Evolução do grau de incapacidade física e do escore olhos, mãos e pés em casos novos de hanseníase: do diagnóstico à alta medicamentosa / Evolution of the degree of physical disability and the eye, hand and foot score in new cases of leprosy: from diagnosis to medication discharge

Este estudo tem por objetivo avaliar a evolução do grau de incapacidade física e do escore olhos, mãos e pés, do diagnóstico à alta medicamentosa, segundo as variáveis sociodemográficas e clínicas, em pacientes diagnosticados com hanseníase. Trata-se de estudo transversal, baseado na análise de 71 pacientes com diagnóstico de hanseníase, acompanhados no Hospital Eduardo de Menezes, centro de referência em Belo Horizonte, Minas Gerais, Brasil, entre janeiro de 2017 a dezembro de 2020. Foi observado predomínio do sexo feminino (53,5%), média de idade de 46 anos, sendo a maioria procedente de outros municípios do interior de Minas Gerais (54,9%). A forma clínica mais frequente foi a dimorfa (64,8%), classificação operacional multibacilar (84,5%). O grau de incapacidade física 0 foi o mais prevalente no diagnóstico (56,5%) e na alta (53,1%), e em relação ao escore olhos, mãos e pés, houve variação entre 0 e 10 no diagnóstico e entre 0 e 8 na alta. Pelo teste de McNemar foi observado que dentre os pacientes que apresentavam algum grau de incapacidade física no momento do diagnóstico, 30,8% apresentaram ausência de incapacidade na alta. Ao comparar a evolução do grau de incapacidade física de paucibacilares e multibacilares no momento do diagnóstico e da alta, houve manutenção em 59,3% e melhora em 17,2% dos pacientes. Os dados apresentados indicam que muitos pacientes foram tratados tardiamente já apresentando as formas graves e com sequelas, já que o estudo foi desenvolvido em um centro de referência, que atende casos mais complexos e com complicações já instaladas. Os dados sugerem que pacientes assistidos que realizam o tratamento com poliquimioterapia podem ter melhora das incapacidades já instaladas. O mesmo ocorreu com o escore olhos, mãos e pés, que ao final do tratamento instituído houve melhora se comparado com a admissão.(AU)

This study aims to evaluate the evolution of the degree of physical disability and the eye, hand and foot score, from diagnosis to medication discharge, according to sociodemographic and clinical variables, in patients diagnosed with leprosy. This is a cross-sectional study, based on the analysis of 71 patients diagnosed with leprosy, followed by Hospital Eduardo de Menezes, a reference center in Belo Horizonte, Minas Gerais, Brazil, between January 2017 and December 2020. There was a predominance of females (53.5%), average age of 46 years old, the majority coming from other municipalities in the interior of Minas Gerais (54.9%). The most frequent clinical form was borderline (64.8%), multibacillary operational classification (84.5%). Degree of physical disability 0 was the most prevalent at diagnosis (56.5%) and at discharge (53.1%); in relation to the eye, hand and foot score, there was variation between 0 and 10 at diagnosis and between 0 and 8 at discharge. By the McNemar test, it was observed that of the patients who had degree of physical disability at the time of diagnosis, 30.8% had no disability at discharge. When comparing the evolution of the GIF in paucibacillary and multibacillary patients at the time of diagnosis and discharge, there was maintenance in 59.3% and improvement in 17.2% of the patients. The presented data indicates that many patients were treated late, already presenting severe forms and with sequelae, since the study was carried out in a reference center, which treats cases with complications already installed and more complex cases. The data suggest that assisted patients undergoing treatment with multidrug therapy may experience improvement in disabilities already established. The same occurred with eye, hand and foot score, at the end of the established treatment there was an improvement compared to admission.(AU)

Discussion on the intellectual property risk and management of international cooperative scientific research from the perspective of human genetic resources protection / 中华医学科研管理杂志

