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Cleaning Validation Roadmap for Reusable Medical Devices

Understanding the differences between how devices are used in a clinical setting is the key to a successful validation. It is important to create a roadmap of the device you wish to validate from patient use to storage. This information is used to create a protocol for the validation where critical details are a required necessity to accurately represent how the device would be used in the field/clinical setting.

Reusable devices come in many different categories from critical to semi-critical to non-critical. Although this Spaulding classification of devices are linked with disinfection studies, the concepts can be applied to cleaning validations.  The important thing to remember is that each category has its own defined validation criteria for controls, test soils, end point testing markers, and simulated use methods. How the devices are challenged for processing and how they are tested depends on the criticality of the device and how they function in use. In this presentation the fundamental principles and concepts that are important to consider when designing a cleaning validation protocol will be discussed.

Alpa Patel

Alpa Patel

BS, RM (NRCM)
Principal Scientist

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 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 principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test...