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Realización del Transporte de Productos Médicos Reusables (PMR)
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.
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.
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.
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.
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 :
Switch in landscape mode to use the flowchart
RMD after point of use processing
Go to Transport– Key principles →
1 of 12 Transporte del PMR contaminadoBy trained operators personal aware of contamination risks
Go to Transport of RMD after use →
2 of 12 PMR en la unidad de reprocesamientoRMD after point of use processing
Go to Transport – Key principles →
3 of 12 RMD in reprocessing unitPackaged sterile RMD or disinfected RMD
Go to Transport– Key principles →
4 of 12 Transport del PMR esterilizado o desinfectadoBy trained operators personal
Go to transport of RMD after disinfection or sterilization→
5 of 12 AlmacenamientoRMD in sterile packaging
Go to transport key principles →
6 of 12 Reproceso en el lugar de usoCare unit or operating theatre
Go to Transport key principles →
7 of 12According to transport SOP
Go to WFHSS recommendation for transport →
Traceability and controls
Go to Transport and quality →
9 of 12According to SOP’s
Go to WFHSS recommendation for transport →
According to SOP’s
Go to transport of RMD after disinfection or sterilization →
11 of 12Traceability and controls
Go to Transport and quality →
12 of 12“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”
“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”
For the present guidlelines reusable medical device (RMD) means:
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 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)
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.