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Introducción: Con la matriz de riesgo se identifican las medidas de control relevantes. El análisis de modos y efectos de fallo posterga definir la efectividad de las medidas correctivas. El uso de uno solo de estos métodos limita el alcance al evaluar los riesgos y la toma de decisiones. Objetivos: Determinar la contribución individual de las causas básicas de fallo en el riesgo radiológico de la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera, a partir del modelo de la matriz y los reportes. Métodos: Se adaptó el análisis de la gestión de la calidad en radioterapia a las prácticas en estudio y la selección individual de las causas básicas más contribuyentes al riesgo radiológico. La base internacional de incidentes aportó las causas que completaron el listado de las derivadas de la aplicación del principio de Pareto. Resultados: Los subprocesos más contribuyentes al riesgo fueron, por orden de importancia, la administración del radiofármaco, su preparación y la prescripción clínica. Para estos se identificaron las etapas, modos de fallo y sus causas más importantes. Existieron causas que contribuyeron a varios modos de fallo. El incumplimiento de procedimientos, protocolos o prácticas, la falta de entrenamiento del personal y la fatiga del personal son las causas de los riesgos identificados. Conclusiones: Se caracterizó la efectividad de las medidas correctivas de las causas más contribuyentes, las que se adicionan a las derivadas de la matriz, en el plan de mejora en la radiosinoviortesis y el tratamiento mielosupresor de la policitemia vera en Cuba(AU)
Introduction: The risk matrix identifies the relevant control measures. Failure modes and effects analysis postpones defining the effectiveness of corrective measures. Using just one of these methods limits the scope when assessing risks and making decisions. Objectives: To determine the individual contribution of the basic causes of failure in the radiological risk of radiosynoviorthesis and the myelosupressor treatment of polycythemia vera, based on the matrix model and the reports. Methods: The analysis of quality management in radiotherapy was adapted to the practices under study and the individual selection of the basic causes most contributing to radiological risk. The international incident base provided the causes that completed the list of those derived from the application of the Pareto principle. Results: The sub-processes that contributed the most to risk were, in order of importance, the administration of the radiopharmaceutical, its preparation and the clinical prescription. For these, the most important, stages, failure modes and their causes were identified. There were causes that contributed to various failure modes. Non-compliance with procedures, protocols or practices, lack of staff training and staff fatigue are the causes of the identified risks. Conclusions: The effectiveness of the corrective measures of the most contributing causes, which are added to those derived from the matrix, was characterized in the improvement plan in radiosynoviorthesis and myelosupressor treatment of polycythemia vera in Cuba(AU)
Subject(s)
Humans , Male , Female , Polycythemia Vera , Effectiveness , Total Quality Management , Disaster Preparedness , Decision MakingABSTRACT
Introducción: El análisis causal de los eventos adversos amerita metodologías validadas para establecer la dinámica de cómo se originan los incidentes que afectan la seguridad del paciente en los ambientes de prestación de servicios de salud. Objetivo: Describir las bases conceptuales y metodológicas de los sistemas de análisis causal de eventos adversos de trascendencia clínica en la biomedicina. Métodos: Se realizó una revisión documental empleando la bibliografía nacional e internacional actualizada. Se utilizó el motor de búsqueda Google Académico, se consultaron artículos de libre acceso en las bases de datos Pubmed y SciELO, desde marzo 2019 hasta igual mes de 2020. Se emplearon como palabras clave: eventos adversos, análisis de causas raíz, seguridad del paciente, según los Descriptores en ciencias de la salud (DeCS). Fueron seleccionados 25 artículos (20 en idioma español, 5 en inglés), de ellos, 18 (72,0 por ciento) corresponden a los últimos 5 años. Análisis e integración de la información: Las metodologías del análisis causa-raíz, el método ANCLA, el análisis modal de fallos y efectos (AMFE) y el protocolo de Londres, comparten como propósito su función de usar el evento o error para revelar las brechas que vulneran la seguridad del paciente y los aspectos inadecuados en el proceso de atención de la salud. Conclusiones: Los sistemas de análisis causal de eventos adversos constituyen herramientas para incrementar la cultura de seguridad del paciente, pues detectan fallas y errores latentes en el sistema, cuya corrección es esencial para implementar estrategias de prevención(AU)
Introduction: Causal analysis of adverse events requires validated methodologies to determine the origin of incidents affecting patient safety in health care settings. Objective: Describe the conceptual and methodological bases of the systems for the causal analysis of adverse events of clinical relevance in biomedicine. Methods: A document review was conducted of updated national and international bibliography. The search was carried out in the search engine Google Scholar, and open access papers were consulted in the databases PubMed and SciELO from March 2019 to March 2020. The key words used were adverse events, root cause analysis and patient safety, obtained from Health Sciences Descriptors (DeCS). A total 25 papers were selected (20 in Spanish and 5 in English), of which 18 (72.0 percent had been published in the last five years. Data analysis and integration: Root-cause analysis methodologies, the ANCLA score, the failure modes and effects analysis (FMEA) and the London Protocol share the common purpose of using events or errors to reveal gaps that weaken patient safety and inappropriate aspects of the health care process. Conclusions: Systems for the causal analysis of adverse events are tools to enhance patient safety culture, for they detect failures and errors latent in the system whose correction is essential to implement prevention strategies(AU).
