医院消毒供应中心

医院消毒供应中心 医院消毒供应中心“两规一标” 第1部分:管理规范 前 言 根据《中华人民共和国传染病防治法》、《医院感染管理办法》制定本。 本标准工作区域温度、相对湿度和照度要求部门参照了美国,,,，/,,,， ,,,,:,,,,医疗设备中蒸汽消毒和灭菌保证综合指南。 本标准第,.,.,、,.,.,.,、,(,.,条为推荐性，其余为强制性。 本标准由卫生部医院感染控制标准专业委员会提出。 1 范围 本标准规定了医院消毒供应中心(central sterile supply department,CSSD) 管理要求、基本原则、人员要求、建筑要求、设备、设施、耗材要求和相关部门管理职责与要求。 本标准适用于医院CSSD 和为医院提供消毒灭菌服务的社会化消毒灭菌机构。暂未实行消毒供应工作集中管理的医院，其手术部(室)的消毒供应工作应执行本标准。 己采取污水集中处理的其他医疗机构可参照使用。 2 规范性引用文件 下列文件中的条款通过本标准的引用而成为本标准的条款。凡是标注日期的引用文件，其随后所有的修改(不包括勘误内容)或修订版均不适用于本标准，然而，鼓励根据本标准达成协议的各方研究是否可使用这些文件的最新版本。凡是不注明日期的引用文件，其最新版本适用于本标准。 GB 5749 生活饮用水卫生标准 GB/T 19633 最终灭菌医疗器械的包装 WS 310.2 医院消毒供应中心第2部分:清洗消毒及灭菌技术操作规范 WS 310.3 医院消毒供应中心第3部分:清洗消毒及灭菌效果监测标准消毒技术规范 消毒灭菌规范 卫生部 3 术语和定义 下列术语和定义适用于本标准。 3.1 消毒供应中心central sterile supply department, CSSD 医院内承担各科室所有重复使用诊疗器械、器具和物品清洗消毒、灭菌以及choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the 无菌物品供应的部门。 3.2 去污区decontamination area CSSD内对重复使用的诊疗器械、器具和物品，进行回收、分类、清洗、消毒(包括运送器具的清洗消毒等)的区域，为污染区域。 3.3 检查、包装及灭菌区inspection and packing sterilization area CSSD内对去污后的诊疗器械、器具和物品，进行检查、装配、包装及灭菌(包括敷料制作等)的区域，为清洁区域。 3.4 无菌物品存放区sterilized articles store area CSSD内存放、保管、发放无菌物品的区域，为清洁区域。 3.5 去污decontamination 去除被处理物品上的有机物、无机物和微生物的过程。 3.6 外来医疗器械loaner instrumentation 由医疗器械生产厂家、公司租借或免费提供给医院可重复使用的医疗器械。 4 管理要求 4.1 医院 4.1.1 应采取集中管理的方式，对所有需要消毒或灭菌后重复使用的诊疗器械、器具和物品由CSSD回收，集中清洗、消毒、灭菌和供应。 4.1.2 内镜、口腔诊疗器械的清洗消毒，可以依据卫生部有关的规定进行处理，也可集中由CSSD统一清洗、消毒。外来医疗器械应按照WS310.2的规定由CSSD统一清洗、消毒、灭菌。 4.1.3 应理顺CSSD的管理体制，使其在院长或相关职能部门的直接领导下开展工作。 4.1.4 应将CSSD纳入本机构的建设规划，使之与本机构的规模、任务和发展规划相适应;将消毒供应工作管理纳入医疗质量管理，保障医疗安全。 4.1.5 鼓励符合要求并有条件医院的CSSD为附近医疗机构提供消毒供应服务。 4.2 消毒供应中心 4.2.1 应建立健全岗位职责、操作规程、消毒隔离、质量管理、监测、设备管理、器械管理(包括外来医疗器械)及职业安全防护等#管理制度#和突发事件的应急预案。 4.2.2 应建立质量管理追溯制度，完善质量控制过程的相关记录，保证供应choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the 的物品安全。 4.2.3 应建立与相关科室的联系制度 4.2.3.1 主动了解各科室专业特点、常见的医院感染及原因，掌握专用器械、用品的结果、材质特点和处理要点。 4.2.3.2 对科室关于灭菌物品的意见有调查、有反馈，落实持续改进，并有记录。 5 基本原则 5.1 CSSD的清洗消毒及检测工作应符合WS310.2和WS310.3的规定。 5.2 诊疗器械、器具和物品的再处理应符合使用后及时清洗、消毒、灭菌的程序，并符合以下要求: a)进入人体无菌组织、器官、腔隙，或接触人体破损的皮肤、粘膜、组织的诊疗器械、器具和物品，应进行灭菌。 b)接触皮肤、粘膜的诊疗器械、器具和物品应进行消毒。 c)被朊毒体、气性坏疽及突发原因不明的传染病病原体污染的诊疗器械、器具和物品，应执行WS310.2中规定的处理流程。 6 人员要求 6.1 医院应根据CSSD的工作量及各岗位需求，科学、合理配置具有职业资格的护士、消毒员和其他工作人员。 6.2 CSSD的工作人员应当接受与其岗位职责相应的岗位培训，正确掌握以下知识与技能: a)各类诊疗器械、器具和物品的清洗、消毒、灭菌的知识与技能。 