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Point of use processing
Point of use processing – Principles

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

  • are conscious of injury risk with sharp items and know measures to be applied in case of accident,
  • verify that all devices and parts are present, 
  • identify damaged RMD and initiate process for repair/maintenance or removal.
  • handle RMD with care and know process to be apply in case of dropping, 
  • handle RMD in a manner that avoid dispersion of contaminant in atmosphere and environmental surfaces. 

 

 

Main objectives of point of use processing are to:

  • Separate RMD from single-use and waste. Single-use items, waste are disposed according to applicable waste management regulation. Specific precautions are required for sharp items and needles.
  • Isolate RMD concerned by specific prion risks measures according to applicable local regulation.
  • Avoid drying of soils on RMD



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



 
  • Prepare an RMD for its  transport to the reprocessing room or sterilization department. 



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 - implementation

Point of use processing operations are performed according to RMD Manufacturer IFU’s.

  • Throughout the surgical procedure, as needed, RMD’s are wiped with sterile moistened surgical sponges to remove gross soil, lumens are irrigated with sterile water.
  • Immediately after use, outer debris are wipped off, working channels are flushed. Flexible endoscopes require specific measures. 



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.



  • RMD composed of more than one piece and surgical motors are disassembled according to RMD manufacturer’s IFU’s. 
  • Soaking at point of use may be recommended for complex devices (for examples, devices with lumen or complex geometries). It might  be required or recommended by local guidelines. If implemented, point of use soaking takes place as follows: 



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)



  • RMD are placed in transport containers in an orderly fashion.



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.



  • If point of use soaking did not take place and if time before cleaning and disinfection is long, RMD are (1) covered with a towel moistened with water (not saline) over the instrument, or (2)  transported in a container able to maintain humid conditions.
  • If time to cleaning is short (maximum 6 hours) “dry disposal” is preferred to “wet” disposal to limit RMD corrosion.
  • Containers are closed and preferably lockable.
Point of use processing and quality

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:

Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS recommendations for point of use processing

  1. Point of use processing separates RMD’s from single use items and waste. Drying of soils is avoided by wiping, flushing of lumen, soaking in a cleaning disinfection bath. If time before cleaning is long additional precautions are taken before placing RMD’s in closed, preferably locked, transport containers. 
  2. Point of use Standard operating procedures (SOP’s) are prepared in partnership with surgical and medical users. 
  1. Handling of contaminated RMD requires a good knowledge of RMD’s and adapted occupational health and safety measures.
  1. Process is implemented according to quality management principles.
Point of use processing flowchart
Soiled RMD

Used on patient or withdrawn from packaging

Go to Preparation for cleaning – Key principles

1 of 7
Preparation for cleaning at point of use

According 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 unit

According to SOP’s

Go to Preparation for cleaning – process

3 of 7
RMD Ready for cleaning and disinfection

RMD prepared for cleaning

Go to Storage – Key principles

4 of 7

SOP’s  prepared in partnership with medical or surgical users

Occupational health and safety measures

Go to WFHSS recommendation for preparation for cleaning

5 of 7

Transfer to sterilization department or reprocessing room

Go to Preparation for cleaning – process 

6 of 7

Controls

Go to Preparation for cleaning and quality

7 of 7
Bibliographic references - Point of use processing
  1. ISO 17664-1: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices (2017) 

Copyright 2019 Ⓒ WFHSS

“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”  

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Maintenance

Combination of all technical and associated administrative actions intended to keep equipment at a state in which it can perform its required function, or restore it to such a state (ISO 11139 : 2018)

Packaging

Packaging is intended to preserve the sterility of teh reusable medical device (RMD) until its use.

Reusable containers

Rigid sterile barrier system designed to be repeatedly used (ISO 11607-1 2018)

International standards

For the puropose of these guidelines, International Standard means standardsor guidance published by international standardization organizations such as ISO or CEN.
Go to the international standards paragraph or Regulation and standards chapter 

Prion

Prion is a small proteinaceous infectious unit that appear in a variety of neurodegenerative diseases, including bovine spongiform encephalopathy, Creutzfeldt-Jakob disease, and scrapie. They derive from a normal body protein that becomes irreversibly misfolded and proliferates primarily in the central nervous system.
Prions are highly resistant to disinfection and sterilization

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces.

Air quality

Levels of purity of ambient air and compressed air used for drying.

Water quality

Chemical, physical, biological, and radiological characteristics of water used for cleaning, disinfection, rinsing and steam sterilization of RMD.

