Problem and management strategy exploration of the investigator initiated out-of-range trial / 中华医学科研管理杂志

Objective:To analyze the problems and risk factors of the investigator initiated out-of-range trial, propose countermeasures and suggestions, and provide reference for improving project standardization and quality, and preventing research risks.Methods:Through literature analysis and field research, combined with personal work experience, this study sorted and analyzed the problems in the regulation of out-of-range IIT conducted in hospital, and proposed countermeasures.Results:Through analysis, it was found that the current out-of-range IIT trial in China faces 5 problems: imperfect management regulations, incomplete IIT management organizational system in medical institutions, insufficient scientificity of research protocols, insufficient ethical review, and insufficient research funds.Conclusions:Out-of-range IIT is of great significance in promoting pharmaceutical innovation. Standardized management of such projects requires the efforts of regulatory authorities, medical institutions, and ethics committees, as well as the continuous improvement of researchers' awareness and research capabilities to promote the orderly, high-quality, and rapid development of IIT. Based on the above analysis, this article proposed countermeasures and suggestions: at the national level, summarize practical experience from various regions as soon as possible, improve IIT management regulations and technical guidelines; establishing clinical research and design guidance departments in medical institutions and strengthening scientific review; the ethics committee formulates ethical review standards and processes for out-of-range IIT projects to enhance review capabilities; establish a normalized clinical research training mechanism in hospitals; expand and standardize the channels for IIT funding.

Preliminary exploration on the ethical governance path of internet medicine from the perspective of medical equity / 中国医学伦理学

Economic development drives the increase of endogenous demand,and Internet medicine integrates regional medical resources,expanding the fairness of the public's access to medical and health services.However,it is also accompanied an ethical crisis with the development of technology,which requires continuous standardization and practice.Starting from the principle of medical fairness,this paper sorted out the main advantaged characteristics of the development of Internet medicine from the aspects of data fairness,cost equity,opportunity equity,and educational equity.The existing ethical problems of Internet medicine were explored including unfair protection of ethical review mechanisms,unfair data collection of scientific and technological subjects,unfair distribution of benefits and risks,and unfair utilization of Internet medical resources.It also proposed the governance paths of compacting the subject responsibility,perfecting review and supervision,improving the sharing mechanism,bridging the digital divide,strengthening risk prevention,protecting the citizens'rights and interests,strengthening education and guidance,and increasing grassroots investment.

Exploration and Prospect of Quantitative Evaluation of Integrity Risk Prevention and Control in Public Hospitals / 中国医院管理

Objective To explore the quantitative evaluation of integrity risk prevention and control in public hospitals,provide reference for improving the quality and efficiency of integrity risk prevention and control.Methods Self-designed"Inspection Standards for Integrity Risk Prevention and Control of Power Matters in Public Hospitals"was used to score and rate the power matters provided by each functional department/clinical department of West China Hospital of Sichuan University from three aspects:the clarity of power operation process,the accuracy of finding integrity risk points,the effectiveness of prevention and control measures.Results A total of 236 power matters of the hospital were inspected for integrity risk prevention and control,and according to the inspection criteria,57 items were rated as first grade,103 items were rated as second grade,and 76 items were rated as third grade,accounting for 24.15％,43.64％and 32.20％,respectively.The score for the special work of integrity risk prevention and control was 5.82±1.92 points,of which the process dimension score was 2.11±0.75 points,the risk points dimension score was 1.89±0.92 points,the prevention and control dimension score is 1.89± 0.79 points,which reflects the problems of unclear workflow,inaccurate finding of individual risk points,and unspecified prevention and control measures in some units.Conclusion Hospitals should focus on the concreteness,accuracy,salience and quantification in the long-term construction of integrity risk prevention and control from the aspects of thought,behavior,effectiveness and evaluation.

