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About Innovation Challenges
For New Developments In Medical Device Sterilization
The FDA is sponsoring two public
innovation challenges to encourage new developments in medical
device sterilization.
1 : Identify New Sterilization
Methods and Technologies
2 : Reduce Ethylene Oxide Emissions
Ethylene oxide sterilization is an
important sterilization method that manufacturers widely use to
keep medical devices safe.
For many medical devices,
sterilization with ethylene oxide may be the only method that
effectively sterilizes and does not damage the device during the
sterilization process. Medical devices made from certain polymers
(plastic or resin), metals, or glass, or that have multiple layers
of packaging or hard-to-reach places (for example, catheters) are
likely to be sterilized with ethylene oxide.
Literature shows that about fifty
percent of all sterile medical devices in the U.S. are sterilized
with ethylene oxide. The types of devices that are sterilized with
ethylene oxide range from devices used in general health care
practices (for example, wound dressings) to more specialized
devices used to treat specific areas of the body (for example,
stents). For ethylene oxide sterilization, two voluntary consensus
standards (ANSI AAMI ISO 11135:2014 and ANSI AAMI ISO
10993-7:2008(R)2012) describe how to develop, validate, and
control ethylene oxide sterilization processes for medical devices
and the acceptable levels of residual ethylene oxide and ethylene
chlorohydrin left on a device after it has \ undergone ethylene
oxide sterilization. These standards help ensure levels of
ethylene oxide on medical devices are within safe limits since
long-term and occupational exposure to ethylene oxide has been
linked to cancer.
The Environmental Protection Agency
(EPA) reviews and enforces the Clean Air Act regulations for
sterilization facilities that emit ethylene oxide to ensure that
they protect the public from significant risk.
On July 15, 2019, the FDA announced
two public innovation challenges :
• Challenge 1 : Identify New
Sterilization Methods and Technologies : The goal of this
challenge is to encourage the development of new approaches to
device sterilization methods or technologies for medical devices
that do not rely on ethylene oxide.
• Challenge 2 : Reduce Ethylene
Oxide Emissions : The goal of this challenge is to develop
strategies or technologies to reduce emissions to as close to zero
as possible from the ethylene oxide sterilization process.
(
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethyleneoxide-sterilization-medical-devices
).
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