Objective:To analyze the intellectual property risk of international cooperative scientific research involving human genetic resources, explore possible risk control measures regarding to intellectual property.Methods:By means of literature review, this paper analyzes the special attributes and strategic position of human genetic resources, reviews the policies and systems involving human genetic resources in international cooperative scientific research, identifies the intellectual property risk points, and puts forward suggestions on risk management and control from the perspective of intellectual property protection.Results:The management of human genetic resources in China is evolving quickly. However, there is still a lack of practical guidelines on intellectual property protection and development, more substantial engagement and contribution of Chinese investigators in the international collaborative research should be promoted, and the perception and awareness of the significance of human genetic resources should be enhanced.Conclusions:In the international cooperative scientific research involving human genetic resources, we should clarify the operating rules at the level of intellectual property protection, improve the substantive participation of Chinese investigators, enhance the strategic awareness and risk awareness of human genetic resources, and provide support at the level of executive management institutions.

Risk Control of UPS Power Supply for Medical Equipment / 中国医疗器械杂志

OBJECTIVE@#Putting forward that the risk of using UPS for medical matching is easy to be ignored by managers.@*METHODS@#The method of UPS inspection was designed and used in hospital.@*RESULTS@#The qualified rate of UPS for equipment matching was 66.7% and the problems were corrected. Based on the Internet of Things technology, the UPS monitoring technology was prospected.@*CONCLUSIONS@#It is effective to control the risk of UPS by recognizing the risk of using UPS and specifying the strategy.

High-alert Drug Management and Risk Control in Our Hospital / 中国药房

OBJECTIVE：To explore high-alert drug management mode of our hospital ，and to provide reference for the management and utilization of this category in medical institutions. METHODS ：According to High-alert Drug Catalog （2019 edition）issued by Hospital Pharmacy Committee of Chinese Pharmaceutical Association ，the high-alert drug catalog of our hospital and their risk points were formulated. Relevant training and assessment were conducted for physicians ，pharmacists and nurses throughout the hospital. Using qualification rate of high-alert drug management and utilization as index ，the effectiveness of high-alert drug management and utilization were compared before and after optimization. RESULTS ：In our hospital ，the risk of high-alert drugs was controlled by establishing inspection and supervision group ，pharmacist education ，information management ， prescription review and individualized administration ，medication guidance ，prescription review and medication error reporting and other measures and with continuous optimization. Compared with before optimization ，qulification rate of high-alert drug management and utilization increased from 37.3％ to 80.1％ in clinical departments （P＜0.01），and that increased from 59.2％ to 85.0％ in pharmacy department （P＜0.01）. There were still some problems ，such as the inconsistency of high-alert drugs accounts and materials ，the failure to report all medication errors in time ，the imperfect establishment of prescription review software rules ， the insufficient medication guidance ，and the lack of individual medication varieties. CONCLUSIONS ：By optimizing the management of high-alert drugs ，the management and utlization of this category is improved effectively in clinical departments and pharmacy departments of our hospital.

Early detection and risk control of safety signals of Chinese medicine / 中国中药杂志

The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts. A variety of methods are employed for the mining of risk signals or analysis and screening of relevant signals to accurately determine the correlation between medication and adverse reactions. The safety signal acquisition and mining techniques are the technical basis for the safety risk management of medicine products after Chinese medicines are marketed, which is critical in drug safety alerts. To accurately collect the safety signals of Chinese medicines and effectively and rapidly track, determine, and assess the sources of signals are important technical links in drug risk management. The ultimate purpose of safety signal discovery is to achieve normalized risk management through downgrading drugs from a high-risk level to a low-risk level.The five main steps in the standard drug risk management are listed below: to extensively collect predicted risk signals; to accurately identify drug risks by the techniques such as data mining; to evaluate the risks with process-based quality risk control; to employ management measures minimizing the impact of drug risks for risk management; to update and apply risk assessment to clinical evaluation after medication.

Construction of model for multidimensional evaluation of value and risk of Chinese patent medicine / 中国中药杂志

It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.

