一次性使用医疗用品改由SFDA一家管理

卫生部近日表示 ,他们将不再管理一次性使用医疗用品 ,原本由两家共管的这种医疗用品今后只由国家食品药品监督管理局 (SFDA)管理。一次性使用医疗用品曾长期处于双重管理状态。《医疗器械监督管理条例》、《一次性使用无菌医疗器械监督管理办法》、《消毒管理办法》等不同的法规和部门规章都对此规定 ,但多头管理反而不利于管理 ,因此 ,卫生部决定 :一次性使用医疗用吕不再纳入《消毒管理办法》管理 ,取消卫生行政部门对一次性医疗用品的备案制度和对一次性使用医疗用品生产企业的卫生许可制度一次性使用医疗用品改由SFDA一家管理…     

《医疗质量管理办法》运行机制初探

经国家卫生计生委委主任会议讨论通过的《医疗质量管理办法》已于2016年11月1日起正式实施。《办法》从管理体系、责任主体、管理内容及患者权利等方面凸显诸多亮点,弥补了原有法律制度的不足。《办法》的系统性、多元性及复杂性昭示着其有效实施势必建立科学的运行机制。应当从外部公权力、社会和医疗机构内部构建互为依托、互为补充、协调运作的发展导向、组织建设、监测评价、激励考核、人才培养、信息流通等机制体系,全方位保障《办法》的落地生根。     

加强手术室管理,控制医院感染

目的加强手术室医院感染的控制与管理,降低医院感染的发生率。方法针对手术室的工作特点,制定并落实各项有效的消毒隔离措施和感染监测制度,严格执行无菌操作规程,创造合格的手术环境。结果制定有效的手术室消毒隔离制度和感染监测制度,并通过医护人员的积极配合,创造合格的手术室环境,使无菌手术切口感染率下降至0.25%,特殊手术无医院感染发生。结论加强手术室医院感染的管理,可有效地防止医院感染的发生,降低无菌手术切口感染率。     

《干细胞临床研究管理办法(试行)》发布

<正>国家卫生和计划生育委员会、国家食品药品监督管理总局近日联合发布《干细胞临床研究管理办法(试行)》(以下简称《管理办法》)。这是我国首个针对干细胞临床研究进行管理的规范性文件,旨在规范干细胞临床研究行为,保障受试者权益,促进干细胞研究健康发展。《管理办法》明确,从事干细胞临床研究的医疗机构     

外科手术及手术医师权限分级管理研究进展

外科手术已成为构成全球卫生保健构成整体所必需的一部分,为防范手术风险,提高手术工作质量,应加强外科手术分级管理,推行手术医师资格准入及手术权限分级授予管理工作。卫生部《医疗技术临床应用管理办法》明确要求医疗机构建立手术分级管理制度。介绍了外科手术及手术医师权限分级管理的相关概念、内涵、外科手术管理国内外发展现状;提出了相磁研究存在的问题,并作出了展望。     

中国埃博拉诊疗中心防护督查机制探索实践

目的 探讨防护督查机制在埃博拉诊疗中心管理中的作用,探索防护督查机制对确保防护隔离制度执行、保障医务人员防护安全的作用和有效模式。方法 在制定八项防护隔离相关制度的基础上,建立防护督查制度、防护督查体系、工作模式以及评价措施。结果 分析2014年12月5日—2015年1月18日中国埃博拉诊疗中心防护督查工作情况,并进行前后期比较,发现通过建立完善的防护督查机制,能有效地纠正和减少防护隔离制度执行中的问题和失误,督促医务人员规范执行相关制度和流程。结论 防护督查机制是烈性传染病医院中进行防护质量控制的必要举措,对督促医务人员严格执行防护隔离相关制度、确保“零感染”具有切实有效的作用。     

代孕——挑战伦理底线？

目前在中国,代孕(理)母亲或代孕行为是违法的。中国卫生部颁布的《人类辅助生殖技术管理办法》和《人类精子库管理办法》于2001年8月1日起实施,其中规定:“禁止以任何形式买卖配子、合子、胚胎,医疗机构和医务人员不得实施任何形式的代孕技术。”然而,法律的禁止并不意味着这一行为在现实生活中不存在。事实上,中国不得不面对代孕行为存在,并逐渐扩大化的现状。     

