Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

A management brief by Patrick Kenny, Accuratus Lab Services

The FDA Draft Guidance for Industry and Staff:Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling was released in May 2011. While labeled draft, experience has shown us that most reusable device cleaning validations are being evaluated on this document. We have performed cleaning validations following the guidance for various instrument types over the past year, and have identified several areas that can cause issues during the validation if they are not thoroughly addressed prior to initiating the protocol.

This brief will focus on the areas of the guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.