Whom it may concern
From: EOSA, The Ethylene Oxide Sterilization Association
Re: INFORMATION UPDATE ON ETHYLENE OXIDE (EtO)
Date: 10 January 2005
is an industry trade group of suppliers and users of
EtO as a sterilant. This memo is intended to eliminate
confusion regarding commercially-motivated “rumors” to
the effect that EtO is being or will be banned. These
rumors are simply untrue. The sterilant, ethylene oxide,
is NOT being banned; it is here to stay.
EtO (or EO, if you please) is not, has not and will not be banned or phased out.
No American federal, state nor other judicial, legislative or regulatory body
is even entertaining such a prospect. The “issue” does not involve
EtO. The only likely link to EtO is the scheduled phase-out of CFC and HCFCs
which have been used as propellants in 12/88 EtO/CFC and/or 10/90 EtO/HCFC blends
or mixtures used in some sterilization systems.
CURRENT EtO FACTS ARE:
- the production of CFCs was banned in the U.S. as of January 1, 1996. Certain
hydroflourocarbons (HCFCs) are scheduled to be restricted in the future in
compliance with the Montreal Protocol. All of this is unrelated to EtO usage
as a sterilant.
- EtO is the number one sterilant. The market for EtO used for sterilization
is strong and continues to grow at 1.5 - 3% per year. Sources: ARC Specialty
Products and Honeywell.
- In calendar year 2000, US hospitals used EtO to sterilize over 75% of their
devices needing low temperature gas processing. Source: Honeywell.*/
- More than 1,200 hospitals currently use the EtO/HCFC
mixture for sterilization purposes. Source: Honeywell.
- In the U.S. the medical sterilant industry (hospitals, medical device manufacturers
and contract sterilizers) used 10 million pounds of EtO in 2000 to sterilize
more than half of all single use items produced/used (the same ones that
hospitals and consumers buy! – 52%
of everything sterilized, in fact. Source: ARC Specialty Products.
- And, the other 8+ billion pounds of EtO produced and utilized in this country
each year are used to make antifreeze, fibers, detergents, surfactants and
numerous other consumer and industrial products. Source: Union Carbide/Dow**/
Specialty Products, a division of Balchem Corporation,
is the number one supplier of 100% EtO to the medical
device and contract sterilizer industries. Honeywell
International, Inc. is the number one supplier of EtO
blend. **/ Union Carbide, a division of Dow Chemical,
one of the world’s largest
manufacturers of EtO. Other domestic producers include: BASF, Dow itself