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March 1, 2021

Medical Device Industry Challenges Misleading Information Campaign About the Safety and Use of Ethylene Oxide in Georgia

AdvaMed and Georgia Bio CEOs team up, saying the misinformation could have "deadly consequences"

WASHINGTON, D.C. – The CEO of the world’s largest medical technology trade association (AdvaMed) and the CEO of Georgia Bio, a trade association representing life sciences companies in Georgia, have teamed up to challenge misleading information that has been propagated by the media about the safety and use of ethylene oxide (EtO) — a chemical which is used to sterilize 20 billion medical devices annually in the U.S. and for which there is no alternative.

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,” wrote AdvaMed CEO, Scott Whitaker, and Georgia Bio CEO, Maria Thacker Goethe in an op-ed published in The Covington News, a community-based weekly newspaper that serves the citizens of Newton County, Georgia.

They listed a few important facts for concerned citizens to keep in mind, noting that EtO is a chemical compound that naturally “exists all around us” and when the Environmental Protection Agency (EPA) has conducted tests, they have found that the presence or absence of an EtO sterilizer or industrial user does not translate to higher or lower EtO levels in the ambient air. In Georgia specifically, the Georgia Environmental Protection Division (EPD), which regularly performs air monitoring, found that average levels of EtO in the ambient air in metro Atlanta are consistent with what EPA found nationwide, thus mitigating any special cause for concern.

Whitaker and Thacker also reminded readers that less than 0.5% of all commercial EtO is used for medical device sterilization, explaining, “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.”

Whitaker and Thacker concluded with a call to action: “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.”

Read the full op-ed here. For more information on ethylene oxide and how its use is regulated in the sterilization of medical devices, visit AdvaMed.org/ethylene-oxide.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.