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A Complete Guide to Cleaning Validations for Reusable Medical Devices

Published Date: September 5, 2023

This webinar took place on day 1 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.

Standards for reprocessing are a top priority for regulatory bodies worldwide in the wake of healthcare-acquired infections related to reusable devices, widespread media coverage, and enhanced public scrutiny. Active work around reusable medical devices brought into question the validations submitted for market approval — and has challenged the industry to reconsider traditional thinking surrounding these validations. Revised standards alone (e.g. MDR, ISO, AAMI) have propelled development in this area, bringing attention to the predicate devices used for submissions for market approval of reusable products. Additionally, advances in technological innovations, design, and functional features of these devices have challenged and brought to light a new layer of complications regarding cleaning validations for reusable devices.

This presentation goes over basic concepts when it comes to validation strategies for reusable medical devices and the requirements needed for compliance for these devices worldwide.

What You’ll Learn:

  • How to use a fishbone model to design a cleaning validation.
  • How to optimize cleaning methods for different categories of reusable devices.
  • How regulatory agencies use standards to ensure compliance for cleaning validations and what they are looking for in submissions.

Learn more about the presenter below.

Alpa Patel

Alpa Patel

Director of Scientific Improvement and Reprocessing Expert

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a Director of Scientific Improvement at Nelson Labs involves overseeing test method validations for reprocessing,...