A Complete Guide to Cleaning Validations (Reusable Medical Devices)

Standards for reprocessing have been a top priority for regulatory bodies all over the world as healthcare-acquired infections related to reusable devices have received widespread media coverage and enhanced public scrutiny. Active work around reusable medical devices brought into question the validations submitted for market approval and challenged the industry to reconsider traditional thinking surrounding these validations. Revised standards—Medical Device Regulation (MDR), International Organization for Standardization (ISO), and Association for the Advancement of Medical Instrumentation (AAMI—alone have propelled development in this area, bringing attention to the predicate devices used for submissions for market approval of reusable products. The 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 talk will go over basic fishbone 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.

Presented by Alpa Patel