Association between skin injuries and the importance atributed to prevention by health professionals during the pandemic / Asociación entre lesión cutánea e la importancia atribuida a la prevención por los profesionales de la salud durante la pandemia / Associação entre lesão cutânea e importância atribuída à prevenção pelos profissionais de saúde na pandemia

ABSTRACT Objective: To verify the association between the occurrence of skin lesions due to the use of products and/or personal protective equipment and the importance attributed to preventive care among health professionals working on the front lines of the struggle against the COVID-19 pandemic. Method: Cross-sectional, analytical study, carried out between May and June 2020, with a convenience sample (n=398) of health workers from 10 professional categories. To verify the existence of an association between the occurrence of skin lesions and exposure variables, a Contingency Table was used to obtain the Prevalence Ratio and respective Confidence Intervals. Results: 260 (65.3%) participants self-declared the development of skin lesions, predominantly nurses (53.8%), women (54.0%), from public institutions (52.8%), characterized by pressure injuries (37.3%), contact/allergic dermatitis (25.8%), or both lesions simultaneously (16.5%). More than half of professionals (53.5%) used preventive products, mainly moisturizers (51.0%). Conclusion: There was probability of an association between professionals who attributed less importance to the predictor "Protocol for proper product PPE and products" and the risk of skin injuries.

RESUMEN Objetivo: Verificar la asociación entre la aparición de lesiones cutáneas por el uso de productos y/o equipos de protección personal y la importancia atribuida al cuidado preventivo entre los profesionales de la salud que trabajaran en la primera línea de defensa contra la pandemia de la COVID-19. Método: Estudio analítico transversal, realizado entre mayo y junio de 2020, con una muestra por conveniencia (n=398) de profesionales de la salud de 10 categorías profesionales. Para verificar la existencia de asociación entre la aparición o no de lesiones cutáneas y las variables de exposición, se utilizó una Tabla de Contingencia para obtener el Índice de Prevalencia y los respectivos Intervalos de Confianza. Resultados: 260 (65,3%) participantes declararon el desarrollo de lesiones cutáneas, predominantemente enfermeras (53,8%), mujeres (54,0%), de instituciones públicas (52,8%), caracterizadas por lesiones por presión (37,3%), de dermatitis contacto/alérgicas (25,8%) y ambas lesiones simultáneamente (16,5%). Más de la mitad de los profesionales (53,5%) utilizan productos preventivos, principalmente hidratantes (51,0%). Conclusión: Hubo probabilidad de asociación de riesgo entre la aparición de lesiones cutáneas y la atribución de menor importancia al factor predictor "Protocolo para el uso adecuado de productos y EPP".

RESUMO Objetivo: Verificar a associação entre ocorrência de lesão cutânea por uso de produtos e/ou equipamentos de proteção individual e importância atribuída aos cuidados preventivos entre profissionais de saúde atuantes na linha de frente durante a pandemia da Covid-19. Método: Estudo transversal, analítico, realizado entre maio e junho de 2020, com uma amostra por conveniência (n=398) de profissionais de saúde de 10 categorias profissionais. Para verificar a existência de associação entre a ocorrência ou não de lesão de pele e as variáveis de exposição utilizou-se Tabela de Contingência para obter a Razão de Prevalência e respectivos Intervalos de Confiança. Resultados: 260 (65,3%) participantes autodeclararam desenvolvimento de lesões na pele, predominando enfermeiros (53,8%), mulheres (54,0%), provenientes de instituições públicas (52,8%), caracterizadas por lesões por pressão (37,3%), dermatite de contato/alérgica (25,8%), e ambas as lesões de forma simultânea (16,5%). Mais da metade dos profissionais (53,5%) usou produtos preventivos, principalmente hidratantes (51,0%). Conclusão: Ocorreu probabilidade de associação de risco entre a ocorrência de lesão de pele e a menor importância atribuída ao fator preditor Protocolo para uso adequado de produtos e EPIs.

