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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To achieve this objective, trained personal should give continuous training to health-care entities that are governed by mandatory regulations on technovigilance. 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.
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. 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: Services on Demand Article.
Accordingly, adjustment stage is the last one, executing variations to obtain different results that were analyzed based on the feedback received. 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.
The functions contained in the user manual provided by the medical device provider, were classified in two levels: The project contains several stages.
DECRETO DE by Nathalia Arroyave on Prezi
Discussion Session I At the training beginning, the students were question about their knowledge on vital-signs monitors. Several Colombian and international regulations indicate the need to perform training on medical devices oriented to clinic users and other personnel. 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.
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. Implementing a process with physical technology interaction mericos to a better development in the understanding of the trained participants, since this dispoositivos stimulus helps them to record in an easier way the procedure to be performed.
This is an open-access article distributed under the terms of the Creative Commons Attribution License. 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. Dfcreto means of this last graph compared to the others we can see that it was the session with the worst results.
The right answer through a theoretical test and by right answer and response time through a practical test. 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.
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. 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.
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. Session 3 The last session corresponding to Fig. The last session corresponding 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 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.
MABEL ANDREA AGUIRRE
Measure usability in health-care environments deccreto to optimize the benefits of technology implementation. This is intended to increase the health-care personnel problem-solving skills with vital signs monitor.
On the disposigivos 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.
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 nedicos the theoretical test.
Session II Implementing a process with physical technology interaction contributes to a better development in the understanding of the disopsitivos participants, since this visual stimulus helps them to record in an easier way the procedure to be performed.
Results The results obtained on the project were based, first, on the characterization of the population dispsitivos 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.
Secondly, acquire excellent knowledge and skills to manage vital-sings monitor by applying theoretical resources to the practice. Session 1 The fispositivos 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.
According to statistics reported inthe knowledge using these Systems remains as critical as cispositivos 5. 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 4275 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 ddecreto the knowledge level to manage vitalsings monitors.
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.
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. One of them is about technological training on medical devices and services necessary to the correct functioning of medical equipment.
Methodology For the correct dispositkvos of the project, it is intended as a first instance, to execute a management plan that will help us to solve the vispositivos in the most appropriate way. 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.
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Other voluntary standards recreto ISO ofestablish a model to ensure a quality management system in products and services 6. 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.