With half of all medical device recalls in recent years caused by packaging and/or labeling errors, it's time for manufacturers to rethink their approach to labeling inspection.
Despite the continual tightening of regulations around the packaging and labeling of medical devices, global device manufacturers continue to persist with traditional approaches to and infrastructure for labeling. The result is that the annual volume of medical device recalls remains consistent and the implications for cost, reputation, and--at the worse extreme--patient safety are as significant as ever.
Data show that more than half of all FDA recalls of medical devices since the first quarter of 2014 have been caused by packaging and/or labeling error. Given this, and with FDA starting to crack down on organizations that do not comply with its Quality System Regulations, medical device manufacturers must start treating compliant labeling inspection as business critical.
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Worryingly, a large percentage of the medical device industry appears oblivious to FDA regulations around the quality requirements for label inspection. A 2016 PRISYM ID survey of medical device and pharmaceutical organizations revealed that almost two-thirds of respondents were either unsure or unaware of FDA's regulations on the quality system requirements for label inspections.
Label inspection is a regulatory requirement in both the U.S. and European markets, irrespective of the size of an organization, with requirements outlined across a number of regulations, including:
- 21 CFR 820.80b, which deals with Quality System Regulation for medical devices.
- 21 CFR 820.120, which is specific to device labeling.
- 21 CFR 211.122, subpart G, dealing with packaging and labeling control, which also specifically highlights the importance of 100% inspection.
- EU Directive 2001/83/EC, article 65, which outlines how detailed guidance concerning a range of medical and healthcare products will be drawn up and published.
The scope and detail of global regulations underline that the 100% inspection of labels in the production, manufacture, and distribution of medical devices is a requirement, not an option. To underline the point, FDA has already begun to issue warning letters to organizations that have fallen foul of these regulations. In 2014, 48 warning letters were issued relating to breaches of 21 CFR 820.80, and an additional four were issued regarding 21 CFR 820.120. These notices, quite literally, serve as a warning that companies must set in place robust mechanisms and processes to manage risk and maintain compliance.
The nature of the regulations, not least 21 CFR 211.122g, which allows provision for human and automated inspection processes, has led to a divergence in approach across the medical device sector. However, as label content becomes more complex and evolves to include variables such as local languages and country-specific requirements, there is increasing concern that current labeling processes and infrastructure do not sufficiently protect companies against error.
In particular, many companies could do more to monitor, identify, capture, and collate errors that occur at the crucial print stage. This is an important distinction. While organizations invest a large amount of time and resources in ensuring preproduction data integrity, in failing to apply the same rigor to inspection once an operator has pressed print, they open themselves up to significant risk.
Making the assumption that a job will print in the way it was intended is ill-judged, not least because a variety of unforeseen mishaps--such as print driver conflict, material quality deterioration, and print hardware issues--can inadvertently impair the print process and lead to print inconsistency or illegibility.
The potential for error during the print process is significant. What's more, it can seriously undermine earlier efforts to secure data integrity in the pre-production setting.
At present, the ways in which companies approach labeling inspection tend to fall into two distinct camps; manual and standalone inspection.
Manual inspection methods include (though are not limited to) the following:
- Manual pre-label and post-label inspection.
- Random inspection.
- 100% manual inspection.
- 100% manual inspection, post-print.
- Manual template.
Standalone vision inspection is an alternative method, whereby the print inspection system is entirely separate from the label management system. The approach uses a standalone application--a "vision system"--to design a label template in line with individual company specifications, then uses the template to form an inspection mask that supports automated checking post-print. While a huge step forward for manual processes, allowing more accurate inspection of every single label, its application within the medical device industry is constrained.
In contrast to commercial pharmaceutical manufacturing, where standalone vision has successfully supported large production runs with limited data to inspect, print runs in the device sector are often smaller, while labeling data and designs are much more complex. As such, the expertise and time required to configure a vision inspection application to identify all errors has often proved prohibitive, resulting in many technology trials failing an operational return-on-investment assessment.
Moreover, this standalone approach treats inspection and label management as two siloed activities. The lack of integration is problematic: It is not inefficient and increases risk throughout the label life cycle, and it leaves companies with two individual audit logs--one for printing, the other for inspection.
While all of the mentioned methods can be used as a risk assessment to determine whether finished labels are accurate, they each have limitations--some more substantial than others. Moreover, the vast majority fail to meet the basic requirement of 100% inspection and leave companies exposed to risk. As FDA turns up the heat on medical device organizations, large and small, to demonstrate compliance, the industry needs a more effective way to mitigate risk.
A Fully Integrated Approach
Companies need to find a solution that gives them end-to-end label tracking and the ability to understand that what was sent to the printer not only physically printed, but can also be proved in a single audit log. For more effective, joined-up thinking, an integrated approach is the only solution.
The full integration of label software and print inspection solutions provide complete print inspection set-up, test, and management functionality, automatically creating inspection masks from label designs and reducing the effort and expertise required for configuration and testing. Moreover, since they are fully integrated with in-line print verification systems, they can successfully marry label management and print inspection, facilitating the automated inspection of every label using the design and content sent to print.
Crucially, as the labeling infrastructure of medical device organizations becomes increasingly scrutinized, these solutions are underpinned by an integrated audit log to document a single source of the truth. In doing so, fully integrated label software and print inspection solutions not only help companies ensure FDA compliance, they minimize operational costs, increase throughput and efficiency, and significantly mitigate the risk of error throughout the labeling process.
The medical device industry spends huge amounts of time ensuring its datasets are accurate, integrated, designed, and approved for compliant labeling outputs. However, few companies spend sufficient time ensuring that the label that emerges at the end of the process is printed correctly. The repercussions of this could potentially be severe. As the regulatory climate becomes ever more challenging, global organizations must do all that they can to ensure that they have optimal labeling systems and processes to meet the demands of the FDA and European regulators. This requires cross-functional, organization-wide collaboration to assure that data formats, integration points and production infrastructure are all aligned--and are underpinned by a system that delivers that single source of the truth.
In the highly regulated environment of medical devices, label life cycle management is without doubt a business-critical system. It should be treated as such.
Warren Stacey is senior vice president of global sales at PRISYM ID. Reach him at [email protected]
[image courtesy of SIRA ANAMWONG/FREEDIGITALPHOTOS.NET]