Medical device sterilizers seek alternatives to ethylene oxide

Alex Kacik: Every surgery requires a sterile instrument or device. Many companies that sterilize medical products have been using a chemical called ethylene oxide, which has been associated with some significant environmental and health related impacts. How will the healthcare industry adjusts amid these concerns? Welcome the Modern Healthcare’s Beyond the Byline, which offers a behind the scenes look into our reporting. My name is Alex Kacik, senior operations reporter, and I’m joined by Kara Hartnett, health [disparities] reporter. Thanks for coming on Kara.

Kara Hartnett: Yeah, thanks for having me.

Alex Kacik: All right, Kara, you just came out with a really interesting story about ethylene oxide and often referred to as EtO. Healthcare industry seems to be at somewhat of a crossroads emissions from sterilization plants using that chemical have been linked to cancer. But new limitations on ethylene oxide would require a massive restructuring of the sterilization industry and pinch the healthcare supply chain. Tell us more about this issue and what you learned.

Kara Hartnett: Yeah, Alex, it’s a huge conundrum for the industry. And it’s getting increased visibility and pressure from communities where these sterilizers operate, and now from federal agencies that are preparing to release a rule on it. So I guess the first thing to know is that ethylene oxide was designated a human carcinogen by the Environmental Protection Agency in 2016. It’s a colorless gas, so you can’t smell it. But if you’re exposed to it, you could get sick. So short term, we’re talking things like coughing, nausea, dizziness, headache, and in long term, it’s known to cause cancer. So in the healthcare industry, manufacturers use it within their sterilization facilities to clean their products. It’s important for infection control, with medical devices like like catheters, pacemakers, and things like surgical kits. But they’re also used in other industries to clean things like spice or make degreaser. And then if you smoke cigarettes, there’s ethylene oxide there. So when the EPA designation came out, it also came with a lot of community outreach. And when people got word that some of these facilities were operating in their communities, it prompted a lot of backlash. So no new regulations came from the EPA at that time, but states really started investigating these plants and putting in their own regulations. So the state by state investigations really helped uncover the risk of emissions made by these facilities. And they also put on full display the very sort of delicate nature of the healthcare supply chain. And then this was all happening in 2019. Mind you, so before the pandemic and all of the issues that came with that. But as sterilizers, were having to shut down or disrupt operations to add new emission controls, amid these states taking action, the FDA was also putting out warnings of product delays and shortages. And so group purchasing organizations were having to work with manufacturers to sort of recoup that supply. And state and federal agencies were having helped coordinate the broader supply chain. And from what I can understand, amid all of that only one product actually fell into a shortage. And it was a Smith’s medical pediatric breathing tube.

But now still, to this day, a lot of our medical devices are being supplied to this very bottleneck sterilization process. And while we’re becoming more informed about, you know, these harmful effects of ethylene oxide on communities who are exposed to it, healthcare providers are also keenly attuned to these potential product shortages. And so as we figure out what we’re going to do next, I think healthcare providers are really watching that, especially as the EPA moves to release some proposed rules around EtO later this year. But But what do you think Alex, you’re you’re the operations and supply chain guy. How big of a role does ethylene oxide actually play here?

Alex Kacik: So yeah, to your point, there’s so many parts of healthcare that was touched by the sterilization process, you know, not just surgical tools, but PPE sometimes is sterilized with ethylene oxide. But overall, about half of medical devices used in the U.S. are still sterilized with EtO. It’s a relatively cheap process that easily penetrates services, making it an attractive choice for device makers. Health systems often look to cut costs from the supply chain. So when they cope with things like labor shortages that’s going on right now. Reimbursement reductions are new regulations often look to the supply chain to try to save some money. That often leads them to the lowest cost option for things like PPE, pharmaceuticals and supplies, although like you said, the COVID-19 pandemic really up ended everything illustrated how go into the lowest cost supplier, left them particularly vulnerable. So a letter from 16 state attorneys and this gets to the point of your state by state regulations, written in 2020 cited that 2016 EPA assessment that the cancer risk of inhaling EtO was 30 times higher than previously estimated. They wrote that ethylene oxide is among the most hazardous air pollutants posing the greatest health risks in the largest number of urban areas in the country. If that led to the closure of some facilities, and that when you mentioned the breathing tubes, it was traced back to in suburban Illinois, the Attorney General forced Sterigenics to close a sterilization plant, following, you know, residents health concerns.

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So, Kara, I was hoping you could speak more about the state responses you mentioned: Illinois, Georgia and Michigan that have cracked down on EtO emitters. What do you find out? And how are the regulations changing?

