UDI and the Right 2D Barcode for Medical Devices

Product trackability in the healthcare industry is no longer a choice; it's a requirement.

Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (MDR) now mandate unique identification systems for specific medical devices to improve patient safety and streamline post-market monitoring processes.

The UDI system allows many medical devices—from advanced machines to specific consumables—to be tracked efficiently through a unique code. However, not all products fall under this mandate. Low-risk items, such as bandages, are typically exempt.

This article unpacks the concept of these numbers, why they matter, the role of GS1 and similar organizations, and why DataMatrix is the preferred 2D barcode for ensuring medical device compliance.

What is UDI?

A Unique Device Identification number is a system used worldwide to identify medical devices. It consists of a code that helps track and accurately identify devices.

The system has two main parts: Device Identifier and Production Identifier.

Device Identifier (DI): This part always tells us the device's model or version and who made it. It is typically an alphanumeric code.

Common DI standards include the Global Trade Item Number (GTIN) by GS1,  identifiers from the Health Industry Business Communications Council (HIBCC), and the International Council for Commonality in Blood Banking Automation (ICCBBA). These standards help label and track medical devices globally.

Production Identifier (PI): This part can change and includes details like the device's lot number, serial number, expiration date, or manufacture date. Whether or not these details are included depends on the device's regulations.

How UDI works

Manufacturers assign a UDI to each medical device, encoded and stored in centralized databases like the Global Unique Device Identification Database (GUDID) in the U.S. These databases hold critical details such as the device's manufacturer, model, and regulatory information.

Once encoded, the codes are made accessible through barcodes, such as GS1 DataMatrix or RFID technology. When scanned, these codes provide healthcare providers with essential data like lot numbers, expiration dates, and other production details, ensuring accurate device identification and reducing the risk of errors.

The system's success is crucial for patient safety, but it depends on proper implementation and adherence to regulatory standards.

Benefits of a product identification system  in healthcare

These types of codes offer important benefits for both manufacturers and healthcare providers. Some of the main advantages are:

Improved patient safety

They make it easier to track devices, reducing the chances of errors. Knowing which device is used helps healthcare providers ensure it's the right one for the patient.

These product codes also make it faster to find device details, reducing record mistakes. If a device has a problem or causes harm, it's easier to trace the issue, track batches for recalls, and manage them effectively.

Better Supply Chain Efficiency

Device identification numbers help manage and distribute medical devices worldwide. They play a key role in product authentication and counterfeit prevention, enabling manufacturers to track devices at every stage. This stops fake products from entering the market and ensures compliance with regulations.

Post-Market Surveillance and Reporting

The product identification system helps track devices throughout their lifecycle, improving post-market surveillance. This system helps find safety problems early and get unsafe devices off the market faster, improving patient safety.

Which types of medical equipment are required to have unique device identification?

The system applies to a broad range of medical devices, but not all devices are subject to the same regulations. The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act established three regulatory classes.

These classifications—Class I, Class II, and Class III—are based on the level of control needed to ensure the device's safety and effectiveness.

Class I Devices

Class I devices present minimal potential harm to users and are often simpler in design than higher-class devices. Examples include elastic bandages, enema kits, and basic surgical instruments.

Regulatory Scope: 95% of Class I devices are exempt from the requirements and premarket notification process. However, manufacturers must register their establishment and list their products with the FDA.

Certain reusable Class I devices, such as manual stethoscopes, may still require direct marking with these numbers.

The minimal risk associated with these devices justifies the relaxed regulations. They are unlikely to cause harm under normal usage conditions.

Class II Devices

Class II devices represent the largest category, encompassing 43% of all medical devices. These devices pose a moderate risk and often require additional controls to ensure safety and effectiveness. Examples include powered wheelchairs, pregnancy test kits, and surgical drapes.

Regulatory scope: Under FDA and EU MDR regulations, most Class II devices are required to have a unique device identification. However, there are exemptions, including certain custom-made devices (e.g., prosthetic limbs and orthopedic implants) and investigational-use devices (e.g., experimental diagnostic devices or clinical trial devices) in its testing phase.

The moderate risk associated with Class II devices necessitates traceability to monitor safety and effectiveness across the supply chain and usage lifecycle.

Class III Devices

Class III devices are the highest-risk category, representing about 10% of all medical devices. These devices sustain or support life, are implanted, or present a significant risk of harm if they fail. Examples include implantable pacemakers and breast implants.

