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Pharmaceutical & Medical Packaging News, November/December 2014

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Page 31 of 43 • Pharmaceutical & Medical Packaging News November/December 2014 32 Planning a Data Standards Journey O ver a decade ago, Cook Medical set out to standardize its approach to product identification, including labeling and bar coding. It has been no small feat, given the thousands of medical device prod- ucts the company markets globally. In 2003 Cook implemented use of GS1 standards by encoding the Global Trade Item Number in GS1-128 bar coded labels. The company has since validated its approach to labeling all packaging levels and is now working toward full compliance with Unique Device Identification. PMP News asked Dave Reed, VP Operations and Healthcare Business Solutions, to answer a few questions about Cook Medical's journey. PMP: How many of your 376,000 SKUs will be required to bear Unique Device Identification? Reed: Today, we have approximately 16,940 total products available. This number isn't static, because products are constantly being introduced and obsoleted, but it's a good representation of what is available from Cook today. The 376,000 number comes from the beginning of our data stan- dards journey, before we adopted GS1 standards. At that time we were using 376,000 diferent num- bers to identify the approximately 20,000 products we sold. The first wave of UDI implementation this year afected about 700 of our products. The next two years will represent a much more significant group of 12,000 products. PMP: Please detail how medical devices are coded. Reed: Cook uses the GS1 GTIN standard to meet the UDI requirement. For our packaged procedural sets, most of the time the set as a whole carries its own UDI. Enabling track and trace of all of those pieces is a critically important piece of UDI regulation. For example, a procedure set for placing a central venous catheter may include wire guides, needles, syringes, dilators, tubing, gauze, a scalpel, sutures, a suture holder, and a sterile surgical drape, in addition to the catheter. Some of these sets may also include prepackaged anesthetic solution and Coding and Marking "Keep moving" no matter how complicated and diffcult the road to Unique Device Identifcation may be, says Cook Medical's VP Operations and Healthcare Business Solutions. One of Cook Medical's labels with a linear GTIN-14 bar code and a GS1-compliant 2-D Data Matrix.

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