Research on Risk Control of Upgraded Design and Development Changes of Laser Treatment Equipment after Registration / 中国医疗器械杂志

This paper analyzes the causes and risks of common design and development changes of laser treatment equipment, studies the changes of key components and their corresponding control measures, forms the identification method of design changes of laser treatment equipment, and gives suggestions on how to deal with design and development changes, so as to provide references for inspectors during on-site inspection.

Risk Control of Old-age Care Institution under Coronavirus Disease 2019 Epidemic / 中国康复理论与实践

Coronavirus disease 2019 brought some risks to the current environment of old-age care institutions, the provision of integrated medical care and nursing services, and the psychology of the elderly. To prevent the risks faced by the suitable environment, it is necessary to carry out architectural planning and design, and transform the suitable environment, to achieve the goal of closed management; quarantine areas, clean areas, and polluted areas should be set up to ensure the quality of life. To prevent the risks related to the integration of medical care and nursing services, it is necessary to establish a long-term care insurance system, promote qualified old-age care institutions to become designated medical institutions, form a training and incentive mechanism for medical staff, and promote the development of internet medical care. To prevent the psychological risk of the elderly, it is necessary to pay attention to the psychological work to deal with the psychological crisis of the elderly. In addition, refined management is needed to avoid cross-infection.

Application of traditional Chinese medicine(TCM) traceability system based on TCM quality characteristics and HACCP system / 中国中药杂志

It is crucial to establish a complete set of traditional Chinese medicine(TCM) quality traceability management process system, in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals. In this study, we reviewed the mature experience of food and drug supervision at home and abroad, analyzed the quality characteristics of TCM, and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP) system in food safety quality control. This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM, but also ideas for improving the quality of TCM products and the safety risk control of TCM. The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.

Measuring Back Injury Risk in Mexican Workers of an Automotive Company / Medición del riesgo de lesión de espalda en trabajadores mexicanos de una empresa automotriz / Medição do risco de lesão de costas em trabalhadores mexicanos de uma empresa automotiva

Abstract Introduction : The Mexican manufacturing sector in the automotive industry employs an average of 8 million 850 thousand workers per year spread across the 32 states, of which Puebla contributes with 465106, developing, in a high percentage, the verification of new parts as part of the manufacture process. This activity is supported by the use of devices known as fixtures, whose equipment and tool forces operators to lift loads between 10 and 50 kilograms by performing manual operations to hold parts, presenting pain at the lumbar level, therefore, it is essential to measure the risks of back injuries in the study population. The objective was to identify and measure the risks of back injuries in the study population. Materials and Methods : The inspection process is analyzed by identifying the potential risk factors. Ergonomic methodologies and instruments are used, such as Quick Exposure Check (QEC), the National Institute for Occupational Safety and Health (NIOSH) equation, the REBA (Rapid Entire Body Assessment) method, Ovako's Work Posture Analysis System (OWAS), among others. Results : The QEC method shows that trunk/back and wrist/hand are the most sensitive parts to risk exposure, indicating that 18 % of the postures are rated 4 in the level of risk, with the back rotated and bent in over 32 % of time. The weight of the operation exceeds 20 kilograms in 71.4 %. Conclusion: Four ergonomic techniques are used to assess the risk of injury, the inspection process of manufactured parts is analyzed.

Resumen Introducción: la industria manufacturera mexicana del ramo automotor emplea en promedio 8 millones 850 mil trabajadores al año repartidos en los 32 estados, de los cuales Puebla contribuye con 465106, desarrollando, en un alto porcentaje, la verificación de piezas nuevas como parte de los procesos de manufactura. Esta actividad se apoya en el uso de dispositivos conocidos como fixtures, cuyo equipo y herramienta obliga a los operarios a levantar cargas entre los 10 y los 50 kilogramos, realizando operaciones manuales para la sujeción de piezas, presentándose dolores a nivel lumbar, por lo que es primordial medir los riesgos de lesiones en la espalda de la población en estudio. El objetivo fue identificar y medir los riesgos de lesiones en la espalda de la población en estudio. Materiales y métodos : se analiza el proceso de inspección identificando los factores de riesgo potencial. Se utilizan metodologías y herramientas ergonómicas, tales como Quick Exposure Check (QEC), la ecuación del National Institute for Occupational Safety and Health (NIOSH), el método REBA (Rapid Entire Body Assessment), el sistema de análisis de posturas de trabajo de Ovako (OWAS), entre otras. Resultados : el método QEC muestra que tronco/ espalda y muñeca/mano son las partes más sensibles a la exposición de riesgo, señalando el 18 % de las posturas en un nivel de riesgo 4, con la espalda rotada y flexionada en más del 32 % del tiempo. El peso que conlleva la operación supera los 20 kilogramos en el 71,4%. Conclusión : se utilizan cuatro técnicas ergonómicas para evaluar el riesgo de lesión y se analiza el proceso de inspección de piezas fabricadas.

