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
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
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
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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