Browsing by Author "Polania Tafur, Michell Julieth"
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Item Análisis regulatorio del reuso y reprocesamiento de dispositivos médicos: Una revisión bibliográfica(Universidad Santiago de Cali, 2024) Polania Tafur, Michell Julieth; Valenzuela Pascumal, Edita Linybeth; Segura Castillo, Linda NeirethIntroduction: The reuse and reprocessing of medical devices (MD) in Colombia is a high demand practice, however, this process involves risks to patient safety and does not have a fully identified regulation, which is why this review is carried out. bibliography with the aim of analyzing the reuse of MD from a regulatory perspective to guarantee patient safety and sustainability of resources. Materials and methods:A bibliographic search was carried out in ScienceDirect, Pubmed, Dialnet and Google academic databases as a repository using keywords taking into account inclusion criteria such as publications in the last 10 years, English, Spanish and Portuguese language and with appropriate level of evidence. Results: 28 articles were analyzed, in which 12 norms were identified between laws and resolutions from 2004 to 2018 that are not specific, but are associated with the surveillance and regulation process by Invima and the FDA, there are risks . associated with reuse such as decreased effectiveness, failures in patient safety (such as bleeding, infection, contamination of equipment), however, the process has advantages both in the reduction of annual costs and an environmental impact in the reduction of waste. Conclusions: Reprocessing of medical devices is promising, however, efforts should be made to strengthen the regulatory framework related to good manufacturing practices that will reduce the associated risks and increase the benefits for both the patient and the health institution