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Labeling of Medical Devices with QR Codes (UDI - Unique Device Identification)

Labeling of medical devices with QR codes (UDI - Unique Device Identification) is a system that facilitates the tracking, monitoring, and identification (serialization) of medical devices. UDI ensures that medical devices have a unique identifier, making these products easily readable. Serializing and labeling products brings significant advantages to manufacturers, importers, warehouses, pharmacies, hospitals, and healthcare institutions.

What is UDI?
Unique Device Identification (UDI) is a standard that requires medical devices to have a unique identifier or code. This code allows each device to be uniquely identified.

Advantages of UDI:

  • Patient safety: UDI helps reduce incorrect device usage and errors.
  • Device tracking: Healthcare institutions and hospitals can better track where medical devices are and when they are used.
    • Product recall: Recall of faulty or dangerous products can be done more quickly and effectively.
  • Regulatory compliance: UDI is used to comply with regulatory requirements. (Product Tracking System)

    • UDI Format: UDI typically consists of two parts: Device Identifier (DI) and Production Identifier (PI). DI includes the product's type and manufacturer information, while PI can include the product's production date, expiration date, and other specific characteristics.

    Application Areas: UDI can be used in many categories of medical devices, including implants, devices, surgical instruments, diagnostic devices, and medical equipment.

    Regulations: Many countries and regions have begun to adopt the UDI system for medical devices. For example, in the United States, the FDA (Food and Drug Administration) has implemented UDI requirements. In Turkey, UDI transitions have become more significant with the implementation of the Product Tracking System, providing significant ease in the shipment of the product among stakeholders.

    Application Methods: UDI can be applied to medical devices on their packaging, labels, or directly on the device itself using methods like laser marking or barcode labeling.

    Labeling medical devices with QR codes (UDI) contributes significantly to the medical industry's efforts for better traceability, safety, and compliance with regulations. This enables medical devices to be used and tracked in a safer and more effective manner.

    UDI Barcode Consists of Two Main Components

    Device Identifier (DI):

  • Identifies the manufacturer: Contains the name of the company producing or importing the product.
  • Device type: Specifies the type, model, or category of the device.
  • Specific product features: Can include special features of the product, such as its batch, version, or variant.

    • Production Identifier (PI):

  • Product serial number: Contains the unique serial number of the device.
  • Manufacturing date: Indicates the date the product was manufactured.
  • Expiration date:Determines the product's usage period.
  • Product batch number:Determines the production batch.
    • May include features that vary based on the expiration date or production date of the product, such as usage time.

    Some UDI Standards

  • ISO 15459-1 and ISO 15459-2: The ISO 15459 series are general standards used to create unique identifiers for medical devices and implement the UDI system. ISO 15459-1 defines the structure and semantics of UDI, while ISO 15459-2 covers UDI data formats and coding rules.

  • FDA UDI Regulations: In the United States, the FDA (Food and Drug Administration) has developed comprehensive guidelines and regulations to implement the UDI system for medical devices. FDA's UDI regulations cover labeling, reporting, and tracking of medical devices.

  • EU MDR and IVDR: In the European Union, UDI requirements for medical devices are regulated under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). These regulations include details on UDI labeling, registration, and tracking of medical devices.

  • GS1 Standards: GS1 is an international organization that develops standards for the unique identification and tracking of products worldwide. GS1 standards support UDI applications, particularly using barcode and RFID technologies.

  • AAMI TIR36: The Barcode Standard for Medical Devices (AAMI TIR36) provides detailed guidelines on barcode labeling for medical devices.

  • HIBCC (Health Industry Business Communications Council) Standards: HIBCC is an organization that develops unique identification and labeling standards for the healthcare industry. HIBCC standards can be used for the UDI system.

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    Keywords

    QR Codes UDI - Unique Device Identification Medical Devices Patient Safety Device Tracking Product Recall Regulatory Compliance UDI Format ISO Standards FDA Regulations EU MDR GS1 Standards AAMI TIR36 HIBCC Standards

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