Product recalls in the medical devices industry are increasing – bringing a trail of destruction to companies’ operational efficiencies and profitability. Labeling error remains a common cause of recall – but it’s one that can easily be avoided. Prisym ID’s Craig Jones, VP Global Supports Services, outlines how vision systems can help companies eradicate costly and unnecessary labeling defects – and win the War on Error.
Product recall is a key issue for the global medical devices industry. With expensively manufactured devices, as well as hard-earned brand reputations, routinely destroyed in the wake of a recall notice, the costs are high; productivity, profitability and speed to market are blown apart, while patient care also takes a hit. Despite this, the incidence of recalls is increasing. In 2013, the number of medical device recalls reached record levels; the FDA’s Enforcement Report showed 1,138 recalls – a 9% increase on 2012 and 19% more than in 2011. Recall causes vary, with design and material/component defects the two most common factors. But in third place, with a combined total of 15% in 2012, labeling and packaging errors are responsible for a sizeable chunk of recalls – two thirds of which are due to labeling defects. A high percentage of these are rooted in onerous manual processes and human error; and many can be avoided. How? It’s time for the War on Error.
The case for war
The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But there are regulatory maneuvers afoot too. The phased introduction of Unique Device Identification (UDI) requirements in the US means that the labeling of medical devices faces unprecedented scrutiny – with ramifications not only for manufacturers but also throughout the entire supply chain. The FDA ruling, which is enforceable for Class III devices from September 2014*, calls for devices to be marked with a UDI of two composite parts; a device identifier that corresponds with the type of device and its manufacturer, and a production identifier that states the lot, batch, serial number, expiration date, date of manufacture and other relevant information. This information must be presented in machine and human-readable formats.
While the transition to UDI compliance may prove straightforward for some of the industry’s larger companies, many of its smaller players could find the new regulations challenging. Conversely, size has not meant that the industry’s biggest organizations have been immune from product recall – with some of the sector’s largest multinationals featuring prominently on the 2013 FDA Enforcement Report. The implementation of UDI is, therefore, an industry-wide challenge. And if companies have not yet begun to address it, they need to act quickly.
As regulations tighten, the need for medical device manufacturers to examine their systems, processes and operations is intensifying. To achieve UDI compliance, companies must ensure that label content is aligned with FDA requirements. This will mean reviewing – and in many cases, transforming – existing labeling processes to ensure they mitigate risks, contain costs and drive productivity. Typically, however, current processes are slow, labor-intensive and vulnerable to human error.
Despite rapid advances in labeling technologies, a surprisingly high percentage of companies still rely on 100% manual inspection of medical device labels. In the area of high-value, Class III devices, such scrutiny may be understandable – but it is also inefficient, expensive and unsustainable.
Some organizations deploy primitive, manual methodologies to assure quality control of labeling output. These companies are often disappointed to learn that such military procedures lead only to military imprecision, and fall well short of the wider mission to deliver zero-defect labels. It’s not surprising; evidence consistently shows that, after a certain period of manual checking, human error rates can reach as high as 80%.
But the War on Error can be won. The emergence of innovative technologies means that there are more effective, efficient and secure ways of assuring zero-defect labeling – accurately, cost-effectively and, crucially, within the regulations.
The vision statement
To complete the mission, medical device companies must be appropriately armed; a highly competitive battlefield calls for a 360° view.
Device companies currently invest heavily in the manual inspection of labels. This investment is chiefly in human capital – with cohorts of employees assigned to painstakingly check label templates, content and data. But is this a false economy? Recent studies suggest that human error is the most frequent cause of defective labels – highlighting the importance of automated inspection systems.
But the risk of label defect is not restricted to internal processes. Even in organizations that have focused heavily on developing systems that integrate design, data control and content audit processes, internal operators invariably relinquish control once data is sent to an external printer for output. Success at that stage is entirely in the hands of the printer.
Vision Systems are designed to address these common challenges. A Vision System combines an image of the printed label, with software that compares that image against a control or sample. The fully automated nature of the process reduces both the risk of error and the human cost of operating manual systems.
While automated inspection systems have actually been in the market for a while, the most effective have evolved to integrate with label lifecycle management software, enabling manufacturers to manage and document their labels through design, approval, print and inspection. This type of end-to-end solution gives device manufacturers 360° vision of the entire process, and closes the loop by securing visibility of the final print output.
The most comprehensive systems allow real-time inspection of labels, eradicating delays that are not only associated with manual legacy systems, but that are also common with traditional camera-based inspection solutions. As ‘just-in-time’ methodologies become an industry ambition, Vision systems can help drive genuine business efficiencies and greater operational agility.
From zero to war hero
The collective mission of teams involved in label and artwork management – from those controlling operations on the ground, right through to QA, Regulatory Affairs and IT – is indeed to produce that zero defect label. The ramifications of failure are significant; product recall may be the worst-case scenario, but defective barcoding can also create supply chain issues and prevent life-changing products from reaching providers and patients. Moreover, the cost of manually checking labels is expensive, both in terms of human resource and the increased risk of human error.
But achieving zero defect labels is not ‘mission impossible’; the bold use of technology can help label and artwork management become heroes. Vision systems present an opportunity to automate many of those costly human processes – and to improve the speed, efficiency and quality of medical device labeling. What’s more, as part of a fully integrated label lifecycle management solution, they can provide true end-to-end visibility to support a process that has traditionally been fraught with expensive risk.
It’s time to win the War on Error. Have you got the Vision?
* Exceptions are permissible