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必须采取预防措施来保护 RMD 的易损部位并避免破坏微生物屏障。 例如,保护RMD 的锐利边缘,并且将 RMD 有条理地摆放在篮筐、托盘或器械固定装置中 包装系统的尺寸和强度适合 RMD 或 RMD 组合的配置和重量。 需要时可增加额外的保护性包装(不是增加包装材料层数)以加强包装的物理强度。 保护性包装也可用于防止包装外表面积聚过多的环境灰尘。 运输和存储过程以及存储设备(例如密封柜和货架)是保持 RMD 和包装完整性的关键因素。 |
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国际标准 ISO 11607-1 将无菌取用定义为: “从无菌屏障系统中转移无菌物品时,将微生物污染风险降至最低的条件和操作”。 为了尽量减少无菌取用期间的风险: 负责无菌取用的人员接受了适当的培训,并参与和指导了包装实施过程。 在无菌取用期间,RMD 不会与包装系统的非无菌表面接触,并采用了正确的无菌技术。 无菌区准备充分。 根据需要,在将无菌物品放入任何无菌区域之前去除受污染的保护性包装 如果需要由无菌区域人员操作,采用双层无菌屏障系统 (SBS) 并无菌地提供给无菌区域人员。 |
国际标准 ISO 11607-11,2 将包装功能定义如下:
无菌屏障系统 (SBS) 是“最大限度减少微生物进入并允许在使用时无菌取用无菌物品的最小包装” 。
保护性包装 (PP) 是“为了防止无菌屏障系统及其内容物从装配到使用的时间段内受到损坏的材料结构”。
包装系统(PS)是“无菌屏障系统和保护性包装的结合”。
市场上可用的无菌屏障技术如下
热封机的温度和压力要根据包装袋制造商指引进行校准。 密封的最小强度和最小宽度由国际标准定义。 必须定义密封的最大强度,不能影响无菌取用。 箭头(人字形)方向表示撕开方向。 RMD 把持部位位于开口侧以方便取用。 锐利的边缘摆放在相反方向,以避免受伤。 留出1/3 的内部空间(在密封性能允许的范围内),以缓冲压力变化。 在密封之前,从袋中挤出空气以避免膨胀。 密封距离袋侧至少 3 厘米,以便于打开。 目视检查控制密封的完整性和连续性。 市场上提供密封完整性测试,以定期检查热封机是否正确使用和校准(例如,使用墨水测试)。 . |
SBS和SBS材料性能必须符合国际标准。 除棉纺织品外,国际标准定义了 SBS 材料的性能。
ISO 11607-1 et ISO 11607-1 et -2.和老化等)的指标和方法。 对于某些指标,可以提出不同的方法。例如,对于无菌屏障性能没有唯一的普遍接受的测试。 制造商可以使用一种或多种方法并在至少应采用一种能检测通过指标或失败指标的方法。
RMD et RMD.定义的。 包装过程与灭菌部门和医疗机构的组织相适应。可参考当地指南或法规。
对于每种包装配置,风险分析应考虑以下危害和危险情况:
SBS(双袋或双层卷材、双层包布或先包布再放在灭菌容器中)。认 SBS是否需要多层包装。 在任何情况下,都必须检查:
包装在受控环境中进行。在清洁区中单独划分包装操作的空间。空气质量由当地法规或最佳实践指南决定
对于给定的 RMD 包装没有唯一正确的方法。根据RMD 特性、灭菌部门的组织和经验,与手术部或其他科室用户合作定义包装过程。例如,拥有内部灭菌部门的综合医院与灭菌服务外包的专科手术中心的需求是不同的。参考当地指南或法规。
书面 SOP 描述了包装过程的每个步骤。 SOP 包括 RMD 和包装材料两者制造商的 IFU。
Guide d’utilisation法规弃置损坏的物品。
检查灭菌容器垫圈、配合面和锁扣结构的清洁度、变形、碰撞、缺陷(可能损害密封性能) 、过滤或锁定功能。 将损坏的灭菌容器送去修理。检查复用的过滤器,如果有缺陷则弃置。
在托盘中,侧放具有凹面的器械,方便灭菌因子的扩散,并有利于排出在凹部中聚集的水分(湿热灭菌)
书面的包装标准操作程序 (SOP)是根据质量管理原则制定的。
具有相同的包装过程的每组 RMD 都有一个 SOP(即相同的灭菌程序、相同类型的 SBS、相同的运输和储存的保护措施)。每个 SOP 都基于从包装准备到无菌取用的全面的分步风险分析。对于每种类型的代表性包装,在现场最坏情况下的测试可对风险分析的结果的正确性提出挑战。
包装工艺确认控制:
已执行培训并提供证书。
所有参与包装准备、运输、储存和取用的人员都接受了适当的培训。 一个包装过程,涉及许多人工或半人工操作,正确执行这些操作至关重要。 在运输或储存过程中,再多的保护也无法防止不恰当的操作。 在最后阶段,如果无菌取用操作不当,将无菌 RMD 带到使用点(即手术室)的所有努力都会付之东流。 |
确认会在每年重复执行,并且在发生更改之后,判定需要执行部分的或全部的确认行为。 根据需要更新程序和培训。
直到RMD被使用之前,包装过程是有效灭菌和保持无菌状态的关键。风险分析用于检查所有包装元素:
包装流程中涉及的所有人员,包括物流和使用点员工,都接受了足够的培训,并意识到他们RMD 和保障患者安全的重要性。
RMD ready to be packaged in preparation for sterilization
Go to objectives of packaging →
1 of 12 已灭菌的RMDRMD sterility preserved by SBS
Go to packaging process →
2 of 12 包装系统中的RMDRMD ready for transport and storage and aseptic extraction
Go to packaging process →
3 of 12 包装系统中的RMDPackaging system ready for transport and storage and extraction
Go to packaging process →
4 of 12 复用的纺织品Reusable Cotton textile to be avoided
Go to choice of the packaging method →
Implementation according to SOP
Go to Packaging process →
5 of 12 复用的灭菌容器Containers compliant to international std cleaned and disinfected and controlled
Go to choice of the packaging method →
Implementation according to SOP
Go to Packaging process →
6 of 12 一次性包装材料Pouches and reels compliant to international std
Validated sealing
Go to choice of the packaging method →
Implementation according to SOP
Go to Packaging process →
7 of 12 一次性包布Wraps compliant to international std
Folding according to validated practices
