Boulder iQ Exec Opens Medical Device Sterilization Conference With Key Presentation
-- Industry expert evaluates ethylene oxide sterilization in light of new EPA regulations --
Kasic will present "Evaluation of Ethylene Oxide Sterilization Going Forward in Light of New EPA Regulations" Tuesday morning,
- Economic analysis of projected cost to meet new requirements
- Operational considerations for meeting new restrictions
- Prevention of product delays while sterilizers upgrade facilities
- Realities of the timeline to compliance, resources to execute
- Cost-benefit models to keep ethylene oxide as the main sterilization method
He will also touch on the role of chlorine dioxide as an environmentally friendly alternative in the evaluation of sterilization methods under the U.S. Environmental Protection Agency's regulations. Last year, the agency issued a final rule that puts in place the strongest measures to date for ethylene oxide (EO) commercial sterilization facilities – a rule that will impact virtually all medical device contract sterilization companies.
"Medical device developers used to sterilizing with EO are understandably concerned about its use and cost going forward," says Kasic. While the EPA is not eliminating EO sterilization, but rather working to reduce EO exposure, he explains that CD offers a viable alternative. "It's an effective, efficient, clean method of sterilization with a long and successful history."
Kasic's presentation topic dovetails with the conference's 2025 focus: "ensuring the sterility and availability of medical devices through adherence to EPA requirements for ethylene oxide emissions, and efficient transitioning to alternative sterilization modalities, with attention to monitoring growth in capacity and materials compatibility with radiation methodology."
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