2003年-2006年鸡西市区医院消毒效果监测分析

目的:了解鸡西市医疗机构消毒效果状况,加强对辖区内医疗机构消毒质量管理,预防和控制医院感染的发生。方法:依据《消毒技术规范》(卫生部2002年版)对我市17家医院消毒物品采样,进行消毒效果检测。结果:17家医院消毒总合格率为97．44% (991/1017),其中室内空气一项市直医院合格率92．05%(81/88)低于区级医院100%(11/11)(x~2=77,P＜0．005);室内空气、物体表面、医务人员手、使用中消毒剂、无菌器械、污水合格率分别为93．43%(128/137)、98．79%(244/247)、97．97%(290/296)、100%(73/73)、97．62%(246,252)、83．33%(10/12),污水合格率明显低于医务人员手(x~2=9．77,P＜0．0031)、物体表面(x~2=14．43,P＜0．0031)和使用中消毒剂(x~2=12．46,P＜0．0031)。结论:本市医院消毒情况以污水合格率偏低,室内空气、物体表面和医务人员手不同程度地存在细菌超标现象,存在院内感染的威胁。     

保健食品注册与备案管理办法亮点解读

《食品安全法》于2015年新修订,将保健食品归为特殊食品类管理并首次引入备案制,为了进一步细化保健食品规范管理工作,维护保健食品行业的良好发展,2016年2月原国家食品药品监督管理总局颁发了《保健食品注册与备案管理办法》并于2016年7月1日起施行。本办法强化保健食品生产经营者义务和法律责任,规范保健食品注册备案工作,为完善保健食品行业的有序运行提供了制度上的保障。本文对保健食品注册与备案办法的亮点进行解读。     

关于印发重大、重点项目管理办法的若干补充规定的通知

(92)国科金发计字第155号各有关单位、科学基金委员会各部门: 《国家自然科学基金重点项目立项、评审、管理试行办法》的若干补充规定和《国家自然科学基金“八·五”重大项目立项、评审、管理暂行办法》的若干补充规定,业经国家自然科学基金委员会委务会议通过,现印发你们,自即日起执行。     

Factors promoting survival of bacteria in chlorinated water supplies

Results of our experiments showed that the attachment of bacteria to surfaces provided the greatest increase in disinfection resistance. Attachment of unencapsulated Klebsiella pneumoniae grown in medium with high levels of nutrients to glass microscope slides afforded the microorganisms as much as a 150-fold increase in disinfection resistance. Other mechanisms which increased disinfection resistance included the age of the biofilm, bacterial encapsulation, and previous growth conditions (e.g., growth medium and growth temperature). These factors increased resistance to chlorine from 2- to 10-fold. The choice of disinfectant residual was shown to influence the type of resistance mechanism observed. Disinfection by free chlorine was affected by surfaces, age of the biofilm, encapsulation, and nutrient effects. Disinfection by monochloramine, however, was only affected by surfaces. Importantly, results showed that these resistance mechanisms were multiplicative (i.e., the resistance provided by one mechanism could be multiplied by the resistance provided by a second mechanism).     

Factors promoting survival of bacteria in chlorinated water supplies.

Results of our experiments showed that the attachment of bacteria to surfaces provided the greatest increase in disinfection resistance. Attachment of unencapsulated Klebsiella pneumoniae grown in medium with high levels of nutrients to glass microscope slides afforded the microorganisms as much as a 150-fold increase in disinfection resistance. Other mechanisms which increased disinfection resistance included the age of the biofilm, bacterial encapsulation, and previous growth conditions (e.g., growth medium and growth temperature). These factors increased resistance to chlorine from 2- to 10-fold. The choice of disinfectant residual was shown to influence the type of resistance mechanism observed. Disinfection by free chlorine was affected by surfaces, age of the biofilm, encapsulation, and nutrient effects. Disinfection by monochloramine, however, was only affected by surfaces. Importantly, results showed that these resistance mechanisms were multiplicative (i.e., the resistance provided by one mechanism could be multiplied by the resistance provided by a second mechanism).     

