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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First of them is search bibliography regarding the basic concepts of healthcare personnel training, which is mainly emphasized in vital-sings monitors. The learning level was assessed by two parameters: In long terms this helps to reduce medicox incidence of medical equipment failure, since a great percentage of accidents and damages originates from mistakes made by the operator when the 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 mwdicos, effectiveness and safety 8.

Table 1 shows the different training sessions, the results and the characteristics of each one. 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. Session II Implementing a process with physical technology interaction contributes to sispositivos better development in the understanding of the trained participants, since this dis;ositivos stimulus helps them to record in an easier way the procedure to be performed.

The first part of the present project was made with students to strengthen their dislositivos as they will have to solve this type of situations in the future, wherefore bioengineers must impart training to assistance personnel in healthcare facilities.

In mdicos 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.

Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received. More training time, make more measurements. Measure usability in health-care environments allows to optimize the benefits of technology implementation.

Discussion Session I At the training beginning, the students were question about their medicod on vital-signs monitors. 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.

MABEL ANDREA AGUIRRE

The functions contained in the user manual provided by the medical device provider, were classified in two levels: Abstract On one hand, technological training on medical devices 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.

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On the part of the satisfaction 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 dissatisfaction or constructive criticism for a next event.

One of them is about technological training on medical devices and services necessary to the correct functioning of medical equipment. The project contains several stages. Several Colombian and international regulations indicate the need to perform training on medical devices oriented to clinic users and other personnel.

Secondly, acquire excellent knowledge and skills to manage vital-sings monitor by applying theoretical resources to the practice.

Other voluntary standards like ISO ofestablish a model to ensure a quality management system in products and services 6. At the training beginning, the students were question about their knowledge on vital-signs monitors. The right answer through a theoretical test and by right answer and response time through a practical test.

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. On one hand, technological training on medical devices 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.

How to cite this article. Conclusion Through the different bibliographic resources it can be mediicos 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.

English pdf Article in xml format Article references How to cite this article Automatic translation Send this article by e-mail. The session was divided into 2 parts in order to compare and analyze the results obtained from a subgroup mdeicos people who were statistically with non-probabilistic sampling 10 chosen to perform the evaluation of theoretical or practical knowledge after the training.

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Initially a global theoretical introduction is made about the monitor and why it is necessary to perform these procedures, later for the training of equipment management.

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 establishment of the training protocol implemented for each variation; and lastly, on the assessment of the established parameters. Session 3 The last session corresponding to Fig. Initially three sessions are held in which the population is characterized and describe the methodology to be performed Session I: Through the different bibliographic resources it can be see the great need to expand knowledge and to strengthen dispositivo 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 decrego with patients and equipment.

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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. Services on Demand Article. An appropriate training to the assistant personnel allows to know and practice the correct technology management which provides greater security to the patients, as well as better diagnostics and treatments.

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: By means of this last graph recreto to the others we can see that it was duspositivos session with the worst results.

There are several and accessible training models that can be carried out by determining the best way to do it. 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.

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.

This is intended to increase mdicos health-care personnel problem-solving skills with vital signs monitor. 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.

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