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Point of use processing includes all operations performed at point of use before transport of a Reusable Medical Device (RMD) to the reprocessing room or sterilization department.
Point of use and reprocessing services may be in different locations (in the same building or distant). Reprocessing operators may not be employed by the health care facility (for example, in case of outsourcing)
Point of use processing is performed by employees who received appropriate training on RMD and occupational health and safety precautions related to handling of contaminated RMD’s
Point of use operators wear adapted protective equipments and
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Main objectives of point of use processing are to:
If left to dry, soils stick to the device and become difficult to remove thereby rendering their cleaning more difficult. Lumens can become obstructed with organic material. Leaving the RMD overnight or over the weekend must be avoided. Long delays in processing contribute to the formation of biofilm that will shield microorganisms from routine cleaning procedures. Blood, other bodily fluids, and saline are highly corrosive and can cause pitting of instruments |
RMD are securily installed in transport containers to avoid shifts and damages during transport. Special attention is paid to fragile and items. Sharp components are separated Transport containers are closed. Containers carry clear indication that the content is biohazardous. Biohazard indications may be defined by local regulation. When the outside of a transport container is visibly soiled, it is careful decontaminated, before transport. |
Point of use processing operations are performed according to RMD Manufacturer IFU’s.
The insertion part is wiped with a lint-free cloth. The cloth is saturated with an instrument-cleaning, cleaner-disinfectant solution which has no protein-fixing effect. The channels are flushed with the same solution. For the air/water channel, water from the rinsing bottle can be used. A leak test is carried out in accordance with RMD manufacturer IFU's. This ensures the early detection of leaks and perforations and the prevention of more serious damage by penetrating liquids. |
Cleaning and disinfection formulations complies to applicable regulation and international standards. Fixative processes such as dry heat or aldehydes are avoided. Soaking baths are prepared in basins dedicated for this use. Concentration and exposure time are according to manufacturer's IFU's. Renewal is acording to local recommendatons (after each patient, every 24 h or before if visibly soiled). Point of use automated pretreament might be recommended by some local guidelines when the transfer time to the sterilization department is long (for example during week-ends or overnight) |
Fragile RMD's are adequately protected from transport shifts. Retainers may be required for microsurgical instruments and endoscopes. Optics are placed in special containers. Sharp instruments are segregated inside the container Heavy instrumentation is on the bottom and lighter, delicate instruments on top. Instrument trays are not overloaded. Size of containers avoids excessive kinking of flexible items. |
Point of use processing standard operating procedures (SOP’s) are prepared in partnership with surgical and medical users, in accordance with quality management principles.
Process validation of point of use processing controls that:
Used on patient or withdrawn from packaging
Go to Preparation for cleaning – Key principles →
1 of 7 Preparation for cleaning at point of useAccording to SOP’s Gross soil removal, soaking, careful installation of RMD in closed container
Go to Preparation for cleaning – process →
2 of 7 Preparation for cleaning in reprocessing unitAccording to SOP’s
Go to Preparation for cleaning – process →
3 of 7 RMD Ready for cleaning and disinfectionRMD prepared for cleaning
Go to Storage – Key principles →
4 of 7SOP’s prepared in partnership with medical or surgical users
Occupational health and safety measures
Go to WFHSS recommendation for preparation for cleaning →
Transfer to sterilization department or reprocessing room
Go to Preparation for cleaning – process →
6 of 7Controls
Go to Preparation for cleaning and quality →
7 of 7“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.