A dirty business: How the medical device sterilization process sickens some to heal others

For more than a year, medical device manufacturer Becton Dickinson has been working with government officials in Tucson, Arizona, to erect a plant that would sterilize products vital to the supply chain. But many residents in the local community don’t want it.

“I have very serious concerns,” Tucson resident Marcos Urrea said at a public hearing last November. “We don’t have a full understanding of the ramifications of the emissions and how severely this would impact the community,” said Urrea, who later waged a short-lived campaign as a Democrat for the U.S. House.

Facilities like the one proposed for Tucson have been under fire since the Environmental Protection Agency designated the chemical involved, ethylene oxide, as a human carcinogen in 2016. Emissions from these sites have been found to leak into the air of nearby communities. And studies have linked long-term exposure to the colorless gas to cancer.

The situation puts the healthcare system in a quandary. Without ready access to medical devices and supplies, patients would go without needed treatments. But the chemical that ensures those products are safe to use can sicken others.

State and federal regulators have slowly been developing policies to reduce ethylene oxide emissions but are caught in the middle of two public health priorities. Health systems have taken some steps to limit use of the chemical but remain beholden to the companies that manufacture and sterilize the supplies they need.

Companies that sterilize medical products say their operations only emit trace amounts of ethylene oxide, also known as EtO, into the air and fear further regulation will hamstring a supply chain that was volatile even before the COVID-19 pandemic. Environmental scientists say alternative means exist to sterilize medical equipment, but reconfiguring plants and processes would require time and investment.

In the coming months, the EPA plans to strengthen protocols for manufacturers that emit ethylene oxide. It would be the agency’s first action on the issue since 2006. But according to industry watchers, little except an outright ban on EtO emissions could make a difference.

“When you’re talking about the safe use of a known human carcinogen, in general, government consensus and government agencies believe in reduction to zero, because we don’t think there’s any safe level of known carcinogen exposure to people,” said Dr. Peter Orris, professor and chief of Occupational and Environmental Medicine at University of Illinois Health.

Meanwhile, device manufacturers continue to expand sterilization operations to meet growing demand as the U.S. population ages and needs more healthcare, and to make up for facilities that closed under scrutiny from state regulators. But communities are raising environmental justice concerns about releasing hazardous chemicals into socially vulnerable neighborhoods. In some locations, vehement opposition hasn’t stopped development. In others, lawsuits and evidence of cancer have spurred state governments to go beyond federal standards.

What is ethylene oxide?

Ethylene oxide has been utilized to sterilize medical equipment since the 1950s. It was previously used in a mixture with Freon-12, a chlorofluorocarbon also called dichlorodifluoromethane that was banned in 1989 due to damage it caused to Earth’s ozone layer. In response, the industry shifted to a process that only involves EtO.

Ethylene oxide is used on 20 billion pieces of medical equipment in the U.S. each year, including syringes, catheters, infusion pumps, surgical kits and pacemakers. The chemical is also used to clean spices, produce antifreeze, in textile manufacturing and as a pesticide. It’s also found in tobacco smoke.

The known health effects of short-term exposure include difficulty breathing, blurred vision, dizziness, nausea, headache, convulsions, blisters and vomiting. There’s also evidence that long-term exposure could increase the risk of lymphohematopoietic cancers, non-Hodgkin’s lymphoma, Hodgkin’s disease, leukemia, and cancers of the stomach, esophagus, rectum, liver, breast, pancreas, prostate, bladder, kidney and brain.

The EPA designated ethylene oxide a human carcinogen in 2016 after concluding the cancer risk it posed to humans was 30 times greater than previously understood. Regulations initially focused on reducing the exposure among workers within facilities where the chemical is used. But recent discoveries have shown it can seep into the air outside facilities, where it can linger for months. In those communities, epidemiologists have detected elevated cancer rates.

Following the chemical’s designation as a carcinogen, the EPA released a list of facilities that emit amounts of ethylene oxide projected to cause more people to develop cancer than the agency deems acceptable. As of July, 23 sterilization plants were on that list.

This has put them under intense public scrutiny. While the EPA has been slow to update regulations for these facilities, state environmental agencies have created a patchwork of rules governing how much EtO in the air is safe and what more companies should do to control it.

States such as Georgia, Illinois and Michigan conducted investigations that revealed insights into the sources of EtO emissions and how facilities that use it affect the health of people who live nearby. The investigations also illustrate the delicate nature of the healthcare supply chain and how regulators are attempting to balance community exposure to a carcinogenic pollutant with maintaining the availability of medical devices.

