Healthcare Hygiene magazine December 2019 | Page 27

products and other products with EtO at their Willowbrook,
Ill. facility. The state EPA order was due to the presence of
levels of EtO higher than the EPA found to be acceptable in
the air around the facility. This closure caused a temporary
shortage of pediatric breathing tubes. Another Sterigenics
contract sterilization facility in Atlanta has been closed
since August while it undergoes construction to reduce
EtO emissions. In October, the Sterigenics Willowbrook,
Ill., facility announced they would not reopen. Because
of these two large sterilization facilities being unavailable,
the FDA continues to coordinate with stakeholders on any
impacts to medical device availability. Because the number
of ethylene oxide contract sterilization facilities in the U.S. is
limited, we are very concerned that additional facility closures
could severely impact the supply of sterile medical devices
to health care delivery organizations that depend on those
devices to take care of patients. The impact resulting from
closure of these and perhaps more facilities will be difficult
to reverse, and ultimately could result in years of spot or
nationwide shortages of critical medical devices, which could
compromise patient care.”
The FDA has urged medical device manufacturers that
use EtO facilities to assess their inventory for any potential
downstream impacts of sterilization facility closures on their
product distribution. Sharpless said that if U.S. manufacturers
are not able to resolve a shortage and it involves a critical
device needed for U.S. patients, the FDA may look for a
firm that is willing and able to redirect safe and effective
product into the U.S. market to address a shortage. The
FDA also has encouraged healthcare facilities to perform
similar inventory assessments of critical medical supplies that
undergo contract terminal sterilization via EtO so that the
agency can assist in identifying potential substitute devices.
“Hospitals and other healthcare delivery organizations
should also work with their purchasing departments, group
purchasing organizations and distributors to help obtain
product needed for patient care.” Sharpless urged facilities
not to hoard product or attempt to purchase larger quantities
of devices beyond their normal purchase volume.
At the November hearings, Jonathan Wilder, PhD,
managing director of Quality Processing Resource Group, LLC,
told the panel that the severity of medical device shortages
depend on a number of factors, including, device type and
intended use; the population impacted; device misallocation
and hoarding; and the effectiveness of mitigation measures.
Wilder said the decision to sterilize medical devices using
EtO is typically made due to excellent product penetration,
reliability of EtO, in that there is an established compatibility
with the process and a long history of validated processing
for the materials used. Additionally, the size of the industrial/
contract sterilizer chambers enables economical sterilization.
Wilder summarized that some materials currently
sterilized in EtO cannot be migrated to radiation sterilization
or to steam or dry-heat sterilization. As well, the effects
of high-temperature sterilization can make migration of
otherwise-compatible devices impossible. He added that
the logistics and equipment for thermal sterilization differ
from EO greatly and that it would require significant capital
and time to implement if medical devices were migrated to
these methods.
www.healthcarehygienemagazine.com • december 2019
EPA Addresses EtO
In
early November, the U.S. Environmental Protection
Agency (EPA) continued its progress on actions to
address ethylene oxide (EtO) by announcing proposed
amendments to the Miscellaneous Organic Chemical
Manufacturing National Emission Standards for Hazardous
Air Pollutants (NESHAP), known as MON, to reduce
hazardous air pollutants, including EtO. The EPA says it is
also addressing EtO from commercial sterilizers; working
closely with other federal partners such as the Food and
Drug Administration (FDA) to address medical device
supplies; and providing an update on its work to better
understand EtO and to characterize air concentrations
of this chemical.
As EPA administrator Andrew Wheeler explains, “The
proposed MON amendments represent the first regulatory
action that EPA is taking to address ethylene oxide under
our two-pronged approach to reduce emissions. This
proposal would reduce other hazardous air pollutants
from our nation’s air, while providing improved compliance
measures for industry.”
The proposed MON amendments are expected to
reduce emissions of hazardous air pollutants from the
source category by 116 tons per year, which includes
a 93 percent reduction in EtO emissions from covered
facilities. The proposal addresses EPA’s obligation under the
Clean Air Act to conduct the residual risk and technology
(RTR) review for the miscellaneous organic chemical
manufacturing source category. EPA has evaluated the
risks posed by air toxics from this source category and
has determined cancer risks for this source category to be
unacceptable. To reduce risks to an acceptable level, EPA
is proposing additional requirements for process vents,
storage tanks, and equipment in ethylene oxide service. In
addition to reducing ethylene oxide emissions, the MON
amendments would include updates to requirements for
flares, heat exchange systems, and equipment leaks. These
proposed requirements would further reduce emission of
air toxics for these covered facilities. The EPA is holding
public hearings in early December.
EPA has addressed EtO emissions after EPA’s National
Air Toxics Assessment, issued in 2018, found that EtO
emissions may be contributing to potentially elevated
cancer risk in some areas around the country. Since then,
EPA has been taking a two-pronged approach to evaluate
these emissions. First, the agency is reviewing existing
Clean Air Act regulations for industrial facilities that emit
ethylene oxide. Second, because the process for revising
our regulations takes time, EPA is gathering additional
information on EtO emissions and is working with state
and local air agencies to determine whether more
immediate emission reduction steps may be warranted.
In addition to the proposed RTR for the MON, EPA is
also reviewing the NESHAP for Ethylene Oxide Commercial
Sterilization and Fumigation Operations. EPA intends to
issue an Advance Notice of Proposed Rulemaking (ANPRM)
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