开展医疗器械不良事件监测和报告工作的探讨

开展医疗器械不良事件监测和报告工作是十分重要的。本文介绍了医疗器械不良事件产生的原因、监测的意义,并对我院在该领域开展相关工作的具体方法措施等进行了探讨。     

浅析美国FDA对医疗器械上市后监测的信息化手段及其启示

研究美国食品与药品管理局（FDA）对医疗器械上市后监测所采用的信息系统以及其为公众提供的信息服务手段,探讨美国医疗器械不良反应监测的基础数据库——厂商和用户使用设备体验数据库（MAUDE）的数据来源及各种应用特点。根据研究结果并结合国内实际情况,对国家建设符合规范的自发报告系统及综合数据库提出内容和结构上的建议。     

医疗器械不良事件的监测与管理

医疗器械安全、有效运行是临床诊疗工作正常开展的必要条件。本文依据医疗器械不良事件监测与管理的实践,讲述了建立医疗器械风险评价体系的重要性和紧迫性。     

浅谈医院医疗器械不良事件的监测管理

在医疗水平高速发展阶段,医疗安全依然是关注热点,由医院医疗器械诱发的医疗纠纷不在少数,因此加强医院医疗器械安全管理成为重中之重。建设医院监测管理体系,实现对医疗器械质量的监测与管理,减少医院医疗器械不良事件的发生率,对保障患者生命安全有重要意义。文章在明晰监测管理工作意义的基础上,就现阶段医院医疗器械监测管理中存在的不良事件予以总结,制定可完善问题的策略,保障患者生命安全,提升医院安全管理工作水平。     

Stressful Life Events,Marital Satisfaction,and Marital Management Skills of Taiwanese Couples

The association between stressful life events and marital satisfaction for 372 Taiwanese couples was examined, as was the moderating effects of three marital management skills (e.g., tolerance/sacrifice, empathy/consideration, soothing/alleviation) on that association. Multilevel modeling analysis showed that stressful life events reduced husbands' and wives' marital satisfaction. Spouses' marital management skills were associated with an increase in their marital satisfaction (actor effects) except for husbands' soothing and alleviation skills. Husbands' tolerance and empathy were also related to an increase in the wife's marital satisfaction (partner effects) and had significant interactions with the relationship between the wife's stress and her marital satisfaction. Husbands' and wives' soothing skills also had significant interactions with the association between stressful life events and their own satisfaction. These results are discussed in relation to the life course, stress process, coping theories, and Chinese cultural values as well as their clinical implications of working with Chinese population.     

青少年学校生活满意度评定问卷的设计与信度、效度评价

目的 编制青少年学校生活满意度问卷并评价其内部一致信度和重测信度,为开展生活满意度研究提供评价工具.方法 从青少年对自己的学习效率与能力、老师和同学对自己的学习表现、师生及同学关系、从老师和同学那里获得的帮助、学习环境等的满意程度方面编制评定项目,以单个项目评分与总分Pearson相关系数≥0.50为初筛条件,确立12个项目构成青少年学校生活满意度问卷.以72名初二学生和61名高二学生间隔2周重测,评定该问卷的重测信度;运用该问卷对3 127名城乡中学生进行调查,计算Cronbach α系数,评价内部一致信度;分析学校生活满意度问卷与Zung焦虑自评量表、流调中心用抑郁自评量表评分的相关及其与危害健康行为的关系.以人口统计学特征和学校生活满意度为自变量,分别以抑郁、焦虑症状、危害健康行为为因变量,进行Logistic回归分析.结果 该问卷2次评分Pearson相关系数为0.91,Cronbach α系数为0.829.该问卷总分与Zung焦虑自评量表和流调中心用抑郁自评量表评分的相关系数分别为-0.464和-0.279（P＝0.000）.吸烟、饮酒、打架、无保护性行为等12项危害健康行为中,具有危害行为较多的男生,学校生活满意度评分显著低于没有或危害健康行为较少的个体;有自杀意念、自杀计划和自杀未遂的中学女生,学校生活满意度评分显著低于对照组.结论 青少年学校生活满意度问卷有较好的信度和效度,可用于青少年心理健康的评定.     

