Cleaning, Disinfection, and Sterilization Validations: Considerations in Reusable Device Design

Reusable devices face significant design challenges that single-use devices do not. A design engineer must think about how the device will perform not only during the first use, but for every subsequent use. Many medical devices need to be able to function safely after hundreds of cleaning and disinfection or sterilization cycles; these devices must therefore be designed to comfortably withstand the stresses of the reuse procedure. Additionally, reusable devices need to be designed so that they may effectively be rendered safe for reuse by either health-care staff or patients at home. If the process is too difficult or complex, there is a possibility that the device will not be fully rendered safe for reuse.