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Introducción: En Cuba, se desarrolló un medio de cultivo cromogénico y fluorogénico, para la detección, aislamiento y diferenciación de Salmonella de otras bacterias Gram negativas. El método que emplea el medio fue validado y su uso se adoptó en una norma cubana. El aseguramiento de la calidad y el control del rendimiento de los medios garantizan la confiabilidad de los resultados analíticos. La norma ISO 11133 establece criterios mínimos y métodos para evaluarlos. Objetivo: Evaluar los criterios de control de la calidad y de rendimiento de CromoCen® SALM, establecidos en la ISO 11133:2014/Amd.1:2018, para demostrar su fiabilidad para el análisis microbiológico de los alimentos de consumo humano. Métodos: Se evaluaron los indicadores de calidad físico-químicos de tres lotes y se definió un conjunto de ellos que caracteriza la calidad del medio antes y después de terminado, así como la consistencia entre lotes. Para el ensayo de rendimiento se seleccionaron 10 cepas de diferentes géneros. Se determinó la relación de productividad, el factor de selectividad y la electividad de CromoCen® SALM, según la ISO 11133. Resultados: La evaluación físico-química mostró una consistencia entre lotes en color, homogeneidad, apariencia del polvo y del medio preparado. Los valores de contenido de humedad y pH se encontraron dentro de los valores establecidos para este producto. La relación de productividad de CromoCen® SALM con respecto al agar triptona soya, fue superior al 50 por ciento, mientras que el factor de selectividad resultó de 4. Se demostró que en el medio de cultivo se puede diferenciar un grupo representativo de géneros microbianos de Salmonella. Conclusiones: CromoCen® SALM cumple con los requisitos de calidad establecidos para este tipo de productos, según la ISO 11133 vigente. La correcta formulación de los lotes, así como el cumplimiento de los requisitos de calidad aseguran el funcionamiento adecuado para lo que fue diseñado(AU)
Introduction: In Cuba, a new chromogenic and fluorogenic culture medium was developed for the detection, isolation and differentiation of Salmonella from other Gram negative bacteria. The method and medium were validated and their use was adopted as a Cuban standard. Quality assurance and control of media is essential and mandatory to ensure the reliability of the results of the analysis in which they are used. ISO 11133 establishes minimum criteria and methods to evaluate them. Objective: To evaluate the quality and performance criteria of CromoCen® SALM, as recommended in ISO 11133:2014/Amd.1:2018 to demonstrate its reliability for the microbiological analysis of food for human consumption. Methods: The physical-chemical quality indicators of three batches were evaluated and a group of them was defined to characterize its quality before and after finishing, as well to evaluate the consistency between batches. For the performance test, 12 strains of different genera were selected. The productivity ratio, the selectivity factor and the electivity of CromoCen® SALM were determined. Results: The physico-chemical evaluation showed a consistency between batches in color, homogeneity, appearance of the powder and of the prepared medium. The moisture content and pH values ranged within the established values for this product. The productivity ratio of CromoCen® SALM with respect to tryptone soy agar was greater than 50 percent, while the selectivity factor was 4. It was shown that in the culture medium a representative group of Salmonella microbial genera can be differentiated. Conclusions: CromoCen® SALM meets the quality requirements established for this type of products, according to the current ISO 11133 standard. The correct formulation of the batches, as well as the fulfillment of the quality requirements ensure the proper functionality and match the design purpose(AU)
Subject(s)
Humans , Quality Control , Total Quality Management/standards , Chromogenic Compounds/standards , EatingABSTRACT
Objectives@#The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. @*Methods@#The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment.