急诊重症监护病房耐甲氧西林金黄色葡萄球菌定植与感染调查分析

目的 调查急诊重症监护病房( EICU)耐甲氧西林金黄色葡萄球菌(MRSA)定植与感染状况,为实时控制医院感染暴发流行提供参考依据.方法 对临床资料进行分析,环境卫生学监测采样方法参照卫生部《消毒技术规范》,制定干预措施.结果 6例MRSA定植和感染病例平均年龄62.5岁,原发性基础疾病重;41份环境标本和16份来自接触阳性患者的医务人员手部标本中均分离到病原菌,阳性率分别为24.39％和18.75％.结论MRSA定植是造成医院感染的源头,将仅出现定植的病例并入感染病例进行统计分析,可实时监控院内医院感染的暴发.     

Effects of Source Water Quality on Chlorine Inactivation of Adenovirus,Coxsackievirus, Echovirus,and Murine Norovirus

More information is needed on the disinfection efficacy of chlorine for viruses in source water. In this study, chlorine disinfection efficacy was investigated for USEPA Contaminant Candidate List viruses coxsackievirus B5 (CVB5), echovirus 1 (E1), murine norovirus (MNV), and human adenovirus 2 (HAdV2) in one untreated groundwater source and two partially treated surface waters. Disinfection experiments using pH 7 and 8 source water were carried out in duplicate, using 0.2 and 1 mg/liter free chlorine at 5 and 15°C. The efficiency factor Hom (EFH) model was used to calculate disinfectant concentration × contact time (CT) values (mg·min/liter) required to achieve 2-, 3-, and 4-log₁₀ reductions in viral titers. In all water types, chlorine disinfection was most effective for MNV, with 3-log₁₀ CT values at 5°C ranging from ≤0.020 to 0.034. Chlorine disinfection was least effective for CVB5 in all water types, with 3-log₁₀ CT values at 5°C ranging from 2.3 to 7.9. Overall, disinfection proceeded faster at 15°C and pH 7 for all water types. Inactivation of the study viruses was significantly different between water types, but no single source water had consistently different inactivation rates than another. CT values for CVB5 in one type of source water exceeded the recommended CT values set forth by USEPA''s Guidance Manual for Compliance with the Filtration and Disinfection Requirements for Public Water Systems using Surface Water Sources. The results of this study demonstrate that water quality plays a substantial role in the inactivation of viruses and should be considered when developing chlorination plans.Disinfection processes are critical for the reduction of infectious virus concentrations in source water, because viruses are less efficiently removed by primary treatment of drinking water (e.g., coagulation and filtration) than are other pathogen types of concern (e.g., bacteria and protozoa). Over the years, many disinfection studies have focused on the inactivation of viruses in purified and buffered, demand-free, reagent-grade water (RGW). However, relatively few investigators have examined the impact of water quality during the disinfection process, even though water quality has been found to be a significant factor for inactivation of viruses.Several researchers found that the inactivation rate of poliovirus by free chlorine increased as the ionic concentration of water increased. In one study, poliovirus 1 was inactivated three times faster in boric acid buffer than in purified water (3). In addition, several investigators found that when the ionic content of buffered water was raised by the addition of NaCl or KCl, poliovirus 1 was inactivated two to four times faster than in the buffered water alone (2, 16, 17). In another study, poliovirus 1 was inactivated 10 times more rapidly in drinking water than in purified water (4).Studies conducted with natural waters have demonstrated both increased and decreased disinfection efficacy of chlorine in these waters compared to purified or buffered waters. In a study comparing chlorine disinfection in purified water and Potomac estuarine water, coxsackievirus A9 was inactivated more rapidly in the source water. The remaining study viruses (coxsackievirus B1, echovirus 7, adenovirus 3, poliovirus 1, and reovirus 3) were all inactivated more slowly in the source water (13). Bacteriophage MS2 was inactivated more slowly by free chlorine in two types of surface water than in buffered, demand-free water. However, there was no difference between the inactivation rates of this virus in the buffered water and groundwater (10). In another study, both feline calicivirus and adenovirus 40 were inactivated more slowly in treated groundwater than in buffered, demand-free water (21).The United States Environmental Protection Agency''s (USEPA) Guidance Manual for Compliance with the Filtration and Disinfection Requirements for Public Water Systems using Surface Water Sources (Guidance Manual) recommends disinfectant concentration × contact time (CT) values of 4, 6, and 8 to achieve 2-, 3-, and 4-log₁₀ inactivation, respectively, with chlorine at 5°C and pH 6 to 9 (23). These CT values, which incorporate a safety factor of 3, were obtained from inactivation experiments conducted with monodispersed hepatitis A virus (HAV) in buffered, demand-free water. As water quality can significantly affect the disinfection efficacy of chlorine, it is unclear whether these CT value recommendations are sufficient for inactivation of viruses in source water. More information is needed to systematically examine the role of water quality in chlorine disinfection of viruses.The objective of the present study was to examine the disinfection efficacy of free chlorine on selected viruses from USEPA''s Contaminant Candidate List (CCL) (22) in one untreated and two partially treated source waters from distinct geographical regions. By comparing the efficacy of chlorine disinfection in the source water types to disinfection in buffered, chlorine-demand-free RGW (7), the impact of water quality could be examined. The four representative CCL viruses selected for this study included human adenovirus 2 (HAdV2), echovirus 1 (E1), coxsackievirus B5 (CVB5), and murine norovirus (MNV), a surrogate for human norovirus (22). The viruses were selected because they were previously found to be the least effectively inactivated viruses of their type in RGW (6). Disinfection experiments were carried out in duplicate in pH 7 and 8 source water at 5 and 15°C using 0.2 and 1 mg/liter free chlorine. Inactivation curves were plotted using Microsoft Excel, and CT values were calculated using the efficiency factor Hom (EFH) model (9).     