Guideline for the prevention and control of occupational exposure risks to cytotoxic drugs in medical institutions / 中国药房

To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions， improve the awareness of protection among medical staff，and reduce potential occupational exposure risks，the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual，the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital，such as transportation，receipt，storage，unpacking，dispensing，use of finished products，and waste disposal. Delphi method is used to construct identification of clinical issues，and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls，administrative controls and personal protective equipment at different levels，a graded control approach is established. A total of 37 clinical issues are identified，resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.

Interpretation on Consensus on drug-induced liver injury by CIOMS Working Group:liver injury attributed to herbal and dietary supplements / 中国中药杂志

With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.

New outlook on safety of traditional Chinese medicine: concept and practice / 中国中药杂志

Profound changes have taken place in human disease spectrum, constitution spectrum, and drug use behavior, and the safety of traditional Chinese medicine(TCM) faces new trends and problems. In particular, serious adverse reactions/events such as liver injury and kidney injury caused by non-toxic TCM have been frequently reported, overturning people's understanding of TCM safety, and even shaking the public's confidence in the development of TCM. In the new era of globalization, correctly understanding the situation and problems of TCM safety and addressing the dilemmas in safety evaluation and risk prevention of TCM are the key missions to be undertaken by TCM practitioners. This paper suggests that the situation and problems of TCM safety should be viewed objectively and dialectically, and the use standard of TCM should be advanced with the times. Furthermore, this paper puts forward the new conception and methodology of TCM safety(including one innovative understanding, two types of evaluation modes, tri-elements injury hypothesis; four-quadrant risk decision processes, and five-grade safety evidence body) for the first time, hoping to provide new theories, new strategies, new methods and successful examples for solving the safety problems of TCM.

Risk identification and prevention and control for medical insurance fund utilization based on fault tree analysis / 中华医院管理杂志

Strengthening the supervision of medical insurance funds is an important measure to promote the healthy and sustainable development of the medical security system. In January 2022, a tertiary general hospital in Beijing carried out risk identification and prevention and control practices for the use of medical insurance funds. By using such methods as fault tree analysis and risk matrix, the probability and impact of events were quantitatively evaluated, high-risk events during the use of medical insurance funds were identified, and corresponding risk prevention and control measures were developed, relying on intelligent regulatory systems. From January to November 2022, the hospital outpatient medical insurance refusal amount(20 080 yuan) caused by such high-risk events as exceeding drug instructions, exceeding medical insurance indications, and exceeding age limits decreased by 42.30% compared to the same period in 2021(11 585 yuan). The discharge and settlement time of medical insurance patients decreased from 3 working days to 1 working day. This practice had effectively improved the quality and efficiency of hospital medical insurance fund supervision, improved patients′ medical experience, and provided reference for strengthening the safe and standardized use of medical insurance funds by medical institutions.

Risk prevention principle of public health data sharing and its application / 中华医院管理杂志

Data sharing is the fundamental work for building a " Healthy China" and a technical support for improving China′s healthcare service system. It is of great significance to the government, society, and individuals. In the digital era, public health data could be referred to various data collected, connected, read, and stored on digital platforms for research, monitoring, prevention, and control of diseases, health events, and the operation of health systems. China′s public health data sharing has initially formed a development pattern of " four modernizations", providing basic conditions and practical preparations for vigorously promoting data sharing. In the process of data sharing, the risk prevention principle should be fully considered and established, including establishing a series of measures to balance legal protection and interest protection for different entities and situations, that is, data information typing to limit data access rights, building a unified public health data sharing platform, and continuously improving public health data sharing mechanisms. At the same time, appropriate data use policies and security measures should be formulated to ensure data privacy and security.

