Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices.
AAMI ST98 Overview
TIR30:2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices and the 2015 Food and Drug Administration (FDA) guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, have guided medical device manufacturers on cleaning validations for reusable medical devices.
Now, the AAMI Sterilization Standards Committee working group, ST/WG has moved to a new standard rather than a revised TIR to better serve the MDM community and drive harmonization regarding cleaning validation requirements.
AAMI ST98 has a much broader range then TIR30 and applies to devices that require processing before clinical use per the Spaulding scale, including single-use devices that require processing by the healthcare facility prior to use. The other key difference is that instead of only providing an overview of cleaning test methods, ST98 lists the requirements for cleaning validations.
ST98 has two sections: normative and informative. The normative section lists the requirements for cleaning validations, and the informative section provides guidance on applying the normative requirements. The cleaning validation requirements are as follows:
- Product families
- Cleaning process definition
- Test soil selection
- Test soil application
- Simulating use on samples and types of controls
- Test method validation
- Sample size
- Endpoints for cleaning validation
Join us for an in-depth review of ST98 with cochairs of the AAMI Cleaning of Reusable Medical Devices Working Group. This course will review the design of validation methods, validation of the cleaning process, and endpoints. The training will include examples from cleaning validations and test method investigations.
ANSI/AAMI ST98:2022 is a new, published standard. It replaces AAMI TIR30 and provides requirements to validate the medical device manufacturer's cleaning processes for processing medical devices. This standard applies to all medical devices that require cleaning before each clinical use of the device.
This course is presented by:
- Nupur Jain. Director, Validation Engineering. Intuitive Surgical
- Steve Turtil, Biologist, FDA/CDRH
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