Partners
Regulación y Estándares

National and international regulation

National and international guidelines

International standards

1 of 14
Recursos humanos

Management and organization

Training

Occupational halth and safety 

2 of 14
Dispositivo médico reutilizable

Reprocessing strategies

Spaulding classification principles

Prion risk

3 of 14
Almacenamiento

Storage of disinfected or sterilized RMD

4 of 14
Transporte

Transfer of RMD before and after reprocessing

5 of 14
Esterilización

Principles of sterilization

Steam and low temperature sterilization

6 of 14
Instalaciones agua y aire

Organization of RMD reprocessing Facilities,

Air and water quality

7 of 14
Mantenimiento

Maintenance of equipments and reusable medical devices

8 of 14
Validaciones de procesos

Principles of process validation

Packaging, cleaning, sterilization validation

9 of 14
Embalaje

Principles of packaging
Wraps, pouches and conntainers

10 of 14
Controles y Montaje

Controls after cleaning &  disinfection

Assembly of RMD and instruments sets

11 of 14
Limpieza y Desinfección

Principles of cleaning &  disinfection

Manual and automated processes

12 of 14
Procesamiento en el punto de uso

Processing steps in surgical or care units

13 of 14
Gestión de la calidad

Quality Management principles

Risks and non conformities

Documentation and  traceability

14 of 14
Regulation & Standards

National and international regulation

National and international guidelines

International standards

1 of 14
Human Resources

Management and organization

Training

Occupational halth and safety 

2 of 14
Reusable Medical Device

Reprocessing strategies

Spaulding classification principles

Prion risk

3 of 14
Storage

storage of disinfected or sterilized RMD

4 of 14
Transport

transfer of RMD before and after reprocessing

5 of 14
Sterilization

Principles of sterilization

Steam and low temperature sterilization

6 of 14
Facilities water and Air

Organization of RMD reprocessing Facilities,

Air and water quality

7 of 14
Maintenance

Maintenance of equipments and reusable medical devices

8 of 14
Process Validations

Principles of process validation

Packaging, cleaning, sterilization validation

9 of 14
Packaging

Principles of packaging
Wraps, pouches and conntainers

10 of 14
Controls & Assembly

Controls after cleaning &  disinfection

Assembly of RMD and instruments sets

11 of 14
Cleaning & Disinfection

Principles of cleaning &  disinfection

Manual and automated processes

12 of 14
Point of use processing

Processing steps in surgical or care units

13 of 14
Quality Management

Quality Management principles

Risks and non conformities

Documentation and  traceability

14 of 14

“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

“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” 

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.

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.