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包装目标
包装目标

包装旨在保持复用医疗器械 (RMD) 的无菌状态,直至其使用。 为了实现这一目标,包装系统:

1 是一种微生物屏障

2 保护 RMD 和微生物屏障在操作、运输储存过程中,其完整性免受破坏。

 

必须采取预防措施来保护 RMD 的易损部位并避免破坏微生物屏障。 例如,保护RMD 的锐利边缘,并且将 RMD 有条理地摆放在篮筐、托盘或器械固定装置中

包装系统的尺寸和强度适合 RMD 或 RMD 组合的配置和重量。 需要时可增加额外的保护性包装(不是增加包装材料层数)以加强包装的物理强度。

保护性包装也可用于防止包装外表面积聚过多的环境灰尘。

运输和存储过程以及存储设备(例如密封柜和货架)是保持 RMD 和包装完整性的关键因素。

 

  1. 与灭菌工艺兼容。

 

    1. 维持微生物屏障特性
    2. 灭菌因子自由扩散到所有 RMD 表面以及冷凝液或灭菌残留物的自由排出空。
    3. 对抗压力变化和高温的物理强度(适用时)。
    4. 不与灭菌因子相互作用产生有毒副产物
    5. 无颗粒释放

      兼容性涉及灭菌前呈现的所有包装属性,意味着:

 

 

  1. 能实现RMD的无菌取用

 

国际标准 ISO 11607-1 将无菌取用定义为:

“从无菌屏障系统中转移无菌物品时,将微生物污染风险降至最低的条件和操作”。

为了尽量减少无菌取用期间的风险:

负责无菌取用的人员接受了适当的培训,并参与和指导了包装实施过程。

在无菌取用期间,RMD 不会与包装系统的非无菌表面接触,并采用了正确的无菌技术。

无菌区准备充分。 根据需要,在将无菌物品放入任何无菌区域之前去除受污染的保护性包装

如果需要由无菌区域人员操作,采用双层无菌屏障系统 (SBS) 并无菌地提供给无菌区域人员。

 

 


    国际标准 ISO 11607-11,2 将包装功能定义如下:

无菌屏障系统 (SBS) 是“最大限度减少微生物进入并允许在使用时无菌取用无菌物品的最小包装”。

保护性包装 (PP) 是“为了防止无菌屏障系统及其内容物从装配到使用的时间段内受到损坏的材料结构”。

包装系统(PS)是“无菌屏障系统和保护性包装的结合”。

包装方式的选择

市场上可用的无菌屏障技术如下

  1. 一次性包装材料由纺织或非纺织纤维素、合成材料或混合纤维素/合成材料制成。包装材料通常用于托盘和器械的包装。包装材料制造商规定了符合国际标准定义的耐受性和微生物屏障指标所需的包装层数。包裹层可以是独立的(按顺序的)或预先粘合的。 使用各种折叠方法(例如,信封式,方形或包裹或平行式,卷状或巴斯德式,详见ISO /TS 16775-2014 附录C)。方法的名称或偏好可能因地区、习惯或两者而异。折叠由胶带固定,胶带通常也用作灭菌指示物。包装操作员的培训是关键。可找到不同语言的教程。
  1. 一次性使用的包装袋或卷材由 2 层在 3边(包装袋)或 2边(卷材)预密封的包装材料制成。 包装袋和卷材有各种尺寸和强度。根据需要切割卷材的长度。 至少,包装袋或卷材的一面是灭菌因子可穿透的。可穿透面由无纺纤维素、合成材料或混合纤维素/合成材料制成。另一面是透明薄膜(通常灭菌因子不能穿透)。 包装袋和卷材通常用于较轻的器械或托盘。 热封是闭合包装袋或卷材的首选方式。默认情况下,当没有热封设备时,可以使用带有自封胶的包装袋。

 

热封机的温度和压力要根据包装袋制造商指引进行校准。 密封的最小强度和最小宽度由国际标准定义。 必须定义密封的最大强度,不能影响无菌取用。 箭头(人字形)方向表示撕开方向。

RMD 把持部位位于开口侧以方便取用。 锐利的边缘摆放在相反方向,以避免受伤。

留出1/3 的内部空间(在密封性能允许的范围内),以缓冲压力变化。

在密封之前,从袋中挤出空气以避免膨胀。

密封距离袋侧至少 3 厘米,以便于打开。

目视检查控制密封的完整性和连续性。

市场上提供密封完整性测试,以定期检查热封机是否正确使用和校准(例如,使用墨水测试)。

.

