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,Improving Patient and Healthcare Worker Safety改进患者与医护人员的安全性,WILLIAM R. JARVIS, M.D.医学博士WILLIAM R. JARVISJASON AND JARVIS ASSOCIATES, LLC,Dr. Jarvis is a paid consultant for Becton, Dickinson and Company. The development of this presentation was commissioned by Becton, Dickinson and Company. The contents of this presentation are intended for general information purposes only and the views expressed therein are solely those of the presenter and not Becton, Dickinson and CompanyJarvis,2,2,Objectives目的,Describe mechanisms of catheter-related infections.描述导管相关感染的机制Outline insertion and maintenance bundles to prevent catheter-related infections.概述预防导管相关感染的置入和维护措施集Discuss the importance of preventing needlestick injuries in healthcare workers.讨论预防医护人员针刺伤害的重要性Describe optimal needleless connector design features identified in third-party clinical evidence描述第三方临床证据中的最佳无针接头设计特征Review 2 recent publications evaluating the performance of a positive pressure needleless connector.回顾最近2篇评价正压无针接头性能的出版物。,3,3,Impact of Primary Bloodstream Infection (BSI) 原发性血流感染的影响(BSI),Crude mortality 粗死亡率10%-40%Attributable mortality 归因死亡率2%-15%Prolongation of hospitalization住院延长5 to 20 days 5-20天Attributable cost可归属成本US$34,000-$56,000,CR-BSI,4,4,Factors That Influence Catheter- Related Bloodstream Infections (CR-BSI) Rates影响导管相关血流感染(CR-BSI)率的因素,Patients diagnosis 患者诊断Inserter education 置管人员教育Patient preparation and standardized insertion methods 患者准备和标准化置管方法Type, insertion location, number of lumens of catheter 导管的类型、置入位置以及管腔数量Design features of needleless connectors/hubs/stopcocks 无针接头/三通的设计特征Pre-entry hub disinfectant. What is used & how? 预连接接头消毒剂。使用了什么,如何使用?Medication infused through the catheter 通过导管输注的药物Method of documenting BSI (central line) and frequency of blood cultures (after symptoms and before antimicrobials) 记录BSI(中心导管)和血培养频率(症状后和抗菌剂前)的方法Interpretation and application of surveillance protocols 监督方案的解释和应用Infection control practices implemented 实施的感染控制实践,5,EXTRALUMINAL: First Week管腔外:第一周Extraluminal biofilm is the major source of CRBSI within the first week of catheterization in short-term catheters.管腔外生物膜是短期导管置入后第1周内的主要CRBSI来源。Extraluminal biofilm is the major source of tunnel infections in long-term catheters.管腔外生物膜是长期导管隧道型感染的主要来源。,5,Microbial Source of Catheter Related Bloodstream Infection (CR-BSI)导管相关性血流感染(CR-BSI)的微生物来源,INTRALUMINAL: After first week管腔内:第一周后Intraluminal biofilm is the major source of CRBSI after 1 week in both short- and long-term catheters.管腔内生物膜是短期和长期导管置入1周后的主要CRBSI来源。,6,6,Skin皮肤Vein静脉,Fibrin Sheath,Thrombus纤维鞘血栓,Contaminated Infusate注入液受污染Extrinsic外在污染Fluid 液体Medication 药物Intrinsic内在污染Manufacturer生产商,7,Trends of CLA-BSI United States, 2008 and 20092008年和2009年美国CLA-BSI趋势,STUDY DESIGN: Centers for Disease Control and Prevention (CDC) estimate of CLA-BSI rates from their National Healthcare Safety Network (NHSN) surveillance system研究设计:疾病控制与预防中心(CDC)根据其国家健康照护安全网络(NHSN)监测系统对CLA-BSI发生率的估计CONCLUSION: Currently, outpatient hemodialysis patients have the highest rate of CLA-BSIs. More aggressive CLA-BSI prevention interventions (proven in ICU patients) need to be applied to these patients.结论:目前,门诊透析患者的CLA-BSI率最高。需要对这些患者使用更积极的CLA-BSI预防干预(在ICU患者中经证实)。,7,Interrupting BSI Trends 中断BSI趋势,Recognize need for improvement 确定改善的需求Embrace technology designed to reduce risks 包括设计用于降低风险的技术Commit to Care & Maintenance protocols 致力于护理和维护方案A newly published clinical study 新发表的临床研究,8,9,9,Impact of Hub Disinfection On Bloodstream Infections In Dialysis Patients接头消毒对透析患者血流感染的影响,Intervention in 17 outpatient hemodialysis centers.17个门诊透析中心的干预。