Traceability in the
medical device industry

Article

Traceability in the medical device industry

In the rapidly changing world of medical possibilities and associated medical devices, as well as in the linked pharmaceutical industry, traceability is becoming increasingly important. Traceability plays a larger role when products are regularly recalled or come into the news because of a alleged danger to the user.

Traceability systems are a crucial part of the production process of medical products. Further automation and professionalisation offer a chance to:

  • Not only comply with strict regulations
  • But also to improve the efficiency and reliability of the production process

In this knowledge article, we list various technologies for traceability in the medical industry. We delve into the core of what traceability means in the context of medical equipment, the current standards and regulations, and how you can integrate these into the production process to not only meet legal requirements but also to gain an edge in the market through improved quality control and process efficiency.

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International regulations

The regulations, such as the FDA rules in the US and the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) in Europe, require manufacturers of medical devices to be able to trace each product from raw material to end-user. For the pharmaceutical industry, the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in Europe are in effect. These regulations are designed to ensure patient safety and hold manufacturers accountable.

Foundation of a strong traceability system

Traceability in the production of medical devices revolves around:

  • The ability to collect various parameters at certain production moments
  • Tracing the location of an item through stored data

In the medical manufacturing industry, where safety and effectiveness of products are of critical importance, traceability is essential for:

  • Quality control
  • Compliance with regulations
  • Risk management

For engineers working on the automation and professionalisation of traceability systems, it is important to have a thorough understanding of the requirements. This includes accurately applying unique device identifiers (UDIs) to products, tracking production data, and ensuring traceability throughout the entire supply chain.

It’s not just about complying with regulations, but also about building a system that promotes efficiency and quality assurance at every stage of the production process. By integrating the latest technologies and methods, you can create a system that is not only compliant but also contributes to the overall optimisation of the medical devices production process.

For the pharmaceutical industry, these rules apply to packages and manuals. Since individual products are not traced, there is less room to optimise the production process through the traceability system.

Traceability technologies

In the medical manufacturing industry, there are two key UDI (Unique Device Identification) technologies that are applied for tracing produced medical devices. These are barcode, Data Matrix, or QR code systems, and RFID technology.

 

  • Barcode, Data Matrix, or QR code systems are widely used traceability systems in production environments. These systems are relatively easy to implement and can be effectively used to track essential information about products, such as production data, expiry dates, and batch numbers.
    • For manufacturing companies looking to automate these systems, integration with production databases, ERP systems, or blockchain offers a seamless way to collect and manage data. In addition to the medical device industry, there is the special Pharmacode for the pharmaceutical industry, a specific bar or data code for pharmaceutical products.
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  • RFID-technology takes a step further by enabling wireless tracking and identification of products. RFID stands for Radio Frequency Identification. RFID tags can be placed on or within medical devices, allowing for real-time tracking throughout the entire production and distribution chain. This not only provides a higher level of traceability but also improves efficiency through automatic inventory management and reduced error margins.
    • RFID tags are also useful in situations where non-line-of-sight reading is required, such as in large warehouses or when products are packaged in a way that makes scanning barcodes, Data Matrix, or QR codes difficult. However, RFID tags can sometimes encounter interference issues with surrounding materials. There can also be concerns about security since the tags can be read wirelessly, which may lead to unauthorized access to sensitive information.

In practice, a combination of these technologies can be used to create a robust and versatile traceability system.

Integration of traceability systems in the production process

Integrating traceability into the production process of medical devices requires a thoughtful approach, combining technology with process design. When designing the production process, you should already know:

  • Which traceability technology you will use from the receipt of raw materials to the final distribution of the product
  • At what point in the production chain the UDI will be applied
  • At which points in the production chain checks must take place

When designing the physical production lines, consideration must be given to the placement and type of traceability systems. You want to apply a traceability marker in your database at strategic points. This could be, for example, at the entry and exit points of the production line, or at critical control points where real-time tracking of products is required.

Preferably, you link the traceability system directly to the quality system. Quality control and assurance are inseparably linked with traceability. By integrating traceability systems with quality control processes, you can not only trace the origin of a product but also ensure its quality throughout the entire production process. This ensures a higher level of product safety and leads to increased efficiency (read our article on Interim quality control).

  • With barcode-, Data Matrix and QR-code systems a physical, visible marking is needed on the product. This must be applied, for example, by laser, printing, or labeling. Then, strategically placed scanners and cameras along the production line are required to read codes at different stages of production. These scanners must be integrated with the production and transport stations to ensure a continuous flow of data.
  • For RFID technology, an RFID tag must first be applied on or within the product. After that, it’s essential to place RFID readers at strategic points in the production line.

The integration of a UDI technology with automation systems enables manufacturers not only to trace products that are on the market. It also allows the movement of products through the entire production line to be tracked, leading to improved process control and efficiency.

Automation and real-time data collection play a key role in this traceability. Automation allows data to be collected efficiently and accurately, reducing the chance of human error. Real-time data collection provides immediate insights into the production status, enabling quick responses to any issues.

The entire production line must also be flexible enough to adapt to future technological upgrades or changes in production processes. This means that machines and systems must be modular and scalable, so new technologies or traceability requirements can be easily integrated without having to redesign the entire production line.

Finally, it is crucial to ensure close collaboration between machine builders, software developers, and production engineers. This collaboration ensures that traceability systems are effectively integrated into both the physical and digital aspects of the production line, leading to seamless, efficient, and reliable production of medical devices.

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Challenges in traceability

For smaller, or start-up manufacturers, implementing a traceability system can seem like an insurmountable challenge. The required investment in resources and time, combined with a global supply chain, call for a solid approach to establishing a reliable system.

Additionally, there is little standardisation regarding global regulations and systems. This makes the choice and implementation of a traceability system unnecessarily complex.

The future of traceability

The future of traceability in the production of medical devices is characterised by the integration of emerging technologies such as:

  • Blockchain
  • Artificial Intelligence(AI)
  • Machine learning

These technologies promise to improve the accuracy and efficiency of traceability systems through advanced data analysis and automation. We can also expect an increase in the use of IoT (Internet of Things) for real-time monitoring and tracking.

These innovations will lead to even smarter, more connected, and fully automated traceability solutions, thereby further increasing the safety and reliability of medical devices, as well as further improving the efficiency of the production line.

Continuous innovation

In the medical manufacturing industry, where accuracy and reliability are essential, traceability plays a crucial role. Looking to the future, with the integration of advanced technologies such as AI, machine learning, and IoT into our production processes, it becomes increasingly clear that the path to success lies not only in embracing new technologies but also in continuously revising and improving methodologies. Continuous innovation and adaptation to new developments are part of this.

By leading in technological developments, medical device manufacturers can not only meet regulatory standards but also improve their efficiency and product quality. The medical manufacturing industry has the responsibility to ensure the quality and safety of its products, not just for the present but also for future generations. The future of medical devices is promising, and with a thoughtful approach to traceability, the possibilities are endless.