Principles for Validation of Reprocessing for Reusable Medical Devices - Cleaning, Disinfection, and Sterilisation

Reprocessing is a process carried out on a used device in order to allow its safe reuse including cleaning (removal of soil and contaminants), disinfection, sterilisation (inactivation of microorganisms) and related procedures, as well as testing and restoring the technical and functional safety of the used device. Due to recent changes in medical device standards and regulations, manufacturers intending to market reusable devices must plan their testing strategy in advance, perform the required tests using state-of-the-art test methods, and evaluate all results in a biological risk assessment document. 

It is critical to consider proposed changes to AAMI/CDV-2 ST98 and  EU MDR, as some changes will require a modified design for cleaning validation. To ensure all requirements are met, close cooperation between various experts, including engineers, analytical chemists, and toxicologists, is necessary.

During this webinar, our experts will provide insight in to:

• Expectations of regulatory authorities regarding the cleaning validation studies
• Details of the test approaches, focusing on the AAMI/CDV-2 ST98 standard and EU MDR
• A high-level overview of requirements for validation of disinfection and sterilisation
• Common feedback from regulatory agencies

Who should attend?

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