Revisión de métodos de calibración para monitores fetales

Abstract

Current national regulations requires health service providers to calibrate biomedical equipment containing measurable variables and used in hospitals. This activity generates greater reliability in the operation of the equipment and increases the quality of health care services. To perform the calibration, it is necessary to create and validate methods for each piece of equipment, taking into account the variables that are part of its system. Currently, the Superintendence of Industry and Commerce (SIC), which is responsible for issuing technical regulations for the standardization of methods, has not issued such guidelines for all biomedical equipment; therefore, each company providing calibration services must create and validate its own methods (non-standard methods). One of the equipment that does not have standardized methods is fetal monitors, which are diagnostic equipment used by medical personnel to evaluate information related to fetal heart rate and uterine activity. Considering their importance in clinical practice, the principle of operation is identified, the variables it measures and the operating ranges relevant to each variable in the clinical setting are analyzed. The use and information evaluated in a cardiotocography test (CTG) is then briefly explained. Finally, a review of existing calibration methods for fetal monitors is provided. It is important to note that the methods mentioned for each variable are taken from various authors with emphasis on those where information is certified by accrediting bodies, where the method and the measuring instrument or simulator applied is evaluated.