The FDA’s Medical Device Unique Identifier (UDI) system provides a standardized method to identify and track medical devices throughout their lifecycle. As a result, by using UDI, manufacturers, healthcare providers, and patients ensure better safety, traceability, and accountability. In this article, UCC will outline UDI, its components, and key requirements for manufacturers and stakeholders.
1. What is a Medical Device Unique Identifier (UDI)?
A Medical Device Unique Identifier (UDI) is a unique code used to identify and track medical devices from production to use. Therefore, the UDI system ensures that each device can be traced and monitored throughout its lifecycle, which is essential for product recalls or medical incidents.
Moreover, the UDI is made up of two main components:
- Device Identifier (DI): This fixed, mandatory part of the UDI identifies the manufacturer and the specific version or model of the device.
- Production Identifier (PI): This part can change and includes various details such as:
- Lot number: Identifies the production batch of the device.
- Serial number: A unique identifier for a specific device.
- Expiration date: Indicates the device’s expiration.
- Manufacturing date: Marks the production date of the device.
- Special Identification Code: For products like human cell or tissue-based devices.
This structure makes it easier to trace, manage, and ensure the safety of medical devices.
2. Who is a Device Labeler?
A Device Labeler is any individual or entity that applies or modifies a label on a device for distribution, without altering or replacing the label afterward. However, in some cases, simply adding the distributor’s contact information does not constitute a label modification.
Typically, the device labeler is the manufacturer. However, other parties may also take on this responsibility, including:
- Specification developers
- Single-use device reprocessors
- Convenience kit assemblers
- Repackagers
- Relabelers
These individuals or entities are responsible for ensuring that the device label complies with UDI requirements. Furthermore, they must also ensure that all necessary information is accurately included and maintained on the label throughout the device’s lifecycle.
3. Medical Device Unique Identifier Requirements
3.1. FDA Requirements of the Unique Device Identification (UDI) Rule
The FDA’s UDI rule mandates that medical device manufacturers (typically the producers) comply with the following:
- Include UDI on labels and packaging: Every device must feature a UDI on its label and packaging unless exceptions apply.
- Mark reusable devices with UDI: If a device is reusable, manufacturers must mark the UDI directly on the device. This ensures traceability during reuse.
- Submit information to the GUDID: Manufacturers must submit device details to the Global Unique Device Identification Database (GUDID). As a result, this international database enables easier device management, inspection, and recalls.
3.2. Labeling Format
The Medical Device Unique Identifier must be presented in two formats on the label:
- Human-readable text: The UDI must be printed in a way that humans can easily read and understand it.
- Machine-readable format: It should also be in a format like a barcode or QR code, which can be scanned automatically by devices for better efficiency and accuracy in tracking.
Both formats are essential for effective device identification and monitoring.
3.3. AccessGUDID
AccessGUDID is a publicly accessible database provided by the FDA in collaboration with the National Library of Medicine (NLM). As a result, it allows users, including patients, healthcare providers, and industry professionals, to search and retrieve information about medical devices. In addition, through AccessGUDID, you can:
- Quickly search for devices: Look up devices using criteria such as device name, company, or UDI.
- Perform advanced searches: Moreover, use multiple fields to refine your search and obtain more precise device information.
- Download GUDID data: Finally, export search results for research or device management purposes.
AccessGUDID is an invaluable resource for those needing to verify or learn more about medical devices.
4. Conclusion of Medical Device Unique Identifier
Understanding and implementing the Medical Device Unique Identifier (UDI) system is vital for ensuring the safety and traceability of medical devices. Therefore, manufacturers must adhere to the FDA’s labeling and submission requirements to maintain device accountability. Additionally, for further guidance on UDI compliance and more, feel free to contact UCC. Our team is ready to assist you with all your UDI-related needs.
For more information: FDA Guidance Labeling Medical Devices: All Critical Standards
