[Securing the implantable medical device circuit]

Abstract

Objectives: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation.

Methods: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit.

Results: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit.

Conclusions: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

Keywords: Application de l’informatique médical; Application of medical informatics; Government regulation; Management par la qualité; Réglementation gouvernementale; Total quality management.