The counterfeiting of health products is a serious and growing concern, with governments and regulators taking increasing action to improve traceability and protect patients and consumers from harm. Today, all prescription pharmaceuticals sold in the EU and the US, and the top 300 pharmaceutical brands in India, are subject to complete end-to-end traceability from the point of manufacture to the point of dispense. However, compliance for medical devices, introduced in the forthcoming EU Medical Device Regulation (EU MDR), is not as stringent.
The medical device sector should draw inspiration from the implementation of serialisation via 2D codes within pharmaceuticals. Going a step beyond current legislative requirements can further reduce the risk of counterfeit products and bring additional benefits to both end-users and manufacturers, as Bart Vansteenkiste, Global Life Sciences Sector Manager at Domino Printing Sciences, explores.
The State of Counterfeiting within the Medical Device Sector
Medical devices encompass a wide range of products, from bandages and personal protective equipment (PPE) to pacemakers and ventilators. The consequences of using counterfeit medical devices can vary significantly, from sub-optimal performance or improper function to causing severe harm to end users.
Counterfeiting is a serious issue in the global medical device industry. Vulnerabilities in global supply chains became evident at the onset of the COVID-19 pandemic when counterfeit test kits, face masks, and PPE appeared almost overnight. Many companies that had not previously manufactured medical devices entered the market with disposable masks and PPE to meet the sudden surge in demand. However, not all these companies produced products that met the standards required for use in medical settings. During the COVID-19 pandemic, authorities in 90 countries confiscated over $14 million worth of counterfeit antiviral medications, face masks, and over-the-counter test kits through a global operation called Pangea XIII. In total, authorities worldwide seized 9 million units of illicit and counterfeit products.
Although significant progress has been made since the start of the pandemic, counterfeiting remains a pressing issue. Interpol’s most recent operation, which ran from 3 to 10 October 2023, resulted in the seizure of approximately 11,000 counterfeit COVID-19 test kits in Australia alone.
The global rise in e-commerce has significantly contributed to the proliferation of counterfeit medical devices. Online marketplaces and e-commerce platforms provide a convenient way for consumers to shop and compare prices, often to find the best deals or access products unavailable in their local markets. However, these platforms also facilitate the sale of counterfeit products. Findings from the US Government Accountability Office suggest that up to two out of every five consumer products available online through third-party retailers could be counterfeit.
The sale of counterfeit medical devices is primarily a safety concern but also has significant economic repercussions. According to the World Health Organization, around 2 billion people worldwide lack access to necessary medical devices and pharmaceuticals, driving the demand for lower-cost products and increasing the supply of counterfeits. This issue is particularly pronounced in low- and middle-income countries, which spend an estimated $30.5 billion on substandard and counterfeit medicines, raising disease prevalence, wasting resources, and increasing out-of-pocket spending.
Medical Device Regulation Today
The EU Medical Device Regulation (EU MDR) mandates that manufacturers of medical devices for sale within the EU must adhere to guidelines ensuring their products are safe to use. The regulations cover all medical devices sold in the EU, regardless of the manufacturer’s location.
While strict, the EU MDR currently includes only minimal requirements for individual device identification. Under the regulations, all medical devices must be assigned a unique device identification (UDI) code and have their UDI recorded, indexed, and registered in EUDAMED, the Central European Database for Medical Devices.
The publication and full functionality of EUDAMED are expected to be in place by the end of 2024, with full use mandatory for all medical device manufacturers, following staggered deadlines from 2026 to 2028.
The UDI includes:
- Device identifier: A unique text code for each specific model of a device. This information is static and remains the same for all instances of the product model.
- Production identifier: A variable text code comprising one or more variable characteristics, such as the date of manufacture, expiration date, lot number, or serial number.
Initially, serialisation and identification of products down to the individual item level will only be required for active implantable devices, such as pacemakers, ventilators, and internal glucose monitors. However, broader medical device manufacturers could benefit from equipping their production lines with technology to enable both UDI compliance and serialisation.
This forward-thinking strategy would help combat the rise and risk of counterfeit medical devices and future-proof manufacturing lines should serialisation requirements extend to more product groups. Additionally, implementing serialisation can provide substantial benefits by tracking a product’s progression from creation to end user, gaining supply chain data to enhance operational and commercial performance, as evidenced by the deployment of serialisation within the pharmaceutical sector.
The Hidden Benefits of Serialised Track and Trace
In recent years, many global regions have mandated serialisation requirements to enable the tracking and tracing of all pharmaceutical products throughout their journey in the supply chain, from manufacturer to end user. Current legislations include the EU Falsified Medicines Directive (EU FMD) and the US Drug Supply Chain Security Act (DSCSA). A similar regulation is being rolled out by the Ministry of Health in India, with an initial phase covering the top 300 pharmaceutical brands launched in 2023.
The benefits of serialised track and trace in boosting patient safety and the security of legitimate medicines are well documented. Additionally, the wealth of data generated through serialisation has enabled pharmaceutical manufacturers to build efficiencies in the broader supply chain, enhancing production line efficiency, access to supply chain data, and overall operational performance.
Moreover, serialisation has opened up new commercial opportunities in other industries, laying the foundation for digital marketing capabilities such as personalised consumer engagement and improved brand positioning. Through serialisation, manufacturers can gain key insights into a product’s lifespan and distribution trends, facilitating strategic planning. This data could, regulations permitting, allow sales teams to engage more effectively with pharmacy chains and retailers to improve sales performance or develop consumer-focused marketing strategies.
Applying product serialisation also helps protect patient and consumer health and safety by making product information more accessible, dynamic, and consumer-friendly. Embedding serialised data within scannable 2D codes allows medical device companies to provide easy access to product-specific information, such as user guides, ensuring that guidance is up-to-date and available in accessible formats.
Furthermore, the cost of serialisation through 2D codes has significantly decreased since the introduction of the EU FMD and US DSCSA, making it more efficient and affordable to implement across various markets. Today, serialised technology is used in many low-cost sectors, including fresh produce and postage stamps.
Conclusion
The addition of serialisation via 2D codes for medical devices is a small step beyond what is already required under EU MDR compliance, but it represents a giant leap in reducing the risk of counterfeit products and offering numerous benefits to both end-users and manufacturers.
Adopting protocols for medical devices based on well-known and trusted serialisation procedures is essential for creating a secure system that ensures transparency and accountability in the medical device sector. Advanced traceability metrics could also allow for further supply chain analytics using artificial intelligence and machine learning tools. With a comprehensive data set enabled by product serialisation, these tools could analyse vast quantities of data to identify trends and inconsistencies in the supply chain.
Globally, an increasing number of manufacturers outside the pharmaceutical sector are recognising the opportunities of 2D code-enabled serialisation. For those in the medical device sector who have not yet explored these possibilities, the time to act is now.