Four year follow-up (even after the study ended)四年随访(即使是在研究结束之后)Intervention: a systematic protocol for disinfecting hubs before and after manipulation (such as connecting the dialysis line).干预:操作前后接头消毒的系统方案(如连接透析导管)Overall Bloodstream infection (BSI) and access related BSI (ARBSI) used Centers for Disease Control and Prevention definitions.总血流感染(BSI)和通路相关BSI(ARBSI)采用疾病控制与预防中心定义。,10,10,Impact of Hub Disinfection On Bloodstream Infections In Dialysis Patients接头消毒对透析患者血流感染的影响,11,11,Impact of Hub Disinfection On Bloodstream Infections In Dialysis Patients接头消毒对透析患者血流感染的影响,An intervention focused on disinfection of hubs in hemodialysis patients resulted in a significant decrease in unadjusted pooled mean BSIs and ARBSIs.集中在透析患者接头消毒上的干预使得未调整的合并平均BSI和ARBSI显著减少。Overall decrease of 44% (P=.005)总降低率44%(P=.005)Central venous catheter decrease of 49% (P=.002)中心静脉导管降低率49%(P=.002)The deceased in BSIs and ARBSIs was sustained for 4 years, even after the funded intervention was completed.BSI和ARBIS降低持续4年,即使在完成资助的干预之后。Sustained reductions in BSIs and ARBSIs are possible with a simple hub disinfection protocol.采用简单的接头消毒方案也可以实现BSI和ARBSI持续降低。,12,12,An Intervention to Decrease Central Line Associated Bloodstream Infections in Hospitals in China中国医院内中心导管相关血流感染的降低干预,OBJECTIVE: A competence building intervention to prevent healthcare-associated infections.目的:强力建构干预,以预防医疗护理相关性感染。METHODS: The project included 49 hospitals which reported data: baseline survey, training, then intervention (October 2013-September 2014). Focus on device associated infections (DAI): catheter-associated urinary tract infections (CA-UTI), ventilator-associated pneumonia (VAP), central line associated bloodstream infections (CLA-BSIs), hand hygiene, and multidrug-resistant organisms.方法:该项目涉及49家医院,均报告了如下数据:基线调查、培训、以及干预(2013年10月至2014年9月)。针对装置相关的感染(DAI):导尿管相关尿路感染(CA-UTI)、呼吸机相关性肺炎(VAP)、中心导管相关性血流感染(CLA-BSI)、手部卫生、以及多重耐药菌。RESULTS:结果:CONCLUSIONS: A multifaceted intervention significantly reduced CA-UTI and VAP, but not CLA-BSIs.结论:多层面干 预显著降低了CA-UTI和VAP,但没有显著降低CLA-BSI。,Catheter-Related Infection (CRI) Prevention Bundles导管相关感染(CRI)预防措施集,A group (not single) of practices/interventions.一组(非一个)实践/干预。Implemented as a package of interventions.当做一系列干预实施。Based on the CRI mechanisms of infection.基于CRI感染机制。Evidence-based (effective) interventions.基于证据(有效)的干预。,14,14,The Insertion Bundle置管措施集,Insert a catheter only when clinically essential.仅临床需要时置入导管。Use a catheter insertion check-list.采用导管置入清单。Use a catheter insertion cart or kit.采用导管置入车或套件。Inserter hand hygiene.置管人员手部卫生。Chlorhexidine-alcohol skin antisepsis.氯己定-酒精皮肤消毒。Maximum barrier precautions (cap, gown, mask and patient drape).最大屏障预防措施(盖、衣服、口罩和患者手术被单)。Select the correct catheter and insert in the correct location.选择正确的导管,置入正确的位置。,15,15,The Maintenance Bundle维护措施集,Minimize catheter site skin bioburden-Chlorhexidine-impregnated sponge dressing.最大程度降低导管部位皮肤生物负载氯己定浸渍海绵敷料。Device selection (best catheter and connector).设备选择(最佳的导管和接头)。Aseptic manipulation of catheter connectorsDisinfect the needleless connector with hospital-approved disinfectant-scrub the hub.导管接头无菌操作采用医院批准的消毒剂消毒无针接头擦洗接头。Sterile flushing of hubs/catheters (every 8 hrs).无菌冲洗接头/导管(每隔8小时)。