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Root Cause Analysis , Patient Safety , Health Services , /methodsABSTRACT
Objective To strengthen the system of drug supply chain collaborative service platform in drug supply, decrease drug inventory backlog, and improve the outpatient pharmacy management capacity in outpatient pharmacy.Methods Failure mode and effects analysis (FMEA) method was used to discover the potential risks in the drug supply chain collaborative service platform and formulate the corresponding improvement measures.Results The number of drug-receiving errors dropped from 137times to 32times and the risk reduction rate was 76.64％after improving the procurement process of the supply chain service platform, which significantly reduced the risk of contracting errors.Conclusion FMEA method could help to figure out the loopholes and hidden dangers of the pharmacy system, which made the outpatient pharmacy more reasonable and accurate by constantly improving the measures of the drug supply chain collaborative service platform.
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OBJECTIVE@#To explore the high-risk fault risk of CT simulator and the main causes of the risk, and to put forward effective risk management strategies.@*METHODS@#The failure mode and effect analysis method was used to identify and control the operational fault risk of CT simulator.@*RESULTS@#5 major fault components, 8 fault failure models and 17 failure causes were analyzed. The top 5 failure causes are:anode target surface burn caused by direct scanning without warming up the tube (590.4), tube failure (518.2), burnout of joints caused by aging of high voltage cables (424.2), motor carbon brush wear (304.8) and belt break (296.4).@*CONCLUSIONS@#The failure mode and effect analysis method can effectively identify the risk of equipment failure, and thus specifically formulate risk management and control measures to ensure the normal operation of equipment and the safety of doctors and patients.
Subject(s)
Humans , Equipment Failure , Risk Management , Methods , Tomography, X-Ray Computed , Reference StandardsABSTRACT
Introdução: O presente estudo descreve a aplicação da ferramenta de gerenciamento de riscos Análise de Modo e Efeito de Falha (Failure Mode Effects Analysis FMEA) a uma pesquisa clínica que estabelecerá um tratamento de indivíduos simultaneamente infectados por HIV e tuberculose. Objetivo: Demonstrar a importância da análise de riscos associada aos protocolos de estudos clínicos na salvaguarda do participante e dos dados do estudo, e como padrão de qualidade do estudo. Método: Os procedimentos demandados na execução do protocolo clínico e os potenciais modos de falha a eles associados foram estipulados com base na programação de visitas do participante ao centro do estudo. Os modos de falha foram valorados entre 1 e 10 de acordo com: Gravidade, Ocorrência e Detectabilidade, calculando-se o Número de Prioridade de Risco (NPR) pela multiplicação dos três valores. Resultados: Num painel de 25 procedimentos e 60 modos de falha, 50% resultaram em NPR > 120; seis deles contendo mais de cinco modos de falha. Os maiores riscos foram associados à estratégia DOT (NPR 294), à coleta de sangue (NPR 288), ao Termo de Consentimento Livre e Esclarecido (NPR 270) e a coletas de dados do participante (NPR 240). Conclusões: Os resultados demonstraram a importância da FMEA como instrumento de avaliação de riscos em estudos clínicos, alinhando-se com recomendações de órgãos normalizadores internacionais.
