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Oxyfume Frequently Asked Questions
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Below mentioned are some Frequently Asked Questions.
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1.
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We hear a rumor that ethylene oxide is being phased
out. Why?
A. Ethylene oxide [EO] is NOT being phased out. This is a false rumor.
Over27,000,000,000 pounds of EO are produced each year. EO is used to make
chemicals for: Engine anti-freeze and brake fluids: detergents and
biodegradable detergents: polyester fibers and plastics;
polyurethanes;cosmetics; solvents and gas purifying and drying agents.
B. Plus - EO is an irreplaceable agent to sterilize heat and moisture sensitive
medical devices. EO sterilizes over half of the heat-sensitive
[Single-Use]medical devices that the USA produces. Manufacturers use radiation
to sterilize most of those devices not sterilized by EO.
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2.
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You say that Oxyfume sterilants provide more sterility
assurance than other low temperature sterilization techniques. Is this really
important? We hear that what we need to control are patient infections;
and,that a high degree of device sterility wont help if the many other problems
that can cause infections are not controlled.
A. Sterility Assurance IS important. We need to sterilize medical devices to
assure good infection control, but we do need to take other steps. If many
other steps to control patient infection are not taken [like washing one's
hands appropriately before handling], a sterile medical device will not provide
enough help. On the other hand, if the medical device is not sterile, then no
matter how well all the other infection control steps are performed, the
patient is still at risk of being infected by the germ-containing device.
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3.
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Oxyfume blends seem to perform better when sterilizing
dirty devices; but, doesnt that indicate that what we should do is to make sure
we properly clean devices? And, if we properly clean devices, do we really need
to rely on a sterilant that performs better in the presence of soil?
A. The medical device should ALWAYS be properly cleaned before
sterilization. This is defined by AAMI [Association for the Advancement of
Medical Instruments], an organization that sets sterilization standards, as
removal of VISIBLE soil. But, much soil, such as biofilm, is not visible. A
properly cleaned device may still contain a bioburden of 10,000 organisms.Also,
it is hard to know if all visible soil is removed - especially in hard-to-see
locations. Oxyfume sterilization provides one more degree of assurance against
the risk of infection - even when trace soil does not get removed in the
cleaning process.
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4.
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How long have people been using ethylene oxide to
sterilize medical devices?
| People have been using ethylene oxide to sterilize medical devices for
over50 years. Here are some important events: |
 | 1859: Scientists discover Ethylene Oxide [EO] |
| 1928: Researchers report that EO fumigation kills pests |
| 1929: Union Carbide receives a patent for a mix of EO in carbon dioxide, so
that fumigators can use EO without fires or explosions |
| 1940s and 1950s: Researchers develop EO systems to sterilize medical
devices. Sterilizers use either [a] 100% EO in explosion-proof equipment or
[b]non-flammable EO - carbon dioxide mixes |
| 1962: A more efficient non-flammable mix of EO in refrigerant 12 [CFC-12]is
reported |
| 1962 until the 1990s: The most widely used EO sterilant, particularly in
hospitals, is the EO in CFC-12 mix, called "12-88" |
| 1980s: Researchers report that CFC-12 [used in 12-88] can deplete
stratospheric ozone. Thus, governments phase out CFC-12 production |
| 1995: CFC-12 production is completely stopped in the USA |
| By 1995: 12-88 users convert over to a mix that contains HCFCs |
| Today: The HCFC mix, which has about 1/50th the ozone depletion potential
of 12-88, is supplied under the brand name, "Oxyfume" |
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5.
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I'm confused. I thought ethylene oxide was flammable.
But, you claim that Oxyfume sterilant blends, which contain ethylene oxide, are
not flammable. Could you please explain why?
A. Ethylene oxide [EO] burns very easily and can explode. It’s classified as
“flammable.” EO burns in air at concentrations as low as 2.5% and can burn at
concentrations all the way up to 100%. [Propane, for example, which we use as a
fuel in home BBQs, is much less flammable. It burns at concentrations as low
as2.2% in air, but it will not burn at more than 9.5% in air.] EO can be
ignited very easily. Static electricity, such as found on your clothes on a dry
day, is sufficient to ignite EO.
That is why non-flammable blends were developed [as early as 1929] - so that
people can ship and use EO without concern for fire or explosions.
Oxyfume,which uses HCFC refrigerants to stop EO from burning, is classified by
the US Department of Transportation as non-flammable. Use our On-line Safety
training program to learn about the ways to control EO flammability.
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6.
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Do we have to use an Oxyfume blend to control fires and
explosions?
A. The other way to use EO in hospital sterilizers is to use very little of
it. 100% EO sterilizers use small chambers and small EO cartridges. This way,if
there is a fire in the chamber, it should be contained without harming
people.
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7.
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Why do we have to use such large sterilizer
chambers?
A. Many health care facilities prefer large chambers. You can sterilize many
devices at one time, and, you can sterilize very large devices. Non-flammable
ethylene oxide sterilant blends enables a hospital to use large chambers.
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8.
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Why does it take so long to sterilize with
Oxyfume?
A. Because the ethylene oxide [EO] in the Oxyfume penetrates so deeply into
the devices being sterilized, it takes a long time to get that EO back out.Deep
penetration is a unique EO benefit. EO can reach and kill germs in
difficult-to-reach spots. But, materials that can kill germs are usually not
good for people. So, to make the devices safe for patients, we take several
hours to aerate them - to get the EO, which we used to kill germs, back out of
the devices before we return them to the operating suite. With today’s new
sterilizer aeration control units, hospitals can start the Oxyfume sterilizer
as late as 8 PM and have devices ready for use by 6 AM, the next morning. Ask
your Oxyfume sterilant specialist, or contact us, for more information.
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