Healthcare Hygiene magazine December 2019 | Page 26

FDA Scrutinizes
EtO Shortage,
Viable Sterilization
Alternatives at
Recent Hearings
By Kelly M. Pyrek
A
potential nationwide shortage of ethylene oxide (EtO)
has triggered investigation in early November by the
Food and Drug Administration (FDA) into viable industrial
sterilization alternatives that can mitigate the impact of
medical device shortages.
“The recent closure of a Sterigenics ethylene oxide
sterilization facility in Illinois, the temporary closure of another
Sterigenics facility in Georgia, and the potential closure of a
large Becton Dickinson sterilization facility in Georgia could
affect the availability of some sterile medical devices used
by healthcare delivery organizations and patients,” said
Norman E. Sharpless, MD, acting commissioner of food
and drugs at the Food and Drug Administration (FDA), in a
statement issued by the agency in late October. “We have
been working diligently with impacted device manufacturers
and healthcare delivery organizations to ensure that they
are aware of these developments and preparing to minimize
adverse effects on patients whose care could be negatively
affected if medical devices sterilized at these large facilities
were not accessible.”
According to the FDA, EtO is the most common method
of sterilization of medical devices in the U.S., and that more
than 20 billion devices sold in the U.S. every year are sterilized
with it, accounting for approximately 50 percent of devices
that require sterilization.
“Without adequate availability of ethylene oxide steril-
ization, we anticipate a national shortage of these devices
and other critical devices including feeding tube devices
used in neonatal intensive care units, drug-eluting cardiac
stents, catheters, shunts and other implantable devices,”
Sharpless said. “It’s important to note at this time there
are no readily available processes or facilities that can serve
as viable alternatives to those that use ethylene oxide to
sterilize these devices.”
In the quest to identify potential alternatives, in early
November the FDA assembled the General Hospital and
26
Without adequate
availability of ethylene
oxide sterilization, the
FDA says it anticipates
a national shortage
of critical devices
including feeding
tube devices used in
neonatal intensive care
units, drug-eluting
cardiac stents, cathe-
ters, shunts and other
implantable devices.
Personal Use Devices Panel of its Medical Devices Advisory
Committee. During panel deliberation on the first day of
the two-day meeting, panel members discussed that, if EtO
sterilization is reduced, eliminated or replaced by a different
sterilization modality, there are options that can mitigate the
impact of medical device shortages. The panel’s consensus
was that the FDA should work to facilitate validation of
sterilization processes.
The panel discussed how the FDA can help mitigate
device shortages due to reduced device sterilization
capabilities. The panel’s consensus reemphasized the need
for stakeholder communication and collaboration to help
manage shortages. The panel deliberated the possibility
of changing EtO sterilization cycles or sterilization loads to
reduce EtO use while maintaining effective sterilization. The
panel’s consensus was that there were potential methods
that appeared viable, but no single method would address all
issues and that manufacturers and contract sterilizers should
pursue all applicable methods for reducing EtO use.
The panel considered various methods to validate EtO
sterilization cycles in hopes of reducing EtO-use while still
maintaining an effective sterilization process. The panel
recommended that FDA encourage the use of alternatives
to the overkill validation method which are included in the
consensus standards for EtO sterilization processes.
The panel discussed the sterilization of some medical
devices to a less rigorous sterility assurance level (SAL) (e.g.
10-5, 10-4, etc. instead of 10-6) be considered as part of
the approach to reduce sterilant use. The panel’s consensus
was that consistent with current standards, the FDA should
consider moving to a risk-based assessment of the SAL for
some sterilized medical devices. The advisory panel also
recommended that the FDA evaluate sterility assurance levels
for medical products to reduce EtO emissions, an unavoidable
byproduct of its use.
“The FDA recognizes that there are concerns associated
with release of EtO into the environment if emissions were
to occur at unsafe levels,” Sharpless said. “Concerns about
EtO emissions have resulted in certain state actions against
sterilization facilities that are currently impacting manufac-
turers’ ability to use the ethylene oxide process to sterilize
their medical devices. In February, the FDA became aware
that the Illinois Environmental Protection Agency (EPA) issued
a state EPA order to stop Sterigenics from sterilizing medical
december 2019 • www.healthcarehygienemagazine.com