Kara Hartnett: Yeah, so those states were sort of the leaders in regulating EtO early on. For them, it usually started, like you said, with a lawsuit by the State Attorney General’s that led to further investigations by their state environmental agencies, just for example. So the findings of these investigations were actually really intriguing, and it helped shape a lot of what we understand about ethylene oxide today. So before all of this, the main concern surrounding exposure to ethylene oxide was actually directed at workers inside these facilities. You know, you see these people outfitted with hazmat suits and all of these layers of protection to protect them from ethylene oxide as they’re going through that sterilization process. But what these investigations actually discovered is that ethylene oxide also leaks into the air of the surrounding communities from the sterilizer buildings themselves, or through something called fugitive emissions.

So in Georgia, for example, they found EtO emissions inside a warehouse where devices were taken after being sterilized. Suggesting that the chemical lingered on the devices and was now being admitted in a place that doesn’t have similar emission safeguards that the sterilizer facilities would have. So all of this has really led to stricter emissions controls. And those states and other states, like California, have also instituted those regulations. And it requires extra layers of technology on the manufacturers side to be able to sort of track and contain those emissions. And all of this is likely to inform the upcoming EPA rule as well.

And all of these new regulations on ethylene oxide emitters are coming while demand for medical devices and supplies is poised to grow as the population ages. What do you think the outlook is in terms of demand here?

Alex Kacik: So the backdrop is that people are getting older, particularly in the U.S., and they’re going to require more healthcare services. So with that, they’re going to need more supplies and devices, the global medical device and supplies industries are expected to increase by more than 5% a year through up until 2030. So between 2020 and 2030, alone, the number of older adults in the U.S. is projected to increase by almost 18 million. This means by 2031, in five Americans is projected to be 65 years old and over. There’s a big push here to find alternatives to ethylene oxide, as you’ve written about. And that being said, you know, healthcare systems are protective of, you know, these supply sources. And this has really kicked into overdrive during the pandemic, they really had to scramble on a short term basis to find sources for PPE. Some types of pharmaceuticals, when international kind of shipping routes shut down, and transport was thwarted. So I imagine, you know, they’re looking for backup supplies. Now, as you know, some of these sterilization plants either have had to close or, you know, temporarily shut down to change their processes. There has been some talk about hydrogen peroxide, for instance, which is commonly mentioned as an alternative because it’s a very good germ killer. Problem is it hasn’t been used before to sterilize large batches or fleets of devices, which is the main issue here. How do you find something efficient and effective that can make sure these devices and supplies are cleaned on a large basis at a big scale?

So, Kara, what do you find out in terms of alternatives to ethylene oxide?

Kara Hartnett: Yeah, you’re absolutely right. And this is like, such an important question really gets to the heart of the problem here, because the answer will vary based on who you ask. But I think that my answer is yes, there are alternatives, but none yet that can reach the scale that ethylene oxide can. So, you know, we rely on ethylene oxide the way we do because it’s very efficient. It allows manufacturers to sterilize truckloads of products all at one time. And it works across most all materials that are used. So for example, manufacturers can can pre-package surgical kits that include metal, paper and plastic and ethylene oxide can sterilize all of those things at once at a grand scale. And none of our alternatives in play are quite there yet.

So another thing that people who are concerned about the supply chain want to see an alternative that can be used with the existing engineering and infrastructure. So changing the way we package and sterilize equipment will take a lot of money. And it’s risky in the current supply chain, as you mentioned, but that’s what it would take with some of the alternatives that we’re currently looking at. As far as what those alternatives are, you know, you mentioned hydrogen peroxide, you also see people using gamma radiation, for example.

The FDA is conducting a pilot program on a new sterilization technology with an aim to reduce EtO use and also find a viable alternative. They’ve not been able to find a substitute yet, but they’ve been able to reduce emissions from about 30% of the facilities that they’re working with. And they’re doing that by encouraging people to: One, transfer products that can be sterilized using a different method to actually do that. And by actually adjusting the concentration of EtO actually used in the process. So it turns out that it’s safe to actually use a little less EtO than what we were using before. But that’s where we stand so far as finding a different solution.

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Alex Kacik: And this is the main part of your beat. So I wanted to make sure I touched on on this. When you’re looking at the EtO emitters, what are the potential health equity concerns here? You know, you have the risk of cancer that’s bigger than what was originally estimated. But you know, also these EtO plants are many of which are are in low income neighborhoods. So what are the impacts there? In terms of the health equity paradigm?

Kara Hartnett: Yeah, totally. So I actually see a lot of environmental justice issues with new sterilizers that are being developed. So obviously, you know, we’ve talked about we’re in this very tight supply situation, and these main manufacturers need to expand their operations to meet demand. Well, they’re also now operating in a patchwork regulatory environment. And they’re picking the locations that they have the least resistance that will cost them the least amount of money and will be the easiest to set up shop in.