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To report 2 cases of Iso-Kikuchi syndrome, both of which were congenital. Case 1, a 7-month-old female infant, visited the hospital due to abnormalities in the nail plate of the left index finger for 7 months; case 2, a 3-year-old male child, also visited the hospital due to abnormalities in the nail plate of the left index finger for 3 years. The 2 patients both presented with 2 tiny, independent nail plates on both sides of the nail bed of the left index finger, instead of normal nail plates. Based on their clinical features, the 2 patients were diagnosed with Iso-Kikuchi syndrome (congenital onychodysplasia of the index finger). The mother of case 1 had a history of progesterone use to prevent miscarriage during pregnancy, the mothers of the two patients both suffered from hypothyroidism and continued to receive thyroid hormone replacement therapy during pregnancy, and the mother of case 2 had a history of gestational diabetes. It is still unclear whether these comorbidities and drugs are directly related to the occurrence of Iso-Kikuchi syndrome.
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Background:ISO 15189 will equip traineeswith effective auditing techniques and will increase understandingof audit methodologies. Trying to improve the quality of training that will be given underNABL ISO 15189. Material And Methods:The study was done forimproving the training of internal audit. Participants who have already taken training were asked to fill questionnaire in the google form regarding the cost effectiveness, mode of training, material of reference,No. of days of training, frequency at which training should be conducted and mock audit. For each question we had given certain option which will be chosen by earlier participants. For each question % of the answers are calculated individually to analyses whether the training is up to mark or has to be improved.Result:The results obtained are as follow s, for the cost of training to be 58.1% answered it to be five thousand. For the no of days maximum people gave the answer as 3 days. For mode of training results obtained was 80.23% offline.60.46% of trainees wanted weekdays as the days to be included for training session.60.4% of participants wanted power point presentation as the method for training to be conducted. Once in year was selected by 40.6% of trainees for how frequently the training should be conducted. All the participants have answered for the mock audit to be conducted.Conclusion:Most of them seem satisfactory with the training. Many of them suggested we have small break sessions during training. Live training sessions was also suggested as it could be more interactive.
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Background Previous studies have confirmed that nicotine exposure is an independent risk factor for miscarriage, but it is not clear whether nicotine causes unexplained recurrent spontaneous abortion (URSA) through oxidative stress. Objective To explore potential mediating effect of oxidative stress on the relationship between nicotine exposure and URSA. Methods Using a 1∶1 matched case-control study, 88 patients with URSA visiting Beijing Obstetrics and Gynecology Hospital affiliated to Capital Medical University from April to October in 2018 were selected as the case group, and 88 pregnant women without adverse pregnancy outcomes and seeking induced abortion in the outpatient clinic of the same hospital were selected as the control group. The levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG) and 8-iso-prostaglandin F2α (8-iso-PGF2α) in urine were determined by enzyme-linked immunosorbent assay, and the level of urinary nicotine was determined by gas chromatography-mass spectrometry. Conditional logistic regression was used to analyze the associations of nicotine, 8-OHdG, and 8-iso-PGF2α with the risk of URSA. Multiple linear regression was used to analyze the association of nicotine with 8-OHdG and 8-iso-PGF2α. The potential mediating effect of oxidative stress on URSA after nicotine exposure was explored by dichotomous mediating model. Results The median concentrations (creatinine corrected) of nicotine, 8-OHdG, and 8-iso-PGF2α in urine of the case group were 7.78, 4.84, and 44.10 μg·g−1, respectively, while those of the control group were 6.48, 3.34, and 29.39 μg·g−1, respectively. The concentrations of nicotine, 8-OHdG, and 8-iso-PGF2α in urine of the case group were all higher than those of the control group (P < 0.05). The results of conditional logistic regression model showed that after adjusting selected confounding factors, compared with the Q1 groups of nicotine and 8-iso-PGF2α, the OR (95%CI) values of URSA in the Q4 groups were 4.20 (1.33-13.29) and 6.25 (1.66-23.59), respectively. Compared with the Q1 group of 8-OHdG, the OR (95%CI) values of URSA in the Q1, Q2, and Q3 groups were 5.47 (1.43-20.93), 4.24 (1.28-14.07), and 6.36 (1.82-22.28), respectively. The results of multiple linear regression showed that after adjusting confounding factors, there was a positive correlation between urinary nicotine and 8-OHdG in both the case group and the control group, and the b (95%CI) values were 0.76 (0.67-0.86) and 0.81 (0.67-0.95) respectively; there was a positive correlation between urinary nicotine and 8-iso-PGF2α in both the case group and the control group, and the b (95%CI) values were 0.65 (0.55-0.75) and 0.76 (0.64-0.87), respectively. The results of dichotomous mediating analysis showed that the mediating effect of 8-iso-PGF2α and its 95%CI on the relationship between nicotine exposure and URSA was 1.518 (0.749-2.311). Conclusion Internal nicotine exposure is a risk factor for URSA and is positively correlated with oxidative stress, and it may lead to URSA through lipid peroxidation damage.
