Healthcare Hygiene magazine December 2019 | Page 28

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to outline potential approaches and gather comments
and data. The ANPRM will seek information on several
key topics, including possible approaches to calculate and
control fugitive emissions; potential improvements to EtO
monitoring technologies; and process differences between
types of sterilization facilities. EPA also will issue a survey
to gather information from several commercial sterilization
companies on facility characteristics, control devices, work
practices and costs for emission reductions.
EPA is also beginning to examine the question of whether
EtO is present more broadly in the air in the U.S., and if so,
at what levels. EPA has analyzed samples from monitors that send samples to EPA’s national
contract laboratory for analy-
sis; the results confirmed the
presence of ethylene oxide,
with six-month aver-
ages ranging from
about 0.2 to about
0.4 micrograms per
cubic meter. The EPA says there is no
immediate, short-term risk from the
levels of EtO found in these limited air
monitoring data.
Retaining EtO sterilization as a viable option is an
imperative, says ECRI Institute, an independent, non-profit
patient safety organization, which adds that statewide bans
of commercial EtO sterilization could result in widespread
shortages of critical medical devices and supplies, significant
harm to patients
ECRI Institute says that it opposes a total ban of commer-
cial EtO sterilization because it could result in widespread
shortages of sterile medical devices.
“Even a partial ban on ethylene oxide could cripple the
delivery of healthcare in the U.S. as critical medical-surgical
supplies would suddenly become unavailable,” says Marcus
Schabacker, MD, PhD, president and CEO of ECRI Institute,
referring to sterilization plant closures, a proposed EtO
sterilization ban in Illinois, and a 2016 report by the EPA
regarding possible health risks from EtO emissions.
“While environmental health concerns certainly need to
be addressed, legislators and the public should be aware
that an ethylene oxide ban could severely impact the safe
delivery of healthcare,” Schabacker adds. “Without access
to medical supplies, many surgeries and procedures would
not be possible.”
For more than 50 years, ECRI points out, the medical
device industry has relied on ethylene oxide to sterilize
temperature- and moisture-sensitive disposable medical
devices, such as syringes, IV bags, and wound dressings,
and lifesaving devices, such as stents and catheters. These
medical device materials and packaging were developed
for EtO sterilization. ECRI Institute says it knows of no safe
alternative commercial sterilization methods that could
immediately replace EtO at this time.
In written comments submitted to the FDA, Ruey C.
Dempsey, vice president of technology and regulatory affairs
at the Advanced Medical Technology Association (AdvaMed),
stated that, “For many medical devices, due to their material
composition, size, shape or complexity, EtO is the only
effective method for sterilization. EtO provides the ongoing
capacity and scale to process the billions of medical devices
required by today’s modern healthcare systems in delivering
care to patients. Heart valves, pacemakers, implantable
cardioverter/defibrillators, drug-eluting stents, feeding tubes
and breathing tubes, surgical drapes and kits, and syringes
are just a few of the many products critical to modern
patient care that can only be sterilized using EtO. Ethylene
oxide’s compatibility and effectiveness with the plastics and
polymers commonly used in medical products allows for the sterilization of many medical devices that would otherwise
be rendered ineffective or unsafe if sterilized by radiation,
moist heat, dry heat, or other alternative methods.”
Dempsey continued, “Medical device manufacturers
have invested in microbiologists, sterility assurance experts,
process safety and environmental engineers; and industrial
hygienists who have worked for decades to ensure that they
have standards and controls in place to responsibly manage
the use of EtO. Manufacturers must conduct exhaustive
studies to demonstrate that the required sterility assurance
levels are achieved and maintained by their equipment and
processes, and to confirm that exposure to the sterilization
process does not adversely affect the device’s performance,
safety or effectiveness over the shelf life of the device.  At
the same time, AdvaMed member companies are committed
to further reducing the amount of EtO used for effective
sterilization processes by actively exploring methods and
processes that reduce the amount of EtO used for a
sterilization cycle. The industry is committed to investigating
alternative sterilization methods that will provide the same
sterility assurance and result in the same device performance
as EtO. Until there is a safe and effective replacement for
EtO, we will continue to pursue our goal to reduce the
amount of EtO used. Optimizing the EtO process itself, the
medical device packaging and the approach to validation
are examples of possible ways to minimize the amount of
EtO sterilant necessary to sterilize devices. However, none
of these potential solutions can be achieved quickly or
easily. Any change to minimize EtO use, if even feasible,
would likely require extensive product and/or process
modifications; validation and verification testing; potential
facility upgrades; and required notifications, clearances and
approvals from FDA.”
In her written comments to the FDA, Linda Rouse O’Neill,
vice president of government affairs for the Health Industry
Distributors Association (HIDA), stated, “HIDA members
share a close relationship with our manufacturer partners
and together we ensure the many medical devices that go
through distribution and ultimately contact with patients
and healthcare providers are both safe and effective. Part of
that process is ensuring their sterility, a critical component in
preventing infections and ensuring the integrity of the device.
HIDA recognizes that the task of studying and implementing
proper safety guidelines on a process this complex and with
an impact on an industry as critical as ours … Due to material
sensitivities, EtO is the only option for sterilizing a large
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december 2019 • www.healthcarehygienemagazine.com
Ethylene
oxide
molecule.
Courtesy
of the
American
Chemistry
Council