Research project – DAST

Again and again we hear about cases where surgical instruments are left in patients. In Germany, about 100 of these cases occur each year. Moreover, the removal of the remaining instrument requires an additional operation. Theoretically, it is possible to check during the operation whether each individual instrument that was delivered to the operating theatre has left it again or is back in its intended position. This project should also be feasible in practice, as the EU has adopted the Medical Device Regulation (MDR) according to which all hospitals in Germany must have their products recertified by 26 May 2020. However, this is no longer feasible with the identification technologies available on the market. One of the obstacles is that the European Medical Devices Database (Eudamed), which will be used to tag the instruments, is not yet fully operational at this stage due to a lack of information.

This is where the project “Digital image of the sterile material cycle by means of new transponder technology” (DAST) comes in. The aim is to develop an application-specific and customized system solution for Unique Identification of Devices (UDI), i.e. product identification, using RFID technology. A digital image of the sterile supply cycle then enables optimized sterile supply surgical planning for operations in real time, so that the right instruments are ready for use at the right time in the right quantity at the right place with the right patient. Since digitisation can support human activity and, through targeted use, help to reduce or avoid errors. With transponder technology, a digital life cycle file is created for each sterile item and automatically maintained during the sterile cycle. In this way it can be seen where the sterile goods are located, whether and when or for what purpose they were used and whether they were sterilized and used in accordance with the process. By digitizing the sterile goods cycle or real time tracking of the sterile goods in the cycle, it can thus be shown whether an instrument is still in the patient’s body.

Official short description of the project on the promoter’s website.