Resumo Introdução : a indústria manufatureira mexicana do ramo automotivo emprega em média 8 milhões 850 mil trabalhadores ao ano repartidos nos 32 estados, dos quais Puebla contribui com 465106 deles, desenvolvendo, em uma alta porcentagem a verificação de peças novas como parte dos processos de manufatura. Esta atividade apoia-se no uso de dispositivos conhecidos como fixtures, cuja equipe e ferramentas abriga aos operários a levantar cargas entre os 10 e 50 quilogramas realizando operações manuais para a fixação de peças, se apresentando dores no nível lombar, pelo que é primordial medir os riscos de lesões nas costas da população em estudo. Materiais e métodos : se analisa o processo de inspeção identificando os fatores de risco potencial. Se utilizam metodologias e ferramentas ergonómicas, tais como Quick Exposure Check (QEC), a equação do National Institute for Occupational Safety and Health (NIOSH), o método REBA (Rapid Entire Body Assessment), o sistema de análise de posturas de trabalho de Ovako (OWAS), entre outras. Resultados : o método QEC mostra que o torso/costas e o pulso/mão são as partes mais sensíveis à exposição de risco, assinalando o 18 % das posturas em um nível de risco 4, com as costas rotadas e curvadas em mais do 32 % do tempo. O peso que leva a operação supera os 20 quilogramas no 71.4 %. Conclusão : utilizam-se quatro técnicas ergonómicas para avaliar o risco de lesão e se analisa o processo de inspeção de peças fabricadas.

Contribuições para a tecnovigilância das luvas de látex e a biossegurança / Contributions to the technovigilance of latex gloves and biosafety

As luvas são fundamentais para a proteção dos profissionais e pacientes contra a contaminação cruzada, especialmente no controle do risco de contato direto com fluidos corporais. O objetivo desta pesquisa foi realizar um experimento in vitro acerca das propriedades físicas das luvas de procedimento de látex, comercializadas nacionalmente, visando produzir evidências científicas para o uso seguro em situações de assistência à saúde. Três lotes diferentes de cada uma das cinco marcas de luvas de procedimento de látex foram avaliados antes do uso quanto à integridade física (presença ou não de rasgos e/ou furos). Os protocolos padrão da Society for Testing and Materials e da Food and Drug Administration American consistiram em preencher cada uma das luvas com 1.000mL de água e inspecionar danos imediatamente e após dois minutos. Ainda, quantificar e comparar a perfusão de corante através das diferentes marcas de luvas por meio de um protocolo original desenvolvido com vistas a simular a punctura acidental por agulha. Inicialmente, uma punção venosa foi simulada em um recipiente contendo cristal violeta (CV) a 1% coberto com uma placa de gelatina a 8%, que simulou a pele humana. Uma microplaca de poliestireno 96 poços foi coberta com uma luva e depois perfurada com uma agulha com calibre de 0,80x30mm acoplada à uma seringa de 20mL contendo 5mL de CV a 1%. Os resultados foram expressos em frequências absolutas e relativas. Além disso, dados obtidos da perfusão do corante através das diferentes marcas de luvas foram submetidos aos testes de normalidade (Kolmogorov-Smirnov e Shapiro-Wilk) e, posteriormente, ao teste de U de Mann-Whitney por meio do software IBM SPSS Statistics (versão 25) e nível de significância ?=5%. As luvas das marcas D (1%) e C (9,2 e 9,4%) apresentaram o melhor e o pior dos resultados de rasgos e/ou furos nas inspeções imediata e após dois minutos, respectivamente. Um total de 7% (n=21) dos rasgos e/ou furos da marca C ocorreram em um dedo/região das luvas, enquanto que 1,3% (n=4) estavam danificadas/rasgadas. A marca D permaneceu com o melhor resultado, pois apresentou somente 1% (n=3) de rasgos e/ou furos em um dedo/região. Os valores medianos das absorbâncias de todas as marcas de luva de procedimento de látex perfuradas foram inferiores ao valor mediano da absorbância da perfuração sem luva, confirmando uma retenção do cristal violeta através de todas as marcas de luva avaliadas (p<0,001). As luvas da marca E apresentaram a maior porcentagem de retenção do cristal violeta dentre todas as marcas (77,2%), seguida das luvas da marca B (65,6%). Em contrapartida, as luvas da marca D sinalizaram a menor porcentagem de retenção do cristal violeta (14,6%). Em conclusão, todas as marcas de luvas de procedimento de látex avaliadas apresentaram danos físicos com maior frequência na região entre os dedos. Ainda, em condições in vitro, as luvas de procedimento de látex mesmo depois de perfuradas barraram parcialmente a carga do material inoculado