Go to choice of the packaging method →
Implementation according to SOP
Go to Packaging process →
8 of 12According to SOP defined after risk analysis
Go to WFHSS recommendations for packaging →
Visual controls
Go to Packaging and quality →
10 of 12Packaging compatible with sterilization process
Go to Objectives of packaging →
11 of 12As needed installation of protective packaging
Go to packaging process →
12 of 12“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.
They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.
Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.
We wish you interesting reading!
On behalf of the Executive Committee
Dr Christine DENIS, President”
“The WFHSS executive committee is pleased to put the WFHSS Guidelines at your disposal.
They have been written for all the professionals working directly or indirectly in the field of the reprocessing of Reusable Medical Devices (RMD) used in Health Care facilities.
They are the result of a consensus from a review of national practices, standards, regulations.
They are intended to provide guidance and the state of the art recommendations from an academic world society focused on science but their purpose is not to supersede local regulation, standards or guidelines.
They will be updated regularly to follow the evolution of the science and the evolution of the RMD and the technologies.
Your feedback is essential to contribute to the improvement of the Guidelines , feel free to use the form to send your comments or suggestions.
We wish you interesting reading!
On behalf of the Executive Committee
Dr Christine DENIS, President”
For the present guidlelines reusable medical device (RMD) means:
The reprocessing of single use medical device is outside the scope of theses guidelines.
Medical device regulations vary between regions. Some items may not be registered as medical devices in some regions.
Sterilization is intended to renders the reusable medical device free from viable microorganisms. Sterilization is implemented on a clean RMD. Most common Sterilization process is steam. Low temperature sterilization processes are available for heat sensitive RMD
Disinfection :
Process to reduce the number of viable microorganisms to a level previously specified as being appropriate for a defined purpose (ISO 11139 : 2018)
Cleaning :
Removal of contaminants to the extent necessary for its further processing or for intended use (ISO 11139 : 2018)
Other definition: The first step required to physically remove contamination by foreign material, e.g. dust soil. It will also remove organic material such as blood, secretion, excretion and microorganisms, to prepare a medical device for sterilization or disinfection (WHO : 2016)
Cleaning may be combined to disinfection in cleaning & disinfections processes (for instance in automated washer-disinfectors)
Sterilization :
Process used to render product free from viable microorganisms (ISO 11139 : 2018)
Reusable Medical device (RMD)
Medical devices wich are not single use i.e. which can be reused under appropriate reprocessing conditions, for an undelimited number of time or for a predetermined number of use.