With the release of ANSI/AAMI ST98 in 2022, medical device manufacturers were provided with a standard that gave additional guidance for implementation and testing for medical device cleaning validations. Even with the introduction of this new standard, there are still a number of challenges that can affect the performance of cleaning validations.

During this webinar, the following topics will be discussed:

• What is ANSI/AAMI ST98? - Reprocessing Overview
  
• Challenges and considerations of ANSI/AAMI ST98, including:
• Complex device designs
• Material incompatibility
• Impact on process residuals and patient safety

Presenter:

Lori Graybill Manager, Microbiology Eurofins Medical Device Testing

As a Manager of Microbiology at Eurofins Medical Device Testing, Ms. Graybill is responsible for leading the medical device reprocessing department, including but not limited to cleaning validations, disinfection validations, sterilization validations, and overseeing testing in support of sub-visible particulate testing and various antimicrobial tests. Ms. Graybill has over 15 years of experience spanning both medical device and pharmaceutical industries, respectively, with a strong background in controlled manufacturing environments and routine microbiological testing for water systems, data analysis, and investigations.