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.”

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