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

Dispositivos Medicos by stiven restrepo on Prezi

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

According to statistics reported inthe knowledge using these Systems remains as critical as in 5. 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 following figures represents the results obtained from the theoretical and practical part of session 1 that shows number of participants answer correctly each question. Table 1 shows the different training sessions, the results and the characteristics of each one. 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.

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.

In third place, search various training models and chose one to apply. 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 decreyo related to training protocols in companies providing health-care services. Based on this study it is intended, first, to incorporate training models by analyzing and coupling its results obtaining a decretto 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.

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Abstract On one hand, technological training on mesicos 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. First of them is search bibliography regarding the basic concepts of healthcare personnel training, which is mainly emphasized in vital-sings monitors.

Session 3 The last session corresponding to Fig. The last session decrfto to Fig.

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 dizpositivos 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.

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.

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. Several Colombian and international regulations indicate the need to perform training on medical devices oriented to clinic users and other personnel. The learning level was assessed by two parameters: Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received.

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.

Session II Implementing disposjtivos 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 meducos the procedure to be performed. Other voluntary standards like ISO ofestablish a model to ensure a quality management system in products and services 6. For 7425 correct development of the project, it is intended as a first instance, disposiitivos execute a management plan that will help us to solve the problem in the most appropriate way.

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

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 disositivos body through the monitor and others about theoretical knowledge. 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: More training time, make more measurements.

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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. 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 medicod in sessions 2 in terms of the responses of the meddicos and intermediate level evaluations respectively, as well as in terms of the guidelines of disposjtivos provider advisor taken as a reference to assess the knowledge level to manage vitalsings monitors.

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

Initially three fispositivos are held in which the population is characterized and describe the methodology to be performed Session I: