Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular.Proponiendo ideas

  1. Juan Donate 1
  2. Luis Arias-Barquet 2
  3. Diego Ruiz-Casas 6
  4. E. Larra-Mateos 34
  5. José Carlos Pastor 45
  1. 1 Hospital Clínico San Carlos de Madrid
    info

    Hospital Clínico San Carlos de Madrid

    Madrid, España

    ROR https://ror.org/04d0ybj29

  2. 2 Universitat de Barcelona
    info

    Universitat de Barcelona

    Barcelona, España

    ROR https://ror.org/021018s57

  3. 3 AJL Ophthalmic S.A., Vitoria, España
  4. 4 Cluster4Eye, Valladolid, España
  5. 5 Universidad de Valladolid
    info

    Universidad de Valladolid

    Valladolid, España

    ROR https://ror.org/01fvbaw18

  6. 6 Hospital Ramón y Cajal
    info

    Hospital Ramón y Cajal

    Madrid, España

    ROR https://ror.org/050eq1942

Revue:
Archivos de la Sociedad Española de Oftalmologia

ISSN: 0365-6691

Année de publication: 2023

Volumen: 98

Número: 12

Pages: 723-726

Type: Article

DOI: 10.1016/J.OFTAL.2023.09.004 DIALNET GOOGLE SCHOLAR

D'autres publications dans: Archivos de la Sociedad Española de Oftalmologia

Résumé

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.