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

Committed to Compliance

The 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 U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (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 relevant environmental and scientific experts to protect public health and the environment.

In 2021, Terumo BCT's emissions of EtO were 85% below our permitted limits.

We have voluntarily made technology investments to implement further emission controls beyond regulatory requirements.

Did You Know?

EtO is created by plants, animals, and human beings and is the byproduct of the operation of cars, gas grills, and generators. It exists in urban, suburban, and rural environments. When EtO is detected in an area far away from a known EtO emission source, that detection is attributed to “background” sources.1 That’s why it’s important to collect air data from areas both near to and far away from a known EtO emission source and to compare risk estimates from an area with an emission source to those involving only background sources.

Investing in Operations

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


1. U.S. Environmental Protection Agency (EPA). EPA’s work to understand background levels of ethylene oxide. 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.


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