- Conference Article
- 10.1136/ejhpharm-2026-eahp.564
5PSQ-139 Enhancing implant safety through patient implant cards: an audit-based assessment of traceability practices in orthopaedic surgery
- Mar 01, 2026
- W Guibane
<h3>Background and Importance</h3> Implantable medical devices (IMDs) play a central role in orthopaedic surgery, yet post-operative complications and device recalls highlight the critical need for robust traceability. International safety frameworks – including the EU Medical Device Regulation and FDA’s Unique Device Identification (UDI) initiative – emphasise the mandatory use of patient implant cards (PICs) to ensure device traceability and patient safety. Nevertheless, implementation remains inconsistent, with limited data on real-world adherence and distribution of PICs. <h3>Aim and Objectives</h3> This study aimed to evaluate the status of implant traceability and the distribution rate of patient implant cards in orthopaedic units, to identify gaps in workflow, professional training and supplier compliance, and to propose actionable recommendations for standardisation and digital integration of PIC processes. <h3>Material and Methods</h3> A cross-sectional observational audit was performed over a three-month period in 2024. Data were collected from 1 240 orthopaedic implant files, responses of 40 healthcare professionals, and information from 7 medical device suppliers. Structured questionnaires were used, and data were analysed using SPSS v26 with chi-square and ANOVA tests (significance p < 0.05). Key variables included PIC availability, staff awareness of PIC obligations, supplier performance, and existence of digital traceability systems. <h3>Results</h3> The global availability rate of PICs was 29%. Among professionals, 53% were unaware of the regulatory requirement to provide PICs, while 47% acknowledged responsibility but reported absence of standard protocols. Supplier compliance differed significantly (p = 0.02), with larger suppliers more likely to provide complete PIC documentation. No unified digital traceability platform was in use; traceability was managed via paper logbooks, contributing to inconsistencies. <h3>Conclusion and Relevance</h3> Significant deficiencies in implant traceability pose risks to patient safety and regulatory compliance. The adoption of a standardised PIC model, integration of UDI data into electronic health records, and development of a digital e-PIC system can strengthen traceability, enhance postoperative surveillance, and align local practice with international standards. Ongoing professional training and supplier accountability are essential to sustain improvements. <h3>References and/or Acknowledgements</h3> 1. Vaillant T, <i>et al. Pharm Hosp Clin.</i> 2018;<b>53</b>(1):3–9. 2. Kozak K, et al. <i>JMIR Med Inform.</i> 2023;<b>11</b>:e41614. https://doi.org/10.2196/41614 <h3>Conflict of Interest</h3> No conflict of interest
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