Transport
RMD 的运输——关键原则

实施运输复用医疗器械 (RMD)的场景:

  1. 使用现场即时处理后。 RMD被转运到灭菌部门或消毒间进行消毒。 污染的 RMD 装在一个密闭容器中,同时采取预防措施以避免RMD损坏。
  2. 灭菌或消毒后。最终灭菌后,有包装保护的无菌 RMD 被运送到存储区,或者如果打算立即使用,则运送到使用现场。 在非最终灭菌或消毒后,没有保护的 RMD 被转运到使用现场或临时存储点。在一定的时间范围内实施转运,并限制再次被污染的风险.


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。

  • 人手直接搬运、或使用手推车或转运车进行院内运输:污染的器械容器按照指定的路线运输,以避开人流量大的区域和病人护理区。转运车和工作台足够大,可以将所有包裹平放,而不会超出推车搁板或台面。污染和无菌或消毒的物品绝不能一起同时放在手推车或转运车上。当手推车交替用于运输污染物品和清洁物品时,在每次使用之间应根据手推车制造商的使用说明 (IFU) 进行处理。推车的设计和材料利于清洁,最好能进行自动清洁。如果手推车离开空气受控的区域,应闭合并受到监控。手推车或其他转运车辆的复用车罩在每次使用后都要清洗,并有一个可密封的开口。
  • 院内运输使用自动推车分配系统和气动系统:在设计上,污染物品路线和无菌物品路线是不同的。由授权人员监督系统运行。根据制造商的 IFU 对设备进行清洁和消毒。
  • 院内运输使用电梯:污染的RMD 或无菌和消毒的RMD使用专用电梯。电梯应足够宽敞,可以安全地放置密封箱。电梯设计应便于清洁,根据使用机构的规定进行定期清洁。专用清洁电梯应位于指定为“清洁”区域。无菌物品放置在密封垃圾箱、封闭的转运车或塑料袋里。
  • 院外运输:运输RMD优先安排专车专用。如果车辆同时用于运输污染和清洁的器械,则将污染和清洁的器械放置在车辆的相互独立的安全区域。所有运输车辆(机动或手动)的设计和材料都适宜进行清洁和消毒。储物柜是完全封闭的。车辆是定制的,便于装卸。推车固定在车厢内,以防止损坏或溢出物污染。已装载完毕并准备出发的车辆不应在不安全的区域停放且无人监管。
  • 所有 RMD 均需要小心运输。人手搬运放置污染物品的容器时,要保持水平,以避免溢出和 RMD 移位。

运输工作人员接受适当的有关物品搬运风险的教育。

运输使用后的RMD

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。

消毒或灭菌后物品的运输

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。

运输和质量

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:

  • 已执行培训,内部和外部员工(如果运输外包)都已获得培训证书。
  • 落实职业健康和安全措施; 特别是涉及到运输污染 RMD的内容。
  • SOP 是最新的,包括了风险分析结果。
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 对运输的建议

  1. 污染物品和无菌或消毒的物品采用不同的运输路线
  2. 运输工作人员(医疗机构员工或外部职员)接受相关的感染风险和物品处理风险的职业健康和安全教育
  3. 运输按照质量管理原则实施并经过流程确认。 风险分析保证物品包装适应运输条件。
Transport flowchart

Switch in landscape mode to use the flowchart

使用现场的 RMD

RMD after point of use processing

Go to Transport– Key principles

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运输污染的 RMD

By trained operators personal aware of contamination risks

Go to Transport of RMD after use

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再处理部门中的 RMD

RMD after point of use processing

Go to Transport – Key principles

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再处理部门中的 RMD

Packaged sterile RMD or disinfected RMD

Go to Transport– Key principles

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运输无菌或消毒的 RMD

By trained operators personal

Go to transport of RMD after disinfection or sterilization

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储藏区域

RMD in sterile packaging

Go to transport key principles

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在使用现场再处理

Care unit or operating theatre

Go to Transport key principles

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According to transport SOP

Go to WFHSS recommendation for transport 

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Traceability and controls

Go to Transport and quality

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According to SOP’s

Go to WFHSS recommendation for transport 

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According to SOP’s

Go to transport of RMD after disinfection or sterilization 

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Traceability and controls

Go to Transport and quality

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参考文献- 运输
  1. ISO 17664-1 :医疗器械的处理- 医疗器械制造商提供的医疗器械处理的信息
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“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” 

Reusable medical device (RMD)

For the present guidlelines reusable medical device (RMD) means:

  • an item that is not intended by its manufacturer for single use.
  • A medical device designated or inrtended by the manufacturer as suitable for reprocessing.

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

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)

Tooltip Content

Sterilization :

Process used to render product free from viable microorganisms (ISO 11139 : 2018)

  • courthouse-3-1 Sterilization is intended to renders the reusable medical device (RMD) free from viable microorganisms.

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.