Gloves are fundamental for professionals' and patients' protection against crosscontamination, especially in control of risk of contact with corporal fluids. The objective of this study was to perform an in vitro experiment about physical properties of latex procedure gloves, marketed nationally, aiming to produce scientific evidences for the safe use in health care situations. Three different batches of each one of five brands of latex procedure gloves were evaluated before and after the use regarding physical integrity (presence or absence of tears and/or holes). The standard protocols of Society for Testing and Materials and of Food and Drug Administration American consisted in fill each one of the gloves with 1,000mL of water and inspect damages immediately and after two minutes. Also, to quantify and compare dye infusion through different glove brands via an original protocol developed to simulate the accidental puncture by needle. Initially, a venipuncture was simulated in a receptacle containing crystal violet (CV) at 1% covered with a gel plate at 8%, that simulated the human skin. A 96-well polystyrene microplate was covered with a glove and then pierced by a needle with 0.80x30mm caliber coupled to a 20mL syringe containing 5mL of CV at 1%. The results were expressed in absolute and relative frequencies. Moreover, the data obtained from the dye infusion through different glove brands were submitted to normality tests (Kolmogorov-Smirnov and Shapiro-Wilk) and, later, to Mann-Whitney U test through IBM SPSS Statistics (version 25) software and ?=5% significance level. The gloves of brands D (1%) and C (9.2 and 9.4%) presented the best and the worst of the tears and/or holes results in the immediate and after two minutes inspections, respectively. A total of 7% (n=21) of tears and/or holes of brand C happened in one glove finger/region, while 1.3% (n=4) were damaged/torn. The brand D remained with the best result because presented only 1% (n=3) of tears and/or holes in one finger/region. The median values of absorbances of all brands of perforated latex procedure gloves were lower than the median value of absorbance of gloveless perforation, confirming a retention of crystal violet through all evaluated glove brands (p<0.001). The gloves of brand E presented the highest percentage of retention of crystal violet within all brands (77.2%), followed by gloves of brand B (65.6%). Conversely, the gloves of brand D indicated the lowest percentage of retention of crystal violet (14.6%). In conclusion, all brands of evaluated latex procedure gloves presented physical damages with higher frequency in the region between the fingers. Also, in in vitro conditions, the latex procedure gloves even after perforated partially blocked the load of inoculated material

Preliminary study of risk management mode for investigator-initiated clinical trials / 中华医学科研管理杂志

Objective To explore the risk management model of investigator-initiated clinical trials (IITs) from the prospective of clinical research management personnel,to provide further reference for its construction and implementation in China.Methods The risks in IITs and its current situation of risk management were analyzed.Risk management standards including ISO 31000 and related guidelines were adopted to explore the risk management mode for China-based IIT.Results This article proposed the new risk management mode for IITs and also introduced the specified frame and procedures of related risk management.Conclusions The risk management model proposed in this article provided reference for clinical research management.