Knowledge, awareness, and risk prevention among hepatitis patients attending a tertiary care hospital in Delhi

Introduction: People living with chronic viral hepatitis in India often lack awareness on risk factors and prevention. Moreover, due to fear of stigma and discrimination, they often delay appropriate and timely treatment, resulting in chronic treatment and impoverishment. The objective of this study is to assess knowledge, awareness, and prevention regarding risk factors among viral hepatitis-infected patients attending a super-specialty hospital in Delhi. Material and Methods: Data were collected from 389 patients using systematically random sampling using a pretested, structured interview schedule from patients attending Institute of Liver and Biliary Sciences, New Delhi. Results: Findings revealed that 90.7% of the respondents believed that hepatitis B virus/hepatitis C virus (HBV/HCV) can be transmitted through sexual contact with a person who is infected, 94.3% said that it can be transmitted by transfusion of infected blood, 90% reported that it can be spread from infected mother to child during child birth, 93.8% responded that it can be transmitted if a person uses a razor, pierced ear ring, needle, or syringe used by an infected person, 83% believed that HBV/HCV can cause cancer in 90% of the respondents in long run, and more than 35% believed that HBV/HCV is curable. Results also show that 7.2% of the respondents have been vaccinated for HBV infection in the past, 20.8% of the respondents have screened their families for hepatitis B infections, and 77.9% of the respondents have received antiviral medications. Conclusion: HBV/HCV-infected patients had less knowledge about various facts regarding disease and continue to experience emotional disturbances, stigma, and discrimination.

Influencing factors of nutritional risks and rehabilitation nursing countermeasures in stroke patients / 上海预防医学

Objective To explore the nutritional risk influencing factors in stroke patients， and to discuss the formulation of rehabilitation nursing countermeasures. Methods We randomly selected 152 patients with acute hemorrhagic stroke admitted to our hospital from July 2018 to July 2020. Based on the results of the mini nutritional assessment （MNA） score， the patients were divided into normal group （49 cases）， risk group （53 cases）， and bad group （50 cases）. Single factor analysis and correlation analysis were used to analyze the nutritional risk factors， and the countermeasures for the influencing factors were discussed. Results Univariate analysis showed that stroke time， mechanical ventilation， swallowing dysfunction， ADL score， upper arm muscle circumference， serum albumin， and total lymphocyte count in risk and bad groups were different from the normal group. In comparison， the proportion of patients with mechanical ventilation and swallowing dysfunction was higher， and ADL score， upper arm muscle circumference， serum albumin level and total lymphocyte count were lower （P<0.05）. The Spearman rank correlation analysis showed that the factors with differences in the univariate analysis also showed correlation （P<0.05）. Among them， the positive correlation factors included the duration of stroke， receiving mechanical ventilation， swallowing dysfunction， NIHSS score， negatively related factors included ADL score， serum levels of albumin， transferrin， and hemoglobin. Multivariate Logistic regression analysis showed that stroke time （OR=1.739， P<0.001） and swallowing dysfunction （OR=3.966， P=0.008） were independent risk factors for malnutrition. ADL score （OR=0.687， P<0.001）， upper arm muscle circumference （OR=0.770， P=0.012）， serum albumin level （OR=0.870， P=0.003） were independent protective factors for malnutrition. Conclusion The nutritional status in stroke patients is not optimistic. Most patients have swallowing disorders， motor dysfunction， and poor self-care ability. At the same time， the body protein content in patients has decreased significantly. The clinical work is needed to deal with the patients' swallowing function recovery together with the treatment of nerve damage.

