The Association for the Advancement of Medical Instrumentation recently updated one of its guidance documents on ethylene oxide (EO) sterilization.
Ethylene oxide usage is a pressing issue, with the medical device industry facing cost concerns and a regulatory landscape transformed by the recent Environmental Protection Agency rule that imposed new emissions requirements.
This AAMI technical information report (TIR) provides a badly needed update to existing guidance on the microbiological aspects of ethylene oxide sterilization and includes information on the design and qualification for biological indicator or parametric release processes.
AAMI TIR16:2023; Microbiological aspects of ethylene oxide sterilization was produced by AAMI’s volunteer Industrial Ethylene Oxide Sterilization Working Group. The working group is co-chaired by Nicole McLees, global director of Sterility Assurance at Olympus and Ken Gordon, principal scientist, Innovation & Industry Representation, at STERIS Corporation.
TIR16 is an innovation, as it condenses relevant information previously available from multiple sources into one resource. It also provides guidance on the use of process challenge devices (PCDs) for routine processing when biological indicator release is used. The new version of TIR16 is founded on best practices that have been successfully implemented in the United States.
Speaking to AAMI, McLees noted that the release of TIR16 is part of a greater international trend towards providing new guidance on methods other than the half cycle overkill sterilization method. “Actually, the ethylene oxide standard ISO 11135 is being updated to include additional guidance on these methods.”
The updated version of TIR16 goes in-depth regarding process and equipment characterization including physical characteristics that impact the use of EO, including:
• EO concentration
• EO dwell time
• Temperature
• Humidity
TIR16 also provides guidance on troubleshooting, sterilization loads, and the maintenance of product effectiveness.
Questions about the guidance document? Reach out to the AAMI Standards team at standards@aami.org.
At the recent AAMI/FDA neXus, ethylene oxide (EO) sterilization was a key topic within the conference’s programming on industrial sterilization. On the first day of neXus, a panel of regulators and industry experts presented on the future of EO. The panel featured Lisa Simone, senior health scientist at the Center for Devices and Radiological Health (CDRH), Brian McEvoy, senior director, global technologies at STERIS and recent winner of AAMI’s Sterilization Science award, and Scott Weiss, head of sterilization strategy at Alcon Laboratories. The panelists began the lecture by polling the audience and found:
• most attendees believed that uncertainty related to U.S. and international regulations was the most important issue related to ethylene oxide (EO) sterilization.
• a small majority indicated that the industry and regulators are doing a good job of reducing EO use through improving processes.
• a majority chose reducing EO using via alternative validation methods as the most important future priority.
The Regulatory Environment
According to McEvoy, “I think the word uncertainty is important.” While regulations in the United States such as the imminently expected EPA rule are important, addressing EO use is a global challenge and readiness is paramount. One positive example of stakeholder collaboration on EO can be found in the European Union, where the entire supply chain from producer to end user is engaged and involved. This way, every stakeholder group is familiar with what actions they need to take to ensure safety and compliance. Weiss further noted that collaboration with regulators can be helpful, calling the 2019 creation of the tiger team within CDRH “phenomenal.”
One way that CDRH has sought engagement and feedback from industry is its master file programs. But the March 1, 2024 deadline for EPA to release its rule on EO creates fundamental uncertainty. According to Simone, “we don’t know what the impact is going to be.” Yet CDRH has made substantial progress while waiting for the rule, such its tiger team focused on making “meaningful reduction[s] in EtO use.” Nevertheless, Simone made it clear that she believes CDRH needs more information from industry. “We’d love to see more participation in these master files.”
The industry representatives on the panel agreed, stressing the need for agility and maintaining capacity. While there is excellent work going on with alternative technologies, McEvoy stated, “our reliance on EO is very firmly there.”
How is Industry and FDA Responding?
McEvoy pointed to the Sustainable EO program at STERIS as a case study of successful stakeholder engagement. Ideally, this engagement will help foster creative solutions; for instance, the more efficient use of sterilization chambers or reducing the amount of paper sterilized along with medical devices. Implementing specific solutions, like the adoption of electronic IFUs, will tend to be global challenges, and better access to new technologies will be important. McEvoy also indicated that while new and novel technologies are important, using existing approaches differently can yield significant improvement. The secondary effects of decisions, like the speed of sterilization, can result in positive knock-on effects like a reduction in EO use.
Per Simone, FDA would like more information about how the innovation challenges may impact the supply chain. While the data resulting from the agency’s innovation challenge is propriety, she stated that the early observation is that some facilities have cut EO use by 25-30 percent. Some facilities are also targeting an EO cycle concentration of 11-60 percent less than the typical EO concentration range. But FDA needs to know where to look, and what medical devices to consider for the agency to adopt regulatory flexibility.
Takeaways
All three panelists expressed some optimism about the future. First, Weiss pointed to ongoing work within AAMI, especially TIR 17, but also cited the opportunity for industry to continue its collaborative efforts with regulators like FDA. Second, McEvoy advocated for a holistic approach that will involve new technologies, better use of existing technologies, and regulatory flexibility where appropriate. Finally, Simone closed her remarks on behalf of FDA.
“Please contact us with your ideas,” she said. “We are listening.”
