Medical Design Briefs - February 2025 - 13

devices, but it is also highly toxic and carcinogenic.
In March 2024, the United
States Environmental Protection Agency
(EPA) issued a final ruling limiting the
use and release of EtO gas by commercial
sterilization operations to 90 percent.1
This ruling was influenced by studies
linking breathing problems and proximity
to EtO sterilization facilities.
Strict regulations prohibit the construction
of sterilization facilities near
schools due to environmental cancer
rates associated with their operations.
As regulations on EtO use continue to
be implemented, the cost of sterilization
using EtO is expected to increase
significantly.
The EtO sterilization process involves
filling the chamber with EtO gas, maintaining
it for a certain period, evacuating
the gas, and allowing time for degassing. It
can take days or up to a week to complete,
depending on the device's complexity.
EtO sterilization is used when no other
Medical Design Briefs, February 2025
techniques are compatible with the materials
in the medical device, making it a significant
consideration in the supply chain
of medical devices due to its time-consuming
nature and regulatory scrutiny.
Sterilization techniques that employ
ionizing radiation, such as gamma and
e-beam, are preferred if the medical device
is composed of materials that can
withstand such high energy radiation.
Exposure to gamma radiation is a favored
method for sterilization due to its
ability to deeply penetrate complex,
densely packed containers full of medical
devices/components.
Gamma sterilization facilities can sterilize
medical devices much more quickly
than EtO facilities. In a gamma sterilization
facility, a container of items is placed
onto a conveyor belt and allowed to traverse
a chamber that has that has a gamma
source centrally located within in it.
After a few hours of passing through the
chamber, the container holding the
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medical devices comes out the other
end. While passing through the chamber,
the contents of the container absorb
enough energy from the radiation to kill
any germs that may be present. This process
allows sterilization without significant
temperature elevation and ensures
that there is no toxic residual chemical
vapor contamination.
Silicones: Designed to Adhere
to Skin
For medical devices that adhere to
skin, it's important to use the most suitable
PSAs for each application. The
most used, skin-compatible PSAs in the
industry are acrylates, hydrocolloids,
and silicones. When comparing these
options, each has its pros and cons, but
silicones are the best adhesives for
skin-friendliness.
The chemical nature of silicone provides
inherent breathability that is unmatched
by other synthetic polymers.
13

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Medical Design Briefs - February 2025

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