Seguridad biológica de los dispositivos médicos: hacia pruebas sin animales

Nadège Sachot, Augusto Vitale

Resumen

Los animales han sido utilizados desde hace tiempo como sujetos experimentales para apoyar el progreso científico y los avances de la medicina. A día de hoy, diversos protocolos incluyendo el uso de animales todavía están en vigor en múltiples campos científicos y aplicaciones, como por ejemplo el de la seguridad de los dispositivos médicos. El objetivo de dichos estudios es determinar si un dispositivo medico es seguro para su uso humano o si supone un riesgo para la salud del paciente. Las pruebas en animales para este propósito están motivadas por requisitos regulatorios, estipulando que el uso de este tipo de test es necesario y justificándolo en un contexto de gestión de riesgos. Los modelos animales ya no se usan de manera sistemática como en el pasado, pero siguen siendo una piedra angular en el proceso de toma de decisión delicado, relacionado con el marketing de los dispositivos médicos. Sin embargo, las pruebas en animales tienen limitaciones, como las preocupaciones éticas y la validez de los datos que cuestionan su uso para este fin. Una atención especial está dada a día de hoy a las alternativas libres de animales para respaldar mejor la aplicación del concepto de los 3R (replacement, reduction, refining) en este campo. Desgraciadamente, los métodos muy avanzados y tecnologías en desarrollo encuentran obstáculos importantes (p.ej. validación y estandarización) que impiden y ralentizan su implementación como alternativas aceptadas del punto de vista regulatorio. Para superar estas dificultades, el proceso de aceptación regulatoria de las alternativas se podría optimizar. Este se puede alcanzar por ejemplo mejorando la cooperación, la coordinación y la comunicación entre los diferentes actores, i.e. investigadores, organismos regulatorios certificadores e industrias. Generalmente, una atención especial se debe prestar al compromiso y a un esfuerzo común para mejorar la eficacia de este proceso, y para establecer un marco regulatorio de comprobación que no dependa más de los modelos animales.

 

Palabras clave

pruebas en animales ; alternativas libres de animales ; seguridad biológica de dispositivos médicos ; toxicología; aceptación regulatoria

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