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

Partners
复用医疗器械
复用医疗器械 (RMD) 的处理

就本指南而言,复用医疗器械 (RMD) 是指:

  • 器械制造商明确不是一次性使用的物品。
  • 器械制造商明确使用后可进行再处理的医疗器械。

 


本指南不涉及一次性医疗器械的再处理.

RMD 可能是:

  • 与皮肤、粘膜接触或进入人体的医疗或手术物品(例如,手术器械、软式内窥镜、牙科器械)。
  • 与患者接触的诊断、监测、治疗设备的组件。
  • 用于输送体液、组织或准备后续使用于人体的制剂(例如血液透析)的物品。

 


   医疗器械法规因地区而异。 有些物品在某些地区可能不会作为医疗器械注册。

 

欧洲医疗器械法规将再处理定义为:

“对使用后的器械规范处置的过程,以保证其重复使用的安全。包括清洁、消毒、灭菌和相关程序,以及测试和保持使用后的器械的性能和功能的安全性”。 

美国食品和药品监督局 (FDA) 将再处理定义为:

“对于用过或受到污染的医疗器械,执行经验证的过程使其适合下一次使用。这些过程旨在通过清洁去除污渍和污染物,并通过消毒或灭菌来灭活微生物。复用器械的再处理包括在器械使用现场附近开始的规范步骤,通常依次包括以下三个步骤:使用现场预处理……、彻底清洁……消毒或灭菌……”

再处理可由医疗机构执行或根据外包合同由外部组织完成。

再处理规范适用于从包装中取出的所有 RMD,即使它们没有被使用。

还可以对以下物品进行再处理:

  • 借出或寄存的RMD,
  • 维修后返回的RMD,
  • 新RMD交付时并非无菌。 RMD 制造商可能会建议进行特定的再处理,以消除新器械上的制造过程污染残留和/或在首次使用前对器械进行灭菌。

为了器械保养人员的安全,送去进行保养的RMD必须进行清洁和消毒(提供再处理证书)

Spaulding分类原则

在 1960 年代后期E.H. Spaulding对用于患者护理的器械和物品根据其使用中的感染风险进行了分类。

  1. 高度危险性物品:进入人体无菌组织器官或脉管系统的物品。高度危险性 RMD如果被任何微生物污染, 存在极高感染风险。因此,进入无菌组织或脉管系统的物体必须是无菌的。任何微生物污染都可能传播疾病。例如:用于无菌体腔的手术器械、手术植入物、内窥镜或超声探头(如胆道镜)。
  2. 中度危险性物品:接触粘膜或破损皮肤的物品。粘膜可能是抵御少量常见细菌孢子的有效屏障。但是,其他生物体的存在会使人处于风险之中,例如细菌、分枝杆菌和病毒。中度危险性物品例如呼吸治疗和麻醉设备,以及一些软式内窥镜。
  3. 低度危险性物品:接触完整皮肤但不接触粘膜的物品。完整的皮肤是大多数微生物的有效屏障。低度危险性物品例如便盆和血压袖带。低度危险性的环境表面包括床边护栏、一些餐具、床头柜、病房家具和地板。在某些地区,成像系统的键盘和控制台也可能被归类为医疗设备,这些也属于低度危险性物品。

Spaulding分类的核心原则仍然有效,但随着时间的推移发生了变化。 例如:

  • 微创手术增加了RMD 的整体复杂性。 管腔和精密器械的清洁可能很困难。带有严重污渍和严重污染物的软式十二指肠镜就是一个很好的例子,清洁的复杂性增加了风险,提倡有效清洁后进一步进行灭菌。
  • 消毒灭菌方式的选择增多,难度加大,以当地规范为准。

 

 