States take action

In October 2018, months after the EPA released its report, then-Illinois Attorney General Lisa Madigan (D) sued medical equipment supplier Sterigenics for EtO emissions at a facility in Willowbrook, near Chicago, which she alleged was sickening nearby residents. The facility opened in 1984 and released between 17,000 and 33,000 pounds of ethylene oxide annually before 1999. Advances in emission control technology enabled the company to reduce emissions to about 5,000 pounds a year since then, according to a state report.

The Illinois Environmental Protection Agency suspended operations at the facility in February 2019, prompting the Food and Drug Administration to warn of delays involving 594 different types of medical equipment, including sutures, clamps, knives, stents and needles. The FDA worked with manufacturers to direct products to other sterilization sites. Medical device companies lost millions of dollars in the process. A month later, the FDA announced that only one product, a Smiths Medical breathing tube for children, was in short supply as a result of those efforts.

In March 2019, the Illinois Department of Public Health published a report describing elevated levels of Hodgkin’s lymphoma, prostate, pancreatic, ovarian and bladder cancer near the Willowbrook plant. In response, the state adopted some of the nation’s most restrictive laws on the commercial use of ethylene oxide. Given the option to resume operations under the new regulations, Sterigenics decided not to reopen the site.

Stephanie Frunk had never even seen that building in Willowbrook before it was shut down, but she’s glad it did. The sterilizer looked as ordinary as the rest of the town where she grew up—a brown brick structure with tall, copper-tinted windows and two garage doors in the front. A “Sterigenics” sign hung on the side.

“If you didn’t know what you were looking for, you would miss it,” Frunk said. 

Frunk, 21, grew up a mile and a half away from the facility, which was just blocks from her school and the community pool where she worked during summers. A public park sits across the street from the site.

She was 5 years old when she was diagnosed with acute lymphoblastic leukemia, a disease that started in her bone marrow and spread to her blood. She remembers panicking after seeing the fear in her parents’ eyes as a pediatrician delivered the news that their only child had cancer. A nurse gave her a cinnamon roll to help calm her down. 

The months that followed included an aggressive chemotherapy regimen. She went to the clinic every Thursday afternoon to undergo countless scans, spinal taps and blood transfusions. Anytime she developed a fever, she was rushed to the hospital. Frunk was told if the cancer spread to her spine, she could be completely paralyzed. 

Frunk’s treatments went as planned and the cancer never returned. It wasn’t until 2018, when the EPA began outreach to communities designated high-risk for EtO exposure, that she learned the possible cause of her cancer.

She is now one of more than 800 people in Illinois who have filed personal injury lawsuits against Sterigenics for its chemical emissions, which they say caused their cancers.

A Cook County, Illinois, jury decided the first such case Sept. 19, and awarded the plaintiff $363 million. Sue Kamuda, 70, alleged she developed breast cancer after living one-third of a mile from the plant for 37 years. She also alleged her son, Brian Kamuda, was diagnosed with non-Hodgkin’s lymphoma in 2021 because he grew up there. Their suit marked the beginning of a long legal battle regarding whether companies such as Sterigenics can be held liable in civil court for increased cancer rates in communities where it operated. [This paragraph has been updated to reflect the outcome of this lawsuit, which was announced after the print edition of Modern Healthcare went to press.]

Other states are following Illinois. In Georgia, the Environmental Protection Division started monitoring EtO levels near sterilization plants and requesting stricter emissions controls. Facilities run by medical device manufacturers Sterigenics and Becton Dickinson signed consent orders in 2019 to temporarily close their plants in the state to improve emission protections and conduct air testing.

These companies have since faced dozens of lawsuits by Georgians who allege their operations caused cancer. Georgia regulators also found what’s known as fugitive emissions in a warehouse where manufacturers sent medical devices after being sterilized, which raised alarms about a new source of ethylene oxide release not previously considered.

A facility in Grand Rapids, Michigan, run by medical device manufacturer Viant, was shut down and fined in December 2019 by the Michigan Department of Environmental Quality after the state discovered fugitive emissions in a parking lot near the facility that exceeded the allowable safety limits.

Last year, New Mexico Attorney General Hector Balderas (D) sued Sterigenics for emissions at a facility in San Teresa that opened in 1989. The site sterilized 2.5 million medical products every day, the company disclosed in legal filings. If it were to shut down, there wouldn’t be enough global capacity to make up the work, said Heather Mallinckrodt, associate vice president of contract and program services at consulting firm Vizient, which does business with companies that sterilize medical products, including Becton Dickinson.

“When [health systems] can’t get those products, they may have to delay a procedure. They may have to use an alternate product, which the clinicians aren’t as familiar with,” Mallinckrodt said.

