Packaging, supply & logistics
Tamper-proof and traceable With approximately one in ten medical products in low and middle-income countries either substandard or falsified, and WHO-commissioned work estimating tens of thousands of additional deaths (e.g., malaria and childhood pneumonia) due to substandard and falsified medicines, there is clearly a strong need to secure the integrity of the medical supply chain. Add to that the financial cost of counterfeit products – analysts estimate the global counterfeit pharma trade at $200bn annually; country-level losses are hard to pin down – and the need becomes even more urgent. Product integrity is also the platform on which patient safety is built, so any successful and robust medical device supply chain must integrate packaging that can show if its contents have been compromised in any way. That principle could manifest in many forms, but tamper-evident seals have become an important tool in ensuring that products remain unopened during transit. There are many options that are relatively simple to adopt if the goal is to provide visible evidence of tampering to ensure the integrity and safety of medical devices and other supplies during transport and storage. These range from self-adhesive security labels that uncover a ‘void’ message or leave residue when removed, to destructible labels and barrier seal labels made with materials that break or visibly distort if tampered with.
Plastic security seals for bags, cartons and containers that make use of ‘pull-tight’ mechanisms serve the dual purpose of enabling quick removal when an item is used in an emergency, and also provide strong tamper evidence. Specialised foil seals for vials and IV ports can be used to make clear any damage if penetrated by a needle. Many are imprinted with clear messages – perhaps simply the word ‘opened’ – that are revealed when a seal is broken.
Other means of providing immediate visual or digital alerts of unauthorised access come with the use of radio-frequency identification (RFID) tags. Using near-field communication (NFC) capability, familiar to us all in our smartphones, these tags enable logistics personnel to use simple mobile scanners to track the journey of a pharmaceutical product or a medical device throughout the supply chain, from the manufacturing site into the hands of the end user.
Indeed, RFID is becoming a common feature in smart packaging because of tamper-evident features – such as fragile circuits that break if tampered with, triggering alerts in the system – and its use of unique identification and serialisation numbers to ensure that products are genuine and free from interference. Each product can be given a
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unique RFID tag with a unique serial number, which acts as a kind of digital fingerprint. Any product without a legitimate tag or a serial number that matches official records can be flagged as counterfeit. As well as tracking the shipment at every stage of its journey in real time, RFID tags also provide a way of verifying a product at the point of use, as healthcare practitioners can scan the item with a reader to verify that it is genuine before use in patient care.
Clarity and compliance
Maintaining the barrier between the product and the external atmosphere is, therefore, relatively straightforward, and advances in RFID and NFC capability are making it easier to put in place a system of alerts to bring to light any threats to the integrity of the supply chain. Yet there are many other ways to build trust and reliability into the supply chain, while also ensuring that product use at the end of the line aligns with best practice. Some methods have become very familiar even beyond the medical device sector in recent years, and QR codes are a prime example. Increasingly, QR codes are embedded into packaging to provide quick and simple links to multimedia educational content. Users can easily gain real-time access to usage instructions and compliance information, which brings noticeable improvements in patient adherence and safety. Collectively, these innovations have brought a transformation in traditional packaging systems, which have become more like interactive platforms that support not only security and traceability, but also user engagement in the medical device industry. A more recent technological innovation, however, could have an even bigger effect on supply integrity and product traceability – namely blockchain.
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QR codes are embedded into packaging to provide quick links to multimedia content.
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