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  7. Interpower Talks Unique Device Identification System

Interpower Talks Unique Device Identification System

Video Transcript

Ralph Bright—
Hello, I’m Ralph Bright, Vice President of Marketing and IT at Interpower. The U-D-I—Unique Device Identification—System is being developed by the F-D-A. To help explain this new system, we have Ron Barnett, Product Development Manager. Welcome, Ron.

Ron Barnett—
Thank you, Ralph.

Ralph—
Why is this Unique Device Identification System needed?

Ron—
Increasing concerns about product recalls, counterfeit devices, and patient safety has led the F-D-A to start the process of developing a U-D-I system. Currently identification methods are fragmented and it’s sometimes difficult to trace the original product back to the manufacturer.

Ralph—
What is the U-D-I?

Ron—
The U-D-I is a unique numeric or alphanumeric code which includes a uniform list of product identifiers. This new system applies to most medical devices. As part of the U-D-I system, the F-D-A has created a database which will have a standard set of basic identifying elements. This database will not include personal privacy information, only information about the device.

Ralph—
When does this go into effect?

Ron—
The F-D-A’s Final Rule was issued in September 2013. As with many new laws, there are several different compliance dates, depending on the type of medical device.

Ralph—
What are the steps that are needed in order to be in compliance?

Ron—
The first one is to create and assign the U-D-I. Next, choose the right labeling software to label the products. And third, submit and store the U-D-I in the database.

Ralph—
Are medical cords included in this?

Ron—
While medical cords are not classified as a medical device by the F-D-A, at Interpower we can provide serial numbers on medical cords per a company’s specific requirements.

Ralph—
Thank you Ron for the information and thank you for joining us today.

If you have a question about the U-D-I system or another question that you would like answered, please let us know by e-mailing us at info@interpower.com or calling us at 1–800–662–2290. For more information, check our website at www.interpower.com.