Effect of exposure to UV-C irradiation and monochloramine on adenovirus serotype 2 early protein expression and DNA replication

The mechanisms of adenovirus serotype 2 inactivation with either UV light (with a narrow emission spectrum centered at 254 nm) or monochloramine were investigated by assessing the potential inhibition of two key steps of the adenovirus life cycle, namely, E1A protein synthesis and viral genomic replication. E1A early protein synthesis was assayed by using immunoblotting, while the replication of viral DNA was analyzed by using slot blotting. Disinfection experiments were performed in phosphate buffer solutions at pH 8 and room temperature (UV) or 20 degrees C (monochloramine). Experimental results revealed that normalized E1A levels at 12 h postinfection (p.i.) were statistically the same as the corresponding decrease in survival ratio for both UV and monochloramine disinfection. Normalized DNA levels at 24 h p.i. were also found to be statistically the same as the corresponding decrease in survival ratio for monochloramine disinfection. In contrast, for UV disinfection, genomic DNA levels were much lower than E1A or survival ratios, possibly as a result of a delay in DNA replication for UV-treated virions compared to that for controls. Future efforts will determine the pre-E1A synthesis step in the adenovirus life cycle affected by exposure to UV and monochloramine, with the goal of identifying the viral molecular target of these two disinfectants.     

Single-cell protein profiling of wastewater enterobacterial communities predicts disinfection efficiency

The efficiency of enterobacterial disinfection is dependent largely on enterobacterial community physiology. However, the relationship between enterobacterial community physiology and wastewater processing is unclear. The purpose of this study was to investigate this relationship. The influence of wastewater treatment processes on enterobacterial community physiology was examined at the single-cell level by using culture-independent methods. Intracellular concentrations of two conserved proteins, the growth-related protein Fis and the stationary-phase protein Dps, were analyzed by epifluoresence microscopy of uncultivated cells by using enterobacterial group-specific polyclonal fluorochrome-coupled antibodies. Enterobacterial single-cell community protein profiles were distinct for different types of biological treatment. The differences were not apparent when bulk methods of protein analysis were used. Trickling filter wastewater yielded Fis-enriched communities compared to the communities in submerged aeration basin wastewater. Community differences in Fis and Dps contents were used to predict disinfection efficiency. Disinfection of community samples by heat exposure combined with cultivation in selective media confirmed that enterobacterial communities exhibited significant differences in sensitivity to disinfection. These findings provide strategies that can be used to increase treatment plant performance, reduce the enterobacterial content in municipal wastewater, and minimize the release of disinfection by-products into receiving water.     