Amid the disruption, manufacturers have had to triage the release of medical devices through a bottlenecked sterilization process. Devices for the most high-risk procedures and illnesses are prioritized, which threatens shortages of other products. Manufacturers have started to bring sterilization in-house to better control their inventory, Mallinckrodt said.

The hospital industry responds

Hospitals have taken note of the EtO dilemma. The American Hospital Association and the Association for Health Care Resource and Materials Management released a quality advisory recommending providers source medical devices from companies that do not use ethylene oxide in order to build resilience to product shortages. Many hospitals have worked to eliminate EtO within their own internal operations but continue to buy from suppliers that use the chemical.

Northwell Health uses a 110,000-square-foot facility in Bethpage, New York, to sterilize reusable medical instruments for its 21 hospitals. The New Hyde Park, New York-based health system transitioned from ethylene oxide to low-temperature sterilization systems a number of years ago in response to concerns over worker safety, said the not-for-profit system’s chief sustainability officer, Donna Drummond.

But Northwell still purchases supplies that have been sterilized with ethylene oxide, Drummond said. The health system plans to start asking suppliers how products are sterilized to better understand the ramifications of their purchasing contracts.

“We’re wrapping our arms around what kind of things that we can say to our suppliers we would like to see them do to reduce their carbon footprint and impact on the environment,” Drummond said. “This is not something that we can mandate on our own. While we may be a big buyer, we still have to work with others if we want to change the way things work.”

Mark Howell, the AHA’s director of policy and patient safety, said he envisions a future where EtO is no longer used for medical devices and supplies. But viable alternatives are needed to mitigate harm to patients and healthcare providers, he said. In the meantime, ensuring that EtO-related emissions are reduced to safe and scientifically established limits is critical, he said. Howell cautioned that imposing overly stringent regulations could limit access to supplies or make them exponentially more expensive.

Especially as hospitals continue to deal with unstable supply chains throughout the COVID-19 pandemic, the EPA needs to coordinate closely with the FDA, the Department of Health and Human Services and the Centers for Disease Control and Prevention on any regulations to limit unintended consequences, said Nancy Foster, the AHA’s vice president for quality and patient safety policy. 

“We believe that there is a way forward here, but it requires thoughtful action, both by the regulatory agencies and by those of us in the field,” Foster said. “We need to manage it for the short term, while we’re striving for that longer-term solution.”

Current and future regulations

So far, federal and state authorities have worked with companies to set up the necessary infrastructure to reduce ethylene oxide emissions. Between 2011 and 2020, the amount of EtO released into the air annually was halved from approximately 300,000 pounds to 150,000 pounds. At present, the EPA requires that 99% of EtO be destroyed before leaving sterilizer chambers. It must be diluted even further before being released into the air, leaving little room for further regulation absent an all-out ban.

Some facilities have the latest technology; others do not. An EPA technology review initiated this year will evaluate that factor as well as the ability to accurately measure ethylene oxide in the air. The findings will inform an upcoming regulation under the federal Clean Air Act.

States have worked with sterilizers to upgrade to the latest technology to contain and convert ethylene oxide into carbon dioxide and water. The process is supposed to eliminate 99.9% of EtO in the air, according to Becton Dickinson, which uses it within its facilities. In most cases, emissions near its plants are in line with normal air quality, barring leaks or malfunctions, according to a company spokesperson.

“We are confident in our controls and that our emissions are not putting any of our communities at risk,” Becton Dickinson said in a written statement. “If there are higher incidences of cancer, a total view of what is happening in the environment must be looked at, not just a singular industrial source.”

The EPA says measuring EtO within the air surrounding facilities is imprecise and needs to be researched further to guide policymaking.

Byron Brown, a senior counsel at Crowell & Moring who served as the EPA’s deputy chief of staff for policy under President Donald Trump, said the agency is in a difficult position regulating a process that could have significant consequences for the healthcare system. The agency has requested information from sterilizers on emissions, emission sources, control technology and operational practices that may reduce the release of ethylene oxide.

“No matter what regulatory approach they take, they’re going to get sued,” Brown said. “That’s just a fact of life on most EPA issues, but this one has increased visibility. … There are a lot of different stakeholders and constituencies that are closely following this issue, and there’s no clear middle ground that would satisfy all of the different stakeholders.”

Alternatives

The EPA recently recommended facilities be outfitted with continuous monitoring systems, new technology that enables real-time emissions tracking that facilitates prompt responses to leaks, and with more emissions controls. The technology is not currently required under federal regulations but may provide the agency with information to guide its upcoming rulemaking.

The FDA has begun several pilot programs with the private sector to explore potential alternatives to ethylene oxide for sterilizing medical devices. They are testing methods that use carbon dioxide, nitrogen dioxide, hydrogen peroxide and radiation, for example.

