The final federal rule limiting ethylene oxide (EtO) emissions from commercial medtech sterilization plants is now set to come out in 2021, according to the Environmental Protection Agency.
Before the COVID-19 pandemic struck, the EPA had expected to issue the proposed rule in the spring of 2020. The agency considers ethylene oxide a carcinogen, and EtO emissions have attracted national scrutiny since Illinois state officials closed a Sterigenics plant in Willowbrook, Ill., in February 2019.
The EPA has been fielding comments on EtO in light of public outcry over emissions from medtech sterilization plants for more than a year. Because nearly one-third of the commercial sterilizers the rule could affect are small businesses, the EPA is required by law to convene a Small Business Advocacy Review Panel. The panel met in June and will meet again on an unspecified date this fall to understand the potential impacts of the rule on small businesses, an EPA spokesperson told Medical Design & Outsourcing.
The panel will then make recommendations to the agency, which will also consider information it has gathered from several commercial sterilization companies on facility characteristics, control devices, work practices and costs for emission reductions. The agency sent that request to nine companies, covering about 40 facilities, in December 2019, the spokesperson said.
The medical device industry relies on EtO sterilization to sterilize about 50% of all devices sold in the U.S. that require sterilization — more than 20 billion medical devices per year, according to the FDA. The gas’ properties are one reason. It works at low temperatures — between 90°F and 135°F — making it a viable option for devices made of multiple components and materials, including plastics, polymers, metals and glass, as well as coatings, bonds and packaging from damage. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.
In July 2019, the FDA announced a two-pronged, voluntary pilot program to encourage the development of new approaches to medical device sterilization — one for sterilization facilities and one for medical device manufacturers. The Ethylene Oxide Sterilization Master File Pilot Program asks facilities that sterilize devices in a chamber to submit a master file when switching to a different site or when making certain changes to processes that use reduced EtO concentrations.
A master file submission provides the FDA with confidential detailed information about establishments, processes, or articles used in the manufacturing, processing, packaging and storing of medical devices. A master file itself is a reference document that the agency uses to evaluate several applications for different products that may use a common material or process, such as the same sterilization method.
The second part of the pilot asks manufacturers and sponsors of Class III (high-risk) devices affected by such sterilization facility changes to reference the master file submitted by their sterilization provider in a post-approval report, rather than in a PMA supplement. The new reporting method would expedite the process, the agency said.
In November 2019, the FDA said it had selected 13 of 46 applications to find alternatives to EtO as a sterilant and to reduce emissions of the carcinogenic gas. The selected entries cover sterilization by nitrogen dioxide or vaporized hydrogen peroxide, reduced sterilant concentration and the use of ethylene oxide-flexible chamber technology. The agency said it will work directly with the selected applicants to accelerate the development and review of innovative technologies for sterilization processes.
“Our submission focused on optimizing the EO sterilization cycle to reduce the mass of EO used during the sterilization process while providing robust patient safeguards,” Boston Scientific spokesperson Emily Anderson told Medical Design & Outsourcing in an email. “These efforts resulted in a greater than 30% reduction in the mass of EO utilized in the sterilization cycles required to ensure the safety of our devices.”
“This is part of our ongoing collaboration with FDA as part of FDA’s Innovation Challenge to ensure patient access to safe medical devices while encouraging innovative ways to sterilize medical devices that reduce the use of EtO,” BD spokesperson Troy Kirkpatrick told MDO in an email. “Manufacturers of Class III medical devices subject to premarket approval (PMA) that make certain changes to sterilization sites or processes will be allowed to reference the Master File submitted in a postapproval report in lieu of submitting a PMA supplement. This is intended to provide expeditious review and feedback from the FDA. To maintain participation in the program, we will be required to submit amendments to our Master File every 6 months with information on any process changes or new devices or PMA submissions brought into the program.”
Kirkpatrick did not elaborate on BD’s process, and the FDA has declined to reveal either company’s master file information.
Leaders of the medtech trade group AdvaMed had been hoping that the EPA would issue its final rule by the end of 2020. But the responses that the agency received from the sterilization companies revealed that each commercial sterilization facility’s equipment, equipment configuration, processes and pace of technological advancement is unique, and that the agency needs more information, the EPA spokesperson said.
The agency also wants information from more sterilization companies and needs permission from the federal Office of Management and Budget before it can issue a request for that.
“The goal of this request is to enable EPA to have a better understanding of emissions, emissions sources, processes and control technologies in use at ethylene oxide sterilization facilities nationwide,” the EPA spokesperson said in an email to MDO. “We will use the information we get from the (information request) in addition to the comments we receive on the upcoming proposal, in developing a final rule, which will be issued in 2021.”
AdvaMed’s position on the subject remains unchanged — “to get out a rule that is reasonable,” group president & CEO Scott Whitaker said in a recent press conference.
The organization had been hoping for a proposed rule to emerge early this fall, allowing time for a final rule by the end of 2020, added Greg Crist, Advamed lobbyist and head of external affairs.
“It’s statutorily required in some states to follow the federal environmental regulations, so it would really clarify for a lot of the states and a lot of our commercial sterilizers in those states,” Crist said.
“In terms of alternatives, the FDA has said in its recent analysis that EtO is the best sterilization modality for hundreds if not thousands of device types and they did not see any time horizon in the short- or mid-term for a good, viable alternative in the quantity that we need not only to fight this pandemic but also to look at the everyday uses, whether it be scheduled procedures or what have you,” he added. “That’s the FDA’s position and it’s certainly been our position. That doesn’t mean that we have not robustly responded to the FDA challenge. We have several participants in that that are looking at other sterilization modalities to assure that the supply chain is not jeopardized in any way.”
This article has been corrected to reflect that the EPA had intended to issue the proposed rule on EtO emissions in the spring of 2020.