are breached and patient safety is put at risk. Organisations need to ensure they’ve got robust mechanisms in place to assure batch integrity. Many companies still rely on manual and random inspection. However, a better approach is to deploy a degree of automation. Standalone vision inspection systems or semi-automated inspection processes are good options. The most effective approach is to integrate the label design and print process with vision hardware, allowing you to inspect every field on every label at the time of printing. Vision systems enable 100% automated inspection of all labels and can capture defects that aren’t easily identifiable with the human eye. The approach reduces time and risk.
Incorrect market specific content
Managing market specific content is one of the biggest labeling challenges. Processes must be responsive to the nuances of local and international regulation, and robust enough to label products for multiple countries with a single label. The complexities of language translation, UDI requirements and symbology are such that companies would be ill-advised to maintain manual processes. Deploying humans to check every character and phrase on every label is time-consuming, costly and risky. A safer alternative is to deploy an integrated labeling system that allows accountability and control of master data sets. The best systems will have a ‘regulatory rule engine’ and version comparison tools to ensure all labels are checked for compliance with local regulations.
Master Data Errors
Linking labels to a source of master data removes many of the weak links in traditional processes. A ‘single source of the truth’ for product data reduces the risk of human error and provides a platform for the transformative benefits of automation. However, costly master data errors can still occur if the system doesn’t have the right tools and checks in place. For example, most integrated systems will link directly to an ERP. However, modifications to data in that ERP could impose changes on the label that will go undetected if your labeling system doesn’t have version control or mechanisms to approve workflows. An effective system will have a Notification Centre that alerts users to tasks relating to supplementary data – as well as a fully configurable rules engine and review/approval processes that flag outstanding errors.
Transformation through automation
The implications of product recall are significant; the direct and indirect costs of removing a product from the market, addressing the cause and managing brand reputation can be hugely expensive. The potential human costs are unquantifiable. However, the risk can be mitigated with better use of digital innovation. Technology is not a panacea, but with a more considered application of it, companies can automate labeling processes in ways that remove risk, reduce cost and strengthen validation. Integrated solutions can help organisations establish labeling systems that are robust, repeatable and traceable.
Getting there requires taking a holistic view of your labeling operations and the touch points they have with the rest of your organisation – rather than trying to resolve issues in isolation. The most progressive organisations have made a proactive assessment of market risk and invested in validated labeling platforms that offer complete label integrity to meet strict regulations. The benefits have been substantial. One company’s deployment of an enterprise labeling system saved it $19 million a year by removing labeling errors. Another has shifted to ‘Just in Time’ labels and IFUs – yielding annual cost-savings of $8 million.
The technology landscape is varied and flexible. With vendors now offering Cloud/SaaS, Hosted and On Premise solutions, today’s systems are scalable to companies of all sizes and can be configured across a range of platforms. However, with implementation a common fear, the best vendors will take a ‘lifetime partnership’ approach to help companies develop labelling strategies that respond to change and future proof operations.
In a global marketplace underpinned by tight regulation, automated solutions present a timely opportunity for medical device companies to end the recurring insanity of labeling recalls. Integrated systems can facilitate greater control of labeling operations and help companies de-risk processes, drive efficiency and increase profitability. Sometimes we don’t need Einstein to spell it out: automation is the definition of common sense.
About the author
Craig Jones, VP enterprise sales engineering, PRISYM ID
Craig Jones is the Vice President of Enterprise Sales Engineering for PRISYM ID with responsibility for understanding customer needs and industry challenges to drive solutions to improve efficiency, minimise risk, address regulatory requirements and provide new approaches to business systems and processes. Craig has 15 years of experience delivering validated label lifecycle management solutions to life science and healthcare industries including medical device, pharmaceutical and clinical trial organisations. His experience includes roles as an industry consultant, in IT management and as a senior manager for global technical support and professional services.