Expensively manufactured devices, as well as hard-earned brand reputations, are routinely destroyed in the wake of a recall notice, and the costs are high; productivity, profitability and speed-to-market are blown apart, whilst 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.
As regulations tighten, the need for medical device manufacturers to examine their systems, processes and operations is intensifying. Despite rapid advances in labeling technologies, a surprisingly high percentage of companies still rely on 100% manual inspection of medical device labels. However, the emergence of innovative technologies means that there are now more effective, efficient and secure ways of assuring zero-defect labeling – accurately, cost-effectively and, crucially, within the regulations.
How does it work?
An automated 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 these 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.