MEDdesign

Reduce Recall Risk with Better Labeling

By Craig Jones
May 29, 2019


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, MEDdesign, RC - Medtech Regulatory Resource Center

Labeling issues were responsible for more than a million medical device units being returned or recalled last year. The on-going product recall issue has barely shifted since 2012 when about 10% of recalls were label related.^1,2 Due to manual processes and archaic labeling systems, product recalls are becoming an increasingly pricey challenge for medical device manufacturers. Although there are various processes and automated technologies available to de-risk the supply chain, many companies still continue to use outdated methodologies, leaving them vulnerable to human error.

Label content is becoming ever more complex, especially with the consistent flow of new regulations. However, companies that implement a more modern approach to the manufacturing and labeling process will not only remove the risk from their business but also transform their supply chain with cost savings, increased productivity and efficiency gains.

The following are tips on how to implement better labeling methods.

1. Just-in-time Labeling

I think it’s safe to say that many manufacturers have been faced with the problem of putting the wrong label or IFU on the wrong product. When this occurs, recall is the only option. To avoid relying primarily on manual processes, which leaves many companies exposed to risk, manufacturers need to implement a labeling system with the right tools to deploy just-in-time labeling and IFU printing at the point of packaging.

Master data management is also an alternative solution. An integrated system that pulls label-specific information from your other business systems provides more control. These rules-based, automated systems can be configured to use barcode scanning of the box, label and IFU to ensure reconciliation is correct.

2. Robust Solutions for Batch Integrity

Of course, like anything, our hardware and software can fail or cause dangerous printing errors. Issue as small as a faulty print ribbon can result in missing, unreadable or misinterpreted content, which then becomes a regulatory issue, and puts patients at risk. It’s vital that manufacturers have robust mechanisms in place assure batch integrity.

While several organizations still rely heavily on manual and random inspection, a better approach is to install a degree of automation. Standalone vision inspection systems or semi-automated inspection processes are good options. Integrating label design and print processes with vision hardware is an effective approach as it allows you to inspect every area and field on each and every label at the time of printing. This ensures 100% of the labels are automatically inspected and in turn can capture any defects that aren’t easily identifiable with the human eye.

3. Labeling for Multiple Countries

Local and international regulation must be considered when printing labels for different markets. Tailoring the content for market-specific labels is a big challenge facing manufacturers today. Processes must be responsive and robust enough to ensure product are covered in multiple countries, all within a single label.

Language translation, UDI requirements and symbology are complex and companies are therefore strongly advised against using manual processes. Not only is it time consuming and costly for humans to check every label printed, but it is also highly risky as well. It is much safer to deploy an integrated labeling system that allows accountability and control of its data. The best systems will have a regulatory rule engine and version comparison tools to ensure all labels are checked for compliance with local regulations.

4. Automation and Data Checks

It is easy to forget that once new procedures are implemented within the organization costly data errors can still occur if the system doesn’t have the right tools and checks in place. Most integrated solutions will link directly to the company ERP. Any modifications that are made within the ERP could impose changes onto the labels you are printing, which can go undetected if the labeling system doesn’t have a version control or mechanisms in place to approve workflows.

An effective system will have a notification center to alerts users to tasks relating to supplementary data , along with a fully configurable rules engine and review/approval processes that flag outstanding errors. A single source of the truth can reduce the risk of human error and provides a platform for companies to see the benefits of automation.

Implementing Digital Solutions

Product recalls can have a significant impact on a manufacturer. The direct and indirect costs of removing a product from the market, addressing the cause and managing brand reputation can be hugely expensive. It is key to highlight that technology is not always the cure; but with a more considered application of it and more control of data, manufacturers can better manage the process.

Integrated systems are the answer, facilitating greater control of labeling operations and helping companies de-risk processes, drive efficiency and increase profitability.

References

1. FDA, CDRH, Office of Compliance, Division of Analysis and Program Operations. “Medical Device Recall Report: FY 2003 to FY 2012.”
2. PRISYM ID. (January 24, 2019). “How to Identify, Address and Remove the Risks of Labeling Product Recalls.” Presentation.