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Since the first edition of ISO15189"Medical laboratories: requirements for quality and competence" was published in 2003, it has been rapidly and widely used in the world under the promotion of the International Laboratory Accreditation Cooperation Organization (ILAC), and has become the basic standard for the quality management, capacity-building and capacity attestation of medical laboratories. The Mutual Recognition Arrangement (MRA) of ILAC for ISO15189 is the most authoritative international permit for examination results, which is accepted by international organizations. Since the establishment of ISO15189 medical laboratory accreditation system in 2004 in China, more than 530 medical laboratories have been accredited, which plays an important role in improving the quality and competence of medical laboratories in China, and improves the influence of Chinese medical laboratories in the world. ISO 15189:2012 is currently being revised by the International Organization for Standardization/Technical Committee on Clinical Laboratory Testing and in vitro diagnostic test systems (ISO/TC212). This revision will bring significant changes and the medical laboratory shall pay attention to these changes. In order to help medical laboratories understand the new ideas in advance, this paper summarizes and analyses the draft of the new international standards, and provides references for users.
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@#The heart valve prosthesis must have excellent hydrodynamic performance which is usually tested in vitro, not in vivo. This paper comprehensively introduced the principles and methods of hydrodynamic performance in vitro testing, helping clinicians to understand valve performance parameters, evaluate valve applicability, and reduce clinical risk of the valve prosthesis. In vitro testing not only serves as the "gold standard" for valve prosthesis assessment, but also provides detailed data for design and optimization of the prosthesis. ISO 5840 defines the items and methods for valve in vitro testing, which consists of three parts: (1) pulsatile flow testing, which reproduces the pulsating flow of the valve prosthesis after implantation in the human body; (2) steady flow testing, which assesses valve forward flow resistance; (3) durability testing, which evaluates the durability of the valve prosthesis and determines the expected failure mode. In addition, the paper presented the differences between atrioventricular and aortic valve testing, the method of mitral valve testing, the differences between transcatheter and surgical valve testing, and the method of valve flow visualization.
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【Objective】 To explore the performance verification of NAT and its procedures for HBV DNA, HCV RNA and HIV RNA-1 using PCR-fluorescence via Cobas s201 automatic NAT system and supporting MPX V2.0 reagents that applied in the laboratories of blood stations, in order to satisfy ISO 15189 accreditation requirements and ensure the accuracy of NAT results. 【Methods】 Samples used in external quality assessment(EQA) of year 2020 were taken to verify the concordance, Performance evaluation panel and sensitivity verification panel of Roche second-generation NAT system were used to verify the sensitivity/ specificity and the lower limit of detection, respectively.And HBV DNA, HCV RNA and HIV RNA-1 quality control products were used to verify the anti-interference ability. 【Results】 The concordance rate of 40 EQA, samples was 100%. The sensitivity and specificity of Cobas s201 automatic NAT system and supporting MPX V2.0 reagents in detecting HBV DNA, HCV RNA and HIV RNA-1 were all 100%. The lower detection limit for HBV DNA, HCV RNA and HIV RNA-1 all met the requirements of reagent instructions. The yielding of HBV DNA, HCV RNA and HIV RNA-1 were affected little with hemolysis at 500 mg/dL but interfered seriously as lipemia reached 3 300 mg/dL. 【Conclusion】 The concordance rate, sensitivity, specificity and lower detection limit of the Cobas s201 fully-automatic NAT system and MPX V2.0 reagents by PCR-fluorescence method all met the requirements of reagent instructions. The verification of anti-interference ability demonstrated the requirements of ISO 15189 and the needs of blood station laboratories could be satisfied, and the detection methods and procedures can ensure the accuracy of NAT results.