So this kind of goes back to how I found the story. Actually, it was it was talking to a public health professor at the University of Arizona, Paloma Beamer. And she told me about a project pending to build a sterilization facility in Tucson, Arizona. So I did some digging, and I found that that facility was going to actually be placed in an environmental justice community. So since this data indicated, you know, a lot of poverty there lots of people of color, there’s also one of the nation’s oldest Superfund sites. It’s where a military contractor dumped degreaser into the land and polluted their water. They also have power plants and airport boneyard about half of the county’s top polluters are located there. And it’s an area that just generally has been desecrated by government and commercial pollution. And so when the community found out about plans to build the sterilizer in their community, they were adamantly opposed to it. I listened to town halls where residents cited these past cases and in Illinois, Georgia and Michigan, and so they didn’t want to end up like them. They said things like, you know, this wouldn’t be allowed in California. And so why would we allow it here? And that really resonated. And so I spoke with a Pima County Supervisor there, who said essentially, most of the local government was opposed to the project and tried to fight it. But they essentially have their hands tied. The facility met all of the air quality criteria. And state law in Arizona actually forbids that criteria from being any stricter than the federal standards, which haven’t been updated since 2006.

So unlike in places like California, Illinois, and Michigan that can go beyond them. Arizona says, you know, we just have to stick with federal regulations. And so these new developments are sort of identifying those locations. And this trend just keeps playing out. And so in other new sterilizer, for example, is going in Tijuana, Mexico to serve the Southern California market. There’s a site going in in rural Arkansas, that’s seeing a lot of community backlash right now. Puerto Rico is another. The EPA just put out a list of the top EtO emitters in the country. And there are four in Puerto Rico alone, and there was just 23 on the list. So they take up just an outsized portion of our EtO emissions.

So yeah, there are huge environmental justice concerns here. And those issues are seeping into the relationship these communities have with the healthcare industry at large. And I think just generally, from the people that I talked to, they just feel really disposable.

Alex Kacik: Puerto Rico’s interesting, too, I mean, during after Hurricane Maria several years ago, you know, that messed up all of the intravenous solution, like bags and some of those sterile injectables, and it sent like the supply chain into a tailspin. So I mean, that’s what’s really interesting. I mean, so much in a lot of our supply chain hinges on Puerto Rico and how fragile the infrastructure is there.

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But I was hoping you could explain a little bit in terms of the changing EPA regulations those are forthcoming. What are the providers and other stakeholders in the industry expecting, you know, as those new regulations take hold? What do they entail?

Kara Hartnett: Yeah. So when I talked to people to try to get their grand predictions, they were very hesitant. One because the EPA hasn’t ruled on any of this since 2006. But also two because they’re dealing with an issue that has real implications for the healthcare industry. And that’s not a place that they’re typically at, it has potential to really disrupt operations and lead to product shortages. And so I think when I talk to healthcare providers about how they want to see this to be solved? They want to see coordination between the EPA, the FDA, the CDC, the HHS, all of these entities to ensure that there is minimal disruption.

As far as what the EPA is going to do. They did a technology review earlier this year, just to sort of see of all the facilities out there, what type of emission controls they have now. In Tucson, where the permit for that facility was ultimately approved. The EPA put a comment requiring them to install new continuous monitoring technology, which basically helps them measure in real time how much EtO they’re putting out into the air. So they can see a leak as it happens and be able to fix it and reduce emissions that way.

So I think those are all clues as to where the EPA will go. I don’t think anybody is expecting an all out ban of EtO emissions at this point, I think that there’s going to have to be, you know, alternatives that can be scaled into place before they go there. So it seems like they’re really just going to be pushing new technology and emission control and being able to reduce those emissions, while also sort of educating the communities where these operations are taking place as what’s going on and what their risk is. So it’s sort of twofold. But I think that’s where we’ll end up is just being able to control and monitor those emissions better than what we can now.

Alex Kacik: It’s really interesting. Hey Kara, I’m excited to see what else you dig up here. As you continue to follow this. I know. Yeah, we’ll be interested to see on these new regulations, how these new regulations come about and how the industry will adapt. So in the meantime, thank you for coming on.

Kara Hartnett: Yeah. Thanks for having me.

Alex Kacik: All right. And thank you all for listening. You can subscribe to Beyond the Byline on Spotify, Apple podcasts or wherever you choose to listen. You can support the reporting of Kara, of myself and our team of reporters by subscribing to Modern Healthcare and giving us a follow on Twitter and LinkedIn. Thank you for your support.

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