 

 

  1. 复用的灭菌容器(底盒和盖子)由铝、不锈钢或高密度聚合物制成。灭菌容器有各种标准尺寸,通常与多个篮筐或器械包一起使用。灭菌因子穿透过滤器,过滤器为一次性使用(最常见)或复用。灭菌容器的清洁和消毒按灭菌容器制造商 IFU规定执行,ji及配置必要的人员、用品和设备。维护计划应到位。 再处理前,弃置一次性物品,拆卸复用的配件。仔细目视检查灭菌容器垫圈、配合面和锁扣结构,以了解清洁度、变形、冲击、缺陷(可能会损害密封)、过滤和锁定功能。污染的灭菌容器重新清洁。损坏的灭菌容器送去修理。 许多制造商推荐一次性过滤器。检查复用的过滤器,如果有缺陷应弃置。如果制造商指定了最多使用次数,在达到该次数时将应弃置过滤器。

 

  1. 复用的纺织品由棉或聚酯制成。 与一次性包装材料一样,它们主要用于托盘和器械包。 传统棉布的阻隔性能较差,经过反复洗涤和灭菌后性能会下降。目视检查穿孔和破损存在人为错误的风险,是不可靠的。 在取用过程中,纺织品释放颗粒可能会污染 RMD 或扩散到无菌区域。 聚酯复用的包布比棉布具有更好的初始阻隔性能。 制造商必须提供证据证明无菌屏障性能在允许的重复使用次数内仍然令人满意。 必须提供能控制复用次数的方法。 为使风险降低至最低程度,质控须由经过培训的人员来执行。

 

SBS和SBS材料性能必须符合国际标准。 除棉纺织品外,国际标准定义了 SBS 材料的性能。


   国际标准 ISO 11607-1 和 -2 描述了测试包装设计、材料和封口(例如,强度、透气性、生物相容性和老化等)的指标和方法。 对于某些指标,可以提出不同的方法。 例如,对于无菌屏障性能没有唯一的普遍接受的测试。 制造商可以使用一种或多种方法并在内部进行测试,或者最好在外部独立实验室的支持下进行测试。 至少应采用一种能检测通过指标或失败指标的方法。

 

对于给定的 RMD 或 RMD 组合包装没有唯一适合的方法。 包装过程是与手术部或其他科室用户合作定义的。 包装过程与灭菌部门和医疗机构的组织相适应。可参考当地指南或法规。

对于每种包装配置,风险分析应考虑以下危害和危险情况:

  • 符合包装材料制造商的IFU 和国际标准
  • 与灭菌过程的兼容性(压力变化、温度、化学影响)
  • 关于运输和储存条件及其对 SBS 和 RMD 的潜在影响的最坏情况。
  • 实现无菌取用的目标
  • 失效期确定。 失效日期是与风险事件相关的(即与运输和存储风险相关)。 失效期总是比包装材料制造商进行的老化测试结论更保守。

 

通常使用多层 SBS(双袋或双层卷材、双层包布或先包布再放在灭菌容器中)。 风险分析应确认 SBS是否需要多层包装。 在任何情况下,都必须检查:

  • 多层SBS 与灭菌过程兼
  • 对于包装袋和卷材:内层 SBS 留有足够的空间。 内层 SBS 预留空间的标准都是基于 RMD 相同需求。 内层包装袋或卷材不折叠以装入外层 SBS。 内层密封部位不会与外层 SBS 的密封部位交错
  • 对于包装:不能因双层包装而减少对折叠的关注
  • 多层 SBS 不会增加取用风险
  •  
包装过程

