Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular.Proponiendo ideas
- Juan Donate 1
- Luis Arias-Barquet 2
- Diego Ruiz-Casas 6
- E. Larra-Mateos 34
- José Carlos Pastor 45
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1
Hospital Clínico San Carlos de Madrid
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2
Universitat de Barcelona
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- 3 AJL Ophthalmic S.A., Vitoria, España
- 4 Cluster4Eye, Valladolid, España
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5
Universidad de Valladolid
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6
Hospital Ramón y Cajal
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ISSN: 0365-6691
Argitalpen urtea: 2023
Alea: 98
Zenbakia: 12
Orrialdeak: 723-726
Mota: Artikulua
Beste argitalpen batzuk: Archivos de la Sociedad Española de Oftalmologia
Laburpena
The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreous (SERV) and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.