Never has the integrity of medical device labels been so scrutinized. As medical care evolves and the devices used become more refined, organizations need to uniquely identify devices to prevent adverse events occurring.
Government directed labeling initiatives (such as the FDA’s UDI) are now becoming reality, with robust regulations and fixed implementation dates. No one would question how essential this is, but these added standards have become a technical headache for the manufacturers… it results in more and more data.
“So what?”, some might say? More data can always be stored. But the problem is not about keeping infinitely more data, but how to manage it in such complex and controlled environments. It is imperative that medical device companies can deliver a single, accurate view of ALL their label data.
Many organizations may not like to admit it, but labeling errors happen more regularly than anyone would like to acknowledge. They have the correct data, but in multiple places and not the necessary means to easily manage it.
In a recent survey, 30% felt data management was their most important challenge for 2015, with a staggering 70% admitting that labeling processes would need to be amended to manage their labeling issues.
With data being such an important driver, organizations must find an air-tight method of handling it as part of their label lifecycle management, allowing the ability to securely design, review, approve and print labels with 100% confidence of the final output being correct. Nothing can be left to chance, companies must implement labeling workflow solutions that offers a 360 degree view of all data globally; presenting the highest level of visibility and traceability.