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World

W3Schools Decontamination and Reprocessing of Medical Devices for Health care facilities – 2016 – World Health Organization – WHO

Europe

W3Schools Good practices for the sterilisation of medical devices – 2017 – Superior Health Council

W3Schools Good practices voor sterilisatie van medishe hulpmiddelen – Herziening van de aanbevelingen voor sterilisatie – 2017 – Hoge Gezondheidsraad

W3Schools Bonnes pratiques en matière de stérilisation des dispositifs médicaux – 2018 – Conseil Supérieur de la Santé

W3Schools Guide des bonnes pratiques de stérilisation – 2018 – SF2S

W3Schools Bonnes pratiques de pharmacie hospitalière – 2001 – Ministère de la Santé – DHOS

W3Schools Hygiene Requirements for the Reprocessing of Medical Devices – RKI — 2012 – BfArM

W3Schools Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices – 2017 – DGKH – DGSV – AKI

W3Schools Recommendations by the Quality Task Group (102) – Low-temperature sterilization processes – 2017 – Central Service

W3Schools Recommendations by the Quality Task Group (98) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – 2016 – Central Service

W3Schools Recommendations by the Quality Task Group (99) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – Part 2 – 2016 – Central Service

W3Schools Recommendations by the Quality Task Group (89) – Programme Controls Part 2: Endoscope washer-disinfectors with chemothermal disinfection – 2015 – Central Service

W3Schools Guideline for the validation of packaging processes according to ISO 11607-2 — 2012 – Central Service – DGSV

W3Schools Guidelines for validation of manual cleaning and manual chemical disinfection of medical devices – 2013 – DGSV – DGHK – AKI – VAH

W3Schools Professional Standard Handbook Cleaning and Disinfection Flexible Endoscope – 2017 – SVN – DSMH – VHIG – VOVN

W3Schools Bonnes pratiques de retraitement des dispositifs médicaux – 2016 – SSSH – SSHH – Swissmedic

W3Schools Guide suisse de validation et de contrôle de routine des procédés de lavage et de désinfection des Dispositifs médicaux – Partie 1 – généralités – 2019 – SGSV – SSHH – IG-WiG – Swissmedic

W3Schools Guide suisse de validation et de contrôle de routine des procédés de lavage et de désinfection des Dispositifs médicaux – Partie 2 – Procédé de nettoyage mécanique et de désinfection thermique – LD pour instruments chirurgicaux, matériel d’anethsésie, bacs, plats, récipients, ustensiles, verrerie, etc, – 2019 – SGSV – SSHH – IG-WiG – Swissmedic

W3Schools Bonnes pratiques de retraitement des dispositifs médicaux pour les cabinets médicaux et les cabinets dentaires ainsi que d’autres utilisateurs de petits stérilisateurs à la vapeur d’eau saturée – 2010 – Swissmedic

W3Schools Buone pratiche di ricondizionamento di dispositivi medici – 2016 – SSSH – SSHH – Swissmedic

W3Schools Schweizerische Leitlinie für die Validierung und Routineüberwachung von Reinigungs- und Desinfektionsprozessen für Medizinprodukte – 2017 – SSSH – SSHH – Swissmedic

W3Schools Turkish guideline for the sterilization and disinfection in healthcare settings – DAS

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part A: Management and provision – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part A: Common elements – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part D: Washer-disinfector – Part A: Common elements – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part E: Alternatives to steam for the sterilization of reusable medical devices – Part A: Common elements – 2016 – Department of Health

North America

W3Schools Reprocessing Medical Devices in Health Care Settings: validation, methods and labeling – Guidance for industry and Food and Drug Administration staff – 2015 – Food and Drug Administration

W3Schools High-Level Disinfection (HLD) and sterilization BoosterPak – 2016 – The Joint Commission

W3Schools Multisociety guideline on reprocessing flexible GI endoscopes – 2016 – SGNA – APIC – SHEA – AASLD – ASGE – ACG – AGA – ASCRS

W3Schools Guidelines for disinfection and sterilization in Healthcare facilities – 2019 – CDC

W3Schools AAMI Standards and Technical Information Reports – Association for the Advancement of Medical Instrumentation

South and Central America
Asia

W3Schools The APSIC guidelines for disinfection and sterilization of instruments in health care facilities – 2017 – APSIC

W3Schools Turkish guideline for the sterilization and disinfection in healthcare settings – DAS

Oceania

W3Schools Reprocessing of reusable medical devices in health service organisations – AS/NZS 4187: 2014

W3Schools Guidelines for the evaluation of sterilants and disinfectants – Therapeutic Goods Administration – TGA – 1998 – Therapeutic Goods Administration – TGA

W3Schools Reprocessing of reusable medical devices in health service organisations – AS/NZS 4187: 2014

W3Schools Decontamination and Reprocessing of Medical Devices for Health care facilities – 2016 – World Health Organization – WHO

W3Schools Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities – 2003 – Standard Australia