Introduction: This study describes the application of the Failure Mode and Effects Analysis (FMEA) as a tool for risk management during clinical research to establish the treatment of patients simultaneously infected with HIV and tuberculosis. Objective: To demonstrate the importance of risk analysis associated with clinical trial protocols in safeguarding the participant and study data, and as a study's quality standard. Method: Procedures demanded by the clinical protocol were detailed and then associated with failure modes based on the programmed visits of the participant to the study center. The failure modes were rated between 1 and 10 according to: Severity, Occurrence and Detectability, and the Risk Priority Number (RPN) was calculated by multiplying the three values. Results: In a panel of 25 procedures and 60 failure modes, 50% resulted in RPN > 120; six of which contained more than five failure modes. The highest risks were associated with the DOT strategy (RPN 294), blood collection (RPN 288), the Informed Consent Term (RPN 270) and participant data collection (RPN 240). Conclusions: The results demonstrate the importance of FMEA as a tool to assess risks in clinical studies, in line with the recommendations of international standardization organizations.
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OBJECTIVE: To investigate the application and control of failure mode and effect analysis (FMEA) in the risk management of food and drug inspection institutions. METHODS: A 25-people team was set up and the factors related to equipments in the management review report and external review were analyzed through brainstorming and expert consultation. Thirty-four large risk factors were idendified. RESULTS: The top five risk factors in respect to risk priority number(RPN) value were as follows equipment not undergoing period verification, lack of experience, communication risk between inspection department and equipment management department, daily use and maintenance not meeting the requirements, inadequate consciousness of equipment management. CONCLUSION: The application of FMEA can identify and deal with the failure mode in the process of equipment management and timely detect high risk projects in the equipment management to achieve better control of quality of laboratories.
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Objective:To explore the process of maintenance management for large medical equipment, and the structure design and core connotation of the maintenance management software of them.Methods: Medical linear accelerator of Precise series of Elekta company was combined to achieve the objective. From the aim of designing normal operation rate to start, the failure mode and effects analysis (FMEA) was operated to analyze the maintenance strategies and maintenance manners which were established on the basis of PDCA(Plan, Do, Check, Action) cycle and the analysis mode of SWOT (Strength, Weakness, Opportunity, Threat), and it could achieve the aim of normal operation rate.Results: Through explored the connotation of maintenance management and the preliminary framework of the software of maintenance management, the detail and process of maintenance management that based on personalized accelerator of process control were established, and the element factors of software of maintenance management of accelerator also was established at the same time.Conclusion: The effective maintenance management of large medical equipment is based on informatization process management of process control, and the element factor of management software need personalized customization. On the other hand, failure mode and degradation mechanism of equipment were the basis for personalized customization, and the creation has practical value.
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Objective:To take quality risk management as the guiding ideology and use failure mode and effect analysis ( FMEA) to evaluat the key of the whole process of cleaning validation which aimed to reduce the risk. Methods: FMEA was applied in the cleanliness verification of APIs. According to the risk priority values, the risk points and risk control measures were determined for the key validation of cleanliness verification. Results:Through the control measures, the final risk score was obtained to assess the impacts on the final product quality and patient safety. Conclusion:Quality risk management is applied in the cleanliness verification of non-sterile APIs, which can effectively verify all aspects of the process, improve the pertinence and reduce the quality system risks in the actual production process with important guiding significance.
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The aim of the study was to optimize compression process variables of Pantoprazole oro-dispersible (Multiunit particulate system) MUPS tablet. Enteric coated Pantoprazole pellets were compressed to oro-dispersible tablet for geriatric and pediatric patients for easy administration. The risk related to compression process variables was identify, assessed and mitigated using Failure Mode and Effect Analysis (FMEA). A full factorial design was applied to develop design space and determine control strategy for compression process, which were developed, have promising chemical and physical results. The compression process variables studied were pre-compression force (X1), main compression force (X2) and turret speed (X3), versus affecting hardness (Y1), disintegration time (Y2), friability (Y3), weight variation (Y4), content uniformity (Y5), drug release in 0.1N HCl (Y6) and assay (Y7) as responses/Critical quality attributes (CQAs). Response surface graphs depicted that X2 had more impact on CQAs than X1. Design space plot revealed that tablet CQAs were within limit when X3 maximum 44 rpm and X2 in the range of 10 to 12.5 kN. Scale up performed on commercial scale compression machine of same make that of lab scale showed reproducible physical and chemical parameters. It could be concluded that a quality Pantoprazole oro-dispersible MUPS tablet was successfully designed using QbD approach to compression process variables.
