Maître Virginie ALDIAS-LOUBIER

Avocat au barreau de Marseille

Compétences : Droit de la santé, Droit des associations et des fondations, Droit du dommage corporel, Droit de la sécurité sociale et de la protection sociale

Barreau : Marseille

Adresse : 6 cours Pierre Puget 13006 MARSEILLE

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Publié le 06/08/2025

Retour sur presque 10 ans de déclarations de matériovigilance concernant la pratique du laser médical.

Article juridique - Droit de la santé

Par Me Virginie ALDIAS-LOUBIER

Retour sur presque 10 ans de déclarations de matériovigilance concernant la pratique du laser médical.

Publication de « Utilisation des dispositifs médicaux à technologie laser : rappel des précautions à prendre pour éviter les incidents » par l’ANSM - 07.2025

Cette publication vient compléter les éléments d’information pré opératoire à apporter aux patients afin d’éclairer leur consentement

L’ANSM partage l’analyse des 834 déclarations de matériovigilance reçues et les met en regard des actions correctives de sécurité (FASC) réalisées par les fournisseurs de matériels.

Que retenir de cette publication ?

La formation des praticiens par les fournisseurs de laser est un élément indispensable à leur bonne utilisation et donc à la limitation des événements indésirables.
Les incidents remontés peuvent être classés en deux grandes catégories : les incidents ayant des conséquences sur le matériel (dysfonctionnement et non fonctionnement du matériel et de ses accessoire) et les incidents ayant des conséquences sur les patients ou professionnels (départ de feu, hémorragie, saignement, blessure, complication …).
Les traitements laser excessifs ou trop intenses sont à l’origine de la plupart des incidents.
23% des événements indésirables rapportés (214/911 EI) ont des conséquences sur la prise en charge des patients.

Quelle utilité en pratique pour les professionnels :

Vérifier les mises à jour des notices et des manuels utilisateurs élaborés par les fournisseurs de matériel
Se former avant d’utiliser l'équipement laser
Informer les patients des risques présentés par cette procédure

Fichier attaché