The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers. Understandable concerns about the cost and consistency of new technologies has convinced many companies to maintain traditional methods of labeling inspection.
but their persistence with an old approach risks the potential breach of global regulations and continues to yield the same results. The annual volume of medical device recalls remains consistent. Likewise, the implications for cost, reputation and, at the worse extreme, patient safety are as significant as ever.