Approche commentée par étape pour réaliser une AMDEC dans le cadre du circuit du médicament

Boulé, Marianne; Lachapelle, Sophie; Collin-Lévesque, Laurence; Demers, Éric; Nguyen, Christina; Lebel, Denis; Bonnabry, Pascal; Bussières, Jean-François

doi:10.1016/j.phclin.2018.05.007

Cited by 3 publications

(2 citation statements)

References 11 publications

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“…The FMECA involved 6 steps: training, functional analysis, qualitative study, quantitative study, determination of the hierarchy of criticality, and proposals for improvement. [8][9][10] Step 1: Training the Team A multidisciplinary working group was trained to ensure consistency in the discussion and rating of failure modes. The group was made up of 8 members: 2 pharmacists (H.S., K.B.J.…”

Section: Study Design and Settingmentioning

confidence: 99%

Application of Failure Mode, Effects, and Criticality Analysis to the Medication-Use Process for Temperature-Sensitive Drugs in a University Hospital

Sakly

Chakroun²,

Jeddou

2022

CJHP

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Background: In the hospital setting, the medication-use system for temperature-sensitive drugs is a high-risk process. Objectives: To analyze the risks associated with the hospital-based medication-use process and to propose corrective and preventive actions for the most critical failure modes. Methods: A multidisciplinary team was trained to analyze the medication-use process for temperature-sensitive drugs and to identify potential failures using a risk analysis method known as failure mode, effects, and criticality analysis (FMECA). The medication-use process, from initial supply to administration to patients, was investigated using “the 5 Ws and How” method (Who? What? Where? When? Why? How?), and the causes of the failure modes were analyzed using Ishikawa diagrams. The most critical failure modes were selected using the Pareto law, and relevant improvement actions were proposed. Results: This analysis identified 41 failure modes for the 9 stages of the medication-use process, of which only 36 were deemed assessable by the participants. Eighteen (50%) of these failure modes were critical, according to the Pareto law, with criticality indices between 12 and 60. The stage of tidying up and storage in patient care units had the highest number of critical failures (n = 5). A total of 48 corrective actions were proposed. Conclusion: The proposed action plan prioritized 3 areas for improvement: the documentation system, staff training, and equipment acquisition. A second FMECA should be carried out to reassess the medication-use process after implementation of these improvement actions. The second FMECA, allowing detection of residual risks and identification of new risks, will be part of a continuous improvement process. RÉSUMÉ Contexte : Le circuit des médicaments thermosensibles en milieu hospitalier fait partie des processus à risque. Objectifs : Analyser a priori les risques liés à ce circuit et proposer des actions correctives et préventives contre les modes de défaillances les plus critiques. Méthodes : Une équipe pluridisciplinaire a été formée pour analyser le circuit des médicaments thermosensibles et identifier les défaillances par la méthode de l’analyse des modes de défaillances, de leurs effets et de leurs criticités (AMDEC). Le processus, qui va de l’approvisionnement jusqu’à l’administration des médicaments aux patients, a été décortiqué en utilisant la méthode « Qui? Quoi? Où? Quand? Comment? Pourquoi? » (QQOQCP) et les causes des défaillances ont été analysées à l’aide de diagrammes d’Ishikawa. Les défaillances les plus critiques ont été sélectionnées par la loi de Pareto, et des mesures d’amélioration pertinentes ont été proposées. Résultats : Cette analyse a mis en évidence 41 modes de défaillances pour les 9 étapes du circuit, dont uniquement 36 sont jugés évaluables par les membres de l’équipe pluridisciplinaire. Dix-huit modes sur 36 (soit 50 %) sont critiques selon la loi de Pareto, avec des indices de criticité répartis entre 12 et 60. L’étape comprenant le nombre le plus élevé de défaillances critiques est celle du rangement et du stockage dans les services de soins, avec 5 défaillances. Au total, 48 mesures correctives ont été proposées. Conclusions : Le plan d’action proposé priorisait 3 domaines d’amélioration : le système de documentation, la formation du personnel et l’acquisition d’équipements. Une deuxième AMDEC devrait être réalisée pour réévaluer le circuit après la mise en œuvre des mesures d’amélioration. La deuxième AMDEC permettra la détection des risques résiduels et l’identification de nouveaux risques et s’inscrira dans une démarche d’amélioration continue.

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Section: Study Design and Settingmentioning

confidence: 99%

Application of Failure Mode, Effects, and Criticality Analysis to the Medication-Use Process for Temperature-Sensitive Drugs in a University Hospital

Sakly

Chakroun²,

Jeddou

2022

CJHP

View full text Add to dashboard Cite

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“…It is a reference method in the medical and hospital world [13]. It was recommended by the Institute Healthcare Improvement (IHI) in United States [8,9,14,15] and by the "Haute Autorité de Santé" (HAS) in France [16]. The major interest of this method is a quantification carried by the criticality index (CI).…”

Section: Fmeca Risk Analysis On the Processesmentioning

confidence: 99%

Automation of Aseptic Sterile Preparation: Risk Analysis and Productivity Comparison with Manual Process

Heloury

Bouguéon

Deljehier

et al. 2019

Pharmaceutical Technology in Hospital Pharmacy

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Abstract Two automation methods for aseptic preparation in hospital pharmacy, robot and peristaltic pump, were compared to manual process both for risk analysis using Failure Modes Effects and Criticality Analysis (FMECA) method and for productivity using time analysis grids built for each process. The results obtained with the different workflow organizations showed that the worst-case conditions for productivity was production “on demand” of tailor-made preparations. in that case, the manual process was not significantly different from the robotic process (p-value=0.72). For the standardized preparations, the semi-automatic process preparing a batch from bulk solution from “to be reconstituted” drugs was significantly superior to the robotic process preparing repetitive series of doses (p-value<0.01). Productivity of the robot was dramatically increased when the robot performed standardized preparations either from ready to use solutions or mixed cycles due to the robot design. When different processes were FMECA analyzed for risk analysis the robotic process was found as the safer process in comparison to others with a total of Criticality Indexes of 1060, 719, 656 for manual, semi-automatic and robot, respectively. Except for the robotic, semi-automatic and manual processes needed additional IT control systems to limit the risk of failures.

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Analyse des risques a priori en unité de rétrocession hospitalière : focus sur le processus de dispensation

Darcissac

Duvert

Hoegy³

et al. 2020

Annales Pharmaceutiques Françaises

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Approche commentée par étape pour réaliser une AMDEC dans le cadre du circuit du médicament

Cited by 3 publications

References 11 publications

Application of Failure Mode, Effects, and Criticality Analysis to the Medication-Use Process for Temperature-Sensitive Drugs in a University Hospital

Application of Failure Mode, Effects, and Criticality Analysis to the Medication-Use Process for Temperature-Sensitive Drugs in a University Hospital

Automation of Aseptic Sterile Preparation: Risk Analysis and Productivity Comparison with Manual Process

Analyse des risques a priori en unité de rétrocession hospitalière : focus sur le processus de dispensation

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