Close up of medical instruments at the hospital

Medical Device Manufacturers, Are You Ready For the FDA’s Unique Device Identifier Requirements?

SencorpWhite medical instruments UDI packagingI can’t believe it’s been nearly a year already.

Last September, the Food and Drug Administration (FDA) released its final rule requiring that most medical devices distributed in the United States carry a unique device identifier (UDI) . . . and now, the first compliance date for that new regulation is just around the corner –on September 24, 2014.

The FDA appears to be staying on track with the timeline it established. For instance, as part of this new system, the FDA created the Global Unique Device Identification Database (GUDID) which includes a standard set of basic identifying elements for each device with a UDI. And then, just two weeks ago, it issued guidance to help labelers understand key GUDID concepts, such as accounts, user roles, the device identifier record life cycle and package configurations, as well as GUDID data attributes and descriptions.

At SencorpWhite, we’ve been gearing up to help medical device and instrument manufacturers comply with these new requirements, too. If you’re a manufacturer in the medical industry, we have the expertise and experience you need to:

  • Integrate auto-ID technology (RFID and others) at the point of packaging. Sencorp brand thermoforming machines are recognized as the industry standard for medical-grade packaging trays for devices, implantables and instruments –and for blister and clamshell packages for consumer products, foods, cosmetics and electronics, as well.  In addition, more than 450 of the world’s leading medical instrument, device and implantable manufacturers rely on our CeraTek brand sealers to create validatable, calibratable and CE and ISO-11607 compliant seals day-in and day-out. SencorpWhite’s Auto-ID technology enables wireless tracking, robust security and real-time monitoring of inventory at all points along the supply chain, including at the point-of-use. Using a secure online portal with real-time data reporting, you and your vendors can use Auto-ID to remotely manage high-value medical, pharmaceutical and biological inventory, balance stock across different facilities and set alerts for product expirations. You can also export this data to your enterprise software systems.
  • Secure and manage inventory through the supply chain with automated storage and retrieval systems. SencorpWhite doesn’t only design and build packaging machines. Our White brand vertical and horizontal carousels have become the gold-standard for automating storage and retrieval, and they are in use in manufacturing facilities, warehouses and distribution centers throughout North America. We also custom design and build vertical carousels for many of the leading providers of automated pharmacies worldwide. Plus, we’re the exclusive North American distributor of the revolutionary EffiMat and ClassicMat VLMs. At SencorpWhite, we combine our manufacturing capabilities with our proprietary Maple Street software to provide customers with the latest in custom, semi-custom and standard inventory management solutions.

By my assessment, the upcoming UDI requirement for serialization and tracking for medical device and instruments, from the point of manufacture to the point-of-use, provides an opportunity for market leaders in product identification technology. SencorpWhite is well-positioned to be a market leader in this area, and if you’re a manufacturer in the medical industry, we’d be happy to talk with you more about how we can help you comply with the FDA’s new UDI rule.

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