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Salient Aspects of Medical Device Packaging
Communication
As with consumer goods
packaging, secondary and primary medical device packages
are a means to convey information through graphics,
materials, and shape. Packaging communication operates at
different levels, depending on the type of medical device.
For over-the-counter
(OTC) medical devices, such as condoms, glucose meters,
adhesive bandages, thermometers, and so on, the
communication role involves motivating a purchase, as well
communicating important information for the safe and
effective use of the medical device. Information may
include directions, warnings, product benefits, brand
differentiation, and so on. A very important aspect of
package communication is product identification. This is
especially true for devices that go into institutional
settings, such as hospitals, where personnel may have to
identify the correct device for a patient when seconds
count.
Key Package Design
Considerations
During the early design
stages, it is critical to define the following parameters:
• Critical product
characteristics.
• Type(s) of protection required (physical, ultraviolet
light, O2, water vapor transmission, etc.).
• Type of sterilization process.
• Where and how the product is going to be dispensed (OTC,
surgery, etc.).
Medical Device
Packaging Requirements
 Complying
with packaging requirements is the responsibility
of the medical device manufacturer. This is the only way
to guarantee that the products will be protected during
transportation, and that they comply with health and
safety regulations.
Pharmaceutical and
medical products have certain special characteristics
(such as their limited shelf life). For this reason, their
requirements for transportation and commercialization must
be aligned with them.
The protocol saimed at
guaranteeing their safety focus on factors such as the
seal integrity, materials or how the package reacts to the
passage of time. At a government level, the most
important regulations are those of the Food & Drug
Administration (FDA) in the United States, and the Medical
Devices Directive in the European Union.
Medical device
packaging doesn’t just need to arrive at the hospital,
clinic, or end customer free from holes, tears or missing
seals; it must also withstand the passage of time in
storage, where it must be able to remain for years
without the drug or device having their composition
altered.
Some of the medical
device packaging protocols include :
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ISO 11607 Packaging for terminally
sterilized medical devices.
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ISO TS 16775, “Packaging for
Terminally Sterilized Medical Devices - Guidance on the
Application of ISO 11607-1 and ISO 11607-2.”
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EN 868 Packaging materials and
systems for medical devices to be sterilized, General
requirements and test methods.
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ASTM D1585 Guide for Integrity
Testing of Porous Medical Packages.
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ASTM F2097 Standard Guide for
Design and Evaluation of Primary Flexible Packaging for
Medical Products.
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ASTM F3475-11 Standard Guide for
Biocompatibility Evaluation of Medical Device Packaging
Materials.
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BS EN ISO 15378:2017 Primary
packaging materials for medicinal products. Particular
requirements for the application of ISO 9001:2015, with
reference to good manufacturing practice (GMP).
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ISTA 3 packaging and transport
standards are now official standards to be used for FDA
approval on medical devices for the US market.
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ISO 11137, which measures Gamma and
E-beam sterilization
Before performing any
of these tests, one must ensure that the package is
sterile, so that protocols are performed on a product that
is exactly in the same condition as that of the product to
be commercialized.
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