Annexes 2a – Beyond the Printout: Ensuring Sterilization Process Success with Sterility Assurance tools: Indicators

• Understanding the sterilization process and necessity for supplementary monitoring tools in health care setting.
• Recognizing the limitations of solely relying on sterilization printouts and its potential for missing failures such as overloading, packing inside chamber, etc..
• Develop best practice strategies for ensuring effectiveness of sterilization protocols (Steam, EO, VH2O2) to enhance patient safety and minimize healthcare-associated infections.

Meet the speakers:

Sylvie Dufresne Ph.D. Microbiologist, with a Chemical engineer Master degree. Sylvie is participating in standard development process since 2001. She is the Standard Council of Canada (SCC) Chair for the ISO TC 198 mirror committee working on the development of standards associated to sterilization that include sterilization processes using EO, radiation, VH2O2 as well as the test required to validate the sterilization processes such as test of sterility, bioburden, and endotoxins. And she is an active member of the Canadian Standard Association working on the CSA Z314 standard on medical device reprocessing In All Health Care Settings. Sylvie has over 25 years of experience in sterilization of reusable and single-use medical devices. She was part of the R&D team, as microbiologist and R&D director, that has developed 2 new sterilization processes, FDA cleared, using ozone and/or hydrogen peroxide including process challenge devices, packaging, biological and chemicals indicators. She is now a Sterilization and disinfection expert for the validation of medical devices sold sterile using VH2O2 (hydrogen peroxide), EO (ethylene oxide), radiation, or NO2 (nitrogen dioxide) sterilization process, including bioburden, endotoxin and residual tests.

Dr. Atila Nozari is a Senior Medical Liaison at Solventum, specializing in Medical Device Reprocessing for the USA and Canada. With over 20 years of experience in industry and academia, he holds A.A.S., B.Sc., M.Sc., and Ph.D. degrees in Chemistry and Polymers. A PMP-certified Project Manager, Atila has extensive expertise in Quality Control, Quality Assurance, R&D, and lecturing. He has published numerous peer-reviewed papers on Polymers, DSSCs, Data Analytics, and Sterilization. Atila actively contributes to Standards Development Organizations such as CSA, AAMI, and ISO, where he serves as a Technical Expert, Convenor for ISO/TC 304 WG 1, and Co-Chair of AAMI ST-WG12.