热敏 RMD 需要若干个适合其材料和结构特性的周期。

一些耐热的微创手术器械使用高温灭菌时存在加速老化的现象(例如,腹腔镜设备)。一些国家允许使用低温灭菌;而其他国家则没有。

最近,也有器械的应用出现了高度危险性与中度危险性之间的交叉重叠。例如,使用无菌活检钳进行上消化道检查的内窥镜。 

并非所有指南都遵循下面定义的 3 个消毒级别。

  • 高水平消毒:杀灭所有微生物但不能杀灭所有细菌孢子的过程。该定义的其他表述是:杀灭除大量细菌孢子外的所有微生物,或杀灭除少量细菌孢子外的微生物。
  • 中水平消毒:杀灭病毒、分枝杆菌、真菌和繁殖体的过程,但不一定能杀灭细菌孢子。此定义的其他表述是:杀灭分枝杆菌、繁殖体、大多数病毒和大多数真菌,但不一定能杀灭细菌孢子或繁殖体。
  • 低水平消毒:杀灭大多数繁殖体、一些病毒和一些真菌,但不杀灭分枝杆菌或细菌孢子的过程。
  • 一些国家有额外的高水平消毒标准。例如,美国 FDA 的定义是:使用灭菌剂在较短接触时间内,对特定的分枝杆菌能达到 6-log10 杀灭效果。在其他国家,中水平和高水平消毒之间没有表征效果的阈值,也没有灭菌剂概念。
  • 当应用上述消毒级别时,应遵循国家或地区法规。
  • 朊毒体、传染病爆发和易感人群(例如免疫功能低下的患者)更需强调护理单元和感染控制部门之间积极的沟通。
  • 监管机构和国际标准的提高对医疗器械制造商提供优化的、经过验证的再处理指引产生了推动作用。

 

国际标准 ISO 17664-11 描述了要求 RMD 制造商提供高度危险性和中度危险性医疗器械的再处理信息。 RMD 制造商制定的指南应基于必要的风险分析和测试。 RMD 制造商确认所推荐的再处理方法是否在销售 RMD 的国家/地区是可用的
  • 职业健康与安全以及环境考虑是关键因素。 例如,首选自动清洁方式,因为有更好的一致性且对操作员更安全。同时要遵循医疗废物管理规范。
朊毒体风险

朊毒体是一种小的有感染性的蛋白质单位,出现在各种人类和动物神经退行性疾病中,包括克雅氏病 (CJd)、牛海绵状脑病 (BSE,也称为疯牛病) 和痒病。

朊毒体病一直存在,但通常非常罕见。 朊毒体蛋白来源于一种正常的身体蛋白质,它会不可逆转地错误折叠。 朊毒体蛋白主要在中枢神经系统 (CNS) 中增殖。

 1980 年代,在一些西欧国家牛肉被BSE感染,一种变异的克雅氏病在食用了受感染牛肉的人中传播。

朊毒体对消毒和灭菌具有很强的抵抗力。 在存在导致蛋白质凝固的物质时它们的抵抗力还会增加。

因此,一些国家实施了应对朊毒体的法规或指南,指导从 RMD上中去除或灭活朊毒体蛋白。 此类法规或指南是适用于特定国家的。 以下章节提供了有关应对朊毒体的信息(参考了某些国家或地区的建议或规范)。

通常基于患者筛查和对 CNS 手术(脑、脊髓或眼后部)的特别关注措施来制定策略。

有风险的患者或手术的应对措施示例如下:

  • 尽可能选择一次性手术器械。
  • 延长所使用的RMD在完成再处理流程后的存放周期,直到可以确认没有风险。
  • 采用已有实验数据表明能够灭活朊毒体的处理过程(即破坏蛋白质而不仅仅是消除)。



 

朊毒体灭活的评估基于复杂的活体实验。 实验表明显示有效的工艺有次氯酸钠、氢氧化钠、高 pH 值碱性洗涤剂、某些低温灭菌周期、还有某些采用清洁剂的低温灭菌周期。在准确定义的条件(即浓度、温度和暴露时间等)下才能获得效果,并且也仅在这些特定条件下才有效。 134°C 18 分钟的蒸汽周期具有很高的功效。 (虽然在最不利的条件下灭活有可能不完全

 

应对朊毒体的法规或指南强调避免 RMD 上的污渍干涸的预防措施,并对涉及蛋白质凝固的工艺过程的使用提出相关的风险警告



已知的一些灭菌、清洁和消毒配方中会加强蛋白质(包括朊毒体)在 RMD 表面上的凝固。 例如,干热、环氧乙烷、醛类消毒灭菌剂如甲醛,戊二醛或酒精。已制定朊毒体监管法规的国家可能会禁止或不鼓励使用包含凝固剂成分的制剂,或要求在使用有潜在凝固后果的制剂之前,采用不含凝固剂的工艺进行彻底清洁



此外,一些地区可能会制定本地区的 RMD 蛋白质残留量标准,并对特定操作中使用的 RMD 采取额外的预防措施,例如与大脑、脊髓或眼后部相关的流程。

由于朊毒体管理因国家而异,故朊毒体的风险管理是由国家法规规定

医疗设备警戒

医疗设备警戒系统用于提高患者安全,通过减少与RMD使用相关的事件再次发生的可能性,来保护医疗保健专业人员和其他RMD使用者的健康和安全。

各国制定了收集和分析事故报告的法规。

一些风险可能与RMD再处理流程有关。 RMD再处理部门必须做出降低风险的努力。

 

