September 2016 brings several 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 specific version or model of device and a production identifier (PI) that includes one or more of 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, particularly in reading UDI codes. This article will identify 8 types of readability issues manufacturers may encounter and explain how sophisticated vision technology could help address them.
Above: The UDI consists of a device identifier and a production identifier.
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 intended 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 (implantable, 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. Click here for more details on the rules.
There have been some recent extensions for devices packaged together and for combination products, but significant numbers of medical devices must now comply with UDI requirements.
Click to the next page to learn about 8 Potential UDI code readability issues