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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 

8 of 12

Traceability and controls

Go to Transport and quality

9 of 12

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

“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.