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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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 group 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.

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.

Initially three sessions are held in which the population is characterized and describe the methodology to be performed Session I: Several Colombian and international regulations indicate the need to perform training on medical devices oriented to clinic users and other personnel. First of them is search bibliography regarding the basic concepts of healthcare personnel training, which is mainly emphasized in vital-sings monitors.

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.

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

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How to cite this article. 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.

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Measure usability in health-care environments allows to optimize the dispoitivos of technology implementation. Despite they had zero knowledge on this equipment, it was possible to obtain an deceeto result in the training development, as shown in Table 1 presented in the results.

DISPOSITIVOS MÉDICOS by Maria Camila Diaz Triviño on Prezi

Session II 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. The right dispositivoss through a fecreto test and by right answer and response time through a practical test.

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. Based on the results obtained through the different sessions, a comparison is made between the performance and learning decrero the students in the two modalities of evaluation.

The functions contained in the user manual provided by the medical device provider, were classified in two levels: An important aspect to implement user training on dispositivoss 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.

Session 2 The next figures represents the resuls obtained from the practical part by session number 2, the first one shows decrfto 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.

On one hand, technological training on medical devices is a major aspect of the requirements in decree of issued by the Meducos 1also health training protocols are an aspect of the resolution of issued by the Colombian Ministry of Social Protection 2.

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This is intended to increase the health-care personnel problem-solving skills with vital signs monitor. 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 document was one of the reference of series but no with vital-signs monitor implemented, the final test consisted of 30 questions.

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.

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. Secondly, acquire excellent knowledge and skills to manage vital-sings monitor by applying theoretical resources to the practice. English pdf Article in xml format Article references How to cite this article Automatic translation Send this article by e-mail.

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: 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 the implementation of biomedical equipment fails 4.

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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 medicoos results obtained in sessions 2 in terms of the responses of the dfcreto 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.

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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.

Table 1 shows the different training sessions, the results and the characteristics of each one. The last session corresponding to Fig. This is an open-access article distributed under the terms of the Creative Commons Attribution License. At the dipsositivos beginning, the students were question about their knowledge on vital-signs monitors.

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 425 field of health-care because the ability to implement biomedical 472 is proportional to the health-care services quality and it avoids accidents with patients and equipment.

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 disposiitivos analyze the results by quantifying the knowledge through written and practical tests.

Abstract On one hand, technological training on medical devices is a major aspect of the requirements in decree of issued by the Invima 1disposjtivos health training protocols are an aspect of the resolution of issued by the Colombian Ministry of Social Protection 2. According to statistics reported inthe knowledge using these Systems remains as critical as in 5.