Research on supervision strategy of high risk areas of hospital incorrupt government based on traditional chinese medical theory of preventing diseases / 中华医院管理杂志

In recent years, the frequency of corruption incidents in public hospitals in China has increased, and it is particularly important to strengthen the construction of hospital incorrupt politics. Based on the traditional chinese medical theory of preventing diseases, the author deeply discusse the prevention and control strategies in high-risk areas of public hospitals incorrupt from 3 aspects: prevention before disease onset, prevention of disease from exacerbating and prevention of recovery from relapse. Based on the common problems found in the political inspection of Beijing municipal health system and large-scale hospitals in the latest years, an incorrupt government risks list of high-risk areas in hospital had been sorted out; A tertiary hospital and its 4 entrusted hospitals were selected to conduct self-inspection on the key links of important power activities and authority behaviors in accordance with the incorrupt government risks list, and putting forward targeted supervision strategies for these problems. Since the implementation of supervision strategy for high-risk areas in the tertariy hospital and its 4 entrusted hospitals in May 2021, the number of letters and visits in the 5 aspects of medicine procurement, equipment procurement, consumables and reagents procurement, engineering construction and logistics service procurement were significantly reduced. Based on the traditional chinese medical theory of preventing diseases, the supervision strategy in high-risk areas could effectively improve the pertinence, operability and effectiveness of discipline inspection and supervision in hospital, and provide a reference for the construction of incorrupt government in public hospitals.

Sobre el suicidio en los profesionales de la salud y la importancia de la creación de estrategias desde un enfoque holístico / On suicide in health professionals and the importance of creating strategies from a holistic approach / Sobre o suicídio em profissionais de saúde e a importância da criação de estratégias a partir de uma abordagem holística

RESUMEN El presente artículo tiene como finalidad analizar y plantear posibles soluciones desde un enfoque holístico para la prevención del suicidio en la comunidad médica, puesto que, es una realidad social que debe ser atendida ya que se encuentra en crecimiento, siendo los profesionales de la salud los que presentan una mayor tasa de suicidio frente a otras profesiones. Por consiguiente, se indaga acerca de los principales factores de riesgo desde el ámbito psicosocial y se cuestiona la forma en cómo se da la formación de los ^ profesionales de la Ciencia de la Salud, ya que se considera que este responde a exigencias sociales y económicas del sector de la salud, pero deja olvidada las condiciones laborales, sociales y psicológicas de los prestadores de salud. En este orden de ideas y reconociendo el escenario globalizado en el que la sociedad está inmersa, es relevante propender por la indagación directa del origen del estrés en el ámbito laboral, analizar las condiciones laborales y los riesgos implícitos a los que se encuentra expuesto el médico dentro de la organización, para poder así brindar herramientas oportunas y preventivas en torno a la disminución de las tasas de suicidios.

ABSTRACT The purpose of this article is to analyze and propose possible solutions from a holistic approach for the prevention of suicide in the medical community, since it is a social reality that must be addressed since it is growing, with health professionals being the that present a higher suicide rate compared to other professions. Consequently the main risk factors are investigated from the psychosocial field and the way in which the training of Health Science professionals is given is questioned, since it is considered that this responds to social and economic demands of the health sector, but neglects the working, social and psychological conditions of health providers. In this order of ideas and recognizing the globalized scenario in which society is immersed, it is relevant to tend to directly investigate the origin of stress in the workplace, analyze working conditions and the implicit risks to which the doctor is exposed within the organization, in order to provide timely and preventive t°°ls around the decrease in suicide rates.

RESUMO O objetivo do artigo é analisar e propor possíveis soluções a partir de uma abordagem holística para a prevenção do suicídio na comunidade médica, visto que se trata de uma realidade social que deve ser abordada porque está em crescimento, sendo os profissionais de saúde quem têm uma taxa de suicídio mais elevada em comparação com outras profissões. Os principais fatores de risco são investigados a partir do campo psicossocial e questiona-se a forma como se dá a formação dos profissionais das Ciências da Saúde, por considerar-se que esta responde às demandas sociais e econômicas do setor saúde, mas deixa esquecidas as condições laborais, sociais e psicológicas dos prestadores deste setor Reconhecendo o cenário globalizado em que a sociedade está imersa, é relevante investigar diretamente a origem do estresse no ambiente de trabalho, analisar as condições de trabalho e os riscos implícitos a que o médico está exposto dentro da organização, a fim de assim, fornecer ferramentas oportunas e preventivas em torno da redução das taxas de suicídio.

Practical exploration of constructing a new system of medical risk prevention and control based on the integration of medical and law / 中华医院管理杂志

Peking Union Medical College Hospital has carried out the practical exploration of a new system of medical risk prevention and control based on the integration of medical and law, broken the traditional practice of legal counsel only handling medical disputes after the event, explored the pre-management and control mode of medical risks. The hospital established a whole process medical risk management mode in which legal counsel, medical administrators and clinical medical staff cooperated and participated, further standardized the medical behavior, legal concept and legal practice awareness of medical personnel, realized standardized management and formed a long-term mechanism. It could not only effectively integrate the fragmented clinical legal service needs and extensively enhance the sense of occupational security of clinical medical staff, but also effectively improve the operation quality of medical safety indicators and promote the high-quality development of the hospital.

Occupational exposure of blood bank staff: Cause analysis and risk prevention / 中国输血杂志

【Objective】 To explore the causes of occupational exposure, so as to prevent occupational exposure that endangering the physical and mental health of staff in blood centers. 【Methods】 Occupational exposure cases reported from May 1, 2014 to April 30, 2020 by Taizhou Blood Center were classified and analyzed in terms of the exposure mode, body parts, post distribution, seniority of operators and whether the operation was carried out as required. 【Results】 From May 1, 2014 to December 31, 2020, 23 cases of occupational exposure (6.66/100000) occurred in Taizhou Blood Center, and the incidence rate was roughly the same in each year. Among the occupational exposure modes, sharp device puncture, wound exposure and mucosal exposure accounted for 65.2% (15/23), 17.4% (4/23) and 17.4% (4/23), respectively. The exposed sites of body were mainly fingers, followed by eyes and mouth. The incidence of occupational exposure of phlebotomist post accounted for 65.2% (15/23), followed by apheresis platelet collection, component preparation and preliminary screening post [21.7% (5/23), 8.7% (2/23) and 4.3% (1/23), respectively, P<0.05]. The incidence of occupational exposure of new staff rotated within one year was 43.5% (10/23), followed by fixed-point staff within 1-5 years and over 5 years [34.8% (8/23) and 21.7% (5/23), respectively], P<0.05. 56.5% (13/23) of occupational exposure was due to employees′ failure to obey the operate as required. 【Conclusion】 Where there is needle contact there is exposure risk. the newer staff are more likely to suffer occupational exposure, and most exposure are caused by non-compliance with the regulations. The establishment of various preventive measures can effectively reduce the incidence of occupational exposure in blood banks and ensure occupational safety.

Integrative medicine in the era of cancer immunotherapy: Challenges and opportunities / 中西医结合学报

Cancer immunotherapy has led to a new era of cancer treatment strategies, and transforming healthcare for cancer patients. Meanwhile, reports of immune-related adverse events have been increasing, greatly hindering the use of cancer immunotherapy. Traditional Chinese medicine (TCM), which has been widely used in Asian countries for thousands of years, is known to play a complementary role in the treatment of cancer. Taken in combined with conventional modern therapies, such as resection, ablation and radiotherapy, TCM exerts its main anti-cancer effects in two ways: health-strengthening (Fu-Zheng) and pathogen-eliminating (Qu-Xie). Theoretically, pathogen-eliminating TCM can promote the release of tumor-related antigens and should be able to increase the effect of immunotherapy, while health-strengthening TCM may have immune-enhancing mechanisms that overlap with immunotherapy. In the era of cancer immunotherapy, it is important to balance the use of TCM and immunotherapy, with the goal of enhancing immune efficacy and antagonizing immune toxicity. In this article, we discuss this issue by considering the mechanism of tumor immunotherapy, alongside the theoretical basis of TCM treatment of tumors, with the aim of bringing new insights to future research in this field.