Regulatory scope: All Class III devices must comply with stringent device identification regulations to ensure traceability from production through post-market monitoring.

Exemptions: Exemptions are rare but may apply to single-use devices intended for reprocessing or sterilization.

Due to their critical role in life-sustaining functions and the high risk of adverse outcomes, these devices require meticulous tracking and regulatory oversight.

Global adoption of  FDA standards for healthcare device identification

The system's adoption has gradually gained significant momentum over the past decade. In the U.S., the FDA regulation was finalized in 2013, setting a deadline for manufacturers to implement UDI on most medical devices by 2018.

The European Union's Medical Device Regulation, including requirements, became applicable in 2021. Other countries, like Japan, Canada, and China, have been aligning their device identification frameworks with global standards.

Why GS1 prefers DataMatrix over QR codes for unique device identification

GS1, the global organization that provides supply chain standards, prefers using DataMatrix over GS1 QR code for medical device identification for several technical and regulatory reasons. Here's why:

Size Efficiency

DataMatrix codes can store more information in a smaller area than QR codes. This makes them ideal for medical device labels, which often have limited space. The smallest size of a DataMatrix code that can still be effectively scanned is 10mm x 10mm (approximately 0.39 x 0.39 inches).

In contrast, QR codes must be slightly larger for the same data capacity. The smallest functional QR code is typically around 25mm x 25mm (about 1 inch square), making DataMatrix the more space-efficient option for devices with limited labeling space.

The compact nature of DataMatrix allows manufacturers to encode detailed device information, such as lot numbers, expiration dates, and serial numbers, while still fitting on small device labels.

Higher Data Density

DataMatrix codes are specifically designed for applications where space is at a premium. The code can store significant information in a small area, making it more suitable for devices with small surfaces, like surgical tools or vials.

While capable of storing data, QR codes typically require more space for the same amount of information, making them less ideal for small devices.

Better Scanning and Readability in Healthcare Settings

In healthcare, 2D barcodes like DataMatrix and QR codes face several challenges that can make them harder to read. These challenges include:

Moisture: Barcodes can get wet from cleaning, spills, or patient contact.

Dirt and Smudges: Gloves and hands can leave dirt or oil on the barcodes.

Chemical Exposure: Cleaning products can damage or blur barcodes.

Physical Wear: Scratches or fading from use can make barcodes hard to scan.

These issues are common in medical settings, where barcodes must be read in harsh conditions.

Error correction

GS1 prefers DataMatrix for medical device identification because of its built-in error correction. DataMatrix codes work even if part of the code is damaged or dirty, thanks to 25-33% error correction levels. This makes DataMatrix more reliable in emergency and regular situations.

QR codes offer more flexibility, with 7% to 30% error correction options. However, this flexibility can make them less consistent regarding scanning reliability depending on how much correction is used.

Higher error correction also requires more data to be stored in the QR code, which means the code itself becomes larger. A larger QR code with a higher error correction level will be able to withstand more damage and still be readable, but it may take up more space.

DataMatrix's fixed and stronger error correction makes it a better choice for healthcare, where barcode scanning needs to work in challenging environments.

QR Codes in Healthcare

While GS1 DataMatrix codes are preferred for UDI, QR codes also play a significant role in healthcare. Their versatility and ease of use make them valuable for various applications, each tailored to enhance patient care, streamline operations, and improve accessibility.

Here’s where they are applied:

• Medical and emergency response IDs (Note: Due to the sensitive nature of the data, robust security measures (e.g., encryption and access controls are essential to protect patient privacy and comply with regulations like HIPAA. Ensure the provider implements these safeguards effectively.)
• Infection control and contact tracing
• Patient check-in and intake

Clarifying the Right 2D Barcode for Healthcare Compliance

The UDI system streamlines medical device tracking and regulatory compliance. This blog clears up which   2D barcode is prescribed for this application, helping manufacturers select the right one for their needs.

The system improves patient care by enabling quick recall responses for healthcare providers. It also helps manufacturers simplify FDA compliance, secure supply chains, and enhance device traceability.

By following GS1 guidelines, manufacturers can confidently use GS1 DataMatrix barcodes to meet regulatory requirements, ensuring efficient tracking and safety in the healthcare sector.

DISCLAIMER: We acknowledge that GS1, as well as the materials, proprietary items, and all related patents, copyright, trademark, and other intellectual property (collectively, “intellectual property”) relating to its use, are the property of GS1 Global, and that our use of the same shall be in accordance with the conditions provided by GS1 Global.