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Ethylene Oxide and Sterilization in Healthcare

Ethylene Oxide and Sterilization in Healthcare

Overview FAQs

Ethylene oxide (EtO) is used in many ways, including medical device sterilization. Terumo Blood and Cell Technologies (Terumo BCT) uses EtO to sterilize lifesaving medical devices in a tightly controlled process that complies with all applicable standards and regulations. The company uses advanced emissions controls that capture over 99% of the EtO we use.

EtO can also be found in the air all around us. It is generated by our own bodies and through other natural processes, and it is emitted from everyday items like SUVs, charcoal grills, lawn mowers, fire pits, and buses.

We care deeply about the Lakewood community and are committed to meeting or exceeding all relevant health and safety standards. Thank you for your interest in our operations.

A Priority Central to Our Mission

A Priority Central to Our Mission

Terumo BCT designs, manufactures, and distributes medical products that help save lives. We make products that collect, separate, and process blood and cells. A simple way to think of it is this: If you have ever donated blood or have a loved one who has received a blood transfusion, you have likely interacted with some of our products.

More than 20 billion medical devices in the U.S. — including those made by Terumo BCT — are sterilized each year using EtO. EtO is the only effective, viable sterilization method for over 50% of healthcare products, including those devices we sterilize at our Lakewood facility.1

Terumo BCT meets or exceeds every standard for EtO use. Our advanced emissions control system captures over 99% of the EtO used in our Lakewood sterilization operations. A new, state-of-the-art, $22-million emissions control system project is underway that will even further reduce our already very low emissions.


Download Our FAQs

Download Our Corporate Fact Sheet


Information Sheet

Our FAQs

Download


Information Sheet

Our Corporate Fact Sheet

Download

At a Glance

At a Glance

Terumo BCT’s EtO emissions are a small fraction of the permitted amount.2

The use of EtO is highly regulated. CDPHE and EPA confirm that Terumo BCT operates in compliance with applicable regulations.

EtO is the only effective, viable way to sterilize more than 20 billion lifesaving medical devices in the U.S.1

The EPA is updating regulations about EtO, and that is why it’s a hot topic.



CDPHE: Colorado Department of Health and Environment
EPA: Environmental Protection Agency




EtO Sterilization — A Critical Role in Protecting Public Health

Used for over 80 years to sterilize medical devices

EtO Sterilization — A Critical Role in Protecting Public Health

Used for over 80 years to sterilize medical devices




Prevention

Eliminating or severely restricting the use of EtO could put patients at risk, and infection risk would likely increase.1



Healthcare

Most surgeries involve at least one device that has been sterilized by EtO.4



Essential

Approximately 50% of all medical devices, including surgical instrument kits, heart valves, pacemakers, ventilators, blood bags, syringes, blood and cell collection kits, and bandages, are sterilized with EtO.1,4







Terumo BCT Goes Above and Beyond EtO Compliance

Terumo BCT Goes Above and Beyond EtO Compliance

Advanced Technology

Terumo BCT’s advanced emissions control system already captures and destroys more than 99% of the EtO we use to sterilize lifesaving medical products.

Cutting-Edge Addition

We have invested $22 million to install a new, state-of-the-art emissions control system that, when complete, will capture even more of the EtO that Terumo BCT uses. That project is underway.

Low Emission Levels

Terumo BCT’s EtO emissions are well below levels allowed by the CDPHE and EPA. In 2021, our emissions were only 15% of the permissible amount. We are working to lower emissions further.





Terumo BCT Products Help Save Lives

Terumo BCT Products Help Save Lives


Terumo BCT’s products are used to help treat many patients around the world, including Bola — who is pictured receiving a procedure called red blood cell exchange (RBCX). RBCX is used to help manage sickle cell disease, a genetic blood disorder that primarily affects people of African descent.


Terumo BCT’s Lakewood roots run deep. The company has called Lakewood home for 60 years — before the city of Lakewood was even incorporated.

Our company makes critical healthcare products that help save lives. These products collect blood and cells from healthy donors, process blood and cells, and deliver effective therapy to patients.

Blood and cells are indispensable in sustaining our lives and hold the potential to treat many serious diseases. Our products are used in lifesaving medical procedures in 150 countries by blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers, plasma centers, and private medical practices.

We are committed to bringing lifesaving treatments to patients around the world. Terumo BCT actively works with local, state, and federal agencies to continue to meet and exceed strict standards designed by these agencies to protect public health and the environment.


Additional Reading

Additional Reading


Colorado Department of Public Health and Environment (CDPHE). Ethylene Oxide and Terumo BCT.










EPA. Ethylene oxide: Technical Reviews and Outreach to Potentially Affected Communities, Status Report – Terumo BCT, Lakewood Colorado (January 2021).









References

1. FDA. Statement on concerns with medical device availability due to certain sterilization facility closures. Published Oct 25, 2019. Accessed February 2024.
https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures.
2. Colorado Department of Public Health and Environment (CDPHE). Ethylene Oxide and Terumo BCT. Accessed February 2024.
https://cdphe.colorado.gov/public-information/ethylene-oxide-and-terumo-bct.
3. Colorado Department of Public Health and Environment (CDPHE). Community risk assessment of ethylene oxide near Terumo BCT in Lakewood, Colorado. Published December 3, 2018. Accessed May 2023.
https://drive.google.com/file/d/1WEe0kCfkXW2RQC4jRFsIC803u_6P1Mub/view.
4. AdvaMed. Ethylene Oxide & Sterilization. Accessed February 2024.
https://www.advamed.org/our-work/key-issues/sterilization-ethylene-oxide/.
5. Colorado Department of Public Health and Environment (CDPHE). Supplemental Cancer Registry Evaluation in Areas Near Terumo BCT, Lakewood, CO (2000-2019) Published August 2023. Accessed February 2024
https://drive.google.com/file/d/1MPtugk5AKquSJbAC9FvsN9-x87_ASjrO/view.

References

1. FDA. Statement on concerns with medical device availability due to certain sterilization facility closures. Published Oct 25, 2019. Accessed February 2024.
https://www.fda.gov/news-events/press-announcements/statement-concerns-medical-device-availability-due-certain-sterilization-facility-closures.
2. Colorado Department of Public Health and Environment (CDPHE). Ethylene Oxide and Terumo BCT. Accessed February 2024.
https://cdphe.colorado.gov/public-information/ethylene-oxide-and-terumo-bct.
3. Colorado Department of Public Health and Environment (CDPHE). Community risk assessment of ethylene oxide near Terumo BCT in Lakewood, Colorado. Published December 3, 2018. Accessed May 2023.
https://drive.google.com/file/d/1WEe0kCfkXW2RQC4jRFsIC803u_6P1Mub/view.
4. AdvaMed. Ethylene Oxide & Sterilization. Accessed February 2024.
https://www.advamed.org/our-work/key-issues/sterilization-ethylene-oxide/.
5. Colorado Department of Public Health and Environment (CDPHE). Supplemental Cancer Registry Evaluation in Areas Near Terumo BCT, Lakewood, CO (2000-2019) Published August 2023. Accessed February 2024
https://drive.google.com/file/d/1MPtugk5AKquSJbAC9FvsN9-x87_ASjrO/view.

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