BD EtO Sterilization: Essential, Safe, and Compliant

BD is among the world’s largest producers of medical products that are critical for patient care.

To protect patients from the risks of infectious diseases caused by bacteria, viruses, and fungi, the FDA requires the sterilization of medical devices and clinical products. In compliance with FDA sterilization requirements, BD must use ethylene oxide gas (EtO) for sterilization in the final stage of manufacturing. For a significant number of sensitive medical products, EtO is the only type of sterilization that can be used to meet sterilization standards without damaging the products.

Products manufactured and sterilized at BD facilities save lives and improve patient outcomes in hospitals and care facilities across the country. BD is committed to meeting public health needs by increasing capacity for U.S. production and sterilization of medical devices and components.

BD EtO Sterilization: Essential, Safe, and Compliant

BD is among the world’s largest producers of medical products that are critical for patient care.

What is EtO Sterilization?

Essential

Medical devices and clinical products are required to meet FDA sterilization standards.

For numerous types of devices and other sensitive medical products EtO is the only type of sterilization that can be used. Other sterilization methods (e.g. radiation, steam, chloride dioxide, vaporized hydrogen peroxide) will damage the products or are unable to ensure the required level of sterility.

Safe

EtO Sterilization is a safe process that protects patients from the risks of infectious diseases caused by bacteria, viruses, and fungi.

BD’s facilities keep communities and employees safe with state-of-the-art technology supported by continuous updates and investments.

Compliant

BD has programs and procedures in place to ensure compliance with all applicable regulatory requirements, including regulations from EPA, OSHA, state environmental protection agencies, FDA and all local permits.

All of BD’s U.S. sterilization facilities capture and control significantly more EtO than currently required by the Clean Air Act.

BD is working with FDA and other industry leaders to develop new sterilization cycles that produce fewer emissions.

At a Glance

50% of all medical products use EtO for sterilization.

The ONLY option to sterilize sensitive medical equipment is EtO.

BD is among the World’s Largest producers of medical products critical for patient care.

Less than 1% of all EtO used for industrial purposes is used for medical product sterilization.

BD’s facilities are at least 20 times more efficient at removing EtO per cubic meter of air than currently required by the Clean Air Act.

BD’s facilities produce More than 35 Billion essential medical products each year.

Going Beyond Compliance

BD is committed to the safe and responsible operation of our medical sterilization facilities. BD uses state of the art technology to ensure that all of our facilities not only comply with all local, state and federal regulations but also keep communities and employees safe. We are focused on constantly improving our sterilization facilities throughout the United States.

BD’s sterilization facilities use the best available EtO emission control technology in the industry, achieving more than 99.95% destruction of EtO from stack emissions. This level of EtO emissions control goes well beyond what is required under the Clean Air Act.

BD has voluntarily made significant investments to upgrade emission controls at facilities nationwide, and continues to evaluate new technologies as they are introduced and validated.

BD Facility Performance vs. Clean Air Act Requirements:

Investing In Safety

BD is the industry leader in developing and implementing capture and control technologies to reduce EtO emissions at our sterilization facilities

The latest emissions controls were installed and tested at our facilities in Georgia and after they proved to be effective, BD began installing similar systems at all of our EtO sterilization facilities nationwide.

BD voluntarily invested more than $30 million to install new best-in-class capture and treatment systems for residual emissions in both Sandy, Utah and Columbus, Nebraska. These systems are now operational and validated, and they remove 85% to 95% of residual emissions at these facilities.

BD in Sandy

Sandy, Utah

BD in Columbus

Columbus, Nebraska

BD in Covington

Covington, Georgia

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BD in Sandy

Sandy, Utah

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BD in Columbus

Columbus, Nebraska

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BD in Covington

Covington, Georgia

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