Feature Article

A counterfeiting explosion

FIGURE 1: A seal wth security hologram. As soon as the seal is lifted off the substrate, it exhibits a conspicuous checkered pattern.

The incidences of counterfeit products that have reached consumers include condoms and dental material for use in fillings. Those found before entering the final stages of the consumer supply chain range from fake glucose test strips for use with insulin to corrective contact lenses, ac-cording to the United Kingdom’s Medicines and Healthcare products Regulatory Authority (MHRA) (www.mhra.gov.uk). Many counterfeit items are distributed through Internet websites, which makes it difficult to track counterfeits. The MHRA reports that most of the counterfeit products seized are usually packaged to a high standard and it is difficult for the untrained eye to distinguish the fake from the genuine article.

The counterfeiting explosion is also being driven by increased globalisation, extended supply chains, the growth of brands, weak regional law enforce-ment and lenient criminal penalties. Moreover, the impact of the Internet as a conduit for counterfeit goods, allied to high quality reprographic technology have also made it easy and affordable to copy brand packaging.

As a result, holography has become the primary choice for an expanding range of applications. The technology’s ability to work with other anti-counterfeiting technologies and to record product-tracking information is becoming increasingly important and commercially acceptable. The technology has the added advantage of being able to link on-pack product identification with supply chain management and market enforcement measures.

Advances in the technology
New imaging techniques and combinations of other covert authentication technologies with holograms are producing a new generation of optical security devices, which combine ease of recognition benefits with significantly enhanced resistance to counterfeits. This enables the identity and distribution of medical devices to be controlled through an expanded system solution that involves security authentication features, tracking mechanisms and investigative services. The latest holograms offer beneficial track and trace features: the hologram carries unique se-quential, encrypted or random serial numbers to mark and identify products overtly or covertly.

The identity of individual items can be linked to product and packaging through a unique code, which in turn can be linked to case identity (ID), pallet ID or container ID. The recording of this “parent–child” relationship allows a medical device to be tracked throughout the many layers of the distribu-tion chain: from the factory and packaging through distribution to the final user. This type of usage can also be employed to capture important events in a product’s life cycle such as quality assurance rejects and product returns, which creates a flexible database that offers pro-duct history and other business reporting benefits.

Of particular value to manufacturers, as well as a strong financial incentive to make the investment in these systems, is the fact that the information generated at this labelling stage can be linked to an enterprise resource planning system. This links within a single database the data needed for a variety of business functions such as manufacturing, supply chain management, finance, projects and customer relationship management.

In the future, a hologram’s ability to incorporate other data forms and product-tracking information will become important. One example of this is serialisation, which can be visible to the naked eye when generated by overprinting or using an optical numbering method. Alternatively, it can remain covert and encrypted and require a special reading tool or machine to decipher it.

This serialisation allows holograms to be used for an ever-widening range of anti-counterfeiting and brand-protection applications. They can link on-pack product identification with supply chain management, market enforcement and forensic support services. In this way, the identity and distribution of medical devices can be controlled through a single solution that involves security authentication features, tracking mechanisms and investigative services.

Endoscope security
Endoscopes provide one example of how a new closure seal has ensured that medical products arrive intact and clinically clean with reduced logistic require-ments. Endoscope manufacturer Karl Storz GmbH & Co. KG (www.karlstorz.com) ships as many as 5000 special cases containing high-end endoscopes to its customers per month. They are often supplied to medical seminars, workshops and conferences, but not all of the cases are actually opened and the con-tents used. As many as 30 percent of them are returned unopened by the events’ organisers. Nevertheless, the contents of each returned case would require in-depth technical inspection and thorough cleaning. This complex, time-consuming and costly process tied up valuable human and material resources. To make the process leaner, the company commissioned the development of a seal that would reliably indicate that the case had been opened.

Seal specification
Although the product cases are used many times, they must always arrive at the customer’s location in impeccable external condition. A seal with security hologram was developed (Figure 1), which can be applied to the thin aluminium strips of the cases. The seal had to provide totally reliable adhesion and exclude any possibility of nondestruc-tive tampering or peel-off. In addition, any adhesive residues left on the opened cases had to come off by simple washing to make the cases ready for reuse quickly. Accordingly, an adhesive was specifically adapted to meet these requirements. “Our research and development testing laboratory proved the reli-ability of the self-destruction effect. In addition, the aluminium substrate is easy to clean after peeling off the label and there are no residues left,” said Uwe Zeller, Deputy Head of Technical Inspections and Congress Logistics at Karl Storz.

For reliable and easily visible indication of any attempt to open the case, the security seal has an integrated void effect. It is triggered as soon as the seal is lifted off the substrate and exhibits a conspicuous checkered pattern. To ensure that this effect is also activated when the case is forcibly opened or in a jolt, the label has an additional separating perforation. Thanks to the new security seal, only cases that have actually been opened are checked and cleaned. As a result, the company benefits from leaner processes and lower inventories: unopened cases can now be used again immediately after their return. This tailor-made solution also visibly documents the company’s quality standards. “The seal significantly optimises our workflow,” emphasised Zeller, “and our customers perceive it as a seal of quality for endoscopes that have been duly inspected.”

Holgrams stay one step ahead
Holograms have demonstrated their ability to deter counterfeiting and they play a vital role in protecting brands and corporate reputations. With advancements in technology and widening applications, there is no reason why their role will not continue to evolve in the on-going battle to stay one step of ahead of medical device counterfeiters. 

Ian Lancaster is General Secretary of the International Hologram Manufacturers Association, Sunbury TW16 7DY, UK
tel. +44 1932 785 680
e-mail: ian.lancaster@reconnaissance-intl.com www.ihma.org