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How to perform cleaning validations for semi-critical and critical devices according to the new ANSI/AAMI ST98 standard?

Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Additionally, many validation testing requirements were formulated using generalities rather than specifics. Now that AAMI TIR30 has recently been replaced by ANSI/AAMI ST98 certain aspects of cleaning validations have become more defined, especially for semi-critical and critical devices as summarized in the infographic below.

For example, the standard number of simulated use cycles recommended or the endpoints to be evaluated are now clearly defined. On the other hand, there are no standard recommendations for sample size, which now must be determined by the device manufacturer based on a sample size justification. Our Nelson Labs team of experts can help you perform sample size justifications, leveraging our experience in validation testing and knowledge of how device complexity relates to cleanability.

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Katleen Peymen, PhD

Study Director Healthcare reprocessing and Microbiology

Katleen Peymen received her PhD in Biochemistry and Biotechnology from the Faculty of Science at the University of Leuven (Belgium) in 2019. After her career as a post-doctoral researcher, she started at Nelson Labs Europe in 2020 as a Study Director for Healthcare reprocessing and Microbiology. She is responsible for the study design, analysis and reporting of healthcare reprocessing validations for reusable medical devices, such as cleaning, disinfection, and steam sterilization validations, and is an active member of several International Organization for Standardization (ISO) committees related to healthcare reprocessing.