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A Basic Overview of Sterilization Validations for Reusable Medical Devices

Published Date: September 5, 2023

This webinar took place on day 3 as part of a 3-day Focus On Fundamentals series, called Reusable Medical Device Masterclass: Cleaning, Disinfection, and Sterilization Validations.

This 3-day course will guide you through the challenges, requirements, methods, and tools for standards-compliant validation of reusable medical devices. Presented in three 60-minute sessions, it will guide you through cleaning validations and pertinent fishbone concepts; requirements for disinfection validation for device decontamination; and an overview of sterilization validations, required data sets, and more.

A critical part of the instructions for use (IFU) provided by a reusable medical device manufacturer are sterilization instructions.  It is important that reusable medical device sterilization validation testing be performed strategically and correctly.  This presentation will cover the basics of sterilization validation for a reusable medical device including the applicable industry standards and the data sets that are needed to support the device instructions for sterilization.  Included in the presentation will be considerations for sterilization accessories and challenges to sterilization in a healthcare setting.

What You’ll Learn:

  • How to design a sterilization validation for reusable medical devices
  • The data sets that are generated with a reusable medical device sterilization validation.
  • The industry standards that may be applicable to a reusable medical device sterilization validation.

Learn more about the presenter below.


Jason Pope

Senior Scientist

Jason Pope is a certified quality auditor and specializes in providing consultations for clients about sterilization of reusable medical devices, endoscopes, and pharmaceuticals and general sterilization validation process development. He has over 19 years of experience working in research and development, validation, and routine control of various sterilization processing modalities including, but not limited to, steam, ethylene oxide (EO), dry heat, and H2O2 gas plasma sterilization. His experience includes commissioning of sterilization vessels for clients including IQ/OQ/PQ performance. As a member of the American Association of Medical Instrumentation (AAMI), he plays an active role, in concert with the FDA and regulatory committees, in developing standards and voting on changes to those standards.