ImpactU Versión 3.11.2 Última actualización: Interfaz de Usuario: 16/10/2025 Base de Datos: 29/08/2025 Hecho en Colombia
Diseño de una metodología para estudiar los efectos de la esterilización por óxido de etileno en las propiedades mecánicas de dispositivos médicos reusables
In the FSFB clinic, single use laparoscopic monopolar scissors are sterilized and reprocessed several times in order to reduce costs to patients. However, there is no scientific evidence to demonstrate whether the mechanical and physical properties of the blades are significantly altered in such degree that pose a risk to the patient such as fractures of material, torn tissue or spread of pathogens among others. This paper presents the design of a protocol that excludes laparoscopic scissors that pose a risk to patients. For this, characterization and comparison of mechanical and physical properties of a blade from a new scissor and a blade from a scissor after four uses or three sterilization cycles were made. Also the cutting of one new scissor and one with four uses was evaluated in four different materials. Tests of metallography, microhardness, scanning electron microscopy (SEM) and chemical analysis by dispersive energy (EDS) allowed characterizing the physical and mechanical properties of the blades. From these tests information was obtained about the properties, characteristics, size and quantity microscopic imperfections and material type of the blades from new scissor and the scissor used by different manufacturers. Finally an experimental design which allows evaluating the cutting characteristics of different materials of a new scissors, and after four uses of the same manufacturer is made. However, we failed to make a relevant comparison between the properties and characteristics of the blade of the new scissor from Applied Medical and the scissor after four uses from Tyco-Covidien due to the difference of materials used by each manufacturer. Finally, it was possible to demonstrate that there is not a significant difference between the cutting with a new scissor and one scissor after four uses.