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Terumo Blood and Cell Technologies' Sterilization Use
Medical device sterilization helps ensure patient safety
Overview Committed to Compliance FAQs


Overview of Our Medical Device Sterilization Process

What is Terumo Blood and Cell Technologies?

Terumo Blood and Cell Technologies (Terumo BCT) designs, manufactures, and distributes medical devices that help save lives. Our 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 at the same time, they hold the potential to treat many serious diseases. A simple way to think of it is this: If you have ever donated blood or stem cells or had a friend or family member receive a blood transfusion or a cellular therapy, you have likely interacted with our products.

Our products include automated blood and plasma donation technology, blood cell collection and therapeutic blood component exchange technology, and cell therapy development tools. Our customers include blood centers, hospitals, therapeutic apheresis clinics, cell collection and processing organizations, researchers, plasma centers, and private medical practices located across the U.S. and in over 130 countries.

What is ethylene oxide (EtO)?

EtO is commonly found in the environment, generated from both natural and human-made sources. EtO is created by plants, animals, and human beings. For example, EtO occurs naturally in our bodies as part of our normal metabolic processes, and a small amount is exhaled with every human breath. EtO also is produced by household goods such as cars, charcoal and gas grills, and generators, as well as by industrial activities.

EtO is critical to patient care because it is used to sterilize medical products that are not suited to other sterilization methods. It is a globally accepted, U.S. Food and Drug Administration (FDA)-approved, clinically and scientifically validated sterilization method for many medical products. In fact, over 50% of medical devices produced today are sterilized using EtO, according to AdvaMed, a U.S.-based trade group for the medical device industry.1 Not only is EtO used to sterilize items we make such as blood bags, but other items sterilized by EtO include surgical masks, gloves and gowns, bandages, ventilators, and syringes.1

Why does Terumo BCT use EtO?

For many life-saving products, including virtually all the ones we make, EtO is the only viable sterilization option. Like many other manufacturers of medical products and devices, as well as hospitals, we sterilize our medical products before they are used by blood and cell donors and for patient care. The sterilization of medical products is critical to patient safety because it is necessary to minimize the chances of infection in patients who are treated with these products.

How do we use EtO?

Our Lakewood facility includes effective emission control equipment that captures over 99% of the EtO used to sterilize medical devices during both the sterilization process and aeration. Medical products are sterilized within specially designed chambers into which our products are loaded. This process occurs at sub-atmospheric pressures, which prevents EtO from escaping uncontrolled into the environment. After the sterilization cycle is complete, EtO is removed from the chamber and directed to our emissions control system. Then, the sterilized medical products are transferred to our controlled aeration room, where remaining EtO continues to be removed from products and sent through our emissions control system until the products are safe for use with patients as determined by the FDA.

Who regulates the use of EtO?

Our use of EtO to sterilize medical products is highly regulated. Medical device manufacturers must follow rigorous controls established by federal and state government entities, such as the FDA, EPA, U.S. Occupational Safety and Health Administration (OSHA), and here in Colorado, the Colorado Department of Public Health and Environment (CDPHE). These controls have been designed by the scientists and technical experts at these agencies to protect patients, workers, public health, and the environment.

Does Terumo BCT comply with emissions standards?

Yes, our emissions are well below permitted levels. In 2021, our emissions were 85% below permitted levels. In fact, even though our emission levels have been well below permitted levels, in 2018, Terumo BCT voluntarily implemented additional controls to further reduce our EtO emissions, as validated by the CDPHE and third-party testing. In 2023, we will bring online a new, state-of-the-art emissions control system at our sterilization facility. This system will convert EtO into carbon dioxide and water vapor and will further decrease emissions. We conduct regular EtO monitoring of our sterilization facility employees to confirm exposure levels are within OSHA limits. We also test our products to ensure residual EtO levels are below those required by the FDA and the International Organization for Standardization (ISO) specifications. CDPHE and EPA have publicly confirmed that we are in compliance with current air pollution control requirements.2

What is the EPA doing currently to raise awareness about EtO?

The EPA is currently reviewing the existing rules in the Clean Air Act for industries that use EtO to determine whether emissions standards should be changed. As part of this review, the EPA has recently began conducting community engagement to share updated risk information about EtO and what the EPA is doing about it.3

Terumo BCT is one of 23 facilities for which the EPA is sharing new computer-modeled risk information. According to the EPA, this is an "estimated risk," which represents "a worst-case scenario that assumes a person stays in the highest risk area 24 hours a day continuously for 70 years”4. The EPA has noted that the company is in compliance with air quality regulations.

We support the EPA’s review of emissions standards. We currently meet or exceed all relevant regulations for use of EtO and will do so in the future.

Is there an increased number of cancer cases around the Terumo BCT Lakewood facility?

No. The CDPHE has found no increase in actual cases of cancer surrounding the facility when compared to the state of Colorado.


1. AdvaMed. Ethylene oxide & sterilization. Accessed 07 September 2022.

2. EPA. Ethylene oxide: technical reviews and outreach to potentially affected communities status report – Terumo BCT, Lakewood, Colorado. Posted January 2021. Accessed 07 September 2022.

3. EPA. Ethylene oxide risk from commercial sterilizers. Updated 16 August 2022. Accessed 07 September 2022.

4. Colorado Department of Public Health and Environment (CDPHE). Ethylene oxide and Terumo BCT. Accessed 07 September 2022


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