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Transport of RMD – key principles

Realización del Transporte de Productos Médicos Reusables (PMR) 

  1. Después del procesamiento en el lugar del uso. El PMR es transportado al Departamento de esterilización o al área de reprocesamiento para su desinfección. Los PMR contaminados se colocan en un contenedor sellado. Se toma la precaución para no dañar el PMR.
  2. Post esterilización o desinfección. Después de la esterilización terminal, los PMR esterilizados, protegidos por el embalaje, son trasladados al área de almacenamiento, o si corresponde el uso inmediato, al lugar de su uso. Post esterilización no-terminal o desinfección, los PMR son transferidos al lugar de uso o su almacenamiento temporal. La transferencia se realiza con cierto margen de tiempo y bajo condiciones que limitan los riesgos de recontaminación.

     


 En países con regulaciones para priones. Los PMR con riesgo se separan de los demás instrumentos, y claramente identificados, son transferidos conforme a las regulaciones locales.

Los contenedores de transporte :  de PMR contaminados se diferencian visiblemente de los contenedores para productos esterilizados o desinfectados. Sea cual sea el tipo de transporte, los productos contaminados no utilizan la misma vía de transporte que los esterilizados o desinfectados. 

  •  Transporte interno, a mano, o en carro o contenedor de transporte : los contenedores de dispositivos contaminados siguen rutas designadas para evitar áreas de alto tránsito y las de atención al paciente. Los carros de transporte y mesas son lo suficientemente grandes como para que todos los paquetes se apoyen en  sobre la superficie, no deben sin sobresalir de los bordes. Los artículos contaminados nunca se colocan juntos con los esterilizados o descontaminados en los carros de transporte. Si los carros se utilizan alternativamente para transportar artículos contaminados y descontaminados, deben limpiarse entre cada uso, conforme a las instrucciones del fabricante de los carros (IUF). Los carros de transporte están son diseñados y fabricados de materiales que permiten la fácil limpieza,  preferentemente automática. Si los carros salen de un área con aire controlado deben ser cerrados y supervisados. La cubiertas reusables para tapar los carros de transpporte u otros medios de transporte deben limpiarse después de cada uso y deben tener aberturas autosellables.
  • Sistemas internos de distribución automatizados y neumáticos : Por diseño difieren las rutas contaminadas de las de material esterilizado. Su operación es supervisada por personal autorizado y el equipamiento se limpia y desinfecta según las instrucciones del fabricante (IUF).
  • Transporte interno a través de ascensores o montacargas : Estos deben ser destinados a productos médicos reusables (PMR) contaminados, o para PMR esterilizados y desinfectados. Los montacargas deben ser lo suficientemente grandes para permitir la colocación segura de los contenedores. Los montacargas son diseñados para su fácil limpieza y se limpian en base a la rutina según las políticas de la Organización. Los montacargas limpios deben estar ubicados en áreas designadas como “limpias.” Los paquetes esterilizados estarán contenidos en un recipiente cerrado, en una caja cerrada o en una bolsa plástica.
  • Transporte externo : Los vehículos serán destinados preferentemente al tralado de PMR. Si el vehículo es usado para el transporte de ambos tipos de dispositivos, los contaminados y descontaminados, deben ser colocados en áreas con separación segura dentro del vehículo. El diseño y material utilizado en la construcción de todos los medios de transporte (motorizados o manuales) deben permitir la limpieza y desinfección adecuada. El compartimiento de almacenamiento es completamente cerrado. Los vehículos son de fácil carga y descarga. Los contenedores se fijan dentro para evitar daños y contaminación por derrames. Los vehículos cargados y listos para el transporte no se dejan desatendidos en áreas desprotegidas.

Todos los PMR se transportan con cuidado. Los contenedores utilizados para el traslado de material contaminado, a mano, deben ser trasladados en planos paralelos al piso para evitar derrames o que el PMR se mueva.

Los operadores de transporte reciben la capacitación apropiada referente a los riesgos relacionados con el manejo de las cargas.

Transporte de los PMR, después de su uso :

Los operadores de transporte, encargados de la carga de elementos contaminados reciben la capacitación apropiada sobre el riesgo relacionado con el contenido contaminado de los contenedores.

En los vehículos de transporte Personal debe disponerse de equipos de protección personal (EPP) y kit de para derrames de biorriesgo.


Corresponde aplicar regulaciones locales para el transporte externo de material peligroso y sustancias infecciosas.

Transporte de los PMR después de la desinfección y esterilización :

Después de la desinfección o esterilización « no terminal », los PMR no están protegidos frente a la contaminación ambiental o manual. La transferencia debe realizarse en condiciones controladas. El nivel de cuidados estará ligado al uso previsto del PMR conforme a los principios de la clasificación de Spaulding

Después de la esterilización terminal, los PMR están protegidos por su envoltura. Se debe tener precaución para evitar rupturas o daños del envoltorio. Los daños son informados sistemáticamente.

Transporte y calidad :

Se preparan procedimientos operativos estándar (POES) conforme a los principios del manejo de calidad.                                                                                            

Se aplica análisis de riesgo.  El embalaje se adapta a las condiciones de transporte. El análisis de riesgo también evalúa las alternativas del transporte, tales como humedad excesiva, condensación a causa de la exposición a temperaturas extremas, polvo y suciedad, excesiva presión y microorganismos. 

La validación del proceso de transporte asegura :

  • Debe realizarse entrenamiento y los certificados de entrenamiento deben estar disponibles,  tanto para el personal interno como externo (cuando el transporte es subcontratado)
  • Se deben cumplir las medidas seguridad laboral y salud ocupacional, en particular para el transporte de PMR contaminados.
  • Los POES están vigentes e incluyen resultados del análisis de riesgo.
Screenshot-2019-09-07-at-13.22.20-e1567939504403

Recomendaciones de WFHSS para el transporte

  1. Seguir rutas diferentes para los elementos contaminados y esterilizados o desinfectados.
  2. Dar al personal de transporte (empleado por la Institución de salud o externo) la adecuada capacitación de seguridad laboral y salud ocupacional, referida a contaminación y riesgos del manejo de carga.
  3. Implementar el transporte de acuerdo a los principios de calidad y someterlo a un proceso de validado. Realizar análisis de riesgo para adaptar los embalajes a las condiciones del transporte.
Flujograma de transporte

Switch in landscape mode to use the flowchart

PMR en el lugar de uso

RMD after point of use processing

Go to Transport– Key principles

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Transporte del PMR contaminado

By trained operators personal aware of contamination risks

Go to Transport of RMD after use

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PMR en la unidad de reprocesamiento

RMD after point of use processing

Go to Transport – Key principles

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RMD in reprocessing unit

Packaged sterile RMD or disinfected RMD

Go to Transport– Key principles

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Transport del PMR esterilizado o desinfectado

By trained operators personal

Go to transport of RMD after disinfection or sterilization

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Almacenamiento

RMD in sterile packaging

Go to transport key principles

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Reproceso en el lugar de uso

Care unit or operating theatre

Go to Transport key principles

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According to transport SOP

Go to WFHSS recommendation for transport 

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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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Referencias Bibliográficas-Transporte
  1. ISO 17664-1: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices (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”  

Reproducir vídeo

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)

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.