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.