2023 in Review: A Clean Start for EtO

Darwell doesn’t venture out much these days.
 
COPD (chronic obstructive pulmonary disease) and other respiratory conditions keep him mostly confined to his home, where the air is safe to breathe. “I don’t really even come outside,” the South Memphis, Tenn., resident told WHBQ-TV (Memphis) this past spring. “I stay in the house most of the time. I worry about the pollutants in the air.”
 
Darwell has good reason to fret: He lives near a 45,000-square-foot sterilization plant that uses ethlyene oxide (EtO) to disinfect medical devices. The colorless, faintly sweet-smelling gas has been used for more than half a century to avert implant- and hospital-related infections, but the longstanding practice garnered new scrutiny after the U.S. Environmental Protection Agency (EPA) deemed EtO a human carcinogen in 2016.
 
That label has since sparked a firestorm of controversy over the gas’s long-term health hazards, pitting community activists against medtech executives in a protracted public health versus public safety tug of war. Concerns about EtO’s penchant for altering genes and changing chromosomes has consistently been met with disdain from an industry that depends on the gas to sterilize devices (pacemakers, catheters, ventilators, heart valves) ineligible for steam cleaning.
 
“EtO sterilization is crucial for preventing infection in patients. The process is used to sterilize half, or 20 billion, of all medical devices in the United States each year,” Khatereh Calleja, vice president of Technology and Regulatory Affairs at AdvaMed, wrote in comments to the EPA this past spring. “…it is the only effective, viable sterilization method for many medical devices. Medical device sterilization is a tiny fraction of commercial uses of EtO, representing only half of 1 percent of all commercial EtO use. But the risk of a public health threat is real if we are constrained in our ability to serve patients with the safe, effective, sterile medical technology…It is critically important that EPA recognize the importance of EtO in our healthcare system, and for individual patients.”
 
The EPA, however, must balance that importance with its namesake duty to protect human health and the environment. Accordingly, the agency proposed stricter new EtO emissions rules in April to help reduce lifetime cancer risks amongst commercial sterilization plant workers and host community residents. Specifically, the agency wants all 86 U.S. sterilization facilities to cut EtO emissions by 80% annually; continually monitor air pollution (and report data biannually); and reduce EtO sterilization cycle volume to a maximum 500 milligrams/liter of air. The updated standards also would require sterilization plants to conduct real-time monitoring to ensure their pollution control efforts keep indoor EtO levels below 10 parts per billion; levels above that threshold would necessitate protective equipment for workers.
 
“EPA’s number one priority is protecting people’s health and safety, and we are committed to taking decisive action that’s informed by the best available science,” EPA Administrator Michael S. Regan stated upon announcing the rules. “These proposals build on EPA’s outreach to communities across the nation and reflects close coordination among key federal partners. Together they would significantly reduce worker and community exposure to harmful levels of ethylene oxide.”
 
The EPA worked with several other agencies to draft the proposed rules, including the U.S. Food and Drug Administration (FDA), U.S. Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry, and the Occupational Safety and Health Administration. The proposals are well-aligned with the Biden Administration’s Cancer Moonshot initiative and its efforts to secure environmental justice and safeguard public health in the nation’s at-risk communities (where a majority of medical sterilization plants are located).
 
“A lot of people feel like they put these [plants] in areas where there are mostly African Americans and people of color,” South Memphis resident Tanesha Bates declared to WHBQ, “knowing that it will cause dangerous things to happen to us.”
 
Dangerous and potentially deadly things: Lifetime cancer risks range from 1 in 36 to 1 in 10 for sterilization plant workers, and 1 in 25 to 1 in 12 for healthcare (hospital) sterilization operatives, EPA data indicate. An estimated 100 in 1 million people living or working near sterilization facilities—like Bates, Darwell, and breast cancer survivor Dolly M. Cross—are at risk of developing the disease, the agency claims, though the Texas Commission on Environmental Quality disputes such statistics. “EtO has not been conclusively demonstrated to cause cancer in people,” the Commission contends.
 
Regardless of disputed proof, the EPA is giving sterilization facilities 18 months to comply with its proposed new rules, once they are finalized (the agency is under court order to do so by March 1, 2024). Predictably, medtech industry groups are balking at the timeline and warning of “grave” supply chain consequences.
 
“We understand EPA’s interest in moving more quickly than usual on these priorities; however, these proposed standards are highly technical and require in-depth analyses and research on the part of organizations that utilize EtO for sterilization. They likely will require significant financial, time and resource commitments,” American Hospital Association Executive Vice President Stacey Hughes told Regan in a June 27 letter. “We are concerned that the proposed 18-month timeline is too aggressive and could result in significant disruption to the supply chain leading to decreased sterilization capacity and supply availability across the country. With device sterilization capabilities already at or near capacity across the country, we strongly encourage the agency to consider employing its traditional three-year implementation timeline to the standards if made final. This will allow these facilities more time to come into compliance prior to enforcement in an effort to help prevent the closure, temporary or permanent, of any of these facilities.”
 
AdvaMed supports a four-year timeline with the “ability to make case-by-case exceptions in special circumstances.” Attempting to meet the EPA’s 18-month compliance deadline could lead to the simultaneous shutdown/suspension of all U.S. sterilization facilities, the organization argues.
 
Thankfully, there’s an escape hatch: The FDA announced a pilot program in April to help companies adopt new ways of sterilizing approved, single-use medical devices. The voluntary program is open to in-house and contract sterilization providers that want to move a gamma radiation process to a different site; switch from gamma radiation or EtO to X-ray or electron beam radiation; or use a lower dose of gamma radiation.
 
Sterilization providers accepted into the program (two of the nine available slots have gone to STERIS and Andersen Sterilizers) must submit a Master File when making changes. Once the Master File is accepted into the pilot program, the pre-market approval (PMA) holder may reference the document in a post-approval report to describe the sterilization changes, thereby freeing manufacturers from submitting PMA supplements for the changes.
 
“FDA recognizes the need to facilitate more timely changes to alternative sterilization methods, processes, or sites among sterilization providers who use gamma radiation or EO to support sterilization supply chain resiliency,” FDA Associate Policy Commissioner Lauren K. Roth wrote in a 12-page document outlining the program. “By helping industry advance alternatives for gamma radiation and EO sterilization of medical devices, the Radiation Pilot Program seeks to help ensure patient access to safe medical devices and, through evaluation of data from pilot participants, provide insights into future regulatory approaches that may help address potential device shortages related to sterilization site, method, or process shifts, and facilitate supply chain resiliency.”
 
Finally, a long overdue cleaning.
 
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