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Print and verify system for UDI regs

As new identification legislation comes into play, medical device makers will need to modify how they code their products. This system is designed to meet their needs.

This high-resolution thermal ink-jet printer and vision inspection system will help medical device manufacturers comply with the FDA’s UDI regulation.
This high-resolution thermal ink-jet printer and vision inspection system will help medical device manufacturers comply with the FDA’s UDI regulation.

Acquire Automation specializes in custom integration of vision inspection systems and automation solutions. Among its key markets is Life Sciences, including makers of medical devices. So naturally the firm has been hearing a fair bit about an FDA initiative called Unique Device Identification (UDI). This legislation will require medical device manufacturers to identify each type of device with a unique number that must be maintained not only by the device manufacturer but also by the wholesaler and distributor right on through to the end user hospital or health care professional. Currently, most medical device packaging is coded with variable information, but it lacks consistency across the industry. This makes adverse event reporting and device tracking inaccurate, cumbersome, and time consuming—all of which UDI is designed to resolve.

What Acquire Automation has introduced is a turnkey system to produce and verify UDI codes. “It will vary from customer to customer depending on what is getting marked and what information needs to be there,” says Adam Stout, Sales and Marketing Manager at Acquire. “But essentially it’s going to consist of a marking device, an inspection point, and a rejection mechanism.”

The printer Acquire has selected for their initial offering of this solution is the Model 8510 from Videojet, a versatile, high-resolution thermal ink-jet printer based on Wolke technology (Videojet acquired Wolke in 2009) that uses TIJ cartridge technology from HP Indigo.

“We work with quite a few different printer manufacturers,” says Stout. “We felt Videojet had some nice features built into its Clarity user interface, which is part of the 8510 package. One such feature is a built-in Web server. It lets us pull a full configuration, setup, status display, and everything else from their controller directly into our main system HMI without having to have two boxes on the system. So we have a printing and inspection system with a single user interface that allows complete control of both systems.” (Go to pwgo.to/1852 for an informational video of how Clarity works.)

Also appealing to Stout and his colleagues is that the Clarity user interface is common to the majority of the printers Videojet makes. “So this same controller and the same protocol that has been written and the same idea about the Web server coming into our software front end so that there is just a single point of interface for the end user—all of these advantages apply to a lot of their printers. It means that if we come up with a turnkey print and inspect system where the customer prefers laser or thermal transfer instead of TIJ, it’s the same setup. That is very appealing to us.”

There’s one additional reason Videojet is a good fit in this turnkey print and inspect system, says Stout. “They use Zipher communications protocol, which is a well-documented communications protocol that our software team is familiar with. The task of writing the driver to control and send data to and from the printer was greatly simplified as a result.”

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