Revisão sistemática de intervenções para prevenção da perda auditiva induzida por ruído ocupacional - uma atualização / Systematic Review of Interventions to Prevent Occupational Noise-Induced Hearing Loss - A Follow-up

Resumo Objetivo realizar uma revisão sistemática sobre a efetividade de intervenções para prevenção da perda auditiva induzida por ruído ocupacional, atualizando os achados da mais recente versão da revisão sistemática Cochrane do mesmo tema. Estratégia de pesquisa As buscas ocorreram nas bases PubMed, Web of Science e Scopus. Critérios de seleção Como intervenções, foram considerados: controles de engenharia/administrativos; dispositivos de proteção auditiva (DPA); vigilância auditiva e monitoramento audiológico. Análise dos dados Para a análise de risco de viés, cada estudo foi avaliado de acordo com a adoção de randomização, alocação, cegamento, desfecho, outras fontes de viés. Resultados Foram obtidas 475 referências no total. Destas, 17 estudos cumpriram os critérios de inclusão: um randomizado, um de série temporal interrompida e 15 de antes e depois. A maioria dos estudos foi realizada em indústrias; três em ambiente militar e/ou de treinamento de tiro; um em orquestra e outro em construção civil. A maioria dos estudos mostrou alto risco de viés. Seis estudos verificaram redução da exposição ao ruído a curto prazo por meio de controles de engenharia/administrativos; um verificou impacto positivo decorrente de mudança na legislação; cinco verificaram efeitos positivos dos DPA na diminuição da exposição ao ruído e dos treinamentos educacionais no uso do DPA; e dois encontraram redução dos níveis de ruído e aumento no uso do DPA decorrentes da implementação de programas de conservação auditiva. Conclusão Todos os estudos analisados concluíram que as intervenções utilizadas resultaram em efeitos positivos sobre a audição e/ou sobre a exposição ao ruído. Em relação aos efeitos de longo termo, a grande maioria dos estudos limitou-se a avaliar efeitos imediatos ou de curto termo, reforçando que estudos incluindo follow-up de longo termo devem ser desenvolvidos.

Abstract Purpose To conduct a systematic review of the effectiveness of interventions to prevent occupational hearing loss, following up on the findings of the most recent version of Cochrane systematic review on the same topic. Research strategy Searches were carried out in PubMed, Web of Science and Scopus databases. Selection criteria The following interventions were considered: engineering/administrative controls; hearing protection devices (HPD); and audiological monitoring. Data analysis For bias risk analysis, each study was assessed according to randomization, allocation, blinding, outcomes, other sources of bias. Results 475 references were obtained. Of these, 17 studies met the inclusion criteria: one randomized, one interrupted time series, and 15 before and after studies. Most studies were conducted in industries; three in military and/or shooting training environments; one in an orchestra, and one in construction. Most studies showed a high risk of bias. Six studies found a reduction in short-term exposure to noise through engineering/administrative controls; one found a positive impact due to changes in legislation; five studies have found positive effects of HPD in reducing exposure to noise and of educational trainings in the use of HPD; lastly, two studies found a reduction in noise levels and an increase in the using of HPD due to the implementation of hearing conservation programs. Conclusão Todos os estudos analisados concluíram que as intervenções utilizadas resultaram em efeitos positivos sobre a audição e/ou sobre a exposição ao ruído. Em relação aos efeitos de longo termo, a grande maioria dos estudos limitou-se a avaliar efeitos imediatos ou de curto termo, reforçando que estudos incluindo follow-up de longo termo devem ser desenvolvidos.

