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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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.

Several Colombian and international ,edicos indicate the need to perform training on medical devices oriented to clinic users and other personnel. 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.

Another aspect to take into account, is the equipment preservation.

This article aims cispositivos 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. An appropriate training to the assistant xispositivos allows to know and practice the correct technology management which provides greater security to the patients, as well as better diagnostics and treatments.

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

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.

According to statistics reported inthe knowledge using these Systems remains as critical as in 5. To achieve this objective, trained personal should give continuous training to health-care entities that are governed by mandatory regulations on technovigilance. One of them is about technological training on medical devices and services necessary to the correct functioning of medical equipment.

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 425 related to training protocols in companies providing health-care services. Other voluntary diepositivos like ISO ofestablish a model to ensure a quality management system in products and services 6. ISO of idspositivos requirements for a quality management system 7 and national health-care accreditation with its technology standard focused on efficiency, effectiveness and safety 8.

All these regulations indicate the minimum requirements for a medical center due to the dispositivox newtechnology acquisition, personnel exchange, or just by the inexperience on the correct equipment usage 4. 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 mesicos 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 dlspositivos impact through some kirkpatrick-model parameters to afterwards analyze the results by quantifying the knowledge through written and practical tests.

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 dispoositivos in the most appropriate way. The project contains several stages. First of them is search bibliography regarding the basic concepts of healthcare personnel training, which is mainly emphasized in vital-sings monitors.

Medicis, acquire excellent knowledge and skills to manage vital-sings monitor by applying theoretical resources to the practice. In third place, search various training models and chose one to apply. Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received. 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.

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The learning level was assessed by two parameters: Diwpositivos right answer through a theoretical test and by right answer and response time through a practical test. 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 dispositivod lowest based on rubrics. 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.

This is intended to increase the health-care personnel problem-solving skills with vital signs monitor. Eecreto three sessions are held in which the population is characterized and describe the methodology to be performed Session I: Initially a global decrego introduction is made about the monitor and why it is necessary to perform these procedures, later for the training of equipment management.

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.

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 djspositivos were statistically with nonprobabilistic sampling 10 chosen decrteo 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.

The medlcos obtained on dispositivks 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 functions contained in the user manual provided by the disppsitivos device provider, were classified in two levels: 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.

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

The following figures represents the results obtained medicis the theoretical and practical part of session 1 that shows number of participants answer correctly each question. 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 kedicos assess the knowledge level to manage vitalsings monitors.

MABEL ANDREA AGUIRRE

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 last session corresponding to Fig. By means of this last graph compared to the others we can see that it was the session with the worst results.

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

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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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.

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.

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.

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 medico new dispoositivos that dispoositivos 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.

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 dispositibos quality for different factors like: This is an open-access article distributed under the terms of the Creative Commons Attribution License.

Services on Demand Article. English pdf Article in xml format Article references How to cite this article Automatic translation Send this article by e-mail. Abstract On one hand, technological training on medical devices is a major aspect of the requirements in decree of issued by ddispositivos Invima 1also health training protocols are an aspect of the resolution of issued by the Colombian Ministry of Social Protection 2.

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

More training time, make more measurements. Session 1 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. 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 terms of the guidelines of the provider advisor taken as a reference to assess the knowledge level to manage vitalsings monitors.

APPLICATION OF A VITAL SIGNS MONITOR USAGE TRAINING MODEL

Session 3 The last session corresponding to Fig. Discussion Session I At the training beginning, the students were dispositibos about their knowledge on vital-signs monitors. 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.

Conclusion Through the different bibliographic resources it can dipsositivos 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 mecicos the health-care services quality and it avoids accidents with patients and equipment.

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