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Resumen Desde una aproximación neoinstitucionalista presentamos el OCI Los Cabos como una nueva organización para la participación ciudadana; según la clasificación de North, es un nuevo cuerpo político, que enfrentando los mismos retos para su autogobierno que Ostrom define para otras organizaciones en El Gobierno de los Bienes Comunes, propone además una nueva institución, el estándar internacional ISO 18091, para la gestión de calidad de los gobiernos locales, con el objetivo de promover la eficiencia y la participación ciudadana en el gobierno del bien común local, y global, según la Agenda 2030. En esta interacción compleja entre organizaciones (OCI Los Cabos) y organismos (gobierno local) con las viejas y nuevas instituciones se requiere de una participación ciudadana consciente y competente que desarrollando una inteligencia política colectiva contribuirá, sin duda, a un cambio institucional hacia una mejor gobernanza local global.
Abstract A neo-institutionalist approach to present ICO Los Cabos as a new citizen participation organization, according to North's classification, is a new 'political body' facing the same challenges for its self-government that Ostrom defines for other organizations for Governing the Commons. ICO also proposes a new institution, the international standard ISO 18091 Quality Management System for Local Governments which promotes efficiency and citizen participation for governing the common good locally and globally according to the 2030 Agenda. In this complex, the interaction between organizations (ICO Los Cabos) and other political bodies (local government) with old and new institutions requires a conscious and competent citizen participation in order to develop a collective political intelligence that undoubtedly will contribute to an institutional change towards a better global local governance.
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Humans , Community Participation , Health Governance , Government , Politics , Local GovernmentABSTRACT
Resumen Introducción. Esta investigación constituye el resultado de una revisión bibliográfica y una validación estadística multivariante. En esta se plantean las aristas de medición del estado actual de responsabilidad social. Objetivo. Diseñar un instrumento de diagnóstico de la gestión de responsabilidad social para el sector agrícola. El instrumento de diagnóstico de la responsabilidad social se estableció en referencia a la ISO 26000 en el sector bananero de la provincia de Los Ríos, República del Ecuador. Materiales y métodos. El presente estudio fue de tipo no experimental. El método teórico utilizado fue el inductivo-deductivo a partir del análisis de cinco modelos de responsabilidad social. El método empírico ejecutado fue de recolección de información con un instrumento estructurado por escalas de Likert de 5 opciones. El procedimiento estadístico empleado en la medición de la calidad instrumental estuvo conformado por análisis de fiabilidad y análisis factorial. Resultados. Los indicadores de fiabilidad evidencian un Alfa de Cronbach de 0,754 y un Alfa de Cronbach de dos mitades de 0,852 y 0,783. Los indicadores del análisis factorial muestran un KMO de 0,788, Prueba de esfericidad de Bartlett con un CHI-cuadrado de 1644,521, grados de libertad de 210 y una significancia estadística de 0,000; Una varianza total explicada de 7 grupos con una varianza acumulada del 80,76 %. Conclusión. El constructo en estudio y las siete aristas en cuestión poseen un alto grado de fiabilidad y validez. Además, el instrumento es apto para su aplicación en las empresas del sector bananero.
