The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or to be used more than once by multiple patients to be marked with a permanent Unique Device Identifier (UDI). This is known as UDI direct marking.
The UDI system seeks to improve the identification of medical devices by making it possible to rapidly and definitively identify a device and certain key attributes that affect its safe and effective use.
The FDA does not specify any particular approach to directly mark devices. The labeler should determine the appropriate method to provide such a marking on the device itself.
The most reliable way to ensure a UDI lasts for the life of a multi-use device is by marking the device itself with permanent a mark, rather than a temporary package or label, which can be discarded, torn, obscured, wiped off, or easily degraded.
In the ever-evolving landscape of healthcare, ensuring patient safety and device accountability is paramount. One critical innovation that is helping to enhance these aspects is the Unique Device Identification (UDI) system, designed to uniquely identify medical devices. The UDI system provides a standardized method for tracking devices from manufacturing through their lifecycle, ensuring that any issues such as defects, recalls, or safety concerns can be quickly addressed.
The Unique Device Identification (UDI) system assigns a unique alphanumeric code to each medical device, enabling its traceability throughout the healthcare system. This system was created to improve the accuracy and safety of medical device usage, making it easier to track devices, report adverse events, manage recalls, and streamline device inventory management.
The UDI code typically appears on the device packaging and the device itself in both human-readable and machine-readable formats, often using barcodes or 2D matrix codes.
A UDI is made up of two key parts:
Device Identifier (DI): This is the fixed part of the UDI that uniquely identifies the device model. The DI includes information about the device’s manufacturer and its specific type or version.
Production Identifier (PI): The PI is the variable part of the UDI. It can include details like the device’s lot or batch number, serial number, manufacturing date, and expiration date. These variables help identify specific units or batches of the device.
Together, the DI and PI provide comprehensive, accurate information about a medical device, aiding in its traceability and accountability.
Improved Patient Safety: By accurately identifying devices, the UDI system helps prevent the use of recalled, defective, or expired devices. It also reduces the likelihood of human error when administering treatments.
Streamlined Device Recall Process: In the event of a defect or safety concern, the UDI system allows for faster, more targeted recalls. This helps ensure that affected devices are removed from circulation promptly, reducing risks to patients.
Enhanced Traceability and Reporting: With UDI, manufacturers, regulators, and healthcare providers can track devices through the supply chain. This improves the ability to detect trends in device performance, adverse events, and other critical data.
Better Inventory Management: Healthcare providers can utilize UDI to manage inventories more effectively, ensuring that they are aware of the exact devices they have in stock and can quickly identify when devices are nearing expiration or need replacement.
Increased Regulatory Oversight: For regulatory bodies like the FDA, the UDI system enhances the ability to monitor devices post-market, ensuring compliance and improving overall safety standards.
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