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  7. Interpower Talks Unique Device Identification System

Interpower Talks Unique Device Identification System

Hello, I'm Ralph Bright, Vice President of Marketing at the Interpower Group of Companies. The unique device identification system is being developed by the food and drug administration. To help explain this new system, we have Ron Barnett, the Product Development Manager here at Interpower. Welcome, Ron. Thank you, Ralph. Why is this unique device identification system needed? Well, increasing concerns about product recalls, counterfeit devices, and patient safety has led the FDA to start a process of developing a UDI system. Currently, the identification means are pretty fragmented throughout the industry and it's hard to trace the product back to the original manufacturer. Okay, so So, what is the UDI? The UDI is a unique numeric or alpha numeric system which includes a uniform list of product identifiers. This new system applies to most medical devices. As part of the UDI system, the FDA has created a database which has a standard set of product identifiers in that database. This database will not include any personal information, but it'll only include information related to the product itself. Okay, so when does this actually go into effect? This law was enacted in September of 2013, but with any new laws there are different compliance dates for different medical devices. So Ron, what are the steps needed in order to become compliant? Well, the first step is to assign a UDI number; next is just choose your labeling software that you need to use for your product; and the third and final step would be to submit and store in the database. Okay, and are medical cords included in this? While medical cords are not classified as medical devices by the FDA, Interpower can provide serial numbers for medical cords per a company's specific requirements. Thank you, Rob. Thank you, Ralph. If you have a question about the UDI or any other question that we can answer for you, email us at info@interpower.com or give us a call at (800) 662-2290. And there is a wealth of information on our website. Go to that at www.interpower.com.