Comprehensive Guidance On Reusable Medical Device Processing Requirements: Cleaning, Disinfection and Sterilization Validations
About
Date/Time
January 25, 2024
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.
Attendees can expect to walk away with a better understanding of:
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
*By registering for this event, you are providing NAMSA consent to contact you directly regarding NAMSA’s services. The information you are providing will be processed by NAMSA to better understand your product needs and interests. At any time, you can submit a request to withdraw your consent for the use of information provided by you by contacting us at: communications@namsa.com. For additional information, please visit our Privacy Policy or contact us at privacy@namsa.com.
NAMSA uses a third-party provider, GoToWebcast, to host NAMSA webinars. For information related to GoToWebcast’s privacy policy and utilization of information, please contact GoToWebcast directly.
Speaker
Staci L. DeMoss, B.S.
Principal Validation ScientistStaci is a technical expert in medical device processing offering over 20 years of experience in single-use and reusable device (re)processing including medical device cleaning, disinfection and sterilization. Her primary focus is assisting medical device manufacturers in the creation and validation of (re)processing instructions to ensure regulatory compliance. Staci worked in both quality and sterility assurance roles, supporting medical device manufacturing, before joining NAMSA in 2008.
Staci has a bachelor’s degree in Chemical Engineering and is a member of the Advancement of Medical Instrumentation (AAMI).
Marie-Eve Cluzel-Valentin
Senior Biological Safety and Validation ScientistMarie-Eve Cluzel-Valentin, who joined NAMSA in 2011, provides regulatory support to medical device manufacturers in various areas such as biocompatibility and microbiological evaluations, clinical evaluations reports (CERs) and submissions to Notified Bodies. Holding a PharmD, a General Chemistry Engineer high school diploma and a PhD in microbiology and molecular biology, she has over a decade of professional experience in regulatory affairs related to medical devices.
Her expertise includes biological safety evaluation plans, toxicological risk assessments, change control assessments, gap analyses, and expert reports based on ISO standards. She also conducts training sessions on biocompatibility and clinical evaluation of medical devices, develops testing strategies for single-use and reusable medical devices, and provides consulting services for CE-marking or post-marketing applications. Additionally, she offers regulatory support to IVD manufacturers by overseeing gap analysis of regulatory strategies and submissions, and developing performance evaluation reports in accordance with IVDR. She also trains Pharmacy students in France and manages multicentric post-market studies to comply with FDA requirements.