The FDA oversees the device approval process, which includes plans for sterilization. The agency’s role is to assess whether devices are sufficiently sterilized without being damaged. According to an FDA webpage dedicated to ethylene oxide, it does not regulate emissions or control what types of sterilants are used in the manufacturing process.

Alternatives to EtO exist, but none are scalable using the current logistics and engineering, the University of Illinois’ Orris said. Ethylene oxide is beneficial in the manufacturing process because it can sterilize several different materials at the same time by the truckload. This enables manufacturers to pre-package surgical kits with different materials, such as metal, paper and plastic, and sterilize them in large quantities.

Other options, such as heat, steam and gamma radiation, have limits. They can’t sterilize the same range of materials as effectively, which reduces throughput and creates patient safety concerns, according to the FDA.

“What you always discover is there are always problems with the alternatives, and we have to safely handle everything. But ethylene oxide just has to go,” Orris said. “You can’t do this stuff without releasing some of it, and when you release some of it, you raise people’s risk of cancer.”

In August, the FDA concluded that the pilot programs have “shown encouraging progress with new strategies to reduce EtO emissions.” Some facilities have been able to cut emissions 20% to 35% by reducing the concentration of EtO used in the sterilization process or by transitioning certain devices to alternative methods.

Environmental justice concerns

By the time Becton Dickinson applied for a permit in April 2021 to operate an EtO sterilization facility in Tucson, word had spread.

The proposed site is located in an industrial park near an Amazon warehouse on the city’s southeast corner. Nearly half of the population in the surrounding census tracts are people of color, and 30% are considered low-income.

Within that same community is one of the nation’s oldest Superfund sites, a 10-square-mile area that is home to Tucson International Airport and U.S. Air Force operations. A military contractor previously dumped degreaser into the land, contaminating the groundwater with trichloroethylene, a chemical known to cause kidney cancer.

Local officials later found polyfluoroalkyl substances, or PFAS, in the water supply. Exposure to PFAS can affect fertility, childhood development and immunity, and increase the risk of cancer, according to the EPA.

The area is split by an interstate highway, has several large industrial parks and a military aircraft boneyard, and houses the city’s largest power plant, according to a spokesperson with the Pima County Department of Environmental Quality. More than half of the county’s top polluters are located there.

“This gas is a known carcinogen,” Tucson resident Jessica Sampson said at the public hearing last year. “It shouldn’t be regulated. It should be banned.”

The county air quality agency said it received more feedback on Becton Dickinson’s permit application than any other before, despite it not being designated a “major” source of pollution. “People are upset that it’s being located there and feel like there may be more appropriate places to put it that aren’t near people,” a spokesperson said.

A University of Arizona environmental justice analysis prepared for Pima County found the operations would potentially cause 19 more people per 1 million to develop cancer in the neighborhoods close to the plant, well within the EPA’s allowable range.

Although the cancer risks and projected ethylene oxide concentrations within the air are expected to be much lower than those that caused plant closures in other locations, residents don’t want it, said Pima County Supervisor Adelita Grijalva (D).

“It’s a community that’s already experienced historical trauma and environmental justice issues,” said Paloma Beamer, professor of public health at the University of Arizona in Tucson and co-author of the report. “Even though the estimates look really low, it’s been hard for people in the community to understand how we would want to allow any amount of carcinogen to be emitted into our community,” Beamer said.

But sterilizer companies need the extra capacity to serve hospitals in Western states. Arizona law forbids regulations to be stricter than federal standards, unlike in California, where tougher rules are in place. Grijalva and other local officials are pushing back and questioning the purported economic benefits the plant would provide the local community. The facility will employ 40 full-time workers, according to Becton Dickinson.

“We only have so much authority,”  Grijalva  said. “So when we are trying to do some really significant changes and do some positive stuff, we also are dealing with the lack of environmental restrictions and oversight at the state level.”

Looser laws have funneled development of ethylene oxide plants to places such as Arizona, Arkansas, Puerto Rico and Mexico. Tucson residents question why local officials would permit air pollution in their city that is outlawed in California. It’s the same feeling of disposability that Frunk said she has felt since learning her cancer may be related to the healthcare industry: “They knew what was going on. They didn’t care,” she said.

This puts healthcare providers working to build trust with communities in an unfavorable situation, the AHA’s Foster said.

“It concerns us that people would perceive healthcare as something that is acting in any way other than to promote their health and their best life going forward. Our members run part of the healthcare system and it’s all intertwined, but communities that have jurisdiction over this land need to be thinking about these issues of justice as well,” Foster said. “We can see the health effects of pollution and other environmental concerns on the poorest of our communities. And that is simply not fair.”

The City of Tucson approved the permit in May.

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