UDI Marking Of Medical Devices And Products

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UDI Marking Of Medical Devices And Products

On medical products that don't require direct part marking, where is the best place to put the UDI (unique device identification) mark? Proper placement really depends on how the healthcare provider or hospital dispenses the product, in addition to whether tracking and/or tracing the use of the individual unit is an important factor. Viewing placement of the UDI mark from a "bottom up" perspective seems to make the most sense, as you're viewing the packaging from the point it is dispensed to the end-user (patient). Where you begin putting the UDI mark (which, by the way is a combination of DI and PI's such as date, expiration, lot #, etc.) can impact how nicely the information flows. In all likelihood, UDI marking will need to be placed on primary packaging for devices with a serial number and where the Unit of Use becomes the Lowest Package Level and Primary DI. Why is this true? If a manufacturer spends the money to place serial numbers on each device, it's probably because having the ability to capture the S/N within the supply chain is critical. Think of pre-filled syringes containing medications for a specific patient, wherein the provider desires to track that individual syringe using a particular lot number rather than serial number; in this case, the UDI and DI marks would be linked to the Primary DI via the Package DI data element. Understandably, there is some confusion as to where UDI marks should be placed on the product - on the device itself, its packaging, and what happens when there is insufficient room on the current label? The FDA requires the UDI mark to be placed on the device itself when the device is intended for multiple uses. Other than that, regulations state the UDI is to be placed on the device label and device packages. This seems a bit vague to many manufacturers, which is why it's important to learn all you can. When there is inadequate space for a UDI mark on the existing label, the FDA currently says it is left to the labeler to decide an appropriate manner to apply the UDI to the device label. The agency also goes on to say that "in some instances" an add-on label may be appropriate. At Markem-Imaje, we have the ideal technology for all of your UDI printing specifications. Our team, along with Bosch Packaging Technology, provides integrated solutions for printing UDI compliant messages on Tyvek bags, foil, poly bags, and more. For all of your UDI marking needs, count on Markem-Imaje for solutions.

January 10, 2014
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