How to Use the FDA UDI Database
Thursday September 17, 2015
What is UDI?
The Global Unique Device Identification Database (GUDID) is a place to store information about different medical devices in a way that is clear and concise. It serves as a reference catalog for every device with an identifier. Medical devices cover a wide range of products, so the GUDID was created to give medical devices a unique identifier that clearly distinguishes one product from another. The database will be utilized by healthcare providers and patients and most of the information will be open to the public through AccessGUDID.
How UDI Works
The UDI system will provide a consistent and standard way for medical devices throughout their distribution and use for a variety of people. Understanding the process of how the system works is important before moving forward. The FDA has issued the complete Global Unique Device Identification Database (GUDID): Guidance for Industry. According to the FDA, this document describes key GUDID elements such as account management, user roles, the device identifier (DI) module, DI record life-cycle, package configurations and the two GUDID submission options (web interface and HL7 SPL). The FDA is encouraging labelers to refer to the guidance document and begin submitting necessary data to the GUDID. There are also more technical documents that can be found on the FDA website that can assist different industries with the requirements they need in order to fully comply with the UDI requirements.
Benefits of UDI
The GUDID provides a resource to report adverse effects of devices and hasten reactions to recalls. The UDI system allows for more accurate reporting, reviewing and analyzing of adverse event reports so that problems can be identified and corrected in a timely manner. It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls. UDI implementation will improve patient safety, modernize device post market surveillance and facilitate medical device innovation.
Arbour Group's experienced professionals are extensively trained to evaluate a client's readiness as well as assist with UDI Compliance. If you have questions about UDIs or UDI compliance, the experts at Arbour Group are here to help.