One explanation for the variability of the bacterial suspension test

Disinfection kinetic studies of sodium dodecyl sulphate, benzalkonium chloride and sodium hypochlorite against Staphylococcus aureus revealed that when a higher inoculum level of Staph. aureus than normal was used (approximately 1 log higher), the efficacy of disinfection was severely attenuated. Kinetic analysis using the Hom model for experiments carried out on tests using 3 x 108 organisms ml-1 were unable to account for the large increase in disinfection power observed when smaller inoculum levels were used. Since the inoculum was the same in every way except for the numbers used, the large variations in the log reduction/time curves could not be explained by a variation in the resistance of the population to the biocide, as identical log reduction-time curves should have resulted. The level of disinfection achieved for a given concentration of biocide was found to be approximately linearly related to the cell number ml-1 of test solution and not to the log number. The variation observed is believed to occur due to intrinsic self-quenching of the biocide by the microbes during the course of the disinfection test. As the level of free biocide decreases, the rate of reaction decreases, giving the tails of the log reduction/time curves. Such intrinsic self-quenching could explain the large variations known to occur in the legally required disinfection suspension tests.     

Single-Cell Protein Profiling of Wastewater Enterobacterial Communities Predicts Disinfection Efficiency

The efficiency of enterobacterial disinfection is dependent largely on enterobacterial community physiology. However, the relationship between enterobacterial community physiology and wastewater processing is unclear. The purpose of this study was to investigate this relationship. The influence of wastewater treatment processes on enterobacterial community physiology was examined at the single-cell level by using culture-independent methods. Intracellular concentrations of two conserved proteins, the growth-related protein Fis and the stationary-phase protein Dps, were analyzed by epifluoresence microscopy of uncultivated cells by using enterobacterial group-specific polyclonal fluorochrome-coupled antibodies. Enterobacterial single-cell community protein profiles were distinct for different types of biological treatment. The differences were not apparent when bulk methods of protein analysis were used. Trickling filter wastewater yielded Fis-enriched communities compared to the communities in submerged aeration basin wastewater. Community differences in Fis and Dps contents were used to predict disinfection efficiency. Disinfection of community samples by heat exposure combined with cultivation in selective media confirmed that enterobacterial communities exhibited significant differences in sensitivity to disinfection. These findings provide strategies that can be used to increase treatment plant performance, reduce the enterobacterial content in municipal wastewater, and minimize the release of disinfection by-products into receiving water.     

医疗服务分档评估指标体系的测试

医疗机构医疗服务具有差别性,原有的医疗服务定价方式已不能完全体现不同级别医疗机构医疗服务价值。医疗服务分档定价方式拉开了不同级别医院的差距,体现了医务人员的技术劳务价值,减少医疗资源的浪费,与以往的医疗服务价格定价方式相比,具有明显的优越性。前期课题组初步建立了医疗服务分档评估指标体系,为了解医疗服务分档评估指标体系在非营利性医疗机构中的运用情况,分别选取三级、二级、一级医院共4家非营利性医疗机构进行测试。测试结果与课题前期研究设想基本吻合。     

Evaluation of the efficiency of peracetic acid in the disinfection of sewage effluents

AIMS: Evaluation of the efficiency of peracetic acid in the disinfection of wastewater in a large treatment plant. METHODS AND RESULTS: Over a period of 18 months 30 sample collections were made, each consisting of three samples taken from: raw incoming sewage, secondary effluent (after 10-12 h) and secondary effluent disinfected with 1.5-2 mg l(-1) of peracetic acid (contact time: 20 min). Total coliforms and Escherichia coli declined from 10(7) MPN 100 ml(-1) in the raw sewage to 10(2) in the disinfected effluent and the enterococci fell from 10(6) MPN 100 ml(-1) to 702 MPN 100 ml(-1). The reduction of bacteria increased with the rise in temperature and decreased with the rise in BOD5. CONCLUSIONS: Disinfection with peracetic acid reduced levels of faecal contamination by 97%, thus attaining the limit recommended by current Italian law (Escherichia coli 相似文献