FDA to track medical devices with IDs

The FDA’s latest announcement confirms its AccessGUDID, is now available to the public. However, the online Global Unique Device Identification Database is set to bring the labelling of medical devices under unprecedented scrutiny.

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. Yet, the latest FDA announcement is likely to bring ramifications not only for manufacturers but also throughout the entire supply chain.

Despite the regulations coming into force for Class III devices from September 2014, many of the industry’s smaller players are still finding the new regulations challenging. Conversely, size has not meant that the industry’s biggest organisations 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 addressed it comprehensively and holistically, 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 labelling processes to ensure they mitigate risks, contain costs and drive productivity. Typically, however, current processes are slow, labour-intensive and vulnerable to human error.

Despite rapid advances in labelling 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 organisations deploy primitive, manual methodologies to assure quality control of labelling 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%.

To comply, 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.

Whilst 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.

With medical device ID data now under public scrutiny, the potential implications of non-compliance go beyond operational matters and into the realm of brand value. Organisations simply can no longer afford not to treat the quality and control of labelling output and content with the utmost importance.