The counterfeiting of health products is a serious and growing concern, and it has come at the forefront of the public mind in recent years with several strict regulations aimed at improving traceability and protecting patients and consumers from harm. Today, all prescription pharmaceuticals sold in the EU and US are subject to complete end-to-end traceability from the point of manufacturing to the point of dispensing. However, compliance for medical devices is not as strict.
Medical devices are an extremely broad category, covering everything from bandages and personal protective equipment (PPE) to pacemakers and ventilators. The implications of counterfeit medical devices can also vary greatly, from not performing quite as intended to putting patients and healthcare staff at serious risk of harm. Even seemingly ‘low[1]risk’ devices such as PPE and face masks can have potentially life-threatening implications if they are not fit for purpose.
Counterfeiting is a serious problem in the 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.
During the pandemic, many companies not previously manufacturing medical devices entered the marketplace with disposable masks and PPE to satisfy a dramatic increase in demand – and not all companies have manufactured products to the high standards required for use in medical settings. According to the National Institute for Occupational Safety and Health, 60% of KN95 face masks evaluated during the COVID-19 pandemic in 2020 and 2021 did not meet the requirements approved for healthcare use in the US.1
While we have come a long way since the start of the pandemic, this is still a significant issue, with COVID-related medical device fraud regularly topping the list of Interpol’s Operation Pangea. In March 2020, Interpol seized some 37,000 counterfeit medical devices, most of which were surgical masks.2 The most recent operation, which ran from 3–10 October 2023, led to the seize of approximately 11,000 counterfeit COVID-19 test kits in Australia alone.3
The global rise in e-commerce has played a significant role in promoting counterfeit sales of medical devices, with online marketplaces and e-commerce platforms offering a convenient place for consumers to shop and compare prices to find the best deals 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.4
The sale of counterfeit medical devices is, first and foremost, a safety concern but can also have significant economic repercussions. Counterfeit medical device sales distort competition and cause damage to legitimate producers who may experience direct loss of sales or see their reputation and brand name tarnished by counterfeit products using legitimate company trademarks.
What more can be done to protect against counterfeit medical devices?