b)相关清洗、消毒、灭菌设备的操作规程。 c)职业安全防护原则和。 d)医院感染预防与控制的相关知识。 6.3 应建立CSSD工作人员的继续教育制度，根据专业进展，开展培训，更新知识。 7 建筑要求 7.1 基本原则 医院CSSD的新建、扩建和改建，应遵循医院感染预防与控制的原则，遵守国家法律法规对医院建筑和职业防护的相关要求，进行充分论证。 7.2 基本要求 choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the 7.2.1 CSSD宜接近手术室、产房和临床科室，或与手术室有物品直接传递专用通道，不宜建在地下室或半地下室。 7.2.2 周围环境应清洁、无污染源，区域相对独立;内部通风、采光良好。 7.2.3 建筑面积应符合医院建设方面的有关规定，并兼顾未来发展规划的需要。 7.2.4 建筑布局应分为辅助区域和工作区域。 7.2.4.1 辅助区域包括工作人员更衣室、值班室、办公室、休息室、卫生间等。工作区域包括去污区、检查、包装及灭菌区(含独立的敷料制备或包装间)和无菌物品存放区。 7.2.4.2 工作区域划分应遵循的基本原则如下: a) 物品由污到洁，不交叉、不逆流。 b) 空气流向由洁到污;去污区保持相对负压，检查、包装及灭菌区保持相对正压。 7.2.4.3 工作区域温度、相对湿度、机械通风的换气次数应符合表1要求;照明宜符合表2 的要求。 表1 工作区域温度、相对湿度及机械通风换气次数要求 工作区域 温度/(?) 相对湿度/(?) 气次数/(次/,) 去污区 ,,,,, ,,,,, ,, 检查、包装及灭菌区 ,,,,, ,,,,, ,, 无菌物品存放区 低于,, 低于,, ,,,, 表2 工作区域照明要求 工作面/功能 最低照度/(,,,) 平均照度(,,,) 最高照度(,,,) 普通检查 ,,, ,,, ,,,, 精细检查 ,,,, ,,,, ,,,, 清洗池 ,,, ,,, ,,,, choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the 普通工作区域 ,,, ,,, ,,, 无菌物品存放区 ,,, ,,, ,,, 7.2.4.4 工作区域与材料要求，应符合以下要求: a)去污区、检查、包装及灭菌区和无菌物品存放区之间应设实际屏障。 b)去污区与检查、包装及灭菌区之间应设洁、污物品传递通道;并分别设人员出入缓冲间(带)。 c)缓冲间(带)应设洗手设施，采用非手触式手龙头开关。无菌物品存放区内不应设洗手池。 d)检查、包装及灭菌区的专用洁具间应采用封闭式设计。 e)工作区域的天花板、墙壁应无裂隙，不落尘，便于清洗和消毒;地面与墙面踢脚及所有阴角均应为弧形设计;电源插座应采用防水安全型;地面应防滑、易清洗、耐腐蚀;地漏应采用防返溢式;污水应集中至医院污水处理系统。 8 设备、设施 8.1 清洗消毒设备及设施医院应根据CSSD的规模、任务及工作量，合理配置清洗消毒设备及配套设施。设备、设施应符合国家相关标准或规定。 8.1.1 应配有污物回收器具、分类台、手工清洗池、压力水枪、压力气枪、超声清洗装置、干燥设备及相应清洗用品等。 8.1.2 宜配备机械清洗消毒设备。 8.2 检查、包装设备:应配有带光源放大镜的器械检查台、包装台、器械柜、敷料柜、包装材料切割机、医用热封机及清洁物品装载设备等。 8.3 灭菌设备及设施:应配有压力蒸汽灭菌器、无菌物品装、卸载设备等。根据需要配备灭菌蒸汽发生器、干热灭菌和低温灭菌装置。各类灭菌设备应符合国家相关标准，并设有配套的辅助设备。 8.4 储存、发放设施:应配备无菌物品存放设施及运送器具等。 8.5 防护用品 8.5.1 根据工作岗位的不同需要，应配备相应的个人防护用品，包括圆帽、口罩、隔离衣或防水围裙、手套、专用鞋、护目镜、面罩等。 8.5.2 去污区应配置洗眼装置。 9 耗材要求 9.1 清洁剂:应符合国家相关标准和规定。根据器械的材质、污染物种类，choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the 选择适宜的清洁剂。 9.1.1 碱性清洁剂:pH 值?7.5，应对各种有机物有较好的去除作用，对金属腐蚀性小，不会加快返锈的现象。 9.1.2 中性清洁剂:pH 值6.5,7.5，对金属无腐蚀。 9.1.3 酸性清洁剂:pH 值?6.5，对无机固体粒子有较好的溶解去除作用，对金属物品的腐蚀性小。 9.1.4 酶清洁剂:含酶的清洁剂，有较强的去污能力，能快速分解蛋白质等多种有机污染物。 9.2 消毒剂:应选择取得卫生部颁发卫生许可批件的安全、低毒、高效的消毒剂。 9.3 洗涤用水:应有冷热自来水、软水、纯化水或蒸馏水供应。自来水水质应符合GB 5749 的规定;纯化水应符合电导率?15μS/cm(25?)。 9.4 灭菌蒸汽用水:应为软水或纯化水。 9.5 润滑剂:应为水溶性，与人体组织有较好的相容性。不破坏金属材料的透气性、机械性及其他性能。 9.6 包装材料:包括硬质容器、一次性医用皱纹纸、纸塑袋、纸袋、纺织品、无纺布等应符合GB/T 19633的要求。纺织品还应符合以下要求:为非漂白织物;包布除四边外不应有缝线，不应缝补;初次使用前应高温洗涤，脱脂去浆、去色;应有使用次数的记录。 