What devices can be reprocessed?
SterilMed develops and provides validated processes, reviewed and cleared by the FDA, to ensure we provide a reprocessed product considered to be substantially equivalent to a new product. In order to be considered for reprocessing, we must ensure a reprocessed single-use device (SUD) is functional (after each clinical use and after the cleaning process), is clean (free of residual biomaterial and any residuals from the cleaning process) and is sterile. Furthermore, the FDA review procedure evaluates all validated processes associated with reprocessing. These validation processes are designed to ensure that reprocessed devices are compatible with cleaning agents, remain biocompatible and maintain their material integrity. SterilMed’s state-of-the-art reprocessing technologies enable our company to supply over 8,000 different Class I and Class single-use devices in all OR departments as well as for the GI and EP/Cath labs.
