Управление и монтаж

Управление и монтаж
Управление и монтаж

Контроль и сборка медицинских изделий многоразового использования (RMD) происходит после очистки и дезинфекции. Проконтролированные и собранные RMD предназначены для использования или стерилизации.

Контроль (т.е. визуальные проверки, технические функциональные тесты или и то, и другое) проводится до и после сборки многокомпонентных RMD или композиций RMD (например, хирургических наборов).

Рабочее место для управления и сборки адаптировано к потребностям (например, поверхность и освещение).


Особое внимание уделяется возврату RMD после технического обслуживания и ремонта.

Элементы управления и сборка многокомпонентных RMD, RMD  композиций должны соответствовать инструкции производителя RMD по использованию (IFU)

Сборка хирургических наборов производится в партнерстве с медицинскими или хирургическими пользователями. Согласованные инструкции определяют:

  • Предметы, входящие в набор, и количество каждого предмета
  • Тип инструментального лотка (сетчатый, перфорированный, термоформованный) и размер (достаточно большой, чтобы обеспечить равномерное распределение веса и массы металла)
  • При необходимости, расположение и используемые защитные принадлежности (например, защита острых и хрупких предметов, клинья для предотвращения смещения или ударов во время транспортировки, вкладыши для лотков и т.д.)
  • При необходимости положение RMD, требуемое для безопасного извлечения в месте использования

Применяются общие правила:

  • Тяжелые инструменты размещаются таким образом, чтобы они не повредили более деликатные предметы.
  • Предметы с вогнутыми поверхностями широкие, плоские поверхности или и то, и другое, которые могут удерживать воду, кладутся на край.
  • Для RMD с каналами — порты каналов открыты.
  • Инструменты с храповым механизмом не защелкнуты. Прилагается описание принадлежностей, необходимых для удержания инструментов в незакрепленном положении.

Идентификаторы инструментов и визуальная помощь упрощают сборку сложных комплектов.

Подтверждено, что:

  • Имеется сертификат совместимости RMD, а также комплектация и защитные принадлежности с предполагаемым циклом стерилизации.
  • Стерилизующий агент имеет свободный доступ ко всем поверхностям RMD. Защитные приспособления для наконечников, если они используются, проницаемы для стерилизующего средства, свободно прилегают и используются в соответствии с инструкцией производителя. Используются только одобренные аксессуары.
  • Вес не превышает применимых ограничений по охране труда (максимальный вес изделия, включая упаковку, варьируется от 10 кг до 11 кг (25 фунтов) в соответствии с руководящими принципами каждой страны).

Для наборов с ёмкостями все ёмкости расположены в одном направлении и обработаны абсорбирующим материалом без ворса между вложенными умывальниками.

Для текстильных изделий проконсультируйтесь с производителем продукта для получения рекомендаций по размеру упаковки, размерам и плотности, которые были проверены для предполагаемых циклов стерилизации паром. Упаковка готовится из свежевыстиранного текстиля.

Контроль и сборка, а также качество

Письменные стандартные операционные процедуры контроля (СОП) подготовлены в соответствии с принципами менеджмента качества.

Валидация процесса  контроля и сборки управляется так:

  • СОП являются современными, соответствуют стандартам производителей RMD и соответствуют ожиданиям медицинских или хирургических пользователей.
  • Обучение завершено, и имеются сертификаты об обучении.
  • Приняты меры по охране труда и технике безопасности.
  • Прослеживаемость является оперативной и эффективной.
Screenshot-2019-09-07-at-13.22.20-e1567939504403

Рекомендации WFHSS по контролю и сборке

  1. Стандартные рабочие процедуры контроля и сборки (СОП) соответствуют требованиям производителя RMD и соответствуют ожиданиям конечных пользователей.
  2. Проверяется совместимость RMD и защитных принадлежностей.
  3. Процесс контроля и сборки осуществляется в соответствии с принципами менеджмента качества и проходит валидацию процесса.
Блок-схема управления и сборки
RMD после очистки и дезинфекции

Used on patient or withdrawn from packaging

Go to Control & Assembly – Principles 

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Контроль и сборка

RMD or multi-component RMD or surgical set

Go to Control and Assembly — Principles 

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RMD готов к следующему шагу

Next step: use or sterilization

Go to Control and Assembly – Principles

3 of 5

SOP prpeared in partnership with user

Go to WFHSS recommendation for Control and Assembly

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User feedback

Go to Control and Assembly and quality

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Библиографические ссылки - Контроль и сборка

1. ISO 17664-1: Обработка изделий медицинского назначения — Информация, которая должна быть предоставлена производителем медицинского оборудования для обработки медицинских изделий (2017)

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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) 

“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”  

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.