As the EPA prepares to issue new regulations for the carcinogenic sterilant gas ethylene oxide, the industry must decide whether to invest in expensive emissions-control upgrades, switch sterilization processes or — in the case of some small sterilization companies — exit the business.

Nancy Crotti, Managing Editor

Ethylene oxide (EtO) gas can penetrate paper, plastic and cardboard packaging and doesn’t discolor or harm plastics used in many devices. (Image from the FDA)

In the next few months, the U.S. Environmental Protection Agency will update its rule governing emissions of the most commonly used substance for sterilizing medical devices: the carcinogenic gas ethylene oxide, or EtO.

Although it’s been in use as a medtech sterilant since the 1960s, EtO has really only been under heightened scrutiny for little more than a year. EtO sterilization plants have shut down in Illinois, Georgia and Michigan over concerns about emissions; the FDA has warned about device shortages (although few have materialized); concerned citizens have formed protest groups and filed lawsuits against sterilization companies; and state and local governments have been wrangling over who has the right to regulate sterilization plant operations.

The bottom line is that medtech sterilizers may have to spend a lot of money to upgrade their facilities to meet the new EPA standards, and possibly settle lawsuits or pay judgments to people who claim that they or their loved ones became ill or died from illnesses tied to ethylene oxide exposure. At least 76 lawsuits have been filed against Sterigenics on these grounds, relating to its now-shuttered EtO plant in Willowbrook, Ill.

Alternatives to EtO exist, but experts say none of them can sterilize as many types of devices in as many types of packages as EtO. The gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. Some of those experts, including Dennis Christensen, have been working with the FDA to determine the path forward.

Christensen has been involved with medtech sterilization since 1967. He has sat on the Association for the Advancement of Medical Instrumentation (AAMI) 11135 EtO sterilization standards committee since 1984 and has been involved in the design, construction and operation of EtO sterilization facilities in the U.S. and abroad. He also spoke on a sterilization panel at the DeviceTalks West conference in San Jose, Calif in December 2019. (Medical Design & Outsourcing and MassDevice have three Device Talks conferences set for 2020. Find out more here.)

Christensen owns SVC, a contract EtO sterilization facility in San Jose, and recently participated in a 2-day FDA meeting on the status and future of medtech sterilization. The conclusion, he said at a DeviceTalks panel in Santa Clara, Calif., in December, was that the industry will have to spend the next decade reducing EtO use and EtO emissions as well as residual EtO left on packages after processing.

“We have to do everything we can to reduce the amount of (EtO) and reduce the amount of exposure and get as much out the device that we can,” he said.

Many of the existing EtO sterilization plants are older and need extensive — and expensive — upgrades, according to Christensen. Some of those upgrades are underway. Becton Dickinson is spending $8 million on emissions controls at two medical device sterilization plants it operates in Georgia. Medline Industries is putting $10 million in emissions controls into its Waukegan, Ill., plant to comply with new state regulations.

Sterigenics’ Willowbrook plant was temporarily shut down by state officials in February 2019. The company was in the midst of emissions-control upgrades plant when its landlord decided not to renew the lease. Sterigenics also cited the “unstable legislative and regulatory environment in Illinois” as a reason for not reopening. Viant Medical decided to close an EtO plant it acquired in 2015 from Integer in Grand Rapids, Mich., after a run-in with state environmental regulators.

The FDA is recommending that medtech companies reduce the amount of paper (such as the labeling and instructions for use manuals) included in a sterile device package and move to delivering that information electronically. A large amount of paper in an EtO sterilization chamber hinders the gas getting to the device and results in higher EtO usage, the agency said in November.

The FDA recently told Medical Design & Outsourcing it is working with applicants to a pair of challenges it issued in July to accelerate the development and review of new sterilization methods. The agency also began a voluntary pilot program in November to expedite its approval of certain changes that medtech manufacturers make to ethylene oxide sterilization methods, processes and facilities, and to streamline the reporting method that manufacturers of high-risk devices use when sterilizers make those changes.

Meanwhile, the EPA is reviewing its National Emissions Standards for Hazardous Air Pollutants (NESHAP) for ethylene oxide commercial sterilizers. The agency received 97 comments from the public and the industry on the topic from December 12, 2019 through Feb. 10, 2020, including a statement from 11 state attorneys general arguing NESHAP fails to adequately protect workers and communities from the harmful effects of EtO.

The medtech trade group AdvaMed urged the EPA to reassess its risk assessment value for EtO, arguing that the threshold is neither practical nor based on the latest science. Pursuing it could pose an increased risk to public health through what the group termed “supply chain and distribution threats.”

“EtO is vital to the continued availability of tens of billions of safe and effective medical devices every year, and the medical technology industry is committed to its safe and responsible use as we look for alternatives and ways to reduce EtO emissions,” said AdvaMed president and CEO Scott Whitaker in February. “The agency’s failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.”

The EPA is due to come out with its new proposed rule covering commercial EtO operations in May 2020. Christensen, who said he has visited just about every EtO operation in the world, predicts the industry has a lot of work ahead of it.

“They’re going to have to improve the technology if they are going to stay in business,” he said.