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DECRETO 4725 DISPOSITIVOS MEDICOS PDF

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Transcript of DECRETO art Documentación para la evaluación técnica de los dispositivos médicos y equipos biomédicos que no. DISPOSITIVOS MÉDICOS Usos, Contraindicaciones y Advertencias (Decreto ) Contenido Introducción Capítulo I: Disposiciones. Por el cual se reglamenta el régimen de REGISTROS sanitarios, permiso de comercialización y vigilancia sanitaria de los dispositivos médicos.

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MABEL ANDREA AGUIRRE

Initially three sessions are held in which the population is characterized and describe the methodology to be performed Session I: Studies carried out in Finland about health-care personnel experience with the EHR Electronic Health Record demonstrate the need to optimize the implementation of health technologies.

Methodology Decrteo the eispositivos development of the project, it is intended as a first instance, to execute a management plan that will help us to solve the problem in the most appropriate way. According to statistics reported inthe knowledge using these Systems remains as critical as in 5. In order to compare the results of session 1, a practical training session is held deecreto a group of 20 bioengineering students coursing the eighth and ninth semester where disposirivos group of 10 people were statistically with nonprobabilistic sampling 10 chosen to perform the practical test and a theoretical training session is held with a group of 10 bioengineering students coursing the six semester, in this session all population realized the theoretical test.

There are several and accessible training models that can be carried out by determining the best way to do it. Results The results obtained on the project were based, first, on the characterization of the population to be trained on biomedical technology; second, on the dispositivod of the training protocol implemented for each variation; and lastly, on the assessment of the established parameters.

The session was divided into 2 parts in order to compare and analyze the results obtained from a subgroup of people who were statistically with non-probabilistic sampling 10 chosen to perform the evaluation of theoretical or practical knowledge after the training.

Discussion Session I At the training beginning, the students were question about their knowledge on vital-signs monitors. The next figures represents the resuls obtained from the practical part by session number 2, the first one shows number of participants answer correctly each question and the others show a comparison between the results obtained in sessions 2 in terms of the responses of the basic and intermediate level evaluations dispositigos, as well as in terms of the guidelines of the provider advisor taken as a reference to assess the knowledge decret to manage vitalsings monitors.

Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received. First of them is search bibliography regarding the basic concepts of healthcare personnel training, which is mainly emphasized in vital-sings monitors.

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The first part of the present project was made with students to strengthen their abilities as they will have to solve this type of situations in the future, wherefore bioengineers must impart training to assistance personnel in healthcare facilities. Through the analysis of the response times we can observe the great need to strengthen these processes since it is remarkable the difference with respect to the expert and from the strengthening of the bases we get to broader knowledge that favor the implementation of technology in medicine.

To achieve this objective, trained personal should give continuous training to health-care entities that are governed by mandatory regulations on technovigilance.

An important aspect to implement user training on medical devices in different health centers is to promote the correct use of these devices, that implies the performing a safe and quality patient care as well as other aspects attending patients.

How to cite this article.

In Colombia it is stablished by the Invima on the decree of 1 and on the resolution of issued by the Colombian Ministry of social protection 2 that is related to training protocols in companies providing health-care services.

Through the different bibliographic resources it can be see the great need to expand knowledge and to strengthen the training plans from the grassroots and then to lead to new projects that extend throughout the field of health-care because the ability to implement biomedical technology is proportional to the health-care services quality and it avoids accidents with patients and equipment.

The learning level was assessed by two parameters: Despite they had zero knowledge on this equipment, it was possible to obtain an optimal result in the training development, as shown in Table 1 presented in the results.

At the training beginning, the students were question about their knowledge on vital-signs monitors. Conclusion Through the different bibliographic resources it can be see the great need to expand knowledge and to strengthen the training plans from the grassroots and then to lead to new projects that extend throughout the field of health-care because the ability to implement biomedical technology is proportional to the health-care services quality and it avoids accidents with patients and equipment.

This is an open-access article distributed under the terms of the Creative Commons Attribution License. From both graphs 2 and 3it is possible to identify some questions in which knowledge should be reinforced, also, it should be noted that the results brought out from the theoretical training were not as satisfactory as the results from the practical training.

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All the results obtained in all the scenes made It is highlighted that in this section the results were obtained More optimistic of the project, in the graphs 67 and 8 Evidence as the subjects in the question Answers to the different types of evaluation According to the satisfaction survey people were comfortable with the way of training, the comments were positive.

Based on this study it is intended, first, to incorporate training models by analyzing and coupling its results obtaining a structured and improved plan to perform this work in an optimal manner; and second, to assess the efficiency of different methodologies implemented in the training as well as their impact through some kirkpatrick-model parameters to afterwards analyze the results by quantifying the knowledge through written and practical tests.

Measure usability in health-care environments allows to optimize the benefits of technology implementation. Session 2 The next figures represents the resuls obtained from the practical part by session number 2, the first one shows number of participants answer correctly each question and the others show a comparison between the results obtained in sessions 2 in terms of the responses of the basic and intermediate level evaluations respectively, as well as in terms of the guidelines of the provider advisor taken as a reference to assess the knowledge level to manage vitalsings monitors.

The process was divided into a theoretical and a practical test, both consist of a series of functions to perform or theory to know about the biomedical device medixos a document provided by the provider with dwcreto modifieds because the document was one of the reference of series but no with vital-signs monitor implemented, the final test consisted of 30 questions.

Session 1 The following figures represents the results obtained from the theoretical and practical part of session 1 that shows number of participants answer correctly each question.

The project contains several stages. By means of this last graph compared to the others we can see that it was the session with the worst results. In long terms this helps to reduce the incidence of medical equipment failure, since a great percentage of accidents and damages originates from mistakes made by the operator when ddcreto implementation of biomedical equipment fails 4.

ISO of specifies requirements for a quality management system 7 and national health-care accreditation with its technology standard focused on efficiency, effectiveness and safety 8. Table 1 shows the different training sessions, the results and the characteristics of each one.