Reprocessing of Reusable Medical Devices: Case studies overview to meet regulatory challenges

Medical device designer and manufacturer are recently facing new requirements, updates and challenges in the reprocessing of medical devices field.

Official guidance documents such as AAMI TIR12, AAMI TIR30, AAMI ST-98 and the FDA’s Reprocessing Medical Devices in Health Care Setting (2015, Annex E updated on 2017), provide indications underlying the most critical aspects. However, depending on the medical device complexity, classifications and clinical applications, is it possible to experience uncertainty about the multiple reprocessing options.

With this webinar, our experts will present various aspects of cleaning disinfection and sterilization validation testing: overall considerations, selection of artificial test soil, soiling challenge sites and contact time, chemicals, requirements and acceptance criteria. It will also cover life cycle considerations and challenges in the design of an appropriate validation study.

• overview about EU MDR and US FDA requirements, normative and relative guidance documents
• actual case studies presentation, including hints and suggestions about cleaning, disinfection and sterilization validations, including the upcoming regulatory changes
• high customized validations: hemodialysis machine disinfection case study
• reprocessing validations issues: sample number vs. sample availability, worst-case inoculation spots vs. reality, sufficient inoculum vs. sample surface, and drying validation

Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance.

Marilena Falcone has a PhD in molecular biology and she is Project Manager and Study Director within the team involved in the validation of cleaning, disinfection and sterilization processes for Reusable Medical Devices