现代医院在用医疗器械风险管理的现状与思考

医疗器械的风险管理是现代医院管理的薄弱环节之一,通过对医疗器械不良事件的介绍,分析了在用医疗器械风险管理的现状,提出了控制医疗器械风险的措施。     

小学生城乡居民基本医疗保险满意度指数模型的构建——模型条目筛选方法

目的 构建适合我国小学生城乡居民基本医疗保险满意度指数模型.方法 根据美国顾客满意度指数模型的理论框架,采用议题小组和核心小组的程序化决策方式构建模型.条目池经专家认可,对559名小学生进行问卷调查后,随机抽取250份有效问卷,采用地板效应、天花板效应、t检验法、克朗巴赫α系数法、相关分析法、逐步回归法、因子分析法等9种方法联合进行条目筛选,由保留条目组建模型测试版.结果 构建了含6个维度17个条目的小学生城乡居民基本医疗保险满意度指数模型测试版.结论 小学生城乡居民基本医疗保险满意度指数模型各条目具有良好的敏感性、独立性、代表性、重要性和内部一致性.     

探讨建立医用电气设备及系统安全使用期限和再生利用法定要求的必要性

本文着重就医用电气设备及系统安全使用期和再生利用限法定要求缺失的原因和危害性,以及建立相关法定要求必要性的现实意义进行阐述,建议对其进行立法要求以保障人民的用械安全。     

Severe and enduring anorexia nervosa: Fertile ground for iatrogenic development

Care providers and individuals with severe and enduring anorexia nervosa (SE-AN) are weathering a perfect storm in which the sickest patients receive the least evidence-based treatment and iatrogenic factors play a significant role. Examining access to treatment from an ethical perspective is one strategy for developing more objective protocols related to the care of individuals with SE-AN.     

超早产儿支气管肺发育不良非血缘脐血干细胞移植治疗发生溶血性贫血及相关文献复习

目的探讨非血缘脐血干细胞移植(CSCT)治疗超早产儿(EPI)支气管肺发育不良(BPD)的不良反应,并进行文献复习。 方法选择2018年12月24日,于中国人民解放军总医院第七医学中心附属八一儿童医院住院,并且采用非血缘CSCT治疗的2例BPD双胎EPI(患儿1：双胎中先娩出者;患儿2：双胎中后娩出者)为研究对象。回顾性分析其临床病例资料,重点分析其生后31 d,接受非血缘CSCT治疗的相关临床资料,如临床表现、不良反应、随访结果及预后等。同时,检索国内外数据库中,新生儿或儿童接受CSCT治疗安全性及不良反应研究文献进行复习。本研究经中国人民解放军总医院伦理委员会批准(审批文号：2015111),监护人对患儿的治疗方案均知情同意。 结果① 2例BPD双胎EPI进行非血缘CSCT治疗的过程均顺利,但是均于治疗后第2天发生血尿、贫血、血胆红素值升高及网织红细胞(Ret)升高,考虑2例患儿发生溶血性贫血。对2例患儿均仅进行碱化尿液治疗1次,以及输同型悬浮红细胞纠正贫血常规处理,5 d后复查血常规均正常,7 d后复查尿常规亦均正常。2例患儿肝、肾功能检查结果均无明显异常,CSCT前、后血气分析无明显改变。患儿1、2分别于入院后52 d、55 d改为混合氧吸入,于72 d、78 d脱离氧气治疗,住院86 d、122 d痊愈出院。对其出院后随访6个月时,发育均达到校正胎龄儿水平;随访至1岁1个月时,生长、运动及语言发育,均无明显落后,目前继续随访中。②文献复习：对早产儿采用气管内间充质干细胞移植(MSCT)治疗BPD,耐受性均良好,近期无严重不良反应、无MSCT后6 h内死亡或与MSCT相关变态反应性休克,以及MSCT剂量限制性毒性发生,88.9%(8/9)患儿远期预后良好。儿童CSCT不良反应包括自身免疫性溶血性贫血(AIHA)、自身免疫性血小板减少性紫癜(ATTP)、慢性移植物抗宿主病(cGVHD)及肾病综合征等,经相应治疗后,均预后良好。 结论对BPD双胎EPI进行非血缘CSCT治疗所致不良反应轻微,经积极处理后患儿预后均良好。     

Revaccination with measles-mumps-rubella vaccine and hospitalization for infection in Denmark and Sweden – An interrupted time-series analysis