Antibiotic/antiseptic lock抗生素/抗菌剂封存Antimicrobial/antiseptic-impregnated-catheters抗菌剂浸渍导管,16,16,Preventing Central Line-Associated Bloodstream Infections (CLA-BSIs)预防中心导管相关血流感染(CLA-BSI),STUDY DESIGN: The PICC team reviewed and selected a combination of behavioral practices and technologies associated with lowering CLA-BSIs, including:研究设计:PICC团队评价并选择了减少CLA-BSI相关的行为实践与技术的组合,包括:Site selection with ultrasound guided insertion通过超声引导置入选择部位Full maximum barrier precautions at all insertions所有置管时完整最大屏障预防措施CHG skin prep and BIOPATCH Disk at insertion and at weekly dressing changes置管和每周敷料改变时的CHG皮肤准备与BIOPATCH DiskNeedleless connector system without clamping sequence requirement无夹紧顺序要求的无针接头系统70% isopropyl alcohol disinfection of connector septum接头隔膜70%异丙醇消毒Eight hour and PRN saline flushing protocol8小时和PRN生理盐水冲洗方案日常监测经外周静脉中心导管(PICC)RESULTS:结果:Implementation of the new bundle decreased the CLA-BSI rate.实施新措施集降低了CLA-BSI发生率。From January 2006 through January 2014 (updated) there was only one CLA-BSIs. 从2006年1月到2014年1月(更新),仅有1例CLA-BSI。,17,17,Impact of Central Line-Associated Bloodstream Infection Prevention Bundles, United States: 2001, 2008, and 2009中心导管相关血流感染预防措施集的影响,美国:2001年、2008年和2009年,In 2001no bundles; in 2008-9Bundles used2001年无措施集;2008年使用9个措施集In 2009, an estimated 25,000 fewer CLA-BSIs occurred.2009年,估计CLA-BSI减少25,000例。58% reduction from 2001 to 20092001年到2009年减少58%6,000 lives saved6,000名幸存$414 million in potential excess healthcare costs in 20092009年潜在的超额医疗费用为4.14亿美元An estimated $1.8 billion cumulative excess healthcare costs since 2001 2001年起估计累计有18亿美元超额医疗费用,18,18,Evolving Role of Needleless Connectors in Reducing Needlestick Injuries无针接头降低针刺伤的重要性回顾,Transition Phase过度阶段,19,19,Needlestick Injuries (NSI) in the United States美国针刺伤(NSI),In the early to mid 1980s, approximately 385,000 sharps injuries occurred annually among hospital-based healthcare personnel (1,000 injuries/day) 80年代初期到中期,医院医护人员中每年大约发生385000例锐器伤(1000例/天)。Many more in other healthcare settings其他医疗机构的发生例数更多Increased risk for bloodborne virus transmission血源性病毒传播风险增加Costly to personnel and healthcare system个人和医疗保健体系的经济负担沉重。Healthcare workers, particularly nurses, led the movement to reduce this risk.医护人员,尤其是护士,掀起了风险降低运动。,20,20,The Needlestick Safety and Prevention Act mandated that针刺安全和预防法案规定“Where engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used.” ”必须采用可通过去除、消除或隔离隐患而减少从业人员暴露的工程控制。 ”,21,21,Percutaneous Injuries Before and After the Needlestick Safety and Prevention Act针刺安全和预防法案颁布前后的经皮损伤情况,The mean (SE) rates of percutaneous injuries obtained from 85 selected hospitals are plotted for each year during an 11-year period (1995 through 2005). After enactment of the Needlestick Safety and Prevention Act in 2001, the rates have steadily declined.将这85家选定医院在11年期间的经皮损伤平均(SE)发生率绘制成年发生率图(从1995年至2005年)。2001年NSPA年颁布后,该发生率稳步下降。,22,22,Secular Trend in Selected Bloodborne Pathogen Infections in China, 2013 vs. 2009中国几种选定血源性病原感染的长期趋势,2013 vs. 2009,23,Healthcare Worker Needlestick Injuries By Type of Procedure医护人员针刺伤(按照操作分类总结),50.1%,24,24,How Can Needle Use Be Eliminated or Reduced?如何取消或减少针头使用?,Use needle-free IV delivery systems使用无针静脉输液系统Luer locking connections鲁尔锁接头Needleless access ports无针接入端口,25,25,Safety Devices Can Reduce Needlestick Injuries by 50%安全装置可使针刺伤减半,Reduce traditional devices to lower sharp injury rates减少使用传统装置,以降低锐器伤发生率Between 2001-2004, the use of safety engineered devices reached 94%, EPINet data shows that IV catheter related injures reduced by 63%在2001-2004年期间,安全设计装置的使用达到94%,EPINet数据表明IV导管相关性损伤下降63%。,26,26,Characteristics of Needleless Connectors无针接头的特征,Access to fluid path:接入液体通路:Needle or blunt cannula?针或钝针?Luer-activated access鲁尔接口激活通路How well does seal prevent bacterial contamination?密闭防止细菌污染的效果如何?Internal Design: Simple or Complex?内部设计:复杂或简单?An unintended design consequence of a complex internal mechanism is that it causes space inside connector but outside the fluid path复杂内部结构产生了一项意想不到的设计后果,即在接头内部、液体通路外部形成了一个空间;Fluid and contamination can leak into this space液体和污染物会渗入到这个空间内;This can contaminate the luer and enter the fluid path污染鲁尔接口,并进入液体通路。