Unique Device Identification (UDI) is an alphanumeric code that marks and identifies medical devices.
These codes are created by manufacturers who follow internationally recognised standards and rules for device identification.
UDI provides a system for tracking and tracing medical devices. It also serves as an identifier in administrative processes, some of which are listed below.
This article will explain the structure of UDI and how it is displayed on medical devices. We will also discuss who issues UDIs, where they are published, and the benefits they offer. Additionally, we will compare UDI with UDID to clear up confusion and outline the requirements for UDI in the USA, Australia, and New Zealand.
A UDI consists of two main components: the Device Identifier (DI) and the Production Identifier (PI).
The Device Identifier is a mandatory, fixed portion of a UDI. It uniquely identifies a device’s specific version, model, and the labeller (manufacturer or entity responsible for the device.)
The Production Identifier is a conditional, variable portion of a UDI. It includes production-related information about the device, such as.
The PI is vital for tracking detailed production information. This information is essential for managing recalls, inventory control, and quality assurance.
UDI codes are displayed on product and package labels and, in some cases, directly on the device itself.
UDI can be presented in two main methods:
Reusable and reprocessed devices, such as surgical scalpels, endoscopes, and surgical forceps, require direct marking because product packaging is often discarded before.
Laser itching or similar techniques are used to apply the UDI number for such devices.
The human-readable format is the UDI code in alphanumeric text. This format must include both the Device Identifier and the Production Identifier.
The text can be displayed as a single line or multiple lines. It should be positioned near the UDI’s AIDC (Automatic Identification and Data Capture) version.
The machine-readable format uses AIDC technology to encode the UDI in a format that can be scanned and entered into computer systems automatically.
This format includes one-dimensional barcodes, two-dimensional barcodes, and RFID tags, which barcode scanners and other AIDC devices can read.
Ideally, the AIDC form of the UDI should be displayed in a single segment. However, it can be split into multiple segments if necessary. For example, the UDI might be presented in a linear and two-dimensional barcode: one for the DI and another for the PI segments.
Labellers can also opt to use multiple types of AIDC technology on a single device label, package, or device to accommodate users who employ different methods of UDI capture.
The quality of printed barcodes must adhere to the following standards and technical references:
Note – It must be explicitly indicated if the AIDC technology used to convey the UDI is not visible upon visual inspection of the device label or packaging. This disclosure ensures that users are aware of the presence of AIDC technology, even if it is not immediately apparent. Some cases where the UDI is not visible are as follows: Barcodes Printed in UV Ink: Surgical sutures may have their barcodes printed in UV ink on the packaging, requiring UV light to be visible. Laser-Etched Codes on Transparent Surfaces: IV fluid bags sometimes use laser-etched barcodes on the transparent bag material, which can be difficult to see without proper lighting. |
The issuance of a UDI device identifier is managed by accredited organisations that follow international standards. These organisations ensure that the UDIs are unique, consistent, and compliant with regulatory requirements.
Each health authority may create its custom list of approved organisations. Here are the primary entities responsible for issuing UDIs:
UDIs are published in centralised databases that act as information repositories. These databases help regulatory bodies, healthcare professionals, and manufacturers track and trace medical devices efficiently throughout their lifecycle.
Once a UDI is established, the data must be stored securely in the manufacturer’s repository. It is then submitted to the respective health authority’s Unique Device Identification Database (UDID) before the device enters the market.
Each country’s health authority maintains its own centralised database. These databases provide a searchable, public-facing index for devices within their respective markets.
Here are some examples.
Unique Device Identification and Unique Device Identifier Database are related but serve different purposes.
UDI is a unique code assigned to medical devices, ensuring each device can be distinctly identified throughout its lifecycle. For example, a pacemaker will have a UDI that includes a Device Identifier for the model and a Production Identifier for production details like the serial number and manufacturing date.
On the other hand, UDID is the database where these UDI codes and related information are stored and managed. For instance, the GUDID in the United States would store detailed information about the pacemaker, including its UDI, regulatory status, and production details.
UDI enhances traceability by providing a unique identifier for each medical device. This identifier allows for precise tracking throughout the supply chain, from manufacturing to distribution to the end user.
The PIP breast implant recall highlighted the importance of the UDI system. These implants, containing industrial-grade silicone, required the identification of 47,000 UK women who had received them. The implants did not have UDI, which made the process difficult and time-consuming. |
Enhanced patient safety is one of the primary benefits of UDI implementation.
With a unique identifier, healthcare providers can quickly identify devices subject to recalls or safety alerts. This rapid identification allows for the swift removal of potentially harmful devices from use, reducing the risk to patients.
FDA’s UDI system helped streamline the recall process during the 2020 recall of certain models of Medtronic’s MiniMed insulin pumps, which were found to have cybersecurity vulnerabilities. |
UDIs contribute to better inventory management by providing accurate and real-time information about medical devices.
Healthcare facilities can maintain precise device quantities, locations, and usage records. This accuracy reduces the risk of stockouts or overstocking and ensures that the right devices are available when needed.
