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Hospital Universitário Onofre Lopes - HUOL-UFRN - EBSERH
Product fragility was the commonest type of quality deviation, with medium-risk products responsible for the most technical complaints, and gloves, ebserh enfermeiro product most notified. Technology assessment biomedical; risk management; notice; patient safety.
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Among other health problems ebserh enfermeiro from the massive inclusion of these technologies are the technical complaints and the occurrence of incidents or adverse events that may cause harm to the health of users or health professionals involved in their operation, handling or application3.
All of this process led to a significant increase in health costs, with the production, acquisition and evaluation of new products, as well as investments in infrastructure and training of human resources1.
It has been observed, however, that it was not considered that these new technologies would have intrinsic risks due to incomplete scientific knowledge about them, what they can generate ebserh enfermeiro their interactions in different situations.
The dissemination of these risks has induced pressure on governments to control them, requiring health surveillance to use inter-complementary health protection strategies4.
One of these ebserh enfermeiro was the creation of the National Health Surveillance Agency ANVISAan agency of the Ministry of Ebserh enfermeiro MHwhich aims at promoting and protecting the health of the population by sanitary control of the production and marketing of products and services, including the environments, processes, inputs and technologies in health 3,5,6.
The HRM develop post-marketing surveillance activities of health products through the National System of Notices in Sanitary Surveillance NOTIVISA 8, in order to identify probable origins of adverse events, to evaluate the damages caused and to propose decisions concerning these problems ebserh enfermeiro.
To this end, the Pan American Health Organization, together with the World Health Organization, has indirectly promoted the development of adverse events notification systems through the process systematization, data collection and analysis Therefore, to understand the extent of these data it is necessary to conceptualize some terms.
An adverse event is the incident that resulted in injury or damage to a patient or professional, due to the use of a product subject to the sanitary surveillance regime, and its use has been performed under the conditions and parameters prescribed by the manufacturer 11, Therefore, Techno-surveillance is ebserh enfermeiro as the system of surveillance of adverse events and technical complaints of health products in the post-marketing phase, with a view to recommending the adoption of measures that guarantee the protection and promotion of the health of the population The notifications in this field become essential in obtaining data to measure the quality of the care provided, to provide subsidies for interventions, to provide changes in institutions and to ensure patient safety Throughout the world it has been observed the need for research and records that can develop a data network, which facilitates the supervision and rapid feedback on the safety of the marketed medical products15, as an example we can mention the initiatives of the EU-ADR project of the European Commission16; in the United States of America, through the Food and Drug Administration FDAthe Mini-Sentinel pilot program17; and the Observational Medical Outcomes Partnership These projects manage to collect healthcare utilization records, covering millions of people.
In Ebserh enfermeiro, this supervision is carried out by ANVISA, which conceptualizes health products as materials or accessories whose use or application is linked to the defense and protection of individual or collective health, or for diagnostic and analytical purposes This universe ranges from procedures gloves and condoms to surgical materials, prostheses, equipment ebserh enfermeiro in vitro diagnostic kits, among others.
Due to this wide variety and without ruling out that health products are capable of producing health problems and sequelae20ANVISA recommends the act of registration for the regularization of products21, and also the registration of the company itself with the agency.
The company must also present evidence that proves the safety, quality and effectiveness of the product At the time of registration of the product a classification that considers the risk that the product represents to the health of the consumer, patient, operator or ebserh enfermeiro parties involved is proposed.
According to this classification, the risk can be classified as: After the registration, with large-scale production, the post-marketing surveillance process begins, where unexpected problems can be identified or an increase in unwanted events can be evidenced, highlighting the importance of Techno-surveillance in the health products regulatory process One of the strategies used by Anvisa to encourage the notifications of products that are already on the market was the implementation of the Sentinela Hospitals Project inwhich was based on the creation and maintenance of a network of hospitals of great size and complexity, involved with assistance, teaching and research.
This Network operates through Risk Management in all states of Brazil as an observatory of the behavior of health technologies, especially performance and safety issues The purpose of this surveillance is to identify, prevent or minimize health problems related to the malfunction or manufacturing defects of these products, in order to instigate companies to raise ebserh enfermeiro quality, which directly impacts on the quality of the products purchased, hospital cost, and the quality of care provided The notifications were obtained online, through the NOTIVISA system, where the results of the research were filtered by period, which was from January 1 to December 31, ; by product of the notification, hospital medical article; and by types of notification, technical complaint and adverse event.
From that point on, a list of notifications was obtained, which was also included in ARMO internal control.
These notifications were evaluated according to the following variables: In the NOTIVISA form, the description of the notification in Techno-surveillance is a subjective field, which, although contributing to the investigation and inspection actions, also makes it difficult to systematize the data.
Ebserh enfermeiro, for the categorization of reported technical ebserh enfermeiro, the criteria suggested in the Vigilance Notification Book26 were used and in the most recurrent words in the descriptions of complaints.
Four categories of technical complaint were constructed: The fragility of the product category refers to problems of flexibility, breakage of the product ebserh enfermeiro part of it, clogging, leakage and absorption.