EDITOR'S NOTE: This is a guest opinion piece.
Recent media stories have unnecessarily and dangerously raised concerns about the safety of ethylene oxide (EtO), a chemical used to sterilize 20 billion medical devices annually in the U.S.
Let me first state that if we had learned about EtO through the media, we would be concerned, too. After all, we are parents, spouses, and we live in communities we want to know are safe. But the reporting has been wrong. Dead wrong. And it could have deadly consequences.
It’s time for the truth about ethylene oxide:
Studies have found EtO to be carcinogenic at high concentrations over an extended period of time, which is precisely why EtO medical device sterilization plants take their responsibility so seriously to operate safely. That’s because our industry’s first priority is — and always will be — safety.
Some of our nation’s leading toxicologists assure us of a few important facts:
First, EtO exists all around us, even in areas where there are no known emitters of EtO to be found. Two years ago, the U.S. EPA initiated a study to determine whether EtO was more broadly found in ambient air than previously understood. Air monitoring readings were taken by EPA at 18 sites across nine states, with broad ranging populations and climates, in rural and urban areas. Results showed higher levels of EtO than expected even in rural areas where there was no manufacturing of any kind.
Additionally, the Georgia Environmental Protection Division (EPD), which regularly performs air monitoring, also found that average levels of EtO in the ambient air in metro Atlanta are consistent with what EPA found nationwide. Even in areas of Georgia where there are no sterilizers or industrial users of ethylene oxide – like General Coffee State Park – levels of EtO were found as recently as January to be higher – yes, higher – than in Covington, on average. While recent data comes from several point-in-time readings, and we should rely on long-term data to get the policy right, the key point here is myriad sources, such as diesel trucks, lawn mowers and even gas grills, contribute to the amount present in the air virtually everywhere. Even our own bodies create EtO.
What this highlights is there’s a serious problem with the media’s understanding and characterization of the chemical.
One final point: Less than 0.5% of all commercial EtO is used for medical device sterilization. Put another way, 99.5% of EtO used by industry is to make everyday products including cosmetics, shampoos, laundry detergents, clothing, and carpets. It is even used to sterilize food. This means if you shut down every medical device sterilization plant and every device manufacturer that uses EtO tomorrow, two things would happen: EtO emissions would not decline measurably, and you’d see a major shortage of crucial medical devices. That is the real threat to public health – particularly during a pandemic that has highlighted the need for sterile medical supplies.
Remember: 20 billion medical devices are sterilized annually with EtO – that’s approximately 50% of all sterilized devices manufactured in the U.S. today. Many cannot be sterilized any other way. Adhesive bandage strips, surgical drapes, gowns, certain personal protective equipment (PPE), IVs, catheters, dialysis sets, and 80 percent of all surgical trays are sterilized with EtO. There’s not one surgery performed today that doesn’t have a device sterilized with EtO. It’s that necessary and that effective in sterilizing equipment and thus helping to prevent infectious disease.
Also keep in mind this industry has studied alternatives to EtO for decades. The simple reality is, for many devices it’s the only choice according to the FDA. Other sterilization methods are effective on some devices, but not all, and that’s why we need to keep EtO as a viable method while we work with FDA, EPA and others to find alternatives.
Now here’s the good news: While we search, our work to control EtO emissions continues. That’s done through:
• Constant vigilance over production operations to ensure patient safety and compliance with federal, state and local requirements designed to protect worker safety, public health and the environment
• Continual advances in the development of technologies to improve emission controls
There are many misperceptions out there surrounding EtO, driven largely and understandably by a concerned but not fully informed public. We need to change that. Working with lawmakers, regulators, patient groups and other stakeholders, we want to educate the public and raise awareness of this complex issue, so we can develop public health policies that are effective, science-based and keep both the communities in which EtO sterilization plants reside and the patients who rely on 20 billion medical devices they sterilize safe and healthy.
Scott Whitaker is president and CEO of the Advanced Medical Technology Association (AdvaMed), the largest trade association in the world representing medical technology and device manufacturers; Maria Thacker Goethe, MPH, is CEO of the Center for Global Health Innovation as well as president and CEO of Georgia Bio, the state’s largest trade association representing Georgia’s life sciences industry.
