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Background and Importance The medical device process, from order to use, involves multiple stages and actors, all potential sources of errors. A study on the implantable medical device (IMD) process was conducted at our hospital. IMD traceability is managed in two ways: a digital traceability process (DTP) using the unique device identifier (UDI) in Cardiology, and a manual traceability process (MTP) in the operating theatre.Aim and Objectives The objective is to assess the actual implementation of the IMD process according to the traceability method used.Material and Methods An audit grid proposed by OMEDIT Ile-de-France 1 was employed. One pharmacist and two residents conducted the audit over four months. The patient-tracer methodology was applied to evaluate the entire process, including document management, supervision, reception, storage, and the use of equipment by medical staff (MS) and paramedical staff (PS), as well as patient information and traceability.Results Fifty-six individuals were audited: 14 in the DTP, including 2 patients, and 42 in the MTP, including 6 patients. The DTP outperformed the MTP across most audited stages: reception procedures were fully compliant in the DTP (100%) compared with 86% in the MTP. Performance during the pre-implantation phase by PS was also higher in the DTP (63% vs 50%), as well as during implantation and post-implantation by MS (84% vs 69%). Patients recalled the implant card in the DTP (100%), versus 56% in the MTP. Storage managed by pharmacy staff showed higher performance in the MTP (88% vs 75%), and document management was identical in both processes (80%). Supervision performance was moderate in both processes, with no improvement observed using the UDI (44% vs 53%). Patients were not always clearly informed about discharge documents: only 3 of 8 recalled the implant card before discharge.Conclusion and Relevance Digitalisation of the traceability process using the UDI allows better control of the IMD process and improves patient information. Both processes share common improvement areas, including staff training and proficiency in adverse event reporting and medical device vigilance. To address these gaps, an interactive Wooclap training for healthcare professionals was developed along with a project to implement pharmaceutical consultations at discharge to reinforce patient education on implant cards.References and/or Acknowledgements 1. https://www.omedit-idf.fr/webinaire-regional-outils-danalyse-des-risques-appliques-au-circuit-dispositifs-medicaux-implantables-dmi-05-12-2024/Conflict of Interest No conflict of interest