包装在受控环境中进行。在清洁区中单独划分包装操作的空间。空气质量由当地法规或最佳实践指南决定

对于给定的 RMD 包装没有唯一正确的方法。根据RMD 特性、灭菌部门的组织和经验,与手术部或其他科室用户合作定义包装过程。例如,拥有内部灭菌部门的综合医院与灭菌服务外包的专科手术中心的需求是不同的。参考当地指南或法规。

书面 SOP 描述了包装过程的每个步骤。 SOP 包括 RMD 和包装材料两者制造商的 IFU。

  • 检查有效期(对于一次性包装材料)或最多重复使用次数(对于复用的灭菌容器)。根据废弃物管理程序,制造商的 IFU和当地法规,弃置过期的包布、包装袋或卷材。
  • 目视检查包装。

应保证包布、包装袋和卷材的完整性(即通过检测穿孔或挤压处)。 根据制造商的 IFU 和当地法规弃置损坏的物品。

检查灭菌容器垫圈、配合面和锁扣结构的清洁度、变形、碰撞、缺陷(可能损害密封性能)、过滤或锁定功能。 重新清洗污染的灭菌容器。 将损坏的灭菌容器送去修理。检查复用的过滤器,如果有缺陷则弃置。

  • 在放入 SBS 之前,RMD 根据需要配备保护附件,并摆放在篮筐、托盘或固定装置中。 保护附件和固定装置方便了无菌取用并降低了操作员受伤的风险。 对于包装袋和卷材,器械把手在开口侧,锐利的边缘在相反方向一端。

在托盘中,侧放具有凹面的器械,方便灭菌因子的扩散,并有利于排出在凹部中聚集的水分(湿热灭菌)

  • SBS 是完全密封的。灭菌容器盖的闭合装置上装有“打开迹象”指示器。折叠包装。包装袋和卷材是密封的。根据风险分析如果需要,可以采用类似的预防措施增加多一层的包装袋、卷材或包布。
  • SBS 带有单独的标签。标签是可见的(即在双层包装的外层包装上)。如果一个保护性包装 (PP) 包含多个 SBS,则要提供识别 PP 中所包含的 SBS 的方法。对于包装袋和卷材,标签放置在不可穿透的一面。不允许在多孔包布上书写或打印,因为墨水可能会渗入包装。相反,允许在不与医疗器械直接接触的多孔包布上书写或印刷。每个灭菌容器都带有一个可追溯性标签。标签与灭菌过程兼容。失效日期是根据 SOP 定义的。
  • 灭菌后,每件物品都经过目视检查。报告和分析损坏、不合格和丢失或不完整的标签。外层包装袋、卷材或包布上的可见损坏是进一步检查内层 SBS 损坏的指征。根据需要,对 RMD 进行重新包装和灭菌或清洁后灭菌。应进行根本原因的分析,并相应地调整风险控制措施。
  • 根据需要,实施保护性包装(灭菌后)。如果一个保护性包装包含多个 SBS,则明显标出保护性包装的内容物。
  • 小心谨慎运输储存器械包。
  • 当使用时,对器械包进行目视检查。 RMD 由经过培训的人员按无菌操作取用。
包装和质量

书面的包装标准操作程序 (SOP) 是根据质量管理原则制定的。

具有相同的包装过程的每组 RMD 都有一个 SOP(即相同的灭菌程序、相同类型的 SBS、相同的运输和储存的保护措施)。每个 SOP 都基于从包装准备到无菌取用的全面的分步风险分析。对于每种类型的代表性包装,在现场最坏情况下的测试可对风险分析的结果的正确性提出挑战。

包装工艺确认控制:

