WFHSS Questions and Answers - Question Q01241

Dear Sir / Madam


We want to procure a low temperature sterilizer. There is a news in a market that hence in near future the use of ETO is going to be totally banned in all European countries,and USA.

1. Is it authentic news.
2. Does regulatory body like EPA, is going to take action on use of ETO.
3. Certification like JCAHO, is not permitted on use of this gas to the hospitals.

Kindly comment briefly on these points.

Thanks.

Dear PB,

Please see from this link:

www.gasdetection.com/TECH/eosa_information_update_on_eto.pdf

Dear,
I didn't hear anything about a possible ban on the use of Ethylene Oxide in Europe.
I can't imagine this will happen in the (near) future.
Best regards,
Wim Renders

Dear PB
THE BAN WILL TAKE PLACE ON 2020, SO YOU HAVE ENOUGH TIME TO DEAL WITH IT, BUT BE CAREFUL IT IS A CARCINOGENIC GAS AS WELL AS MANY CHEMICALS IN OUR CSSD ENVIRONMENTAL
BEST REGARDS SAMIR

Can I please once and for all kill this silly rumour.

There is NO BAN nor is there likely to be a ban on the use of Ethylene Oxide for the sterilization of medical devices, ANY WHERE IN THE WORLD !! As a matter of fact the use of Ethylene Oxide for this purpose has actually GROWN over the last ten years.

As far as the issue of toxicity is concerned, ALL gaseous systems used for sterilization are toxic, this includes Ethylene Oxide, Hydrogen Peroxide and Formaldehyde. But some are more toxic than others, as an illustration NIOSH (National Institute of Safety and Health) in the USA provides levels associated with IDLH (Immediate Danger to Life and Health) and lists EO at 800 ppm but Hydrogen peroxide at 75 ppm i.e. 10 TIMES more dangerous.
A properly installed EO sterilizer, operated according to manufacturers instructions by properly trained staff using an appropriate quality system and controls, and following an appropriate maintainence schedule poses no threat to anyone and is a valuable addition to any department where low temperature sterilization is required.
As with any toxic substance treat with respect and there is nothing to fear!

Dear Ladies and Gentlemen - we at The Ethylene Oxide Sterilization Association (EOSA) are unaware of any proposed ban on EtO - such is the stuff of rumors that pop up from time to time.

In point of fact the contrary is true. EtO is still the preferred sterilant for heat and moisture sensitive devices. Its use continues to grow in the USA and internationally with EtO being dominant with manufacturers and contract sterilizers. The use of EtO-sterilized medical devices continues to grow each year.

As with all effective but dangerous materials EtO is carefully regulated everywhere. At present, for example, the US Environmental Protection Agency (EPA) is in the final stages of EtO re-registration and the prime issue under consideration is the exposure of sterilization workers to the substance. EPA is most aware that any untoward restriction on the use of EtO would have devastating, world-wide effects on a very wide assortment of both everyday and critical medical devices.

And, quoting from the US Food and Drug Administration (FDA) comments to EPA in this proceeding "...at this time EtO is the only feasible sterilant for a wide variety of medical devices. While research is continuing to search for alternatives, none are {sic} currently available to replace all EtO applications and there is nothing 'on the horizon' today."

In short, as opposed to that suggested by your correspondent in Jordan, Kamol had it right: no such ban is contemplated anywhere.

Let us kill this rumour now. EO is NOT being banned now, in the future or even in 2020 as suggested by our friend in Jordan, it would be interesting to know where that date came from. As a matter of fact the use of EO for processing medical devices has actually GROWN OVER THE LAST TEN YEARS.
At an EPA meeting in the USA IN DEC2005 the EPA did NOT raise the issue of banning EtO as a sterilant, and following that meeting the FDA communicated to the EPA ( 17/02/06) that ..."at this time EO is the only feasible sterilant for a wide variety of medical devices. while research is continuing to search for alternatives, none are currently available to replace EtO applications and there is nothing "on the horizon" today"
One delegate is quoted as saying "EO is an indispensible infection control tool"
on the issue of toxicity, let's be clear - ALL low temperature systems in use today are toxic, EO, Hydrogen Peroxide (Plasma is not a sterilant) and Formaldehyde, but some are more toxic than others. Levels given by NIOSH for immediate danger to life and health are as follows: EO 800 PPM - Hydrogen Peroxide 75 ppm ! that is 10 times more dangerous than EO.
EO machines Properly installed, properly operated by properly trained staff and properly controlled and maintained create no danger to the users.