The medical device manufacturing industry is highly competitive and highly regulated. Manufacturing high-quality, life-saving products requires strict oversight of all aspects of production—from inventory to manufacturing and distribution to the end user. The Food and Drug Administration (FDA) has established a unique device identification (UDI) system to track medical devices with the end goals to improve patient safety, strengthen post-market surveillance, and improve the continued advancement of medical devices.
According to “” and other information posted on FDA.gov, the UDI final rule was released in 2013 and established a system to identify certain medical devices through their distribution and use. While there is a phased approach to this system, labels on the devices and packaging will include information about the labeler, the specific model or version of the devices, and must be in a format that includes both plain-text and automatic identification and data capture (AIDC) technology. A production identifier (PI) must also be included in the labeling that identifies the lot or batch number within which the device was manufactured, serial number, expiration data, date of manufacture and the identification code for human cell, tissue, or cellular and tissue-based product that is regulated as a device.
Strengthen Medical Device Inventory Management with a Good Inventory System
Clearly there is a lot of precise data that will need to be captured and associated with each medical device released into the marketplace. Medical device manufacturers will need to take steps to strengthen inventory management whether it’s with simple assembly or for more complicated manufacturing operations. Basic enterprise resource planning (ERP) or inventory management software isn’t enough to maintain UDI compliance.
At the heart of the UDI system is a reliance on the simplicity and accuracy gained by barcoding each individual medical device. The UDI barcode typically consists of several pieces of important data that are concatenated together so that it can be captured with a single scan. This barcode commonly contains the item identifier, a serial or lot number, an expiration date, and several other pieces of data important to the supply chain. The goal is to scan this single barcode and inform all handlers of this critical information.
A barcode-based inventory system that is capable of intelligently printing and parsing this important barcode data is critical. The system must be able to interpret the complicated data standard and inform the host system. Furthermore, the ability to configure this complicated barcode parsing is important to support variations across different vendors. Panatrack has developed a highly-flexible method to handle this UDI barcode format and has implemented it in our PanatrackerGP Inventory module.
extends the functionality of Microsoft Dynamics GP to handheld computers with barcode scanners. You can track inventory from receiving, adjustments, site transfers or bin moves, and stock count with PanatrackerGP. Advanced features further strengthen inventory movement with order fulfillment, pick and pack, label printing, assembly, direct transfer and shipping integration. Automating inventory tracking saves valuable time, improves productivity of your team and provides a higher level of control over the inventory and finished products, whether they are in your warehouse, in distribution, or being used by a customer.
The FDA’s UDI system doesn’t have to be complicated or time-consuming, especially when you have the right technology in place. Contact Panatrack for more information about improving UDI compliance with the support of PanatrackerGP.
By Panatrack,
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Medical device regulations are clearly stricter than other manufacturing functions, for good reason. That’s why med device manufacturers must invest in modern technology, to stay current and ensure compliance.