W3Schools Guidelines for the evaluation of sterilants and disinfectants – Therapeutic Goods Administration – TGA – 1998 – Therapeutic Goods Administration – TGA

W3Schools Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities – 2003 – Standard New Zealand

W3Schools Hygiene Requirements for the Reprocessing of Medical Devices – RKI — 2012 – BfArM

W3Schools Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices – 2017 – DGKH – DGSV – AKI

W3Schools Recommendations by the Quality Task Group (102) – Low-temperature sterilization processes – 2017 – Central Service

W3Schools Recommendations by the Quality Task Group (98) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – 2016 – Central Service

W3Schools Recommendations by the Quality Task Group (99) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – Part 2 – 2016 – Central Service

W3Schools Recommendations by the Quality Task Group (89) – Programme Controls Part 2: Endoscope washer-disinfectors with chemothermal disinfection – 2015 – Central Service

W3Schools Guideline for the validation of packaging processes according to ISO 11607-2 — 2012 – Central Service – DGSV

W3Schools Guidelines for validation of manual cleaning and manual chemical disinfection of medical devices – 2013 – DGSV – DGHK – AKI – VAH

W3Schools Professional Standard Handbook Cleaning and Disinfection Flexible Endoscope – 2017 – SVN – DSMH – VHIG – VOVN

W3Schools Good practices for the sterilisation of medical devices – 2017 – Superior Health Council

W3Schools Good practices voor sterilisatie van medishe hulpmiddelen – Herziening van de aanbevelingen voor sterilisatie – 2017 – Hoge Gezondheidsraad

W3Schools Bonnes pratiques en matière de stérilisation des dispositifs médicaux – 2018 – Conseil Supérieur de la Santé

W3Schools Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices – 2011 – Health Canada

W3Schools Guidance document – Safety and Effectiveness Requirements for High-Level Disinfectants and Sterilants for use on Reusable Semi-Critical and Critical Medical Devices (2018) – 2018 – Health Canada

W3Schools Retraitement des dispositifs médicaux critiques – 2014 – Institut National de Santé Publique du Québec

W3Schools Bonnes pratiques de retraitement des dispositifs médicaux – 2016 – SSSH – SSHH – Swissmedic

W3Schools Guide suisse de validation et de contrôle de routine des procédés de lavage et de désinfection des Dispositifs médicaux – Partie 1 – généralités – 2019 – SGSV – SSHH – IG-WiG – Swissmedic

W3Schools Guide suisse de validation et de contrôle de routine des procédés de lavage et de désinfection des Dispositifs médicaux – Partie 2 – Procédé de nettoyage mécanique et de désinfection thermique – LD pour instruments chirurgicaux, matériel d’anethsésie, bacs, plats, récipients, ustensiles, verrerie, etc, – 2019 – SGSV – SSHH – IG-WiG – Swissmedic

W3Schools Bonnes pratiques de retraitement des dispositifs médicaux pour les cabinets médicaux et les cabinets dentaires ainsi que d’autres utilisateurs de petits stérilisateurs à la vapeur d’eau saturée – 2010 – Swissmedic

W3Schools Buone pratiche di ricondizionamento di dispositivi medici – 2016 – SSSH – SSHH – Swissmedic

W3Schools Schweizerische Leitlinie für die Validierung und Routineüberwachung von Reinigungs- und Desinfektionsprozessen für Medizinprodukte – 2017 – SSSH – SSHH – Swissmedic

W3Schools Guide des bonnes pratiques de stérilisation – 2018 – SF2S

W3Schools Bonnes pratiques de pharmacie hospitalière – 2001 – Ministère de la Santé – DHOS

W3Schools The APSIC guidelines for disinfection and sterilization of instruments in health care facilities – 2017 – APSIC

W3Schools Reprocessing Medical Devices in Health Care Settings: validation, methods and labeling – Guidance for industry and Food and Drug Administration staff – 2015 – Food and Drug Administration

W3Schools High-Level Disinfection (HLD) and sterilization BoosterPak – 2016 – The Joint Commission

W3Schools AST Standards of Practice for Packaging Material and Preparing Items for Sterilization – 2009 – Association of Surgical Technologies

W3Schools Multisociety guideline on reprocessing flexible GI endoscopes – 2016 – SGNA – APIC – SHEA – AASLD – ASGE – ACG – AGA – ASCRS

W3Schools Guidelines for disinfection and Syerilization in Healthcare facilities – 2019 – CDC

W3Schools AAMI Standards and Technical Information Reports – Association for the Advancement of Medical Instrumentation

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part A: Management and provision – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part A: Common elements – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part D: Washer-disinfector – Part A: Common elements – 2016 – Department of Health

W3Schools Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care – Part E: Alternatives to steam for the sterilization of reusable medical devices – Part A: Common elements – 2016 – Department of Health

W3Schools Turkish guideline for the sterilization and disinfection in healthcare settings – DAS

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“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” 

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.