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New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

Orthopaedic device manufacturers that have long questioned how to apply unique device identification (UDI) to products in procedure trays may have a few more answers, with FDA’s recently-released draft guidance on direct marking requirements.

The guidance indicates that direct marking on the device itself is required if the device is intended to be used more than once and intended to be reprocessed before each use, in order to ensure identification of the devices through their distribution and use.

“Because such devices are intended to be reprocessed and reused, they will inevitably be separated from their original labels and device packages,” the guidance says. “Direct marking best assures the adequate identification of such devices.”

FDA did not specify a particular approach to direct marking, but recommends possible methods of etching, attaching a permanent plaque to durable equipment or affixing a permanent tag such as a radiofrequency ID to the device.

A question related to direct marking was posed to experts at OMTEC® 2015 during the education session, UDI: The Ins and Outs of Global Compliance and Value.

An audience member asked, “How do you identify a small screw within a kit?”

Jay Crowley, architect of FDA’s UDI initiative and Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences, responded, “FDA is saying, ‘We’re not going to tell you how to do it or what to do.’ ”

FDA doesn’t want to hear that UDI compliance is hard, Crowley says. “But if you say, ‘I can get this done for 80 percent or 50 percent of my products,’ or whatever the number is, and ‘I’ve done it this way, but for this other stuff I can’t get there from here,’ or ‘I need five more years to figure it out,’ then have that conversation.”

Crowley also discussed the existing inventory exception, another common area of concern for labelers of life-sustaining and life-supporting devices, facing the looming deadline later this year.

“Say we have a Class II implant that is otherwise subject to the September 24, 2015 compliance date,” Crowley says. “If you have a product in existing inventory that is manufactured, packaged and labeled, prior to that, you have an additional three years to distribute that product without it needing to be UDI compliant. It doesn’t matter where that inventory is.”

To access the full guidance document, click here.


UDI: Uncover and Overcome Challenges Facing Orthopaedics

was also presented at OMTEC 2015 by Karen Conway
and Dennis P. Orthman, CMRP, Senior Director for Strategic Marketplace Initiative.