Medical Devices Biological Safety Assessment: Towards Animal-free Testing

Abstract

Animals have been used since a very long time as experimental subjects to support scientific progress and medical advances. Currently, various testing procedures implying animals are still being conducted within a broad range of scientific fields and applications, as for example the assessment of medical devices safety. The aim of this assessment is to investigate whether a medical device is safe for human use or poses a risk for patients' health. Animal testing for that purpose is especially encouraged by regulatory requirements, which prerequisite however that the use of such testing is deemed necessary and justified in the context of a risk management process. Thus, animal models are no longer systematically used as in the past, but they remain a cornerstone within the delicate decision-making process related to the marketing of medical devices. Though, animal testing has some critical limitations, such as ethical concerns and relevance of animal data, which challenge its further use to that objective. A particular attention is therefore currently given to the development of animal-free alternatives to better support the application of the 3Rs Principle (replacement, reduction, refining) within this field. Unfortunately, the highlyadvanced methods and technologies being developed face barriers (e.g. validation and standardization) which hinder and slow down their implementation as regulatory-accepted alternatives. To overcome these difficulties, the process of regulatory acceptance of these alternatives may be optimized. This may be achieved for example by improving the cooperation, coordination and communication between the different stakeholders, i.e. researchers, regulatory approval bodies and industries. Mostly, a special focus may be set on commitment and shared effort to enhance the efficiency of that process and to establish a regulatory testing framework that no longer relies on animal models.

10 (2019) A Commemorative Volume

“…En el volumen conmemorativo se han publicado investigaciones de gran interés científico: la evaluación de la seguridad biológica de los dispositivos médicos, con el fin de realizar pruebas de laboratorio sin animales 30 ; un estudio sobre la industria australiana de la carne de conejo enjaulado y la consiguiente necesidad de una reforma 31 ; un estudio sobre la certificación de bienestar animal para gallinas ponedoras en Brasil 32 ; una investigación sobre el abuso sexual de animales en España y Portugal, un tema poco conocido, realizada mediante encuestas y a través de datos contrastados 33 ; un estudio sobre la relación entre la violencia doméstica y el maltrato animal, una plaga social que afecta a los agresores y a los demás sujetos vulnerables, que pueden ser seres humanos o animales 34 ; una propuesta de definición universal del fenómeno de la domesticación hecha de manera científica 35 ; la propuesta de un protocolo práctico, que tiene como objetivo garantizar el bienestar de los animales involucrados en las actividades de trabajo 36 ; el estudio de un protocolo para que los veterinarios evalúen el abuso animal 37 .…”