Discussion on safety evaluation and risk control measures of Epimedii Folium / 中国中药杂志

Epimedii Folium,a commonly used traditional Chinese medicine,has the effect of tonifying kidney Yang,strengthening bones and treating rheumatism. However,in recent years,the number of reports on adverse reactions of Epimedii Folium and its Chinese patent medicines such as Xianling Gubao Capsules and Zhuanggu Guanjie Pills has been gradually increased,and the toxicity of Epimedii Folium has attracted more and more attention. In this article,the ancient and modern literature on Epimedii Folium was traced through a comprehensive and systematic literature analysis method. According to the 2015 edition of the Chinese Pharmacopoeia,Epimedii Folium refers to the dried leaves of Epimedii Folium brevicomu,E. sugittutum,E. pubescens or E. koreuuum. The Chinese Pharmacopoeia also includes E. wushanense of Wushan Epimedium,which is the same plant variety as Epimedium. The study showed that there were differences in the geographical distribution,composition and toxicity among five species of Epimedium. This paper also explained the toxicity mechanism as well as efficacy enhancing and toxicity reducing effects of Epimedii Folium,and reported its related adverse reaction cases. Through a retrospective comparative study on the toxicity of the modern Chinese patent medicines Xianling Gubao Capsules and Zhuanggu Guanjie Pills containing Epimedii Folium,it was believed that Epimedii Folium had cardiovascular system toxicity,neurotoxicity,hepatotoxicity,long-term toxicity,acute toxicity,genotoxicity and special toxicity; its safe medication factors included patient syndrome,doctor factors,drug factors,processing and compatibility factors. Meanwhile,strategies were proposed to improve patient safety medication awareness,standardize Epimedii Folium varieties and quality supervision,and the toxicity of Epimedii Folium was studied,hoping to draw attention from scholars to the safety of Epimedii Folium,improve the safe use of Epimedii Folium,and prevent adverse reactions.

The clinical engineering strategy for reducing application risk of ventilator / 中国医学装备

Objective: To reduce the risk of ventilator in clinical use by using technical management so as to enhance cure rate for patients. Methods: Through a series of methods included of clinical investigation, statistic analysis of data, socio-technical system model and others to analyze and assess risk factors which were possibly produced in the cure process of ventilator. And the relevant risk regulation indicators were formulated as above information. Results: The formulation about risk control criterion of operation in the cure process of ventilator provided various aspects, which included of the material qualities of ventilator and breathe pipeline, clinical service environment, human factor and others, for clinical engineer to control risk so as to ensure the life safe of patients. Conclusion: The clinical engineering department should adopt technique management way to analyze the cure process of ventilator, and control risk from aspect of clinical engineering. Therefore, it can efficiently reduce the risk of ventilator in clinical application and promote the safety and efficiency of ventilator in the treatment.

Research on risk control of hematodialysis equipment based on statistical data of failure / 中国医学装备

Objective:To investigate various risk factors that influence the safety of using hemodialysis equipment, and carry out risk control and reduce risk of using equipment through analyzed the statistical result of failure data of equipment.Methods:Based on all kinds of fault messages record in 2016, the failure data of 390 cases were carried out classified statistic analysis by using Microsoft Excel.Results: Through the statistic analysis of failure rate of 2016 year, there were four main factors were obtained. Aimed at the three higher percent factors that were equipment fault(85.1％), material(11.2％) and human reason(3.7％), respectively., the current management system of hemodialysis equipment was optimized and operation process was standardized from three aspects that included equipment management, material management, and the training and check for staff.Conclusion: Based on the analysis and research for the failure types of hemodialysis equipment purchased from different years, and the analysis of relevant reasons, the corresponding countermeasure of quality management is established, and the main body of responsibility is clarified, and the operative risk of hemodialysis equipment is effectively reduced.

