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MedTech POV Podcast: Dr. Lucy Fraiser, Board-certified Toxicologist, Shares Facts About Ethylene Oxide, a Critical Medical Device Sterilization Method

MedTech POV Covering the intersection of medtech and policy from every perspective

WASHINGTON, D.C. – AdvaMed’s Scott Whitaker sits down on the latest episode of the MedTech POV podcast with toxicologist Dr. Lucy Fraiser to discuss the recent news about ethylene oxide (EtO) used to sterilize medical devices, the nearly non-existent risk to public health from this sterilization method, and what would happen to health care delivery if the chemical were banned as a sterilizer of medical devices and component parts.

“Ethylene oxide is used to sterilize critical medical devices that are both moisture- and heat-sensitive, which means that they can’t be sterilized via steam,” Fraiser said. “Ethylene oxide is used to sterilize 50 percent of all medical supplies that require a high level of disinfection. That includes everything from plastic surgical gowns, syringes, catheters, bandages, gauze, and even things like pacemakers and hardware for knee replacements.”

Many medical devices cannot be sterilized by methods other than EtO:

Learn more about EtO here.

Ethylene oxide is used to sterilize more than 20 billion devices annually in the United States. When asked what the impact would be if these sterilization plants were shut down, Fraiser said:

“We’d have a medical device shortage [if we shut down EtO sterilization plants across the United States today]. In fact, we’ve had a shortage in the past when a single plant was shut down. And if we had a medical device shortage, that would certainly lead to surgeries being postponed or canceled across the country. [T]here are a lot of medical devices that can only be sterilized with ethylene oxide because other methods of sterilization damage the items themselves, for example, medical equipment made from plastic, or paper, or even cloth. Another thing about ethylene oxide that is really beneficial for sterilization is that it can penetrate through most types of packaging. And it can penetrate through many layers of packaging. And so, what that means is that device makers can sterilize whole pallets of hospital supplies at the same time without ever having to unwrap them.”

Fraiser set the record straight on the sources of ethylene oxide in the air. The substance occurs naturally, such as from decaying vegetation, in addition to its commercial production and emissions as byproducts of lawn mower and fire pit use. Ethylene oxide’s use to sterilize medical devices is less than 1 percent of commercial use.

“[Shutting down all the plants in the United States] wouldn’t have much impact at all on the amount of ethylene oxide that’s in the air around us because there are many, many sources of ethylene oxide besides sterilization facilities,” Fraiser said. “Ethylene oxide is present in the air all around us, and across the entire United States, even in areas that are nowhere near a sterilization plant. Because of its presence in the air everywhere, the amount of ethylene oxide in air near sterilization plants isn’t substantially different from the levels that we see anywhere else in the United States.”

AdvaMed has been concerned about the EPA’s release of a list of 23 EtO sterilization facilities the agency sees as posing an elevated health risk to local communities. The agency has used language about risk raising alarm among neighbors, in contrast to its separate language qualifying the list as using a “worst-case scenario that assumes a person stays in the highest risk area 24 hours a day continuously for 70 years.”

Of the EPA’s list, Fraiser said, “EPA has stated that they feel that their obligation is to talk about the ethylene oxide that’s coming from sterilizers because those are the facilities that are being impacted by the rule that EPA is working on right now, and that is due out later this year. EPA has also indicated that, you know, [the agency] worries about talking about the high background levels of ethylene oxide because they don’t want to unnecessarily scare the public. And they’ve also indicated that they don’t have a lot of confidence in the data on background levels. But the problem with that approach is that if the public hears that they’re at risk from facility emissions without hearing that ethylene oxide in the air is already higher than the ethylene oxide that’s contributed by the sterilizers, they are, understandably, going to be more alarmed than if they knew that ethylene oxide was in the air all around. The exposure to ethylene oxide in air is nothing new. It’s been going on for decades.”

An important consideration is the modern use of EtO in sterilization facilities versus the past.

“In my opinion, there is not a need for concern about ethylene oxide levels either inside of sterilization plants or in the outdoor air today,” Fraiser said. “In the past, sterilization plants and chemical plant workers were exposed to very high levels of ethylene oxide that were anywhere from 10,000 to a million times higher than what’s inside plants or in the air today. And there is some evidence that at those extremely high levels ethylene oxide can increase the risk of cancer. But those very high ethylene oxide levels are the ones that have been linked to increased cancer, not the much lower levels that we encounter today. And in fact, there’s not a single study out there to suggest or show that the levels of ethylene oxide that are present in the air today are capable of causing cancer in anybody.”

Other experts agree with Fraiser, including:

“[T]here is no cancer threat from the tiny amounts of ethylene oxide released from these sterilization plants.”—Gail Charnley, PhD, Senior Toxicologist, HealthRisk Strategies LLC

“…Ethylene oxide is a commonly used method of medical device sterilization. It’s considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care.” —Dr. Scott Gottlieb, former FDA commissioner

“Ethylene oxide has been, and is, extensively regulated. The rules that EPA first put into place to establish ethylene-oxide sterilization procedures were carefully designed and extremely stringent… As a result of these regulations, ethylene-oxide emissions remain incredibly low—far lower than a number of other potentially harmful HAPs [Hazardous Air Pollutants], in fact.”—Richard J. Trzupek, The Heartland Institute

Listen in to hear more about EtO from Dr. Lucy Frasier, or find past episodes of the podcast, download the MedTech POV podcast on SpotifyApple Podcasts, or wherever podcast streaming is available.

AdvaMed, the world’s largest medical technology association, launched the MedTech POV podcast in April 2021. The program has featured medtech and health care policy leaders such as Dr. Steven Hahn and General James Mattis. In each episode, guests and host Scott Whitaker cover the intersection of medtech and policy from every perspective, including current issues in business, policy, and current events