Factores que intervienen en la aplicación de medidas de bioseguridad del profesional de enfermería / Factors Associated with the Application of Biosafety Measures Taken by Nursing Professionals

Introducción: Las medidas de bioseguridad son normas preventivas que debe aplicar el personal de salud para evitar el contagio por la exposición de agentes infecciosos que pueden provocar daño. Objetivo: Determinar factores que intervienen en la aplicación de medidas de bioseguridad del profesional de enfermería. Métodos: Estudio cuantitativo, descriptivo de corte transversal. La población fue de 30 profesionales de enfermería que laboran en un Centro Quirúrgico de un Hospital de Lima, específicamente en el Hospital Nacional Dos de Mayo de Lima, Perú, meses de marzo a julio del 2019. La técnica utilizada fue la encuesta y el instrumento, un cuestionario estructurado. Para el cálculo de la confiabilidad estadística la prueba Alpha de Cronbach, juicio de expertos y "r" de Pearson. Resultados: En referencia a los factores que intervienen en la aplicación de las medidas de bioseguridad del profesional de enfermería, 56,70 por ciento presentaron factores desfavorables y 43,30 por ciento, factores favorables. En cuanto a los factores personales, 66,70 por ciento presentaron factores desfavorables y 33,30 por ciento, factores favorables; y con respecto a los factores institucionales, 53,30 por ciento presentaron factores favorables y 46,70 por ciento factores desfavorables. Conclusiones: Los factores desfavorables que intervinieron en la aplicación de las medidas de bioseguridad en el profesional de enfermería fueron la edad adulta joven, sin estudios de especialidad y no tener capacitación en bioseguridad; y los factores favorables, en minoría, fueron contar con oficina de epidemiología, supervisión permanente en la aplicación de medidas de bioseguridad y disponer de ambientes exento de riesgos(AU)

Introduction: Biosafety measures are preventive standards that the health personnel must apply to avoid contagion due to exposure to infectious agents that can cause harm. Objective: To determine factors that intervene in the application of biosafety measures by the nursing professional. Methods: Quantitative, descriptive and cross-sectional study. The study population consisted of 30 nursing professionals who work in a Surgical Center at Dos de Mayo National Hospital in Lima, Peru, from March to July 2019. The technique used was the survey, and the instrument, a structured questionnaire. For the calculation of statistical reliability, Cronbach's alpha test, expert criteria and Pearson's "r" were used. Results: Regarding the factors involved in the application of biosafety measures by the nursing professional, 56.70 percent presented unfavorable factors and 43.30 percent, favorable factors. Regarding personal factors, 66.70 percent presented unfavorable factors, and 33.30 percent, favorable factors; and with regard to institutional factors, 53.30 percent presented favorable factors, and 46.70 percent, unfavorable factors. Conclusions: The unfavorable factors that intervened in the application of biosafety measures by the nursing professional were young adulthood, without specialty studies, and not having training in biosafety. The favorable factors, in a minority, were having an epidemiology office, permanent supervision in the application of biosafety measures, and having risk-free settings(AU)

Research on the Risk Prevention and Quality Control of Public Hospital Procurement / 中国医疗器械杂志

Through the functional combination of relevant departments involved in hospital procurement, to simplify and unify the work process, we establish a standardized procurement system, to realize the pre-procurement budget and approval, power balance, strengthen the fairness and openness of procurement process. By introducing the closed-loop process of in-process supervision to ensure the impartiality of review and post-evaluation control, it comprehensively strengthens the internal control of procurement management, and finally realizes the purpose of strengthening procurement risk prevention and procurement quality management.

Analysis of Risk in Production for PET/MR and Suggestions for Field Inspection / 中国医疗器械杂志

PET/MR is a high-end medical imaging equipment with integrating PET and MR equipment into the highly sophisticated one and has rich clinical and molecular diagnosis functions, can obtain comprehensive information about the human body structure, function and metabolism, is of great value for the diagnosis and treatment of disease improvement. In this paper, through the analysis of existing production risk points on one of the primary stages of the whole product life cycle, combining with the medical device good manufacture practice, some suggestions have been put forward exploratively to field inspection for PET/MR manufacturers. It has certain significance for regulators of medical devices to clear the production risk point and improve verification efficiency during field inspection.