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5PSQ-117 Traceability of implantable medical devices/patient information: where do we stand?
  1. K Lefevre1,
  2. M Poulard2,
  3. A Ferre1,
  4. J Clouet1,3,
  5. F Rondeau1,
  6. F Nativel1,3
  1. 1Chu Nantes, Pharmacy, Nantes, France
  2. 2Chu Nantes, Quality- Risks and Evaluation Department, Nantes, France
  3. 3UFR Of Pharmaceutical and Biological Sciences, Pharmacy, Nantes, France


Background and Importance Health traceability of implantable medical devices (IMD) is a major public health issue. In the event of materiovigilance, this information can be used to trace patients who have received an IMD. Legal information relating to IMD is included in the patient file and must be transmitted to the patient on an implant card (Article R5212–42, French Public Health Code).

Aim and Objectives To assess the compliance of this traceability in our facility to comply with the new version of the Contract for the Improvement of Quality and Efficiency of Care (CAQES).

Material and Methods Ten IMD representative of the facility’s activity, with different management and financing modes were selected and 50 interventions were analysed. Twenty-seven items were evaluated divided into four areas: traceability by pharmacy (9), by user service (6), traceability of patient information in the electronic patient record (EPR – 9) and transmission to the patients (3). This retrospective analysis was compared to a similar audit conducted in 2020.

Results Compliance rates are 86% for pharmacy traceability, 84% for service traceability, 52% for patient information traceability in the EPR and 96% for information transmission to the patient. There is a loss of information observed between traceability in business software and information recorded as transmitted to the patient, especially for IMD denomination, manufacturer name, lot and serial numbers. Practices vary depending on surgical specialties. The main non-compliances concern the provision of the implant card, the Unique Device Identifier (UDI), and the Individual Healthcare Identifiers (IHI) number, which are not tracked. Since 2020, practices have improved, especially in terms of patient information traceability, which has increased by 43%.

Conclusion and Relevance Despite the positive results for pharmacy and service traceability, the target set by CAQES for 2022–2024 (>75%) is not met for all criteria. Improvement areas include UDI traceability upon receipt and use, integration of the IHI number into the business software, and harmonising processes across different operating rooms. Improvement avenues for patient information traceability involve standardising liaison letters between surgical specialties, interoperability of business software, and traceability of the delivery of the operative report and implant card to the patient, all to maintain a high level of care quality.

Conflict of Interest No conflict of interest.

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