Protocolo de verificação do processo de esterilização por vapor de formaldeído

Abstract

This work presents the study of the sterilization process of surgical materials and instruments in autoclaves using the sterilizing agent, the low temperature vapor of formaldehyde. This process is used for thermosensitive materials, is they do not withstand temperatures above 80 ° C. The objective of this study was to evaluate the low temperature sterilization technology, which has been used for more than 20 years in several countries, including here in Brazil, but with little details of conclusive studies on the subject in the national and international literature. This study was based on the ABNT NBR 15659 and NF EN ISO 25424 standards that specifically deal with the requirements, methods and care in low temperature steam sterilization and formaldehyde, implementing a verification protocol for technology study. For this, an evaluation methodology was elaborated for the installation of sterilizers that use formaldehyde as the sterilizing agent. In the verification of the effectiveness of the methodology 3 types of sterilization equipment were tested. The equipment tested is of Brazilian manufacture (02 of them) and one of Swedish manufacture. The tests were carried out in 6 hospitals, where they were evaluated since its installation, evaluation of parameters of time, temperature and pressure (with equipment calibrated and tracked by INMETRO), evaluation of the level of residues in the material (with reports made by accredited laboratories), use of process indicators (biological and chemical), environmental assessment (air and exits to the sewage), preventive maintenance controls and operator safety (EPI). All the evaluated cycles presented results within the minimum parameters suggested in the Standard ABNT NBR 15659 and NF EN ISO 25424. Concluding that strictly following the norms and the manuals of the equipment manufacturers, it is perfectly possible to obtain a safe process of sterilization To the Hospital, and meet all levels of safety for both the operator and the patient who will use the material processed in the sterilization cycle.