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Pharmaceutical & Medical Packaging News, October/Fall 2016

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pmpnews.com • Pharmaceutical & Medical Packaging News Fall 2016 28 Printing & Coding 8 potential UDI code readability issues and the critical role of vision Can vision technology overcome printing and coding issues? By Kasey Tipping, Technical Marketing Specialist–ID Products, Cognex Corp. S eptember 2016 brings sever- al key deadlines for Unique Device Identification (UDI), a system of medical device identification rules issued by FDA in 2013. UDI requirements state that the device labeler, in most cases the manufacturer, must include on medical devices a device identifier (DI) that identifies the labeler and the spe- cific version or mod- el of device and a production identifier (PI) that includes o n e o r m o r e o f the following: lot or batch number, serial number of a specific device, expiration date of the device, and the date the device was manufactured. As medical device manufacturers work toward compliance, they are encountering serious challenges, par- ticularly in reading UDI codes. This article will identify 8 types of readabili- ty issues manufacturers may encounter and explain how sophisticated vision technology could help address them. THE RULES While Class III medical devices have been required to carry UDI labeling since September 2014, by September 24, 2016, these Class III devices must carry UDI as a permanent mark on the device itself if that device is intend- ed to be used more than once and is intended to be reprocessed before use. In addition, all Class II devices must now bear UDI on their labels and packages, and the dates on these labels must meet formatting rules (implant- able, life-saving, and life-sustaining Class I and II devices have had to carry UDI labeling since September 2015). By September 2018, all Class I devices must carry UDI labeling, and Class II devices that require DPM must carry the UDI on the device. Finally, Class I devices that require DPM must carry a permanent UDI on the device by September 2020. (For details, visit www.fda.gov/MedicalDe- vices/DeviceR egulationandGuid- ance/UniqueDeviceIdentification/ C o m p l i a n c e d a t e s f o r U D I R e q u i r e - ments/default.htm.) Kasey Tipping To overcome warped 2-D DataMatrix codes or codes with missing perimeter features, Cognex offers 2DMax with PowerGrid algorithm. PowerGrid reads codes without quiet zones or clocking or fnder patterns.

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