The medical device industry is one of the fastest growing and dynamic industries today. With this growth comes a greater need for enforced labeling standardization, and the Food and Drug Administration (FDA) is keeping a keen eye out.
Discrepancies in standard formula labels for medical devices have been difficult to track thanks to the fast change rate the industry is seeing. But the FDA has high hopes that these labels will not only reveal where and when items were manufactured, but also help healthcare providers to better understand the risks and benefits of a device prior to its use one day. So how is medical device labeling changing to start evolving these needed standards? Here are 3 must-have components you’ll be seeing from now on:
1. A Unique Device Identification (UDI).
http://perspectives.3ds.com/life-sciences/fda%E2%80%99s-unique-device-identifier-4-steps-to-successful-implementation-for-medical-device-companies/
Since 2014, the increased FDA standards call for the use of UDIs, a system used to adequately identify medical devices through their distribution and use. This change has the potential to improve the quality of information on medical devices, which will then allow the FDA to more easily recognize recalls and improve patient safety with an accelerated speed of investigation. The medical device industry is struggling, though, with the new need for a larger label footprint to accommodate the must-have UDI information.
2. Labels need to be both dynamic & data-driven.
By providing information in both human- and machine-readable form (such as GS1 data strings) there is a far greater checks and balance system in place on all medical devices. Barcodes and other machine-read formats allow for rapid label changes and integrating with business systems, while the human-read formats provide information that can be consumed by the variety of audiences keeping an eye on the industry, including health authorities, customers, internal personnel and partners.
3. Symbols are now replacing words.
With the UDI and the need for both human- and machine-read information on labels, there is barely enough space for one language alone to be featured on medical device labels. As a solution to this problem, the industry is using FDA-approved symbols to communicate across multiple languages—an adoption that helps simplify product labeling while also providing sufficient information for users. Symbols used have been established as part of an internationally recognized Standards Development Organization (SDO).
At AWT, we’re following all of these trends in the medical device industry and working with the appropriate team contacts to come up with solutions that will get your product ahead of the game when it comes to all the quick changes the industry is seeing.
For more information on our medical labeling capabilities, check out our website: http://www.awtlabelpack.com/markets/medical/ or reach out to the AWT team http://www.awtlabelpack.com/contact/ who will be happy to help ideating with you and your team.