All new and exchanged devices shipped to an investigator are sterile and ready for implantation. In studies where devices are implanted for short periods; significant battery life may remain at the end of the study allowing reuse of the device. DSI has developed procedures for cleaning and sterilizing devices on-site, and for regelling pressure catheters. These procedures will increase the number of times an investigator can use each device before returning it to DSI via the Device Exchange program, helping to reduce overall costs per study.
DSI only recommends cold sterilization between uses and does not recommend ETO machines. The devices will have changed compared to the unused product in that there would likely be more retained moisture and in particular disruption of gel (e.g. water, blood, or air mixing in the gel). This change in gel property may cause an increased risk for gel extrusion in pressure catheters. Secondly, there are numerous variables and specific parameter settings per ETO machine, and the customized settings used at DSI are proprietary. Lastly, even with our current process, there are some unused devices that do have gel or fill blowouts and must go back to be re-filled and gelled. Note: If a device is re-sterilized with an ETO machine, it will be at the customer's risk and "off label”.
All products being returned to DSI must be cleaned and decontaminated. Please reference the tech note “Cleaning and Decontaminating Devices for Exchange or Return to DSI” for the recommended procedures for exchanges and returns.