Critical To Effective Healthcare
It’s well known across our industry that sterilized medical products
are critical to healthcare. Poor or incomplete sterilization can lead to
transmission of infectious diseases, compromised patient health, or
even death.
While there are a handful of sterilizing agents to choose from when
it comes to medical devices, the most common is via ethylene oxide. The
Food & Drug Administration recognizes that there are no viable
alternatives currently available to replace EtO sterilization for
certain medical products. EtO is used to sterilize 50% of all medical
devices sold in the United States. That’s a total of more than 20
billion devices annually. EtO is often a device manufacturer’s top
choice for sterilization because it’s toxic to microorganisms but
non-corrosive to common materials used to make medical devices such as
plastic, metal, glass, and rubber.
EtO sterilizes many life-saving items commonly used to treat patients
across all care settings. It can effectively sterilize materials as
diverse as polyurethane and gels for hydrocolloid wound care dressings,
stents for heart surgery, and custom procedure packs for emergency
Caesarean sections. It’s often the most effective sterilizing agent for
devices that have many packaging layers or hard-to-reach areas such as
with catheters. For example, the damaging effects of steam and radiation
on anti-microbial coatings on single-use plastic devices make them
unacceptable alternatives.
FDA Studying Public Health Factors
An FDA committee held a hearing on the matter to gather input from
stakeholders so it could better understand the impact and importance of
environmental, public health, and other factors related to the use of
EtO. HIDA Government Affairs Director Josh Babb spoke at the meeting in
Maryland, relaying to the panel that “HIDA recommends a thoughtful
approach that considers the impact on the delivery of healthcare
nationwide. Any changes to EtO policies must include a realistic and
feasible plan to anticipate and address any potential product
disruptions.”
A Magnified Impact
Disruption at a single sterilization facility can have a magnified
impact across the country and across all healthcare settings. Devices
sterilized in one facility often support healthcare providers and
patients in all 50 states. It’s important that policymakers understand
the complexities of device sterilization to protect patients, circumvent
unintentional supply chain disruptions, and avoid product shortages.
HIDA has created a resource page outlining the issue, HIDA’s related
activity, news updates, and links to government resources, including
educational information from the FDA and Environmental Protection Agency
on the use of EtO for medical device sterilization.
Visit our information and resource page: HIDA.org/EtO►
(Members log in to see all the member-only resources.)
To learn more about HIDA Government Affairs efforts on this and other issues, please contact us: HIDAGovtAffairs@HIDA.org►