Chlorine dioxide (CD) gas
is now being used for the sterilization of medical devices. Over the past two years, extensive testing
has been done to learn more about its limits within the medical device sterilization
market. Some of the testing was done in
partnership with a leading medical device manufacturer who was looking at new
technologies which could replace Ethylene oxide (EO) for certain medical devices
types. This testing pushed the
boundaries of what conditions CD gas was known to be effective within, and we’ll
be discussing that in our upcoming free webinar on July 15th that
you can sign up for by clicking here.
Ethylene oxide first
began its tenure in medical device sterilization in the in the 1950’s. EO was favored due to a lack of sterilization
options for heat and moisture sensitive medical devices, gaining popularity due
to its ability to penetrate packaging materials and device lumens, its material
compatibility, as well as ease of use. However,
EO soon began facing challenges. In 1987
Ethylene Oxide was determined to be a carcinogen by California. In the following years the National Institute
of Occupational Safety and Health (NIOSH) studied more than 18,000 workers at
17 sterilization plants and concluded that EO causes breast cancer and
lymphomas. In 2006, and after reviewing
NIOSH studies, the EPA released a draft of its review of EO and determined it
is a human carcinogen. Pressure peaked in 2018 with lawsuits stemming from
claims an Illinois plant’s EO emissions resulted in many incidents of cancer
throughout the community. This pressure
resulted in major facilities closing down and forcing added strain on others. This resulted in increased wait times and
overall fears from manufacturers as well as the FDA that the threat of a lack
of alternatives besides EO could mean critical medical supplies may not have a
mode of sterilization available to them.
Overall, critical
disadvantages associated with EO are the lengthy cycle time, cost, and its
potential health dangers. Another serious
issue is that EO can be explosive, creating a risk for sterilizing devices with
embedded batteries. EO’s overall risk profile prevents many medical device and
pharmaceutical companies from having in-house EO sterilization chambers due to
the complexity and safety complications EO sterilizers result in.
Chlorine dioxide gas is a
near identical replacement to ethylene oxide in terms of cycle structure and
effectiveness. Chlorine dioxide is
non-carcinogenic, non-explosive, and cycles can be completed within one
chamber, allowing for a simpler sterilization process. Gaseous chlorine dioxide is a
non-carcinogenic, EPA registered sterilant.
Since it is a gas, the chlorine dioxide molecules will fill the entirety
of a space and reach all areas of a component while retaining high material
compatibility. Without the risk of
explosion, CD gas is able to sterilize devices containing embedded batteries. Recent testing proved its ability to
sterilize devices within packaging, which was thought to be prohibitive in the
past. The simplicity of the process also
allows firms to install and utilize in-house CD gas sterilizers which can help
expedite processes and reduce costs. We
have recently registered as an FDA medical device contract sterilization
facility (FDA registration number 3013115071), allowing medical devices to be sterilized
at our facility before being returned or shipped out to their next location.
Join us on July 15 forour free webinar to learn more.
