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There have been many great strides surrounding the guidance for reprocessing (cleaning, disinfection, and/or sterilization) validations of reusable medical devices, such as AAMI ST98:2022 and recent updates to established standards like AAMI TIR12:2020 and ISO 15883-5:2021. It can be difficult to navigate these updates and ensure that your reusable devices have the proper reprocessing validation. In addition, there are still gaps in guidance that have led to “gray areas” of reprocessing. These gray areas include reprocessing validations for single-use devices provided non-sterile, reprocessing validations for novel reusable devices being used for clinical trials, reprocessing instructions for at-home devices, and wearable non-critical devices. While we can rely on published documents to provide guidance in these gray areas, there are questions that need addressing to ensure the safety of the devices associated with these situations. 

Key Learning Points:

• Review the major updates for cleaning and disinfection validations for reusable medical devices.
• Understand how different guidance documents linked to reprocessing of reusable devices are aligned.
• Review the gaps these “gray areas” bring to reprocessing validations and possible solutions.

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. We serve over 3,000 customers across 13 facilities in the United States, Mexico, Asia and Europe. With a comprehensive array of over 900 laboratory tests and the expertise of Regulatory Compliance Associates, a recognized leader in life science consulting, we support our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety and quality assurance. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.


SPEAKERS:
Branna Barber – Consulting Study Director at Nelson Labs
Griffin Cammack – Expert Technical Consultant at Nelson Labs 
Sean Fenske – Editor-In-Cheif of MPO & ODT