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Almacenamiento
Almacenamiento : principios claves

Después de la esterilización o desinfección, los Productos Médicos Reusables (PMR) pueden ser utilizados inmediatamente o almacenados hasta su uso.

Las condiciones de almacenamiento dependen del nivel de riesgo del PMR según los principios de la clasificación de Spaulding.

Después de la esterilización terminal, los PMR quedan protegidos por sus embalajes de la contaminación ambiental y resultantes de la manipulación .

  • Después de una esterilización no terminal, PMR críticos no están protegidos por embalaje y no pueden guardarse.
  • Después de la desinfección, los PMR semicriticos pueden almacenarse temporalmente bajo condiciones controladas. El tiempo máximo previo al uso se define por regulaciones locales (habitualmente de 3 a 12 horas). Excedido el tiempo límite, el PMR debe ser reprocesado.

 

En algunos países, El almacenamiento temporal de endoscopios flexibles semicríticos se puede prolongar utilizando gabinete de almacenamiento. El tiempo máximo de almacenamiento es definido por regulaciones locales o lineamientos. Las válvulas deben sacarse y almacenar por separado en condiciones secas y libres de polvo.


     Algunos países exigen que el gabinete de almacenamiento cumpla el estándar internacional EN 164421.


     Los endoscopios flexibles no deben almacenarse e las cajas de transporte.

 

  • El almacenamiento de PMR no críticos se realiza según regulaciones internas.
Almacenamiento de artículos esterilizados :

El almacenamiento se realiza en una habitación adyacente al departamento de esterilización central o en el lugar de uso.

  • El área de almacenamiento es un espacio cerrado destinado a los insumos esterilizados.

 

A los materiales se les ha quitado el contenedor externo de transporte en un espacio de transferencia externa al depósito.
El acceso al área de almacenamiento está limitado al personal autorizado.

 

  • La superficie de las áreas de apoyo y el equipamiento de almacenamiento (depósito) está adaptado a las necesidades. Se déjà suficiente espacio alrededor del equipamiento para permitir la circulación de aire y evitar el contacto de los materiales empaquetados con condensación que puede provenir de la superficie interna de las paredes. Debe haber suficiente espacio para la fácil limpieza del piso (por ejemplo, al menos 8 a 10 pulgadas, alrededor de 20 cm). El piso debe ser liso e impermeable al agua, sin defectos y fácil de limpiar. La distancia del cielorraso y los picos de los rociadores las define el código local de bomberos. Los materiales nunca se apoyan en el piso, ni siquiera pasajeramente.  
  • Los PMR se almacenan en condiciones controladas de polvo, luz y humedad. 

 

Desagues abiertos, artefactos y ductos no deben existir, en caso de existir, los productos esterilizados, incluyendo los contenedores rígidos, no se almacenan en la proximidad o debajo de piletas, debajo de cañerías de agua o aguas residuales, ni lugar alguno donde puedan mojarse.
Los paquetes no se exponen a la luz solar directa UV acelera el envejecimiento de los materiales. Se evitan las variaciones de temperatura y humedad para prevenir la acumulación de humedad (condensada) en la superficie de los instrumentos.
air quality or aero-contamination limits for storage area. Local recommendations may apply.

 

  • El sistema de almacenamiento es elegido conforme al lugar y el tipo de productos y al sistema de barrera estéril utilizado.

 

Estantes abiertos (estantes de tejido de alambre o sólidos) son adecuados para áreas destinadas al depósito se controla el tráfico y la ventilación.
Gabinetes cerrados y cubiertos se necesitan para áreas de mucho tráfico donde se acumula polvo.
El estante inferior, la base de los carros y las estanterías debe ser sólida (no perforada).
Se pueden utilizar bandejas de base perforada o sólida para prevenir rupturas en envolturas o sobres por la manipulación.
Pouches y mangas se almacenan en posición vertical y plana en canastas. La compresión puede forzar el ingreso de aire y microorganismos al contenido del paquete, generar la ruptura del sello o punción del embalaje.
Las envolturas (campos textiles) no se apilan. Los paquetes de textiles no se almacenan debajo de contenedores rígidos en el mismo estante.

 

  • La limpieza se realiza regularmente y se registra. Estanterías, carros y contenedor usados para guardar material esterilizado se mantienen organizados, limpios y secos.
  • Para un manejo fácil y seguro, las bandejas de instrumental pesados se  guardan en los estantes de la media altura.
  • El almacenamiento se organiza en base al principio de que lo primero ingresa debe ser lo primero en salir para permitir la rotación de los PMR. Periódicamente se realiza el control de la integridad de los paquetes y de las fechas de vencimiento. La fecha de vencimiento se define en base al análisis de riesgo.

 

La vida estante del PMR evento-relacionada y basada en la calidad del material de envoltura, las condiciones de almacenamiento, los métodos y condiciones de transporte, y el número y condiciones del manejo. La probabilidad de daño se incrementa a través del tiempo y el número de manoseos.

 

Almacenamiento y calidad.

Los procedimientos operativos estandarizados (POEs) se redactan según los principios de manejo de calidad

La validación del proceso de almacenamiento controla que :

  • Se ejecuta el entrenamiento de todos los operadores permitidos en el espacio del almacenamiento y los certificados estén disponibles.
  • Las medidas de salud ocupacional y seguridad se encuentren en el lugar de manejo de materiales pesados.
  • Los procedimientos operativos estandarizados (POEs) estén vigentes referente a las reglas de almacenamiento y limpieza del espacio del depósito.

Se realiza el análisis de riesgo para la determinación de las fecha de vencimiento.

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

Recommendations de WFHSSS para el almacenamiento

  1. Dedicar el área de almacenamiento sólo al almacenamiento de materiales esterilizados.limitar el acceso sólo a personal autorizado y entrenado. Adecuar el espacio y el equipamiento. Controlar las condiciones de almacenamiento (iluminación, T°C, humedad. Adoptar  precauciones para el almacenamiento en base a los materiales y las características de los empaques.
  2. Implementar el proceso de almacenamiento en base a los principio del manejo de calidad y es sometido a un proceso de validación
  3. Definir la fecha de vencimiento en base al análisis de riesgo de las condiciones de almacenamiento.
  4.  
Diagrama de flujo del almacenamiento
PMR esterilizado o desinfectado

Sterile in packaging or sterilized but not packaged or disinfected

Go to Storage – Key principles

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no almacenar – uso inmediato

Transfer under controlled conditions

Go to Storage – Key principles

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Almacenamiento de productos no críticos

According to type of RMD and hospital policy

Go to Storage – Key principles

3 of 8
Almacenamiento de PMR semi criticos

Maximum storage times according to local regulation

Might be prolonged with flexible scopes storage cabinets

Go to Storage – Key principles

4 of 8
Almacenamiento de productos esterilizados

In storage area under controlled conditions

Go to Storage of sterile items

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PMR seguros para su uso

RMD safe for delivery to final users

Go to Storage – Key principles

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According to SOP’s

Go to WFHSS recommendation for storage

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House keeping of storage area and control of expiration dates according to SOP’s

Go to Storage and quality

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Referencias bibliográficas- Limpieza
  1. EN 16442 : Controlled environment storage cabinet for processed thermolabile endoscopes (2015) Copyright 2019

“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.