Complexity in the development of a protocol for the reuse of single use devices

Abstract

In Brazil, the reuse of single use devices is a reality. Specific 2.606/2006 Resolution of the National Sanitary Surveillance Agency, which deals with the guidelines for the development, validation and implementation of protocols for the reprocessing of medical products, emphasizes microbiological aspects, recommending the need for detailed description of the stages of cleaning , rinsing, drying, disinfection, packaging, sterilization, labeling and packaging. We understood that to develop a protocol for reprocessing, other safety-related aspects should be included, such as assessing the integrity and functionality of the reused materials, the presence of biofilm, endotoxins, residues of proteins and prion and other toxic waste products used for cleaning and sterilization. Based on these weaknesses in the legislation, this article proposed discussing other risks inherent to the reuse of single use devices besides those directly related to infection.