[Review of practices concerning the delivery of an international implant card following the implantation of a medical device].

Abstract

Introduction: The European regulation 2017/745 requires the delivery of an international implant card to the patient following the implantation of implantable medical devices (IMD). Currently, there are no procedure to describe the process for providing traceability documents to patients in our institution. The objective of this work was to evaluate the practices of the various departments concerned in our institution and to think about actions to meet the current regulation.

Material and method: The evaluation of practices concerning the delivery of traceability documents to patients was evaluated through a questionnaire with 13 departments. Then, for each specialty, three electronic patient record (EPR) were audited. Finally, IMD's suppliers were asked about their ability to provide an international implant card.

Results: In total, 85% (11/13) of the departments sent an IMD traceability document to patients, and in 91% (10/11) of cases, this transmission was done with the international implant card or the operative report. However, 63% of the operative report analyzed did not contain the traceability data of the IMD. Finally, only 60% of the suppliers contacts accompanied their IMD with an international implant card.

Conclusion: While waiting for the suppliers to send an international implant card, it was proposed to the departments to give patients the IMD traceability sheet from the IMD traceability software. However, this document does not allow us to be in full compliance with the European regulation to the absence of regulatory information (UDI, address and manufacturer's website).