What You Need to Know About a UDI Implementation Strategy
In 2007, the government passed the Food and Drug Administration Amendments Act (FDAAA). This act required the Food and Drug Administration (FDA) to establish a unique device identification provision for the purpose of increasing patient safety by improving the handling of medical device information.
In 2013, the FDA implemented the Unique Device Identification (UDI) System. In this system, all medical devices distributed in the United States must be registered and must include a UDI – a numeric and/or alphanumeric code that identifies the device, its model type, and any current production information.
If you have not thought about your UDI implementation strategy, now is the time, as, by 2020, all medical devices must have a UDI.
Why UDI with Net at Work? Hear from Abraham Farhan, General Manager at OPHTEC BV.
The device identification system provides manufacturers and distributors with a universal set of standards to manage devices, which eliminates the duplicate codes that result in poor quality standards and the inability to track a device in the event of a recall.
In 2015, the FDA required medical device labelers to register UDIs for implantable, life-supporting, and life-sustaining medical devices. This is an important step toward increasing the traceability, transparency, and accuracy across the global healthcare supply chain.
The new legislation will also offer benefits such as:
Enhanced Reporting Accuracy
Because UDIs make devices easily identifiable and trackable, manufacturers can find and review product information more quickly and accurately during adverse events like recalls. As a result, such issues are solved much more quickly and efficiently.
Reduction of Medical Related Errors
Because UDIs enable healthcare professionals to quickly and precisely identify devices and obtain important data/device characteristics, the quality of care provided will improve while negative medical related issues will be reduced.
With global standardization, manufacturers, distributors, and healthcare facilities can effectively manage medical device recalls and their potential consequences. This provides a foundation for a globally secure distribution chain that addresses counterfeiting.
In addition to assisting with device data management, UDIs help resolve widespread labeling challenges.
Using the Device Identification System, manufacturers must:
- Create a globally unique Device Identification (DI) code.
- Create and maintain descriptive attributes for each device.
- Submit the DI and required descriptive attributes to the FDA’s Global UDI Database (GUDID).
- Include both Device Identifier and Production Identifier (lot, batch, serial) information on the product, either etching it onto the device or affixing a label to it.
This change is significant – and mandatory – for the worldwide medical field and all medical devices must contain a UDI by 2020.
Are you overwhelmed? Do you have questions? Do you need help? Contact us today.