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灭菌或消毒后,复用医疗器械 (RMD) 可立即使用或存储直至使用。
存储条件取决于Spaulding分类原则下 RMD 的风险程度。
在一些国家,中度危险性软式内窥镜的临时存放可以通过使用存放柜来延长。 最长存储时间由当地法规或指南规定。 阀门必须在干燥和无尘的条件下拆卸和单独存放。
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在消毒供应中心或使用现场存储。
在存储区外的拆箱区域将物品从外部运输容器中取出。 仅限于授权人员进入存储区域。 |
避免开放式的排放设施、供水设施、管线。 如果存在这样的情况,包括使用灭菌容器包装在内的所有无菌物品均不可以存放在水槽旁边或下方、与水接触的地方或下水管线的下方,或存放在任何可能被打湿的位置. 不要将无菌包材暴露在阳光直射下。 紫外线会加速包装材料老化。 避免温度和湿度的变化以防止水分(冷凝物)在器械表面积聚。 避免温度大幅度波动防止水分(冷凝物)积聚。 推荐的温度和相对湿度范围随当地指南而异(温度从 15°C 或 18°C到 25°C,RH大约 为60% 或在 40%到75% 之间)。 对于某些敏感的物品,制造商 IFU 可能需要指定湿度范围。 存储区域没有空气质量或气流污染限制的标准。参考当地指南。 |
避免开放式的排放设施、供水设施、管线。 如果存在这样的情况,包括使用灭菌容器包装在内的所有无菌物品均不可以存放在水槽旁边或下方、与水接触的地方或下水管线的下方,或存放在任何可能被打湿的位置. 不要将无菌包材暴露在阳光直射下。 紫外线会加速包装材料老化。 避免温度和湿度的变化以防止水分(冷凝物)在器械表面积聚。 避免温度大幅度波动防止水分(冷凝物)积聚。 推荐的温度和相对湿度范围随当地指南而异(温度从 15°C 或 18°C到 25°C,RH大约 为60% 或在 40%到75% 之间)。 对于某些敏感的物品,制造商 IFU 可能需要指定湿度范围。存储区域没有空气质量或气流污染限制的标准。参考当地指南。 |
无菌 RMD 的有效期是与事件相关的,取决于包装材料的质量、存储条件、运输方法和条件以及操作物品的次数和条件。损坏的可能性随着时间和操作次数的增加而增加。 |
存储和质量
根据质量管理原则制定书面的存储标准操作程序 (SOP)。
存储过程确认控制以下内容:
Sterile in packaging or sterilized but not packaged or disinfected
Go to Storage – Key principles →
1 of 8 存储 - 立即使用Transfer under controlled conditions
Go to Storage – Key principles →
2 of 8 低度危险性物品的存放According to type of RMD and hospital policy
Go to Storage – Key principles →
3 of 8 度危险性 RMD 的存储Maximum storage times according to local regulation
Might be prolonged with flexible scopes storage cabinets
Go to Storage – Key principles →
4 of 8 无菌物品的存放In storage area under controlled conditions
Go to Storage of sterile items →
5 of 8 RMD 安全使用RMD safe for delivery to final users
Go to Storage – Key principles →
6 of 8According to SOP’s
Go to WFHSS recommendation for storage →
House keeping of storage area and control of expiration dates according to SOP’s
Go to Storage and quality →
8 of 8EN 16442 : 提供受控环境存放经处理的不耐热内窥镜的储存柜
“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.