许多地区都有不同的警戒系统在运作。 例如,在欧盟,医疗设备法规规定设备制造商负有向欧盟主管部门报告不良事件和现场安全纠正措施 (FSCA) 的法律责任。 医疗设备用户也可以向管辖范围内的主管部门报告事故。 这些报告汇总到名为 EUDAMED 的中央数据库。 美国食品和药品监督局 (FDA) 运行类似的系统,并拥有自己的数据库,名为制造商和用户设施设备体验 (MAUDE) 数据库,其中包含自 1996 年 8 月以来向 FDA 报告的所有医疗设备报告。

其他国家如加拿大、日本和澳大利亚也运行类似的系统。 许多地区现在通过国际医疗设备监管机构论坛 (IMDRF) 在医疗设备监管方面进行合作。

 

 

RMD再处理和质量

遵循以下质量管理原则进行安全的再处理流程:

  1. RMD 制造商:IFU 包含经过验证的再处理指引。必要时需指明最多重复使用的次数。
  2. 再处理流程中涉及的设备和耗材的制造商:灭菌器、清洗消毒器、清洁剂和消毒剂等……符合国际标准和适用的法规。
  3. 医疗保健机构:在标准操作程序 (SOP)中详细定义所有再处理。再处理中的所有环节都关系到患者安全:干涸在 RMD 上的污渍更难清洁,未能正确清洁的 RMD 无法灭菌或消毒,不正确的包装、运输、储存或无菌取用都可能意味着RMD受到污染或  损坏

通过过程确认,用户验证下面内容:

  • 再处理设备安装符合制造商的指引
  • 能获得IFU、测试和校准证书。
  • SOP 是最新的。而且在必要时,应包括对特定风险(如朊毒体)的管理。
  • 已制定了日常控制措施。
  • 已执行了培训并获得培训证书。
  • 知晓并实施职业健康和安全预防措施。
  • 知晓并积极履行医疗设备警戒义务。
  • 知晓并积极实施废物管理措施。
  • 制定了器械再处理设备的保养计划。
  • 追溯是可行的。
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 对 RMD 再处理的建议

WFHSS 对 RMD 再处理的建议

  1. 购买新的RMD 前应咨询负责器械再处理的人员。 医疗保健机构应确保能应用 RMD 制造商推荐的器械再处理的方法。 复杂的 RMD需要特别注意。
  2. 器械再处理的标准操作程序 (SOP)应遵循 RMD的IFU 和适用的指南。 如果需要对 RMD 制造商的 IFU 进行调整,则必须对其进行论证、风险评估和记录。 当 按Spaulding原则判定器械类别存在疑问时,应选择适用的最高类别。 如果发现缺陷,则根据适用的医疗设备警戒规范进行报告。
  3. 护理单元和院感控制部门合作组织和实施RMD 的再处理。 从使用现场使用后到下一次的无菌取用之间的措施都应是明确的。 充分考虑朊毒体风险、传染病爆发和易感人群这些因素。
  4. 已执行质量管理和工艺验证。
RMD再处理流程图
污染的RMD

SOP’s according to Spaulding classification principles, Manufacturers IFU’s and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

1 of 13
低度危险性

contact with intact skin

Go to Spaulding classification principles

2 of 13
l中度危险性

contact with mucous or injured skin

Go to Spaulding classification principles

3 of 13
高度危险性

Contact with sterile tissue and vascular system

Go to Spaulding classification principles

4 of 13
根据之前的使用情况评估风险(传染病爆发 - 朊毒体)

In partnership with care or surgical user and infection control

Go to Recommendations of WFHSS for reprocessing of RMD’s

5 of 13
使用现场预处理、清洁、包装(用于最终灭菌)和控制

Thorough cleaning and preparation of RMD

Go to recommendation of WFHSS for RMD

6 of 13
◁消毒 ▷

Level of disinfection according to risk

Go to recommendation of WFHSS for RMD

7 of 13
◁ 灭菌 ▷

Sterilization method according to RMD manufacturer IFU and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

8 of 13
朊毒体应对措施

According to applicable regulation

Go to prion risk

9 of 13
RMD 可安全使用

Functional, reprocessed according to manufacturer IFU’s and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

10 of 13

Consult services in charge of reprocessing before purchase of a new RDM

Go to Recommendations of WFHSS for reprocessing of RMD’s

11 of 13

Validated processes

Go to recommendation of WFHSS for reprocessing of RMD’s

12 of 13

Controls

Go to RMD and quality

13 of 13
参考文献 – 复用医疗器械
  1. ISO 17664-1 : 医疗保健产品的处理 – 医疗器械制造商提供的处理医疗器械的信息

“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”  

播放视频

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.