BackgroundIn a previous cohort study of 4-year-old Danish children, revaccination with the live measles-mumps-rubella vaccine (MMR) was associated with a 16% reduction in the rate of hospitalization lasting two days or longer for non-measles-mumps-rubella infections.AimTo examine if the introduction of revaccination with MMR at 4 years of age in Denmark (spring 2008) and at 7–9 years of age in Sweden (autumn 2009), at a time when there was virtually no measles, mumps or rubella cases, was associated with a reduction in the rate of hospitalization-for-infection lasting two days or longer at the population level.MethodsWe included 4-year-olds in Denmark and 7–9-year-olds in Sweden. We obtained the number of hospitalization-for-infection lasting two days or longer from nationwide hospital registers. Person-years at risk were approximated from population statistics for each season and year. We performed an interrupted time series analysis using Poisson regression to estimate the change in hospitalization incidence rates following the introduction of MMR revaccination, adjusting for seasonality. We also performed analyses with control series (3-year-olds in Denmark and 4-year-olds in Sweden).ResultsComparing the incidence of hospitalization-for-infection lasting two days or longer after the introduction of MMR revaccination with the expected level without an introduction of MMR revaccination resulted in an incidence rate ratio of 1.07 (95% confidence interval [CI] = 0.89–1.28) for 4-year-olds in Denmark and 0.89 (95% CI = 0.77–1.02) for 7–9-year-olds in Sweden in analyses without controls. Analyses with controls gave similar results.ConclusionThis population-level study of the introduction of MMR revaccination in Denmark and Sweden had inadequate power to confirm or refute the findings from an individual-level Danish study of an association between MMR revaccination and a lower incidence rate of hospitalization-for-infection lasting two days or longer.     

Operational lessons learned in conducting a multi-country collaboration for vaccine safety signal verification and hypothesis testing: The global vaccine safety multi country collaboration initiative

Timely and effective evaluation of vaccine safety signals for newly developed vaccines introduced in low and middle- income countries (LMICs) is essential. The study tested the development of a global network of hospital-based sentinel sites for vaccine safety signal verification and hypothesis testing. Twenty-six sentinel sites in sixteen countries across all WHO regions participated, and 65% of the sites were from LMIC. We describe the process for the establishment and operationalization of such a network and the lessons learned in conducting a multi-country collaborative initiative. 24 out of the 26 sites successfully contributed data for the global analysis using standardised tools and procedures. Our study successfully confirmed the well-known risk estimates for the outcomes of interest. The main challenges faced by investigators were lack of adequate information in the medical records for case ascertainment and classification, and access to immunization data. The results suggest that sentinel hospitals intending to participate in vaccine safety studies strengthen their systems for discharge diagnosis coding, medical records and linkage to vaccination data. Our study confirms that a multi-country hospital-based network initiative for vaccine safety monitoring is feasible and demonstrates the validity and utility of large collaborative international studies to monitor the safety of new vaccines introduced in LMICs.     

Adjuvant Systems for vaccines: 13 years of post-licensure experience in diverse populations have progressed the way adjuvanted vaccine safety is investigated and understood

Adjuvant Systems (AS) are combinations of immune stimulants that enhance the immune response to vaccine antigens. The first vaccine containing an AS (AS04) was licensed in 2005. As of 2018, several vaccines containing AS04, AS03 or AS01 have been licensed or approved by regulatory authorities in some countries, and included in vaccination programs. These vaccines target diverse viral and parasitic diseases (hepatitis B, human papillomavirus, malaria, herpes zoster, and (pre)pandemic influenza), and were developed for widely different target populations (e.g. individuals with renal impairment, girls and young women, infants and children living in Africa, adults 50 years of age and older, and the general population). Clearly, the safety profile of one vaccine in one target population cannot be extrapolated to another vaccine or to another target population, even for vaccines containing the same adjuvant. Therefore, the assessment of adjuvant safety poses specific challenges. In this review we provide a historical perspective on how AS were developed from the angle of the challenges encountered on safety evaluation during clinical development and after licensure, and illustrate how these challenges have been met to date. Methods to evaluate safety of adjuvants have evolved based on the availability of new technologies allowing a better understanding of their mode of action, and new ways of collecting and assessing safety information. Since 2005, safety experience with AS has accumulated with their use in diverse vaccines and in markedly different populations, in national immunization programs, and in a pandemic setting. Thirteen years of experience using antigens combined with AS attest to their acceptable safety profile. Methods developed to assess the safety of vaccines containing AS have progressed the way we understand and investigate vaccine safety, and have helped set new standards that will guide and support new candidate vaccine development, particularly those using new adjuvants.Focus on the patientWhat is the context? Adjuvants are immunostimulants used to modulate and enhance the immune response induced by vaccination. Since the 1990s, adjuvantation has moved toward combining several immunostimulants in the form of Adjuvant System(s) (AS), rather than relying on a single immunostimulant. AS have enabled the development of new vaccines targeting diseases and/or populations with special challenges that were previously not feasible using classical vaccine technology.What is new? In the last 13 years, several AS-containing vaccines have been studied targeting different diseases and populations. Over this period, overall vaccine safety has been monitored and real-life safety profiles have been assessed following routine use in the general population in many countries. Moreover, new methods for safety assessment, such as a better determination of the mode of action, have been implemented in order to help understand the safety characteristics of AS-containing vaccines.What is the impact? New standards and safety experience accumulated over the last decade can guide and help support the safety assessment of new candidate vaccines during development.     

