Soil residues include organic soil such as proteins, hemoglobin, and endotoxins, inorganic soil, and biological soil in the form of suspensions of microorganisms.
If the reuse procedure adequately removes the soil and all reprocessing criteria are passed, then that procedure is validated for 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.
A design engineer must think about how the device will perform not only during the first use, but for every subsequent use.
To understand the requirements for cleaning, disinfection, and sterilization validations, it is also necessary to be aware of the different classifications of reusable medical devices.
The more invasive the device, the more stringent the reprocessing procedures must be.
Material Selection Porous materials are often prone to retaining high levels of soil residuals and can be difficult to clean thoroughly.
A highly porous material may also retain residual amounts of a cleaning or disinfecting agent that can then harm patients during use.