Abstract Introduction. This research is the result of a literature review and a multivariate statistical validation. This raises the edges of measurement of the current state of social responsibility. Objective. Design a diagnostic tool for the management of social responsibility for the agricultural sector. Therefore, the social responsibility diagnostic instrument was established in reference to ISO 26000 in the banana sector of the province of Los Ríos, Republic of Ecuador. Materials and methods. This study was not experimental. The theoretical method applied corresponded to inductive deductive analysis from five models of social responsibility. The empirical method was used. The information was collected with an instrument structured by Likert scales of 5 options. The statistical procedure used to measure the quality of the instrument was made up of reliability analysis and factor analysis. Results. Reliability indicators show a Cronbach's Alpha of 0.754 and a Cronbach's Alpha of two halves of 0.852 and 0.773. The indicators of the factor analysis show a KMO of 0.788, Bartlett's sphericity test with a Chi square of 1644.521, degrees of freedom of 210 and a statistical significance of 0.000; A total variance explained that shows 7 groups with an accumulated variance of 80.76 %. Discussion and Conclusion. The construct under study and the seven edges in question have a high degree of reliability and validity. In addition, the instrument is suitable for application in companies in the banana sector.
Resumo Introdução. Esta pesquisa é resultado de uma revisão de literatura e de uma validação estatística multivariada. Isso eleva os limites da medição do estado atual da responsabilidade social. Objetivo. Elaborar uma ferramenta de diagnóstico para a gestão da responsabilidade social para o setor agrícola. Portanto, o instrumento de diagnóstico de responsabilidade social foi estabelecido com referência à ISO 26000 no setor de bananas da província de Los Ríos, República do Equador. Materiais e métodos. Este estudo não foi experimental. O método teórico aplicado correspondeu à análise dedutiva indutiva de cinco modelos de responsabilidade social. O método empírico foi utilizado. As informações foram coletadas com um instrumento estruturado em escalas Likert de 5 opções. O procedimento estatístico utilizado para medir a qualidade do instrumento foi constituído por análise de confiabilidade e análise fatorial. Resultados. Os indicadores de confiabilidade mostram um alfa de Cronbach de 0,754 e um alfa de Cronbach de duas metades de 0,852 e 0,773. Os indicadores da análise fatorial mostram um KMO de 0,788, teste de esfericidade de Bartlett com um quadrado de Qui de 1644,521, graus de liberdade de 210 e significancia estatística de 0,000; Uma variação total explicou que mostra 7 grupos com uma variação acumulada de 80,76 %. Discussão e conclusão. O construto em estudo e as sete arestas em questão têm um alto grau de confiabilidade e validade. Além disso, o instrumento é adequado para aplicação em empresas do setor de banana.
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@#Cytotoxicity is a predominant biological evaluation applied to search for a suitable and non-toxic bioactive compound and to determine the biocompatibility of medical devices-related human body. The broad usage of cytotoxicity tests leads to a robust establishment of cytotoxicity assays with high sensitivity and prompt results. In vitro assays are always prioritized over in vivo due to the reproducible data, reduce numbers of animal used and easily accessible material. Compounds concentration that execute 50% of cell population is determined by calculating the IC50. According to ISO10993, cytotoxicity tests must be performed to determine the biocompatibility of medical devices that has contact with human body. This is crucial to ensure the safety of research and its clinical use. Under the recommendation of ISO10995-Part 5, three categories of tests have been documented; extract elution, direct contact and indirect contact test. Each category plays significant role depending on the nature of experiment and sample used.
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Quality assurance is the responsibility of Organ Procurement Organization (OPO). The establishment of OPO quality management system is a novel task for implementing high-quality human organ donation. At present, the quality management of OPO still has certain problems, such as lack of comprehensive management organization, standardized management process, scientific evaluation index, qualified professionals and strong safety culture atmosphere, etc. It is necessary to deliver top-level design from three perspectives of ideological concept change, quality management system construction and process implementation management in combination with the actual situation of OPO and reference to the criteria of international general quality management system. More importantly, the managers of OPO should play a leading role in ensuring the efficient operation of OPO in the persistent improvement of quality management system.
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ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.
Subject(s)
Humans , Equipment Safety , Magnetic Resonance Imaging , Prostheses and ImplantsABSTRACT
@#International Academy of Pathology, Malaysian Division has initiated and run the external quality assurance program for general diagnostic histopathology since the year 2017. This article introduces the educational philosophy of this external quality assurance program and the technicalities in running such a national program. Challenges in ensuring the successful running of this program to gain wide acceptance by histopathology laboratories in Malaysia as well as experience in overcoming these challenges are detailed. This article charts the future direction of this external quality assurance program.