Safety evaluation and risk control measures for Aconiti Kusnezoffii Radix / 中国中药杂志

Through the comprehensive and systematic research of domestic and overseas literature and information, we studied ancient original records on Aconiti Kusnezoffii Radix and its toxicity, analyzed related adverse cases and the animal toxicity experiments in recent years, then systematically analyzed the safety of Aconitum and its preparations, and finally we summarized the clinical characteristics and potential risk factors related to the safety of Aconitum. A report on adverse events of Aconitum in 76 patients with myocardial damage and renal damage accounting for 53.9% and 42.1% respectively, indicated that the safety problems of Aconitum may be related to heart toxicity and liver-kidney toxicity. Aconitum had complex compositions, and based on the animal experiments, Aconitum decoction had the highest toxicity at 2 h, and it reduced significantly at 4 h, which showed that the toxic components mainly depend on the hydrolysis or the decomposition degree of diester diterpenoid alkaloids. According to the toxicity study, Aconitum toxicity might occur in cardiovascular system, nervous system, kidney, embryo, reproductive system, and it was contraindicated in pregnant women. So far, specific antidote for aconitine poisoning is still a blank. The key for treatment is to correct arrhythmia timely and effectively, maintain stable vital signs, and meanwhile, give gastric lavage, intravenous fluid infusion and other therapies. So we suggest that the basic study for Aconitum toxicology should be strengthened, and the pharmacology and mechanism of toxicity, as well as the mechanism of processing for raising efficiency and reducing toxicity, should be further clarified to determine the quantity-effect relationship and eliminate safety hazards in using Aconitum.

Single-use Medical Devices Re-processing: Regulatory Status Quo / 中国医疗器械杂志

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.

Optical Radiation Safety Evaluation and Control of Laser Medical Equipment / 中国医疗器械杂志

Optical radiation hazards and the evaluation method of optical radiation safety of laser medical equipment are introduced in this paper. According to the requirement of YY/T 0316-2008, the corresponding solutions of safety control are put forward in this paper to minimize the risk of optical radiation, making sure the safety and effectiveness of laser medical equipment.

Management and Risk Control of 4 Kinds of Special Drugs in PIVAS of Our Hospital / 中国药房

OBJECTIVE:To strengthen the management and risk control of 4 kinds of special drugs in pharmacy intravenous admixture service(PIVAS),and promote the drug use safety. METHODS:The 4 kinds of special drugs(high-alert drugs,hazard-ous drugs,important drugs/costly drugs and drugs needed for skin allergy test)in PIVAS were precisely managed by classification. The effect evaluation was carried out by tracer methodology. RESULTS:The 4 kinds of drugs were classified and managed by de-veloping specified directory,mading special logo,fixing position storage,strengthening medical order review,establishing emer-gency plan,daily inventory,batch number management,etc. It had standardized the management and use process of high-alert drugs,ensured the operational safety for hazardous drug and occupational protection,made the compliance rate reached 100% of important drugs/costly drugs,and ensured the consistency of preparation and use batch number of drug for skin allergy test basical-ly. Compared with before management(2015),the items ratio achieving good level(class B)and above in 18 evaluation indicators had increased from 22.23% to 94.44% after management (2016). CONCLUSIONS:The precise management by classification in PIVAS of our hospital has better controlled the management and risk of 4 kinds of special drugs in clinical use,and ensured the safe operation of PIVAS.

Application of risk control in hospital large-scale medical equipment management / 医疗卫生装备

Objective To analyze the risk factors affecting the safe running and efficiency of large medical equipment and to put forward countermeasures for prevention and control.Methods The risk factors affecting large medical equipment were analyzed and evaluated comprehensively,and risk control measures were determined and executed to enhance medical safety and equipment efficiency.Results The measures made the availability rate of large medical equipment being 100.0％,perfectness ratio being 98.5％,accident rate being 0％ and idleness rate being 0％.Conclusion The introduction of risk control in the management of large-scale medical equipment can improve the personnel awareness to prevent risk,enhance medical quality and equipment efficiency,and protect the vital interests of the patients.