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INTRODUCTION: This paper presents the failure modes and effects analysis (FMEA) tool in a clinical laboratory through the introduction of new technology for blood gas and serum ionized calcium in multi-parameter analyzers such as Point of Care Testing (POCT). OBJECTIVE: To present FMEA as a tool for risk managing and improvement with the introduction of new technologies in a public laboratory. METHODS: The change of multiparameter gas analyzer type POCT was defined and described as a process. Subsequently, the criteria were presented to the risk assessment and its quantification. We studied the failure modes that might occur in this process. We established three action plans involving improvements to be made in the technological change. FMEA was applied in two stages: at the beginning of the project and after the implementation of the proposed measures. RESULTS: The first plan involved administrative measures related to the bidding process; the second preventive action involved the possibility of which supplier would win the bid by studying the efficiency of the analyzer and its impact on productivity; the third set of actions was directed to improvements in the relationship with the clinical staff in order to minimize occasional complaints. The last actions referred to employing new employees to meet the growing demand. CONCLUSION: FMEA proved to be a reliable tool for performance improvement, which proactively identifies, prioritizes and mitigates patient risks.
INTRODUÇÃO: O artigo apresenta a ferramenta de análise do modo e do efeito de falhas (FMEA) dentro de um laboratório clínico por meio da introdução de nova tecnologia para gasometria e cálcio iônico sérico em analisadores multiparâmetros do tipo testes laboratoriais remotos (TLR) ou point of care testing (POCT). OBJETIVO: Apresentar a FMEA como ferramenta de gestão de riscos e de melhoria em um laboratório público ao introduzir novas tecnologias. MÉTODOS: A mudança de analisadores de gases multiparâmetros do tipo POCT foi definida e descrita como um processo. A seguir, foram apresentados os critérios para a avaliação dos riscos e a sua quantificação. Foram estudados os modos de falha pelos quais algo poderia falhar nos componentes desse processo. Estabeleceram-se três planos de ações que envolviam melhorias a serem introduzidas na mudança de tecnologia. A FMEA foi aplicada em dois momentos: no início do projeto e após a implantação das medidas propostas. RESULTADOS: O primeiro plano envolveu medidas administrativas vinculadas ao processo licitatório; a segunda ação preventiva envolveu a possibilidade de qual fornecedor venceria a licitação, estudando-se a eficiência do analisador e seu impacto na produtividade; o terceiro conjunto de ações foi dirigido às melhorias no relacionamento com o corpo clínico para minimizar as eventuais reclamações. As últimas ações referiram-se à contratação de novos funcionários para atender à demanda crescente. CONCLUSÃO: A FMEA revelou-se um instrumento de melhoria de desempenho para o laboratório, que de maneira proativa identifica, prioriza e mitiga os riscos do paciente.
Subject(s)
Equipment Failure Analysis , Blood Gas Analysis/instrumentation , Laboratories , Patient Safety , Risk AssessmentABSTRACT
Lacidipine (LCDP) is a dihydropyridine derivative categorized as an Anti-hypertensive Ca+2 channel blocker belonging to BCS class IV drug with low solubility and low permeability which presents a challenge to the formulation scientists. The development of a solid dispersion by solvent evaporation is a practically viable method to enhance dissolution of LCDP from oral dosage form. Solvent evaporation by Fluidized Bed Process (FBP) was the method of choice for SD as it improves wettability with simultaneous increase in porosity of granules resulting enhanced surface area producing higher dissolution rate and bioavailability of poorly water-soluble drug. Thus, the main object of the present invention is to provide stable pharmaceutical dosage form of LCDP with desired dissolution rate i.e. at least 80% drug release within 45 minutes, without use of disintegrant(s) and/or surfactant(s) or without micronization of the active ingredient per se. One more object of this invention is to provide a sophisticated robust process for the preparation of said pharmaceutical dosage form by Quality by Design (QbD) concept focusing on thorough understanding of the product and process by which it is developed and manufactured along with a knowledge of the risks involved in manufacturing by IRMA & FMEA study of the product with process and how best to mitigate those risks by developing design space with DoE & MVDA with outlined control strategy.
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As the importance of clinical risks management grows hospital management,reducing hospital medical errors for patients safety has become a key quality management process.Failure Mode and effect analysis( FMEA) is a proactive technique for error detection and reduction.In this paper,based on a brief review of it's history of development,described in detail the implementation method and steps of FMEA,mainly introducing the research progress for using FMEA in reducing hospital medical errors.