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A farmacovigilância é definida como "a ciência e atividades relativas à identificação, avaliação, compreensão e prevenção de efeitos adversos ou quaisquer problemas relacionados ao uso de medicamentos". Os medicamentos têm tanto o potencial de trazer benefícios quanto o de causar danos. O ácido 13-cis-Retinoico ou isotretinoina é um retinoide antiacne de referência no tratamento de doenças dermatológicas não responsivas a terapias convencionais, como a acne cística severa. Os efeitos adversos descritos na bula do medicamento implicam alterações em vários sistemas do corpo humano. Aqueles relacionados ao tecido ósseo, como a calcificação dos ligamentos e tendões, a redução na densidade óssea, o fechamento epifisário e hipercalcemia, possuem maior relevância na odontologia, levantando a hipótese para possível interferência na cicatrização dos alvéolos, após exodontia. Este artigo teve por objetivo realizar uma revisão de literatura reunindo informações sobre a possibilidade de interferência da isotretinoina em cirurgias maxilofaciais. Apesar da escassez de dados científicos conclusivos sobre a interferência da isotretinoína na cicatrização alveolar em humanos, estudos recentes sobre as vias de sinalização dos retinoides abrem novas perspectivas de pesquisa na influência dos retinoides no tecido ósseo alveolar. Esta possibilidade reforça a importância de uma atualização sobre os efeitos adversos da isotretinoína, bem como da anamnese criteriosa em pacientes com histórico de acne severa a fim de evitar complicações.
Pharmacovigilance is defined as "the science and activities related to identification, evaluation, understanding and prevention of adverse effects or problems related to the use of drugs". All drugs have both the potential to cause harm and benefit. 13-cis-Retinoic acid or isotretinoin is a reference anti-acne retinoid in the dermatological diseases treatment not responsive to conventional therapies, such as severe cystic acne. The drug-related side effects described in the medicine package insert imply changes in various human body systems. Those related to bone tissue, such as ligaments and tendons calcification, bone density reduction, epiphyseal closure and hypercalcemia, have great relevance for dentistry, raising the hypothesis of a possible interference in alveoli wound healing after extraction. This article aimed to conduct a literature review in gathering information about the possibility of isotretinoin interference in maxillofacial surgeries. In despite of the scarcity of conclusive scientific data about the influence of isotretinoin on human alveolar wound healing, recent studies on retinoid signaling pathways open new research perspectives for the isotretinoin interference on alveolar bone tissue. This possibility reinforces the importance of an isotretinoin drug-related side effects update, as well as a patients' careful anamnesis with historical severe acne, in order to avoid complications
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Corrosive oesophageal strictures are a common and debilitating condition in India. Patients generally have dysphagia, cachexia, drooling of saliva, aspiration pneumonitis, and lung abscess. Though endoscopic dilatations are done in cases of short segment strictures, surgical oesophageal by pass is the permanent solution for this condition. A 24 years female presented with complaints of dysphagia and cachexia, due to corrosive stricture. Patient had a history of poison ingestion 2 years back. Intra-operatively stricturous mucosa is excised and an iso peristaltic colonic loop by pass was carried out. Post operatively patient had a complication of anastomotic leak which was treated conservatively, excepting which patient is symptom free and gaining weight on a follow up period of 1 year. Ever since first described by Kelling and Vuillet in 1911 colonic interposition is mostly used around the globe for oesophageal bypass in both benign and malignant conditions. Stomach and jejunum are the other conduits that can be used. Iso peristaltic loop is mostly used to reduce the incidence of reflux. Right colon or transverse colon graft based on the mid colic artery or the left colic artery owing to the reliable blood supply and less diameter. This procedure has a high complication rate of around 27% most of which are due to the vascular comprise of the graft.
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Total Quality Management (TQM) is a managerial and managemental approach of an organization focused on quality, based on participation of all of its members and while aiming at long term benefits to the organization and consumers health. It is focused on continuous improvement of all processes approached with combined fundamental management techniques and specialized tools under quality systems. TQM is a process of managing the whole organization so that it progress in all the dimensions of products and services that are important to the consumers. It roots from the belief that mistake can be avoided or mininimised and defects can be prevented, with sole objective being the continuous process improvement. The introduction of Hazard Analysis Critical Control Point (HACCP) has signaled a shift in emphasis from resource intensive end product inspection and testing to preventive control of hazards at all the stages of food supply chain. It also identifies and controls hazards that are fundamentals for food safety. The integrated approach to implementation of ISO standards and HACCP concept is vital for management of quality and safety of dairy products hence safeguarding the customer’s requirements, ensuring that certified products conform to minimum standards set internationally. These standards ensure and enhance transparency in the development of food quality and safety procedures, thus helping to upgrade and update food safety systems. ISO laid down guidelines, codes, specifications and requirements to evolve effective TQM system.
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RESUMEN Fundamento: la implementación de un sistema de gestión de la calidad basado en la norma NC: ISO 9001 conlleva el establecimiento de la metrología como garantía de calidad de la confiabilidad de sus equipos de medición. Objetivo: demostrar la importancia del aseguramiento metrológico para la implementación de un sistema de gestión de la calidad. Métodos: se realizó un estudio descriptivo de corte transversal en el Centro de Inmunología y Productos Biológicos en la Universidad de Ciencias Médicas de Camagüey, en el período enero de 2014 a mayo de 2018. Resultados: en el primer levantamiento metrológico realizado ninguno de los instrumentos estaba verificado, se realizó un subregistro en el 2014, en el 2017 se incrementó el número de instrumentos registrados en la universidad, durante el estudio se actualizó el plan de verificación y se logró la verificación de la mayoría de los instrumentos de medición que posee el centro. Se constató la necesidad de contar con una asignación en el presupuesto para la adquisición de algunos instrumentos en déficit. Conclusiones: el diagnóstico realizado como parte del aseguramiento metrológico permitió conocer la situación real de los instrumentos de medición en el Centro de Inmunología y Productos Biológicos y lograr la verificación de un número importante de los mismos.
ABSTRACT Background: the implementation of a quality management system based on the NC standard: ISO 9001 entails the establishment of metrology as a guarantee of the reliability quality of its measuring equipments. Objective: to demonstrate the importance of metrology assurance for the implementation of a quality management system. Methods: a descriptive cross-sectional study was carried out at the Center of Immunology and Biological Products of the Camagüey University of Medical Sciences, from January 2014 to May 2018. Results: according to the first metrological survey none of the instruments had been verified, there was an underreporting in 2014, in 2017 the number of registered instruments in the university was increased, during the study the verification plan was updated and most of the measuring instruments were verified. It was found that there is a need of a budget allocation for the acquisition of some of the lacking instruments. Conclusions: the diagnosis made as part of the metrology assurance allowed to know the actual situation of the measuring instruments in the Center of Immunology and Biological Products and to verify an important number of them.
ABSTRACT
Resumen En esta revisión, se describen los retos que el Sistema Nacional de Salud debe afrontar para cumplir la agenda internacional mediante resoluciones emitidas por organismos líderes, una de ellas por la Organización Mundial de la Salud y la otra por la Organización de las Naciones Unidas que tiene que ver con las metas para el año 2030, a través del tercer Objetivo de Desarrollo Sustentable: Salud y Bienestar. México ha reformado estructuralmente su Sistema Nacional de Salud para poder cumplir como país miembro. Con la reforma, se establecieron las bases de la Cobertura Sanitaria Universal al crear el Sistema de Protección Social en Salud. Los dos últimos Planes Nacionales de Salud pretendierón fortalecerlo, modificarlo y mejorarlo incluyendo a la calidad como eje transversal incidiendo en la atención de la salud de las unides hospitalarias. Para apoyar esta acción, el Consejo de Salubridad General crea la Certificación de Hospitales con estándares homologados a la Joint Commission, uno de los estándares indispensables tienen que ver con la gestión de equipo médico, la cual debe realizarse bajo lineamientos dictados por estándares nacionales e internacionales que permitan establecer políticas, objetivos, procesos y gobernanza estructurados y alineados a otros estándares internacionales.
Abstract In this review, we describe the challenges that the National Health System must face in order to comply with the international agenda with resolutions issued by leading organizations, one of them by the World Health Organization and the other by the United Nations, it has to do with the goals for the year 2030, with the third Sustainable Development Goal: Good Health and Well-being. Mexico has structurally reformed its National Health System in order to comply as a member country. With the reform, the bases of the Universal Health Coverage were established when creating the Social Protection System in Health, the last two National Health Plans pretended to strengthen it, modify it and improve it including quality as a transversal axis to influence the attention of the health of the hospital units. To support this action, the General Health Council creates the Certification of Hospitals with standards approved by the Joint Commission, one of the indispensable standards related to the management of medical equipment, which must be carried out under guidelines dictated by national and international standards. that allow establishing policies, objectives, processes and governance structured and aligned to other international standards.
ABSTRACT
Introducción: En 2018 la Organización Internacional de Normalización publicó la norma ISO 21001 para los sistemas de gestión de las organizaciones educativas. Su implementación en la formación académica de posgrado permitirá brindar un servicio educativo que cumpla de manera consistente con los requisitos legales, encaminado a elevar la satisfacción de todas las partes interesadas. Estos planteamientos se evidenciaron en dos organizaciones que brindan programas de maestría y de especialidad en el posgrado. Objetivo: Analizar los requisitos de la norma ISO 21001 para su uso en organizaciones que brindan servicios de formación de posgrado académico, fundamentalmente programas de maestría. Desarrollo: Con la implementación de la norma ISO 21001 se pretende ofrecer un mejor servicio educativo, a partir de evaluar el grado en el que se satisfacen los requisitos de los estudiantes, sus familias, los profesores, el mercado laboral y la sociedad en general. Para ello, el sistema de gestión de la organización educativa incluye a todos los procesos, las personas y las formas de actuación necesarias para lograr servicios y productos educativos de calidad. Para demostrar la aplicación de la norma al posgrado académico se emplearon como casos de estudio los programas de maestría del Centro de Biomateriales de la Universidad de La Habana y del Centro Nacional de Cirugía de Mínimo Acceso. Conclusiones: La norma ISO 21001, aplicada al posgrado académico, permite gestionar internamente la calidad de los servicios formativos para satisfacer las necesidades y expectativas de todas las partes interesadas y lograr categorías superiores de acreditación(AU)
Introduction: In 2018, the International Organization for Standardization published the Standard ISO 21001, Educational Organization Management System. Its implementation in postgraduate academic training will allow providing an educational service that consistently complies with the legal requirements, aimed at raising the satisfaction of all interested parties. These elements were evidenced in two organizations that provide master's and specialty programs in postgraduate education. Objective: To analyze the Standard ISO 21001's requirements for its usage in organizations that provide academic postgraduate training services, mainly master's programs. Development: With the implementation of the Standard ISO 21001, the aim is to offer better educational service, based on the evaluation of the degree to which the students', their families', professors', the labor market's, and the overall society's requirements are met. In view of this, the educational organization management system includes all the processes, people and forms of action necessary to achieve quality educational services and products. In order to show the Standard's application to the academic postgraduate course, we used, as study cases, the master's programs from the Center of Biomaterials at University of Havana and from the National Center of Minimum Access Surgery. Conclusions: The Standard ISO 21001, applied to the academic postgraduate course, allows managing internally the quality of training services, in view of fulfilling the needs and expectations of all interested parties and achieving higher accreditation categories(AU)