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BARCODING, LABELLING & PACKAGING
COMBATTING MEDICAL DEVICE COUNTERFEITS WITH 2D CODES
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 upcoming EU Medical Device Regulation (EU MDR), is not as strict. The medical device sector should take inspiration from the deployment of serialisation via 2D codes within pharmaceuticals. Taking a step beyond current legislative requirements, can reduce the risk of counterfeit products further, and bring additional benefits to both end-users and manufacturers, as Bart Vansteenkiste, Global Life Sciences sector manager, Domino Printing Sciences, explores.
ventilators. The consequences of using counterfeit medical devices can also vary greatly, from sub- optimal performance or improper function to causing severe harm to end users. Counterfeiting is a serious problem in the
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global medical device industry. Vulnerabilities in global supply chains were brought to the fore at the very start of the COVID-19 pandemic, when counterfeit test kits, face masks, and PPE appeared seemingly overnight. Many companies that had not previously manufactured medical devices entered the marketplace with disposable masks and PPE to satisfy a dramatic increase in demand – and not all companies manufactured products to the standards required for use in medical settings. During the COVID-19 pandemic, authorities in 90 countries confiscated more than $14 million worth of counterfeit antiviral medications, face masks, and over-the-counter test kits through a global
edical devices are an extremely broad category, covering everything from bandages and personal protective equipment (PPE) to pacemakers and
operation called Pangea XIII. In total, authorities around the globe confiscated nine million units of illicit and counterfeit products. While we have come a long way since the start of the pandemic, this is still a significant issue. Interpol’s most recent operation, which ran from 3 to 10 October 2023, led to the seizure of approximately 11,000 counterfeit COVID-19 test kits in Australia alone. The global rise in ecommerce has played a
significant role in promoting counterfeit sales of medical devices, with online marketplaces and ecommerce platforms offering a convenient place for consumers to shop and compare prices to find the best deals – or access products not available in their local markets – while providing a breeding ground for counterfeit products. Findings from the US Government Accountability Office have suggested that as many as two of every five consumer products available online through third-party retailers could be counterfeit. The sale of counterfeit medical devices is, first
and foremost, a safety concern but can also have significant economic repercussions. According to the World Health Organization, around two billion people worldwide lack access to necessary medical devices and pharmaceuticals,
which has driven the demand for lower-cost products and increased the supply of counterfeit products. This is especially true for those 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 upcoming EU Medical Device Regulation (EU MDR) stipulates that manufacturers of medical devices for sale within the EU must adhere to guidelines to ensure their products are safe to use. The regulations cover all medical devices sold in the EU, irrespective of the manufacturer’s location. Whilst strict, the EU MDR currently contains
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. Publication and full functionality of EUDAMED
are expected to be in place by the end of 2024, and full use will be mandatory for all medical
14 SEPTEMBER 2024 | FACTORY&HANDLINGSOLUTIONS
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