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Good practices for the sterilisation of medical devices – 2017 – Superior Health Council
Good practices voor sterilisatie van medishe hulpmiddelen – Herziening van de aanbevelingen voor sterilisatie – 2017 – Hoge Gezondheidsraad
Bonnes pratiques en matière de stérilisation des dispositifs médicaux – 2018 – Conseil Supérieur de la Santé
Hygiene Requirements for the Reprocessing of Medical Devices – RKI — 2012 – BfArM
Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices – 2017 – DGKH – DGSV – AKI
Recommendations by the Quality Task Group (102) – Low-temperature sterilization processes – 2017 – Central Service
Recommendations by the Quality Task Group (98) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – 2016 – Central Service
Recommendations by the Quality Task Group (99) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – Part 2 – 2016 – Central Service
Recommendations by the Quality Task Group (89) – Programme Controls Part 2: Endoscope washer-disinfectors with chemothermal disinfection – 2015 – Central Service
Guideline for the validation of packaging processes according to ISO 11607-2 — 2012 – Central Service – DGSV
Guidelines for validation of manual cleaning and manual chemical disinfection of medical devices – 2013 – DGSV – DGHK – AKI – VAH
Bonnes pratiques de retraitement des dispositifs médicaux – 2016 – SSSH – SSHH – Swissmedic
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
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
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
Buone pratiche di ricondizionamento di dispositivi medici – 2016 – SSSH – SSHH – Swissmedic
Schweizerische Leitlinie für die Validierung und Routineüberwachung von Reinigungs- und Desinfektionsprozessen für Medizinprodukte – 2017 – SSSH – SSHH – Swissmedic
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
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
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
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
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
High-Level Disinfection (HLD) and sterilization BoosterPak – 2016 – The Joint Commission
Multisociety guideline on reprocessing flexible GI endoscopes – 2016 – SGNA – APIC – SHEA – AASLD – ASGE – ACG – AGA – ASCRS
Guidelines for disinfection and sterilization in Healthcare facilities – 2019 – CDC
AAMI Standards and Technical Information Reports – Association for the Advancement of Medical Instrumentation
Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities – 2003 – Standard Australia
Guidelines for the evaluation of sterilants and disinfectants – Therapeutic Goods Administration – TGA – 1998 – Therapeutic Goods Administration – TGA
Hygiene Requirements for the Reprocessing of Medical Devices – RKI — 2012 – BfArM
Validation and routine monitoring of automated cleaning and thermal disinfection processes for medical devices – 2017 – DGKH – DGSV – AKI
Recommendations by the Quality Task Group (102) – Low-temperature sterilization processes – 2017 – Central Service
Recommendations by the Quality Task Group (98) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – 2016 – Central Service
Recommendations by the Quality Task Group (99) – Recommendations for validation preparation of steam sterilization processes in large sterilizers – Part 2 – 2016 – Central Service
Recommendations by the Quality Task Group (89) – Programme Controls Part 2: Endoscope washer-disinfectors with chemothermal disinfection – 2015 – Central Service
Guideline for the validation of packaging processes according to ISO 11607-2 — 2012 – Central Service – DGSV
Guidelines for validation of manual cleaning and manual chemical disinfection of medical devices – 2013 – DGSV – DGHK – AKI – VAH
Good practices for the sterilisation of medical devices – 2017 – Superior Health Council
Good practices voor sterilisatie van medishe hulpmiddelen – Herziening van de aanbevelingen voor sterilisatie – 2017 – Hoge Gezondheidsraad
Bonnes pratiques en matière de stérilisation des dispositifs médicaux – 2018 – Conseil Supérieur de la Santé
Guidance Document: Information to Be Provided by Manufacturers for the Reprocessing and Sterilization of Reusable Medical Devices – 2011 – Health Canada
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
Retraitement des dispositifs médicaux critiques – 2014 – Institut National de Santé Publique du Québec
Bonnes pratiques de retraitement des dispositifs médicaux – 2016 – SSSH – SSHH – Swissmedic
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
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
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
Buone pratiche di ricondizionamento di dispositivi medici – 2016 – SSSH – SSHH – Swissmedic
Schweizerische Leitlinie für die Validierung und Routineüberwachung von Reinigungs- und Desinfektionsprozessen für Medizinprodukte – 2017 – SSSH – SSHH – Swissmedic
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
High-Level Disinfection (HLD) and sterilization BoosterPak – 2016 – The Joint Commission
AST Standards of Practice for Packaging Material and Preparing Items for Sterilization – 2009 – Association of Surgical Technologies
Multisociety guideline on reprocessing flexible GI endoscopes – 2016 – SGNA – APIC – SHEA – AASLD – ASGE – ACG – AGA – ASCRS
Guidelines for disinfection and Syerilization in Healthcare facilities – 2019 – CDC
AAMI Standards and Technical Information Reports – Association for the Advancement of Medical Instrumentation
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
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
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
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
“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.