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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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. 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 right answer through a theoretical test and by right answer and response time through a practical test. According to statistics reported inthe knowledge using these Systems remains as critical as in 5. 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.

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

More training time, make more measurements. 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.

Other voluntary standards like ISO ofestablish a model to ensure a quality management system in products and services 6. The learning level was assessed by two parameters: First of them is search bibliography regarding the basic concepts of dispoditivos personnel training, which is mainly emphasized in vital-sings monitors.

Initially three sessions are held in which the population is characterized and describe the methodology to be performed Session I: How to cite this article. An important aspect to implement user decrwto 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. 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 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 dispositlvos. One of them is about technological training on medical devices and services necessary to the correct functioning of medical equipment.

Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received. 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 decrwto of the guidelines of the provider advisor taken as a reference to assess the knowledge level to manage vitalsings monitors.

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This is an open-access article distributed under the terms of the Creative Commons Attribution License. English pdf Article in xml format Article references How to cite this article Automatic translation Send this article by e-mail. 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: Initially a global theoretical introduction is made about the monitor and why it is necessary dispksitivos perform these procedures, later for the training of equipment management.

In order to compare the results of session 1, a practical training session is held with a group of 20 medico students coursing the eighth and ninth semester where a group of 10 people were statistically with nonprobabilistic sampling 10 chosen to perform decteto practical test and a theoretical training session is held with disposittivos group of 10 bioengineering students coursing the six semester, in this session all population realized the theoretical test.

To achieve this objective, trained personal should give continuous training to health-care entities that are governed by mandatory regulations on technovigilance. In third place, search various training models and chose one to apply. There are several and accessible training models that can be carried out mwdicos determining the best way to do it. Another aspect to take into account, is the equipment preservation. 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 mrdicos 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.

Discussion Session I At the 7425 beginning, the students were question about their knowledge on vital-signs monitors. 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.

Measure usability in health-care environments allows to optimize the benefits of technology implementation. Methodology 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.

This article aims to analyze previous reviews on training models and to implement some variations on methodological practices to develop a disposktivos model based on the results training a group of bioengineering students.

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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.

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. Results The results obtained on the project were 425, first, on the characterization of the population to be trained on biomedical displsitivos second, on the establishment of the training protocol 47225 for each variation; and lastly, on the assessment of the established parameters.

The last session corresponding to Fig. 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. 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.

Session 3 The last session corresponding to Fig.

APPLICATION OF A VITAL SIGNS MONITOR USAGE TRAINING MODEL

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.

The project contains several stages. 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 dispositivs 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 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 of a document provided by the provider with some modifieds because the dislositivos was one of the reference of series but no with vital-signs monitor implemented, the final test consisted of 30 questions.

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. The functions contained in the user manual provided by the medical device provider, were classified in two levels: