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实施运输复用医疗器械 (RMD)的场景:
在实施朊毒体防控措施的国家,将有潜在风险的 RMD 与其他器械分开,并根据当地法规做出明确标识和实施转运。
污染的运输容器:运输污染RMD的容器与运输无菌或消毒物品必须有明显区别。无论采用何种运输方式,污染的物品都不使用与无菌或消毒物品相同的运输路径。
运输工作人员接受适当的有关物品搬运风险的教育。
负责污染物品运输的工作人员已经接受运输容器内污染物品风险相关的教育。
运输车应准备好个人防护设备和生物危害泄漏应急装备。
消毒或非最终灭菌后,RMD 依然会受到环境和操作的污染。在受控条件下进行转运。 根据斯波尔丁分类原则,按RMD 的预期用途确定预防措施级别。
最终灭菌后,无菌 RMD 有包装保护。 采取预防措施以避免包装破裂或损坏。若发生损坏,则按系统流程报告。
运输的标准操作程序 (SOP) 是根据质量管理原则制定的。
应执行风险分析。 包装应能适应运输的条件。 风险分析还应评估运输中的不利情况,例如湿度过高、暴露于极端温度下出现的冷凝、灰尘和污垢、过高的气压和微生物。
运输过程确认管理下面的内容:
Switch in landscape mode to use the flowchart
RMD after point of use processing
Go to Transport– Key principles →
1 of 12 运输污染的 RMDBy trained operators personal aware of contamination risks
Go to Transport of RMD after use →
2 of 12 再处理部门中的 RMDRMD after point of use processing
Go to Transport – Key principles →
3 of 12 再处理部门中的 RMDPackaged sterile RMD or disinfected RMD
Go to Transport– Key principles →
4 of 12 运输无菌或消毒的 RMDBy trained operators personal
Go to transport of RMD after disinfection or sterilization→
5 of 12 储藏区域RMD in sterile packaging
Go to transport key principles →
6 of 12 在使用现场再处理Care unit or operating theatre
Go to Transport key principles →
7 of 12According to transport SOP
Go to WFHSS recommendation for transport →
Traceability and controls
Go to Transport and quality →
9 of 12According to SOP’s
Go to WFHSS recommendation for transport →
According to SOP’s
Go to transport of RMD after disinfection or sterilization →
11 of 12Traceability and controls
Go to Transport and quality →
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.