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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。

 

用低纤维絮擦布擦拭软镜插入人体的部分。 抹布应浸湿了无凝固蛋白质作用且兼容器械的清洁消毒液。

用相同的溶液冲洗管腔通道。

可以使用冲洗瓶中的水冲洗空气/水通道,。

根据 RMD 制造商 IFU 进行测漏。 这可确保及早发现渗漏和穿孔,并防止液体渗入造成更严重的损坏。

 

  • 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Used on patient or withdrawn from packaging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)

“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”  

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Maintenance

Combination of all technical and associated administrative actions intended to keep equipment at a state in which it can perform its required function, or restore it to such a state (ISO 11139 : 2018)

Packaging

Packaging is intended to preserve the sterility of teh reusable medical device (RMD) until its use.

Reusable containers

Rigid sterile barrier system designed to be repeatedly used (ISO 11607-1 2018)

International standards

For the puropose of these guidelines, International Standard means standardsor guidance published by international standardization organizations such as ISO or CEN.
Go to the international standards paragraph or Regulation and standards chapter 

Prion

Prion is a small proteinaceous infectious unit that appear in a variety of neurodegenerative diseases, including bovine spongiform encephalopathy, Creutzfeldt-Jakob disease, and scrapie. They derive from a normal body protein that becomes irreversibly misfolded and proliferates primarily in the central nervous system.
Prions are highly resistant to disinfection and sterilization

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces.

Air quality

Levels of purity of ambient air and compressed air used for drying.

Water quality

Chemical, physical, biological, and radiological characteristics of water used for cleaning, disinfection, rinsing and steam sterilization of RMD.

Point of use reprocessing

Processing operation performed at point of use of the Reusable Medical Device (i.e. operating theatre or care unit)

Quality management 

Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement.
In the present guide the quality management chapter includes a description of the processus approach, performance evaluation, risk and non-conformity management, documentation management and traceability

Go to quality management chapter →

Spaulding classification

The Spaulding classification qualify the RMD as non critical when they touch intact skin, semi-critical when they are brought in contact with mucous membranes and critical when they enter sterile body cavities. Processing requirements increase with level of risk involved in their use.

Occupational health and safety (OHS)

OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards (WHO : 2016)

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.

Standard operating procedures

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Routine control (or routine test)

technical operation conducted periodically to establish that the operational performance of the equipment or process remains within the limits established during validation (ISO 11139 : 2018) 

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the anchorage of proteins, including prion on RMD surfaces. For instance, dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such formaldehyde or glutaraldehyde, alcohol used to accelerate drying of some RMD. For this reasons, some national guidelines recommend to avoid use of this subtances or require specific precautions (for instance thorough cleaning)

“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” 

Non terminal sterilization

Non terminal sterilization is a process whereby product is not sterilized in a sterile barrier system and hence not protected from environmental and handling contamination after the sterilization cycle.

Terminal sterilization

Process whereby product is sterilized within its sterile barrier system (ISO 11139 : 2018)

Standard operating procedures (SOP's)

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Outsourcing

For the needs of the present guidelines outsourcing means a process in which a healthcare facility employs another organization to perform some or all reusable medical device reprocessing tasks. The organization can be another healthcare facility, a shared reprocessing unit or a private service company. The services can be perfomed within the healthcare facility or externalized.

Pyrogen

Pyrogen are substances that induces fever. Endogenous pyrogen are low-molecular weight protein produced by phagocytic leukocytes in response to stimulation by exogenous pyrogens. Exogenous pyrogens are produced by bacterial endotoxins and other microbial product such as antigen, antibody complexes, virus

Endotoxin

Endotoxins are lipopolysaccharide components of the cell wall of Gram-negative bacteria that are heat stable and elicits a variety of inflammatory responses in animals and humans (ISO 11139: 2018)

Traceability

Ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

Training

For the purpose of theses guidelines, training means the certified acquisition of the theoricital, practical skills and behavior adapted to the assignment. Skills are periodically controlled and updated as needed.

Routine controls

Routine control check that performances of process or equipment are maintained over time between 2 process validations. Routine controls can be systematic (at each cycle) or at predefined periodicities. For instance, for the sterilization process, at end of each cycle, it is checked that process parameterare are within the validated tolerances, leak tests are performed daily or at periodicity defined by local recommandations. 

Go to process validation chapter →

Instruction for use (IFU)

Written indication provided by the manufacturer to ensure correct and safe use of a products (including but not limited to reusable medical device, reprocessing equipment and consumables). IFU of RMD include the instruction for reprocessing. IFU are also available for reprocessing equipment and consumables.   

Risk analysis

Identification and analyzis of potential issues that could negatively impact a given process. Risk analysis includes an evaluation of the consequence and likelihood. The issues with the more severe consequences and higher likelihood of occurence are addressed in priority. As needed measure are then to minimize the occurence or consequence. Methods are available to improve the reliability of the risk analysis. 

Storage

Storage concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions.

Transport

Transport includes:

  • The transfer of soiled reusable medical device from the point of use to the reprocessing site and
  • the transfer of the sterilized or disinfected RMD to the point of use.

Process validation

Process validation means establising, by objective evidence that a process consistently produces a results or product meeting its predeternined objective. Process validation applies to all steps of RMD reprocessing from point of use processing to storage. When equipments are used validation include their installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Process validation is perfomed before implementation of a new process or equipment (initial validation). Revalidation takes place periodically (usually each year) or after event justifying total or partial revalidation (change in the process, maintenance of equipments).

Waste management

Waste management groups all activities and actions required to manage waste including the collection, transport, treatment and disposal of waste together with monitoring of the waste management process. Instrument reprocessing waste are are solid (i.e., single use packaging, detergent or disinfectant empty bottles, cleaning brushes, possibly sharp devices), liquid (i.e., cleaning, disinfecting, rinsing solutions) or gazeous (i.e., sterilization, cleaning or disinfection effluent). Waste might be non hazardous, infectious, or toxic. Waste management regulation limits impact on environment and protects staff. Waste management rules are country dependent.

Traceability

Traceability is the ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

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.