3M Sterilization

Proven performance, effective results, definitive answers

EO

Ethylene oxide (EO) has long been a key tool in the sterilization of medical devices that cannot be steam sterilized – because it has proven to be an effective, and cost-effective, sterilant.

But some in our industry have raised questions about 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Is it outdated technology?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 the answers.

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

You can use proven EO technology with confidence –

and comply with current regulatory restrictions on EO

emissions – with the 3M™ EO Abator System.

The 3M EO Abator is a highly effective device used to

convert EO exhausted from a sterilizer airstream. The

3M EO abator uses an exothermic (heat producing)

reaction to convert EO exhaust into CO2 and water

vapor. At normal operating temperatures and

concentrations, conversion efficiency is 99.9+%* –

virtually eliminating emissions of EO to the

environment.

* When EO concentrations are greater than 100ppm. When EO concentrations are less than 100ppm, conversion efficiency is 99.0%

Ethylene oxide has been used for over fifty years in

health care institutions as the primary method for

sterilization of heat and moisture sensitive items.

Today, more than 56% of all medical devices are

sterilized by EO in the medical device manufactur-

ing industry. There are a number of other low- and

high-temperature sterilizing technologies that do have

their place in a healthcare facility’s overall equipment

strategy; however, for best practice on today’s most

critical low temperature sterilization challenges, EO

stands the test of time.

Easier on instruments

EO is gentler on device materials compared to oxida-

tive sterilants (such as hydrogen peroxide), helping

extend device life and reduce the need for repairs. In

fact, EO sterilizers are the only low temperature steril-

izers available without lumen or materials restrictions.

There are times when “classic” technology performs better.

EO is not a sprinter. But it can be a winner in the long run.

If you judge your low temperature sterilizers on cycle

time alone, other sterilants win. Their cycle times are

faster. But if you look at the benefits of efficacy and

efficiency, the outcome might be judged differently. In

addition to being effective in killing microorganisms,

including bacterial spores, EO sterilizers have a larger

sterilizing chamber, which allows users to sterilize a

single batch of devices daily rather than constantly be

loading and unloading instruments throughout the day

with a smaller unit. Departments that are “planful” do

not 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.

Like many tools, EO sterilization is safe 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 and

minimize exposure.

OSHA Exposure Limits

To protect workers, OSHA has established

exposure limits for EO. 3M Steri-Vac sterilizers, when

properly installed and operated according to instruc-

tions, are designed to ensure operator exposure is

below 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.

1. U.S. EPA HCFC Phaseout Schedule hhttp://www.epa.gov/ozone/title6/phaseout/hcfc.html

2. 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

EO is not being banned by regulatory agencies

Ethylene oxide, used for decades in the processing

of food products, cosmetics, museum artifacts and

medical devices, is a broadly regulated chemical.

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. Confusion regard-

ing this point may be the result of the EPA regulation

scheduling phaseout of HCFCs, used in EO/HCFC

sterilant blends, by December 2014.1

However, this regulation does not apply to 3M™

Steri-Vac™ sterilizers, since they use 100% EO, and

no HCFCs. The EPA recently reviewed the eligibility

of ethylene oxide for registered uses, including EO

sterilization in healthcare facilities, and determined

that “the benefits of ethylene oxide use outweigh the

occupational risks associated with its use,” provided

that certain risk mitigation measures such as single

chamber sterilization and aeration are adopted.2

3M and Steri-Vac are trademarks of 3M. Please recycle. Printed in U.S.A. © 3M 2011. All rights reserved.70-2010-8447-5 (1011.25) DPI

3M Health CareInfection Prevention Division3M Center, Building 275-4E-01St. Paul, MN 55144-1000USA1-800-228-3957www.3M.com/infectionprevention

To learn more of the answers about Ethylene Oxide, visit www.3M.com/infectionprevention or call the 3M Health Care Helpline at 1-800-228-3957.