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About Anti-Counterfeiting Packaging Technology for Medical Devices


Counterfeit products are those which are fake, or those which have been deliberately mislabeled or tampered with - Not same as sub-standard devices, which have failed quality control checks.


In 2010, WHO reported that 8% of all medical devices in circulation are fake, with actual numbers expected to be even higher. They have significant impact on the health of the users. Counterfeit devices are a threat to the society and there is an urgent need to detect such devices.


Detecting counterfeit devices is challenging : Firstly, many anticounterfeiting devices do not function properly in tropical climates. Also, it is difficult to determine if the poor performance of a device is due to poor quality or poor practice. Poor lab practices, inadequate training, or an inability to interpret results can lead to investigators falsely believing that the device is counterfeit.


Anti-counterfeit packaging : Protecting the authenticity of a device through anti-counterfeit technology is one of the ways through which companies detect fake products.


Nano/microparticles : One of the methods against counterfeiting involves incorporation of dust-sized or micro particles in to the packaging, labels, or the device itself. These particles are made of silicon dioxide, and they can carry digital information which can be used to identify, trace, and authenticate products for product identification.


These particles are incorporated covertly such that the packaging is not affected. These particles can also be incorporated using pre-existing laminates and varnishes.


SignatureDNA : Another anti-counterfeit method creates unique identification marker using DNA called ‘SignatureDNA’ technology where specific DNA signatures can be incorporated in to packaging and the material itself. It works as a “lock and key” model where the DNA in the package/material can only be unlocked using its complimentary DNA pattern.


Tamper-evident opening system or TOES : Which contains a peelable cover foil in the packaging. Cover is destroyed if the packing is tampered, and this can provide protection if the package is illegally opened or misused.

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