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. 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 around the world. 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, chlorine 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 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 from EPA, OSHA, FDA and all state and local agencies.

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

At a Glance

Approximately 50% of all medical products use EtO for sterilization.

The ONLY option to sterilize sensitive medical equipment is EtO. Other sterilization methods (e.g., radiation, steam, chlorine dioxide, vaporized hydrogen peroxide) will damage the products or are unable to ensure the required level of sterility.

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 sterilization facilities use the best available EtO emission control technology in the industry, achieving >99.9% destruction efficiency of direct emissions.

BD facilities produce more than 35 billion essential medical products each year, helping deliver lifesaving treatments to patients around the world.

Safe and Responsible Operations

BD is committed to the safe and responsible operation of our medical sterilization facilities. We use state-of-the-art technology to ensure our facilities meet or exceed all local, state and federal regulations, prioritizing the well-being of our employees and the communities where we operate. Across the U.S., we are continually improving our sterilization facilities.

For decades, BD sterilization facilities have used the best available EtO emission control technologies, achieving >99.9% destruction efficiency of direct emissions.

We have voluntarily made significant investments to upgrade emission controls nationwide and continue to evaluate and adopt new technologies as they are validated. BD is currently evaluating its U.S. facilities to ensure compliance with new EPA air emission requirements and remains committed to ongoing investment in safe, compliant operations.

Investing in Safety

BD is an industry leader in the implementation of capture and control technologies to reduce EtO emissions at our sterilization facilities. At every step of the sterilization process, safety is our top priority.

EtO Sterilization

1. Preconditioning

Product is loaded into a specialized room or cell where it is exposed to heat and humidity within a specific range to condition the product prior to sterilization. No EtO is used during the preconditioning phase.

2. Sterilization

Product is moved by conveyor into an air-tight specialized sterilization chamber where it is treated with EtO gas under vacuum. This renders the product sterile. All exhaust from the chamber is sent to the oxidizer for treatment of emissions.

3. Aeration

Product is then moved by conveyor into a specialized cell where heated air is used to remove residual EtO. After aeration, the product is tested to ensure that it meets FDA sterility and EtO residual requirements. The exhaust from the aeration cell is sent to the oxidizer for treatment.

4. Warehouse Storage

Once the aeration process is complete, the product is moved to the post-sterile warehouse where dry bed treatment technology is installed to treat trace amounts of EtO that diffuse from sterilized product.