Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.

Why Should You Attend:

Reusable medical devices continue to receive scrutiny from regulatory agencies both in the United States and internationally. Since the advent of ANSI/AAMI ST 98 there has been more clarity in how to perform these validations but it is still important to know the regulatory expectations to reduce the likelihood that submissions will not be accepted and require additional testing or worst case that the testing needs to be repeated.

This presentation will address the most current expectations for cleaning validations of reusable medical devices that are performed in support of the instructions in the instruction for use (IFU). It will include both manual and automated cleaning processes as well as information on how to choose test soils, markers for challenging cleaning, and the acceptance criteria to use to establish effective cleaning.

Areas Covered in the Webinar:

• Cleaning validation design - automated cleaning.
• Cleaning validation design - manual cleaning
• IFU information to be supported.
• Choosing test soils.
• Choosing markers.
• Expectations for controls.
• Acceptance criteria selection.
• Report preparation.

Who Will Benefit:

• This webinar will provide valuable information to all companies that manufacture reusable medical devices in environments:
• QA personnel
• Validation specialists
• Regulatory
• R&D