  • 充分设计和配置灭菌部门的包装区域(例如照明、包装工作站等),空气质量满足要求并受控。
  • 正确安装和校准密封设备。
  • SBS 和热封设备的制造商已提供使用说明 (IFU)。
  • 提供符合国际标准的包装材料证书和质量符合性的测试证书。
  • SOP 是最新的
  • 重视职业健康和安全。充分设计、安装和配备包装设施和工作站;采取预防措施防止锐器伤害 或负载超重。包装物品的最大总重量不超过 10 公斤(包括灭菌容器,如果使用该类型的复用 SBS)

已执行培训并提供证书。

 

所有参与包装准备、运输、储存和取用的人员都接受了适当的培训。 一个包装过程,涉及许多人工或半人工操作,正确执行这些操作至关重要。 在运输或储存过程中,再多的保护也无法防止不恰当的操作。 在最后阶段,如果无菌取用操作不当,将无菌 RMD 带到使用点(即手术室)的所有努力都会付之东流。

 

  • 制定了复用灭菌容器和密封设备的维护计划
  • 为所有类型的 SBS 定义了系统的和定期的例行控制措施。
  • 追溯是可行的
  •  

确认会在每年重复执行,并且在发生更改之后,判定需要执行部分的或全部的确认行为。 根据需要更新程序和培训。

Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS 包装的关键建议

直到RMD被使用之前,包装过程是有效灭菌和保持无菌状态的关键。风险分析用于检查所有包装元素:

  • 符合无菌屏障标准
  • 与灭菌工艺兼容
  • 充分保护 SBS 及其内容物以防止最坏情况下的运输和存储事故
  • 实现无菌取用目标。
  •  
  • 包装工艺确认检查
  • 提供SBS 的IFU和符合国际标准的证书。 当给定指标(例如微生物屏障)没有唯一的标准化测试方法时,首选使用明确的通过阈值和失败阈值的方法。 由独立实验室进行的测试比制造商的内部测试更好。 不使用不符合要求的SBS,特别是棉纺织品。。
  • 充分设计、安装和维护包装设备和工作站。
  • SOP 是最新的
  • 失效日期与事件相关(注:参考ISO11607-1)
  •  

包装流程中涉及的所有人员,包括物流和使用点员工,都接受了足够的培训,并意识到他们自己对提供安全和功能完整的 RMD 和保障患者安全的重要性。

包装流程图
清洁干燥装配好的 RMD

RMD ready to be packaged in preparation for sterilization

Go to objectives of packaging

1 of 12
已灭菌的RMD

RMD sterility preserved by SBS

Go to packaging process

2 of 12
包装系统中的RMD

RMD ready for transport and storage and aseptic extraction

Go to packaging process

3 of 12
包装系统中的RMD

Packaging system ready for transport and storage and extraction

Go to packaging process

4 of 12
复用的纺织品

Reusable Cotton textile to be avoided

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

5 of 12
复用的灭菌容器

Containers compliant to international std cleaned and disinfected and controlled

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

6 of 12
一次性包装材料

Pouches and reels compliant to international std

Validated sealing

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

7 of 12
一次性包布

Wraps compliant to international std

Folding according to validated practices

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

8 of 12

According to SOP defined after risk analysis

Go to  WFHSS recommendations for packaging

9 of 12

Visual controls

Go to Packaging and quality

10 of 12

Packaging compatible with sterilization process

Go to Objectives of packaging

11 of 12

As needed installation of protective packaging

Go to packaging process

12 of 12
参考文献 - 包装
  1. ISO 11607-1:最终灭菌医疗器械的包装 – 第 1 部分:材料、无菌屏障系统和包装系统的要求 (2019)
  2. ISO 11607-2:最终灭菌医疗器械的包装 – 第 2 部分:成形、密封和装配过程的确认要求(2019)
  3. ISO/NP TS 16775:最终灭菌医疗器械的包装——ISO 11607-1 和 ISO 11607-2 应用指南
  4. EN 868 2 至 10 最终灭菌医疗器械的包装 – 第 2 至 10 部分。
  5. 卫生保健机构医疗器械的去污和再处理——世界卫生组织(2016 年)
  6. ISO 17664:医疗保健产品处理——医疗器械制造商提供的医疗器械处理信息: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.