National and international regulation
National and international guidelines
International standards
1 of 14 Человеческие ресурсыManagement and organization
Training
Occupational halth and safety
Reprocessing strategies
Spaulding classification principles
Prion risk
3 of 14 Место храненияStorage of disinfected or sterilized RMD
4 of 14 ТранспортTransfer of RMD before and after reprocessing
5 of 14 СтерилизацияPrinciples of sterilization
Steam and low temperature sterilization
6 of 14 Вода и воздухOrganization of RMD reprocessing Facilities,
Air and water quality
7 of 14 Техническое обслуживаниеMaintenance of equipments and reusable medical devices
8 of 14 Валидации процессовPrinciples of process validation
Packaging, cleaning, sterilization validation
9 of 14 УпаковкаPrinciples of packaging
Wraps, pouches and conntainers
Controls after cleaning & disinfection
Assembly of RMD and instruments sets
11 of 14 Очистка и ДезинфекцияPrinciples of cleaning & disinfection
Manual and automated processes
12 of 14 Обработка в точке использованияProcessing steps in surgical or care units
13 of 14 Управление качествомQuality Management principles
Risks and non conformities
Documentation and traceability
14 of 14National and international regulation
National and international guidelines
International standards
1 of 14 Human ResourcesManagement and organization
Training
Occupational halth and safety
Reprocessing strategies
Spaulding classification principles
Prion risk
3 of 14 Storagestorage of disinfected or sterilized RMD
4 of 14 Transporttransfer of RMD before and after reprocessing
5 of 14 SterilizationPrinciples of sterilization
Steam and low temperature sterilization
6 of 14 Facilities water and AirOrganization of RMD reprocessing Facilities,
Air and water quality
7 of 14 MaintenanceMaintenance of equipments and reusable medical devices
8 of 14 Process ValidationsPrinciples of process validation
Packaging, cleaning, sterilization validation
9 of 14 PackagingPrinciples of packaging
Wraps, pouches and conntainers
Controls after cleaning & disinfection
Assembly of RMD and instruments sets
11 of 14 Cleaning & DisinfectionPrinciples of cleaning & disinfection
Manual and automated processes
12 of 14 Point of use processingProcessing steps in surgical or care units
13 of 14 Quality ManagementQuality 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”
“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.