Geisinger Health improved inventory efficiency by implementing a UDI-based inventory management system. The integration eliminated manual tracking processes, reduced human errors, and ensured precise inventory levels. This reduced over-ordering and product expirations and streamlined the tracking of approximately SKUs across their facilities. |
UDIs enable the collection of detailed data on device usage and outcomes, facilitating better analysis and reporting. This data helps identify trends and potential issues early, supporting proactive measures to address problems and improve device quality over time.
UDIs help manufacturers and healthcare providers meet national and international regulatory requirements. By maintaining accurate records of device identifiers, companies can demonstrate compliance during inspections and audits.
UDIs also simplify the reporting process to regulatory authorities, making it easier to submit required information and maintain up-to-date records.
UDIs play a crucial role in making recalls and safety alerts more efficient.
When a device is found to be defective or harmful, the UDI allows for precise identification and swift action. Manufacturers can quickly notify all stakeholders, including healthcare providers and patients, about the recall.
This targeted approach ensures that affected devices are promptly removed from circulation, reducing the risk of harm and maintaining trust in the healthcare system.
UDIs provide a consistent method for identifying medical devices across different regions and systems. This standardisation facilitates international trade and regulatory harmonisation, making it easier for manufacturers to comply with diverse regulations.
It also ensures that healthcare providers worldwide can access accurate and consistent information about medical devices, improving patient care and safety.
The FDA has established detailed requirements for the Unique Device Identification system to enhance the traceability and safety of medical devices in the USA. Here are the key elements of the FDA’s UDI requirements.
The UDI consists of two main components.
Additionally, device labellers must present dates such as manufacturing and expiration dates on device labels and packages in a standard format that aligns with international standards, specifically YYYY-MM-DD.
Manufacturers must submit UDI information to the Global Unique Device Identification Database (GUDID), which the FDA maintains and manages. This submission should include details about the device’s DI, PI, and other relevant information.
The FDA has established a phased implementation schedule for UDI requirements based on the device’s risk class. Higher-risk devices (Class III) have earlier compliance dates, while lower-risk devices (Class I) have later deadlines.
The FDA allows for certain exceptions and alternatives to the standard UDI requirements. These include.
The Therapeutic Goods Administration (TGA) has established specific guidelines for Unique Device Identification. Here are the key elements of Australia’s UDI requirements.
The UDI consists of two main components.
If a device is intended for more than one use and reprocessed between uses, the UDI must be directly marked on it. The manufacturer determines the direct marking method, but it must withstand normal usage and cleaning procedures for the device’s lifetime.
If there is insufficient space for AIDC and HRI carriers, the manufacturer shall decide which carrier to mark based on the best method for the expected end-use.
Direct marking exemptions apply for the following.
Unless exempt, medical and in vitro diagnostic (IVD) devices must comply with UDI requirements. Compliance is based on device classification.
Certain medical devices and IVDs are exempt from UDI requirements under Schedule 4 of the Therapeutic Goods Regulations 1990. These include.
While these devices are exempt, manufacturers can voluntarily choose to meet the UDI requirements.
Manufacturers must submit UDI information to the Australian UDI Database (AusUDID). In addition to the UDI-DI, manufacturers must submit device information, including.
Mandatory compliance will be phased in by device classification, starting with high-risk and implantable medical devices, followed by lower-risk devices. Full implementation and the launch of the AusUDID are expected in 2024, with staged compliance for different device classes over subsequent years.
The TGA recognises certain issuing agencies to ensure the uniqueness of the UDI. Recognised agencies include.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.Implementing the Unique Device Identification system is a significant step forward in enhancing medical devices’ traceability, safety, and efficiency. Adhering to the detailed requirements, manufacturers and healthcare providers ensure that devices are accurately identified and tracked throughout their lifecycle.
UDI requirements contribute to a safer healthcare environment, improve patient outcomes and facilitate medical device innovation. As global standards continue to evolve, staying informed and compliant with UDI regulations is essential for all stakeholders in the medical device industry.
No set standard or rule specifies the exact character length of UDIs. However, the character length is often limited by the AIDC technology used.
For example, a GTIN by GS1 can encode 8, 12, 13, or 14 digits, so the UDI length must conform to these lengths.
The UDI system must use characters and numbers from the invariant character set of ISO/IEC 646, 7-bit Coded Character Set for Information Interchange, including the following.
Yes, the UDI has a check digit. The check digit is used to verify the integrity of the UDI and ensure it has been correctly entered or scanned.
Issuing Agencies design the check digit rules to validate the UDI.
The Basic UDI-DI is the main identifier of a device model. It is key to device registration and regulatory activities such as certification.
The manufacturer or labeller of the device is responsible for complying with UDI system regulations and placing the UDI carrier on the device, label, and package.
An issuing agency is an organisation accredited to assign UDIs to medical devices. These agencies ensure that the UDIs are unique, standardised, and compliant with international regulations. Examples include GS1, HIBCC, and ICCBBA.
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