3M Sterilization Ethylene Oxide Brochure


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Ethylene Oxide has long been a key tool in the sterilization of medical devices that cannot be steam sterilized; it has proven to be an effective, and
cost-effective, sterilant.

With an EO abator system, you have almost no effect on the environment.

EO is gentler on device materials compared to oxidative sterilants (such as hydrogen peroxide), helping extend device life and reduce the need for repairs. In fact, EO sterilizers are the only low temperature sterilizers available without lumen or materials restrictions.

In the U.S., the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA), among others, have all established regulations for the use of EO. They have not banned it.

Learn more about 3M Sterilization products like the 3M Steri-Vac sterilizers and 3M EO Abator.

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3M Sterilization Ethylene Oxide Brochure

  1. 1. 3M Sterilization EO Proven performance, effective results, definitive answers
  2. 2. Ethylene oxide (EO)has long been a key tool in the sterilization ofmedical devices that cannot be steam sterilized– because it has proven to be an effective, andcost-effective, sterilant.But some in our industry have raised questionsabout its continued use. Is it being banned? Is it outdated technology? Is it too dangerous? Is 3M getting out of the EO business? Is it too slow? Is it harmful to the environment?Chances are, you’ve heard the questions.Now, on these pages, you can learn theanswers.
  3. 3. With an EO abator system, you havealmost no effect on the environment.You can use proven EO technology with confidence –and comply with current regulatory restrictions on EOemissions – with the 3M™ EO Abator System.The 3M EO Abator is a highly effective device used toconvert EO exhausted from a sterilizer airstream. The3M EO abator uses an exothermic (heat producing)reaction to convert EO exhaust into CO2 and watervapor. At normal operating temperatures andconcentrations, conversion efficiency is 99.9+%* –virtually eliminating emissions of EO to theenvironment.* When EO concentrations are greater than 100ppm. When EO concentrations are less than 100ppm, conversion efficiency is 99.0%
  4. 4. There are times when “classic”technology performs better.Ethylene oxide has been used for over fifty years inhealth care institutions as the primary method forsterilization of heat and moisture sensitive items.Today, more than 56% of all medical devices aresterilized by EO in the medical device manufactur-ing industry. There are a number of other low- andhigh-temperature sterilizing technologies that do havetheir place in a healthcare facility’s overall equipmentstrategy; however, for best practice on today’s mostcritical low temperature sterilization challenges, EOstands the test of time.Easier on instrumentsEO is gentler on device materials compared to oxida-tive sterilants (such as hydrogen peroxide), helpingextend device life and reduce the need for repairs. Infact, EO sterilizers are the only low temperature steril-izers available without lumen or materials restrictions.
  5. 5. EO is not a sprinter.But it can be a winner in the long run.If you judge your low temperature sterilizers on cycletime alone, other sterilants win. Their cycle times arefaster. But if you look at the benefits of efficacy andefficiency, the outcome might be judged differently. Inaddition to being effective in killing microorganisms,including bacterial spores, EO sterilizers have a largersterilizing chamber, which allows users to sterilize asingle batch of devices daily rather than constantly beloading and unloading instruments throughout the daywith a smaller unit. Departments that are “planful” donot see the lack of pure speed as an impediment. 3M will remain a global supporter of EO technology. We are not getting out of the EO business. More than 7,000 100% EO 3M sterilizers are in use today, in over 70 countries and every state in the continental U.S. Just as important, 3M continues to install more units to address the needs of sterilizing complex medical devices, for both device manufacturers and healthcare facilities, as well as the need for low-cost, low-temperature sterilization. We intend to support our customers today and long into the future.
  6. 6. Like many tools, EO sterilization issafe when it’s treated with respect.As with any known carcinogen identified by IARC,including tobacco smoke, asbestos and formaldehyde,it’s important to be respectful of the chemical andminimize exposure.OSHA Exposure LimitsTo protect workers, OSHA has establishedexposure limits for EO. 3M Steri-Vac sterilizers, whenproperly installed and operated according to instruc-tions, are designed to ensure operator exposure isbelow these levels. 3M Steri-Vac sterilizer safety features: > Self-diagnostic system checks before each cycle > Negative chamber pressure throughout the cycle, eliminating potential operator exposure in the event of a leak > In-chamber aeration immediately following sterilization cycle > Single-dose EO cartridges, eliminating the need for handling of large EO tanks. Engineered for operator safety, the canister is punctured only when the chamber door is sealed and the proper vacuum has been drawn inside the negative pressure sterilizer chamber.
  7. 7. EO is not being bannedby regulatory agenciesEthylene oxide, used for decades in the processingof food products, cosmetics, museum artifacts andmedical devices, is a broadly regulated chemical.In the U.S., the Food and Drug Administration (FDA),the Environmental Protection Agency (EPA) and theOccupational Safety and Health Administration (OSHA),among others, have all established regulations for theuse of EO. They have not banned it. Confusion regard-ing this point may be the result of the EPA regulationscheduling phaseout of HCFCs, used in EO/HCFCsterilant blends, by December 2014.1However, this regulation does not apply to 3M™Steri-Vac™ sterilizers, since they use 100% EO, andno HCFCs. The EPA recently reviewed the eligibilityof ethylene oxide for registered uses, including EOsterilization in healthcare facilities, and determinedthat “the benefits of ethylene oxide use outweigh theoccupational risks associated with its use,” providedthat certain risk mitigation measures such as singlechamber sterilization and aeration are adopted.21. U.S. EPA HCFC Phaseout Schedule hhttp://www.epa.gov/ozone/title6/ phaseout/hcfc.html2. U.S. Environmental Protection Agency. Reregistration Eligibility Decision for Ethylene Oxide (EPA 738-R-08-003), March 2008. http://www.epa. gov/oppsrrd1/reregistration/REDs/ethylene-oxide-red.pdf
  8. 8. To learn more of the answers about EthyleneOxide, visit www.3M.com/infectionpreventionor call the 3M Health Care Helpline at1-800-228-3957.3M Health CareInfection Prevention Division3M Center, Building 275-4E-01 3M and Steri-Vac areSt. Paul, MN 55144-1000 trademarks of 3M.USA Please recycle. Printed in U.S.A.1-800-228-3957 © 3M 2011. All rights reserved.www.3M.com/infectionprevention 70-2010-8447-5 (1011.25) DPI