5PSQ-136 Computerisation of medical devices, traceability and unexpected loss of data: reports and prospects for improvement

Background In order to face up to the national health insurance’s exigencies about the tracking of implantable medical devices (IMD), hospital pharmacies have to improve their own processes with computerisation. This new process, set up in 2013 in our hospital centre, is expected to secure the medical data and to replace the paper-tracking (PT) process. Purpose The purpose of this study is to understand why computerised traceability (CT) leads to a loss of information and to identify remedial actions to improve its efficiency. Material and methods A pharmaceutical team performed three retrospective audits limited to the orthopaedic IMD in a period of 6 months in 2014, 2015 and 2017. Thirty files were extracted by random selection and evaluated using a specific audit grid. Criteria analysed were denomination, manufacturer, batch number, date of use and surgeon name. Complete traceability is certified by the presence of all items. Both CT and PT were analysed and compared. Results The 30 medical files that had been analysed in 2017 included 124 IMD (71 in 2015 and 59 in 2014). There was 100% conformity for the entire PT versus 23.4% (2017), 40% (2015) and 3% (2014) for the CT. The IMD’s denomination (CT) was correctly described in 60.5% (n=75) of all cases in the 2017 study, versus 83% in 2015 and 22% in 2014. Batch number was found in 80.7% (n=100) of all cases, versus 87% in 2015 and 71% in 2014. The manufacturer appeared in 32.3% (n=40) of all cases, versus 40% in 2015 and 23% in 2014: it was the main missing data. The improvements made in 2015 have not been confirmed in 2017. Conclusion As things stand at the moment, the computerised system definitely cannot replace the old PT. The main difficulty rests in the fact that full data have to be filled in manually by the operating room nurses despite the availability of barcode readers. Indeed, the IMD have different barcodes that do not contain all data. The new European regulations will improve the coding system by the creation of a Unique Device Identifier (UDI) which might solve these problems in the future. No conflict of interest