Arrêté Royal du 30/09/2020 : un tremplin pour l'amélioration du circuit des dispositifs médicaux - Gap analysis et démarche qualité

Details

Supervisors

Evrard, Jean-Michel ; Hannesse, Didier

Faculty

Faculté de pharmacie et des sciences biomédicales

Degree label

Master de spécialisation en pharmacie hospitalière

Abstract

Objectives – The aim of this work was to reconcile the local context (increase in the number of Medical Device (MD) out of stock linked with european reglementation 2017/745 and 2017/746, Covid19 crisis and international conflicts; complex processes; roles and responsibilities unclear;...) and legal context (new royal decree of 30/09/2020) by improving quality and security of MD circuit. Methodology –1) Define state of the art of MD flow on 3 sites in relation to the 30/09/2020 Royal Decree (RD) – descriptive study through a Gap analysis method. 2) Propose solutions to improve non-compliant steps – literature review, visits of other hospitals, further analysis of some internal processes. 3) Edit the action plan – Discussion and validation with staff members of 3 department. 4) Implement some corrective actions. Results – 37 criteria that concern MD circuit have been identified in the RD. Three major themes were extracted from deviant step identified during the gap analysis : infrastructure on Godinne’s site, human resources & work organization, software & tracability. Corrective solutions were validated and included in action plan for each deviant step. For example : Storage label with barcode for secure delivery by scan and refitting of premises - Creation of a link between the supply department and the pharmacy on the basis of a “service level agreement” reinforced by a training and audit system - Definition of term for MD under the responsibility of the pharmacy :”MD Pharma” – Definition of a standardized nomenclature for “product card” in the software. Conclusion - The Royal Decree can be seen as a springboard for improving the quality and safety of the MD management process and the well-being of staff members. In this work, we have built an action plan that corresponds to local challenges and legal requirements. The national obligations helped to plan the changes