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How surgical devices are cleaned and decontaminated determines the efficacy of the sterilization process. For this to be effective, each item must be cleaned according to its instructions for use (IFU). But, how do manufacturers validate cleaning processes for their instruments?
In episode 157, host Casey Czarnowski speaks with Dr. William Levia of Medtronic about the manufacturer validation process. Dr. Levia describes the many detailed steps that manufacturers must go through to test cleaning protocols and the reasons behind them. He refers to the different classes of medical devices and discusses the roles of regulatory agencies, standards-setting organizations and testing laboratories. He also introduces listeners to ANSI/AAMI ST98:2022 Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices. Dr. Levia believes in bridging “the standards, the core science and the real-world setting.” Listen to learn more about how instrument manufacturers do their jobs, so we can do ours.
ABOUT OUR GUEST
Dr. William Levia
Global Senior Program Manager for Sterile Processing
Medtronic
Dr. William Leiva received his PhD in Cybernetics and Statistics from Bucharest University of Economic Studies in 2024 and his MPH in Epidemiology and Health Economics from Andrés Bello National University in 2018. He has worked as a Senior Manager for Scientific Affairs at 3M Healthcare (2008–2023), sterilization and reprocessing subject matter expert at the FDA, and in a leadership role at Medtronic since 2024. He also holds a visiting professorship at Bucharest University of Economic Studies. Dr. Leiva is a recipient of AAMI’s Kilmer Grant, serves as a reviewer of peer-reviewed articles, and has presented internationally, including at AAMI eXchange and WFHSS. His research topics include reusable medical device decontamination, terminal sterilization, sterile barrier systems and reprocessing economic epidemiology.