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants has significantly reduced the efficacy of some approved vaccines. A fourth dose of NVX-CoV2373 (5 µg SARS-CoV-2 recombinant spike [rS] protein + 50 µg Matrix-M™ adjuvant; Novavax, Gaithersburg, MD) was evaluated to determine induction of cross-reactive antibodies to variants of concern. A phase II randomized study (NCT04368988) recruited participants in Australia and the United States to assess a primary series of NVX-CoV2373 followed by two booster doses (third and fourth doses at 6-month intervals) in adults 18–84 years of age. The primary series was administered when the SARS-CoV-2 ancestral strain was prevalent and the third and fourth doses while the Alpha and Delta variants were prevalent in AUS and US. Local/systemic reactogenicity was assessed the day of vaccination and for 6 days thereafter. Unsolicited adverse events (AEs) were reported. Immunogenicity was measured before, and 14 days after, fourth dose administration, using anti-spike serum immunoglobulin G (IgG) and neutralization assays against ancestral SARS-CoV-2 strain and Omicron sublineages. Among 1283 enrolled participants, 258 were randomized to receive the two-dose primary series, of whom 104 received a third dose, and 45 received a fourth dose of NVX-CoV2373. The incidence of local/systemic reactogenicity events increased after the first three doses of NVX-CoV2373 and leveled off after dose 4. Unsolicited AEs were reported in 9 % of participants after dose 4 (none of which were severe or serious). Anti-rS IgG levels and neutralization antibody titers increased following booster doses to a level approximately four-fold higher than that observed after the primary series, with a progressively narrowed gap in response between the ancestral strain and Omicron BA.5. A fourth dose of NVX-CoV2373 enhanced immunogenicity for ancestral and variant SARS-CoV-2 strains without increasing reactogenicity, indicating that updates to the vaccine composition may not be currently warranted.     

Evaluation of BioThrax® and AV7909 anthrax vaccines in adults 66 years of age or older

BackgroundMultiple Anthrax vaccines are licensed or in development for post-exposure prophylaxis in individuals 18 to 65 years of age. No information exists on anthrax vaccines in populations over the age of 65. It is critical that we assess the capacity of anthrax vaccines to generate a protective immune response in older individuals. In this study, we compared BioThrax® to a formulation containing a CpG adjuvant (AV7909).MethodsWe conducted a Phase 2 clinical study to evaluate safety and immunogenicity of three vaccination schedules of the AV7909 vaccine candidate and one vaccination schedule of BioThrax® vaccine in adults over 65 years of age. A total of 305 subjects were enrolled to assess safety and immunogenicity by seroprotection rates, toxin neutralizing antibody titers, and anti-Protective Antigen ELISA titers.ResultsCompared to BioThrax, AV7909 elicited a more robust immune response in older subjects, especially with three doses of AV7909 at Days 1, 15, and 29, or two doses at Days 1 and 29. These trends were true with both seroprotection rates as defined by the percentage of subjects with 50 percent neutralization factors greater than 0.56, and geometric mean antibody titers. The responses to both AV7909 and BioThax were lower in older subjects compared to those aged 18–50.ConclusionThe immunogenicity data suggest that the CpG adjuvant in the AV7909 vaccine helps to elicit a more robust immune response in subjects over the age of 65. Alternative dosing strategies may be considered in this population given the high seroprotection rates with Day 1 and 29, or Day 1, 15, and 29 regimens.Trial Registration: clinicaltrials.gov Identifier: NCT03518125.