Partners
使用现场处理
使用现场处理-原则

使用现场处理包括将复用医疗器械 (RMD) 运送到再处理部门或灭菌部门之前,在使用现场执行的所有操作。


    使用现场和再处理服务部门可能位于不同的位置(在或不在同一建筑物内)。再处理部门的工作人员不一定属于医疗机构的雇员(例如,在服务外包的情况下)

使用现场处理由接受过有关 RMD, 以及与处理污染 RMD 相关的职业健康和安全预防措施的正确培训的员工来执行. 

使用现场操作人员穿戴合适的防护设备,并且

意识到锐器伤害的风险,并知道在发生事故时应采取的措施,
确认所有设备和部件完备,
识别损坏的 RMD 并启动维修/保养或报废流程。
小心处理 RMD,了解器械掉落时适用的流程,

使用现场处理的主要目标是:

  • 将 RMD 与一次性物品和医疗废物分开。 一次性物品、医疗废物根据适用的医疗废物管理法规进行处理。 对于锐器和针头,需要采取特定的预防措施。
  • 按照特定的朊毒体风险应对措施,根据当地法规, 隔离可疑的RMD。
  • 避免 RMD 上的污渍干凅
当污渍干凅时,会粘在器械上变得难以去除,后续的清洁会更加困难。 管腔可能会被有机物堵塞。 必须避免没有经过处理的RMD过夜或放置一个周末。 长时间的延误处理会让微生物形成保护层促使生物膜的形成,导致常规清洁程序无法去除。 血液、体液和生理盐水具有很强的腐蚀性,会导致器械出现点状腐蚀。
 
  • 准备好 RMD将其运送到再处理部门或灭菌部门

将RMD 安全地放置在运输容器中,以避免在运输过程中移动和损坏。 特别注意易碎物品。 锐器需分开放置。

闭合运输容器。 容器带有明确的指示,表明所装的物品具有生物危害性。 生物危害的指示符号由当地法规规定。

如果运输容器的外部有明显污渍,在运输前首先对其进行仔细地清洁去污。

使用现场处理 -实施

使用现场处理操作按照 RMD 制造商的 IFU 执行。

  • 在整个手术过程中,根据需要,使用湿润无菌的手术海绵擦拭 RMD 以去除较大的污渍,用无菌水灌注管腔。
  • 器械使用后立即擦去外部污染物,冲洗管腔工作通道。软式内窥镜需要特定的措施。

将RMD 安全地放置在运输容器中,以避免在运输过程中移动和损坏。 特别注意易碎物品。 锐器需分开放置。

闭合运输容器。 容器带有明确的指示,表明所装的物品具有生物危害性。 生物危害的指示符号由当地法规规定。

如果运输容器的外部有明显污渍,在运输前首先对其进行仔细地清洁去污。

  • 按照RMD 制造商的IFU 拆卸手术马达和由多部件组成的RMD 。

  • 对于复杂的器械(例如,具有管腔或复杂形状结构的器械),可建议在使用现场进行浸泡。 当地指南可能会有类似的要求或推荐。使用现场浸泡按如下方式实施进行:

清洁和消毒配方符合相应法规和国际标准的要求。 避免如干热或醛类化学剂导致凝固后果。

在专门的水槽中进行浸泡。

溶液浓度和暴露时间取决于制造商的 IFU。

使用中溶液的更换按照当地指南进行。(在处理每一个患者使用过的器械之后,每 24 小时或当溶液出现明显可见污渍时)。

当运送器械到灭菌部门的时间需要很长时(例如在周末或过夜),一些当地指南可能会推荐在使用现场进行自动化预处理措施。

  • RMD 有序放置在运输容器中。
充分保护易碎的 RMD,免受运输人员换班的影响。 微创器械和内窥镜可能需要定位装置。 光学部件放置在专门容器中。 锐器被分隔在容器内 重器械在底部,轻的精密器械在上部。 器械托盘不超载。 容器的大小应避免软式器械过度弯曲。
  • 使用现场如果没有进行浸泡,并且进行下一步清洁和消毒前的间隔时间很长, (1) 用一条蘸有水(不是生理盐水)的毛巾覆盖在器械上,或 (2) 在能够保持潮湿条件的容器中进行运送。
  • 如果进行下一步的清洁的间隔时间很短(最多 6 小时),“干式处理”优于“湿式”处理,能减少 对RMD的 腐蚀。
  • 容器是封闭的,最好是可上锁的。
使用现场处理和质量

使用现场处理标准操作程序 (SOP) 是根据质量管理原则, 与手术部和医疗诊疗科室合作制定。

使用现场处理的过程验证是为了控制:

  •  已经执行培训
  • 职业健康和安全措施到位。
  • 知晓并应用医疗废物管理规定。
  • 追溯是可行的。
  • 标准操作程序 (SOP) 是最新的。
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 对使用现场处理的建议

  1. 使用现场处理将 RMD 与一次性物品和医疗废物分开。 采用擦拭、冲洗管腔、在清洁消毒溶液中浸泡来避免污渍干凅。 如果下一步的清洁间隔的时间很长,则在将 RMD 放入闭合的(最好是上锁的)运输容器之前,应采取额外的预防措施。
  2. 使用现场标准操作程序 (SOP) 是与手术部和医疗诊疗科室合作制定的。
  3. 处理污染的 RMD, 需要充分了解 RMD,和实行相应的职业健康和安全措施。
  4. 按质量管理原则实施操作过程。
Point of use processing flowchart
污染的 RMD

Used on patient or withdrawn from packaging

Go to Preparation for cleaning – Key principles

1 of 7
使用现场的清洁准备

According to SOP’s Gross soil removal, soaking, careful installation of RMD in closed container

Go to Preparation for cleaning – process

2 of 7
再处理部门的清洁准备

According to SOP’s

Go to Preparation for cleaning – process

3 of 7
可进行RMD的清洁和消毒

RMD prepared for cleaning

Go to Storage – Key principles

4 of 7

SOP’s  prepared in partnership with medical or surgical users

Occupational health and safety measures

Go to WFHSS recommendation for preparation for cleaning

5 of 7

Transfer to sterilization department or reprocessing room

Go to Preparation for cleaning – process 

6 of 7

Controls

Go to Preparation for cleaning and quality

7 of 7
参考文献 – 使用现场处理
  1. ISO 17664-1 :医疗保健产品的处理 – 医疗器械制造商需要提供的处理医疗器械的信息 (2017)

Comments on WFHSS guidelines

Please fill the form

Click words or phrases color for definitions and descriptions

When a word or phrase is the title of a chapter, a link is provided to give direct access to the chapter

Close or expand to hide or show functions :

Display a window with additional information
Close a window

Using icons :

Provides explanations or examples
Provides additional indications on international standards
Are regulatory insights
Provides WFHSS advice or recommendations

In the flowchart

Move the cursor on colored cells to open an explanation or tool tips.

Click a link for direct access to a paragraph

“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”  

播放视频

“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.