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

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, sterilization (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.