9.7 消毒灭菌监测材料:应有卫生部消毒产品卫生许可批件，在有效期内使用。自制测试标准包应符合《消毒技术规范》有关要求。 10 相关部门管理职责与要求 10.1 护理管理部门、医院感染管理部门、人事管理部门、设备及后勤管理等部门，应在各自职权范围内，对CSSD 的管理履行以下职责: a)根据工作量合理调配CSSD 的工作人员。 b)落实岗位培训制度;将消毒供应专业知识和相关医院感染预防与控制知识纳入CSSD 人员的继续教育，并为其学习、交流创造条件。 c)对CSSD清洗、消毒、灭菌工作和质量监测进行指导和监督，定期进行检查与评价。 d)发生可疑医疗器械所致的医源性感染时，组织、协调CSSD和相关部门进行调查分析，提出改进措施。 choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the e)对CSSD新建、改建与扩建的设计进行卫生学审议;对清洗、消毒与灭菌设备的配置与质量指标提出意见。 f)负责设备购置的审核(合格证、技术参数);建立对厂家设备安装、检修的质量审核、验收制度;专人负责CSSD设备的维护和定期检修，并建立设备档案。 g)保证CSSD的水、电、压缩空气及蒸汽的供给和质量，定期进行设施、管道的维护和检修。 h)定期对CSSD所使用的各类数字仪表如压力表、温度表等进行校验，并记录备查。 10.2 物资供应、教育及科研等其他部门，应在CSSD主管院长或职能部门的协调下履行相关职责，保障CSSD的工作需要。 choose water fountains, water-saving products should be purchased. As compared to open v-Groove type water supply system, sealed nipple water system can save water 81.35% saving bedding consumption 56.3%; sanitation and drinking water, and a variety of harmful gases concentrations decline, increased laying rate 13.79%, economic efficiency improved. Chicken Coop construction should pay attention to several problems, chicken distribution notes: a rational structure of the hen-house layout, can provide a good environment for chicken, making its full productive potential, so other than in understanding the physiological characteristics of the chicken itself, and must be properly planned and constructed sheds. 1. sites to choose away from populated areas, traffic convenient, away from the road 2. Gaozao terrain, a lot of sunshine. Winter sun as possible, summer wind, and not after the rain water. Larger, leaving room for development 3. Abundant water resources pollution-free, easy to access, sufficient power is guaranteed 4. Building structure, the economy, saving money, and saving energy, it is facing in accordance with local environmental and physiological condition, lighting is good, easy to ventilation, easy to operate, so conducive to cooling in the summer, to insulation in winter cold 5. Layout of premises should be reasonable, do distinguish between production and non-production areas and non-production areas and water sources are on a chicken farm in the wind, net road and dirt road separating uncrossed, dung farm is located in the