,27,27,Characteristics of Needleless Connectors无针接头的特征,Visibility: Clear or opaque能见度:透明或不透明When clear, visibility should work to improve flushing of the entire catheter如果透明,可提高整个导管的冲洗效果Connector Access surface:接头通路表面:Solid, sealed, flat紧实、密闭、平整More intricate access surface design could present difficulty for adequate disinfection通路表面的复杂设计会导致无法充分消毒。,28,28,Characteristics of Needleless Connectors: Access Surface无针接头的特征:通路表面,Sealed密闭,Cannula or luer activated接入或鲁尔接口激活,Unsealed未密闭,Luer activated鲁尔接口激活,29,29,Characteristics of Needleless Connectors: Visibility无针接头的特征:能见度,Visibility should enhance catheter flushing and patency能见度可以增强导管冲洗效果和通畅性。,Clear that enhances flushing透明,可增强冲洗效果,Clear that does not透明,不增强冲洗效果,Meta-Analysis 荟萃分析,Meta-analysis on central line-associated bloodstream infections associated with a needleless intravenous connector with a new engineering design 采用新工艺设计的无针输液接头相关的中心导管相关性血流感染的荟萃分析 Analysis of studies reporting CLABSIs in patients when using a positive displacement needleless connector (study NC) compared with negative or neutral displacement needleless connectors CLABSI的研究报告分析:比较正压无针接头(研究无针接头)与负压或平衡压无针接头在患者中的使用。,30,Tabak YP, et. Al. Am J Infect Control. 2014;42:1278-84.,31,31,Meta-Analysis Results荟萃分析结果,Pooled fixed effect showed 59% CLA-BSI risk reduction associated with MaxPlus connectors (RR: 0.41; 95% CI: 0.26-0.65). 固定效果汇总结果表明MaxPlus接头使得CLA-BSI风险下降达59%(RR:0.41; 95% CI:0.26-0.65)。Pooled random effect method showed 62% CLA-BSI risk reduction associated with MaxPlus (RR: 0.38; 95% CI: 0.21-0.68). 随机效果汇总结果表明MaxPlus使得CLA-BSI风险下降达62%(RR:0.38;95% CI:0.21-0.68)。The random effect Poisson model showed 69% CLA-BSI risk reduction associated with MaxPlus (RR: 0.31, 95% CI: 0.19-0.47). 随机效果泊松模型表明MaxPlus使得CLA-BSI风险下降达69%(RR:0.31, 95% CI:0.19-0.47)。,Feasibility of Using Existing Public and Private Data Sources for Nationwide Medical Device Post-marketing Safety Surveillance已有公共和私人数据源用于全国医疗器械上市后安全性监测的可行性,CareFusion undertook the largest analysis known to-date for needleless connectors. CareFusion针对无针接头开展了一项迄今为止最大型分析Used 2013 Center for Medicare and Medicaid Services Hospital Compare data 使用2013版的医疗保险和医疗补助中心医院的对比数据库3,074 hospitals; 3074家医院Nearly 11,000 CLA-BSIs;近11000例CLA-BSINearly 10 million catheter-days;导管天数达一千万Merged with Manufacturers client database 与生产商的客户端数据库合并,In press. Journal of Infusion Nursing.,32,33,33,Hospital Compare Results医院对比结果,34,34,A Simple Intervention That Can Save Lives & Money: Closed IV System一种既有效又经济实惠的简单干预:密闭式静脉系统,Needleless Connectors 无针输液接头,Simple needleless connector with a sealed surface and luer-lock design 简单的无针接头,密闭表面,螺口连接设计,Single-use Prefilled Flushing Devices (SUF)一次性使用预充冲洗装置(SUF),A prefilled single use vial for IV injection or line flushing一次性预填充式注射器,用于静脉注射或管路冲洗,35,35,Impact of Closed Intravenous Systems on Patient Outcomes 密闭式静脉系统对患者结局的影响,OBJECTIVE: To compare the clinical impact and cost-effectiveness of using split septum needleless connectors (SS) + single-use prefilled flushing devices (SUF) vs. three-way stopcocks (3WSC) + multiple use container (MUC) on the incidence rate of central line-associated bloodstream infection (CLA-BSI).目的:比较以下两种组合在中心导管相关性血流感染(CLA-BSI)发生率方面的临床意义和成本效益:分隔膜无针接头(SS) + 一次性预充冲洗装置(SUF)与三通(3WSC) + 多用途液袋(MUC)。STUDY DESIGN: 5 intensive care units (ICUs) in two cities in India. Randomized clinical trial (RCT); clinical and cost effectiveness analysis.研究设计:印度两个城市的5个重症监护病房(ICU)。随机临床试验(RCT);临床和成本效益分析。PATIENT GROUPS: 1,096 adult ICU patients who needed a central line were block
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