Comprehensive Guidance On Reusable Medical Device Processing Requirements: Cleaning, Disinfection and Sterilization Validations

In the ever-evolving landscape of healthcare, ensuring the safety and efficacy of reusable medical devices is paramount. The intricate processes of cleaning, disinfection, and sterilization validations are essential components in guaranteeing the integrity of these instruments. This webinar aims to equip you with the latest insights, methodologies and best practices in the validation processes, addressing the unique challenges posed by reusable medical devices. Our speakers, each an authority in their respective fields, will guide you through the intricate nuances of validation protocols. From navigating requirements of the new AAMI ST98 guidance to reviewing common hurdles for device manufacturers, we will delve into practical approaches and strategies that align with industry regulations and guidelines.

Reusable medical device manufacturer duties, including:

• Use Instructions (IFU), Risk Analysis and Validations
• Recognizing reprocessing needs for critical, semi-critical and non-critical reusable medical devices
• Common challenges in developing IFU and validation planning

Key cleaning, disinfection, and sterilization validation requirements focusing on the new AAMI ST98 guidance

• Validation method design, process validation, and acceptance criteria
• Common issues for device makers (how study design and failures affect timelines and testing fees)

End of Life Testing

• Requirements and guidance
• Common hurdles for device makers