DECRETO 4725 DISPOSITIVOS MEDICOS PDF

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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Session 3 The last session corresponding to Fig. Measure usability in health-care environments allows to optimize the benefits of technology implementation. The questionnaire was carried out after the training and consists of 30 questions about appropriate connections, functions or commands to perform some action or measurement of the body through the monitor and others about theoretical knowledge.

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All these regulations indicate the minimum requirements for a medical center due to the constant newtechnology acquisition, personnel exchange, or just by the inexperience on the correct equipment usage 4. 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 learning level was assessed by two parameters: The project contains several stages. Implementing a process with physical technology interaction contributes to a better development in the understanding of the trained participants, since this visual stimulus helps them to record in an easier way the procedure to be performed.

Services on Demand Article. 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.

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

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 mediccos related to training protocols in companies providing health-care services.

Despite they had zero knowledge on this equipment, it was possible to obtain an optimal result in the training development, medicox shown in Table 1 presented in the results. On the part of the dispksitivos responses on the part of the personnel, the change was observed in the good comments by the students trained under the practice that were motivated and interested in the subject with respect to the students trained under the theoretical modality Which made comments of mediccos or constructive criticism for a next event.

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The last session corresponding to Fig. This article aims to analyze previous reviews on training models and to implement some variations on methodological practices to develop a training model based on the results training a ddecreto of bioengineering students. We took the answers from a vital-sings monitor expert as the reference to establish the assessment range from 1 to 3, being 3 the highest level and 1 the lowest based on rubrics.

For the correct 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. Several Colombian and international regulations indicate the need to perform training on medical devices oriented to clinic users and other personnel.

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.

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.

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 eecreto the subjects dereto 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.

This is intended to increase the health-care personnel problem-solving skills with vital signs monitor. From both graphs 2 and 3it is possible to identify some ddispositivos in which knowledge decrteo be reinforced, also, it should be noted that the results brought xispositivos from the theoretical training were not as satisfactory as the results from the practical training.

The results obtained on the project were based, first, on the characterization of the population to be trained on biomedical technology; second, on the establishment of the training protocol implemented for each variation; and lastly, on the assessment of the established parameters.

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.

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Other voluntary standards like ISO ofestablish a model to ensure a quality management system in products and services 6. On one hand, technological training on medical medios is a major aspect of the requirements in decree of issued by the Invima 1also health training protocols are an aspect of the resolution of issued by the Colombian Ministry of Social Protection 2. By means of this last graph compared to the others we can see that it was the session with the worst results.

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At the training beginning, the students were question about their knowledge on vital-signs monitors. Through the analysis of the response times we can observe the great need to strengthen these processes since it is remarkable disposirivos 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.

In order to compare the results of session 1, a practical training session is held with a group of 20 bioengineering students coursing the eighth and ninth semester where a 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.

How to cite this article. Based on the results obtained through the different sessions, a comparison is made between the performance and learning of the students in the two modalities of evaluation. In third place, search various training models and chose one to apply. 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.

Table 1 shows the different training sessions, the results and the characteristics of each one.

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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. The functions contained in the user manual provided by the medical device provider, were classified in two levels: One of them is about technological training on medical devices and services necessary to the correct functioning of medical equipment.

Based on the different graphics and on every process that represents the vital signal monitor trainning, it was found that the number of participants affects the training quality for different factors like: Secondly, acquire excellent knowledge and skills to manage vital-sings monitor by applying theoretical resources to the practice.