Point of use reprocessing

Processing operation performed at point of use of the Reusable Medical Device (i.e. operating theatre or care unit)

Quality management 

Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance, and quality improvement.
In the present guide the quality management chapter includes a description of the processus approach, performance evaluation, risk and non-conformity management, documentation management and traceability

Go to quality management chapter →

Spaulding classification

The Spaulding classification qualify the RMD as non critical when they touch intact skin, semi-critical when they are brought in contact with mucous membranes and critical when they enter sterile body cavities. Processing requirements increase with level of risk involved in their use.

Occupational health and safety (OHS)

OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards (WHO : 2016)

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)

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.

Standard operating procedures

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Routine control (or routine test)

technical operation conducted periodically to establish that the operational performance of the equipment or process remains within the limits established during validation (ISO 11139 : 2018) 

Fixative properties

Some sterilizing, cleaning and disinfecting formulations are known to favor the anchorage of proteins, including prion on RMD surfaces. For instance, dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such formaldehyde or glutaraldehyde, alcohol used to accelerate drying of some RMD. For this reasons, some national guidelines recommend to avoid use of this subtances or require specific precautions (for instance thorough cleaning)

“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” 

Non terminal sterilization

Non terminal sterilization is a process whereby product is not sterilized in a sterile barrier system and hence not protected from environmental and handling contamination after the sterilization cycle.

Terminal sterilization

Process whereby product is sterilized within its sterile barrier system (ISO 11139 : 2018)

Standard operating procedures (SOP's)

SOP’s are written, step-by-step instructions that describe how to perform a routine activity. SOP’s aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

Outsourcing

For the needs of the present guidelines outsourcing means a process in which a healthcare facility employs another organization to perform some or all reusable medical device reprocessing tasks. The organization can be another healthcare facility, a shared reprocessing unit or a private service company. The services can be perfomed within the healthcare facility or externalized.

Pyrogen

Pyrogen are substances that induces fever. Endogenous pyrogen are low-molecular weight protein produced by phagocytic leukocytes in response to stimulation by exogenous pyrogens. Exogenous pyrogens are produced by bacterial endotoxins and other microbial product such as antigen, antibody complexes, virus

Endotoxin

Endotoxins are lipopolysaccharide components of the cell wall of Gram-negative bacteria that are heat stable and elicits a variety of inflammatory responses in animals and humans (ISO 11139: 2018)

Traceability

Ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

Training

For the purpose of theses guidelines, training means the certified acquisition of the theoricital, practical skills and behavior adapted to the assignment. Skills are periodically controlled and updated as needed.

Routine controls

Routine control check that performances of process or equipment are maintained over time between 2 process validations. Routine controls can be systematic (at each cycle) or at predefined periodicities. For instance, for the sterilization process, at end of each cycle, it is checked that process parameterare are within the validated tolerances, leak tests are performed daily or at periodicity defined by local recommandations. 

Go to process validation chapter →

Instruction for use (IFU)

Written indication provided by the manufacturer to ensure correct and safe use of a products (including but not limited to reusable medical device, reprocessing equipment and consumables). IFU of RMD include the instruction for reprocessing. IFU are also available for reprocessing equipment and consumables.   

Risk analysis

Identification and analyzis of potential issues that could negatively impact a given process. Risk analysis includes an evaluation of the consequence and likelihood. The issues with the more severe consequences and higher likelihood of occurence are addressed in priority. As needed measure are then to minimize the occurence or consequence. Methods are available to improve the reliability of the risk analysis. 

Storage

Storage concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions.

Transport

Transport includes:

  • The transfer of soiled reusable medical device from the point of use to the reprocessing site and
  • the transfer of the sterilized or disinfected RMD to the point of use.

Process validation

Process validation means establising, by objective evidence that a process consistently produces a results or product meeting its predeternined objective. Process validation applies to all steps of RMD reprocessing from point of use processing to storage. When equipments are used validation include their installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
Process validation is perfomed before implementation of a new process or equipment (initial validation). Revalidation takes place periodically (usually each year) or after event justifying total or partial revalidation (change in the process, maintenance of equipments).

Waste management

Waste management groups all activities and actions required to manage waste including the collection, transport, treatment and disposal of waste together with monitoring of the waste management process. Instrument reprocessing waste are are solid (i.e., single use packaging, detergent or disinfectant empty bottles, cleaning brushes, possibly sharp devices), liquid (i.e., cleaning, disinfecting, rinsing solutions) or gazeous (i.e., sterilization, cleaning or disinfection effluent). Waste might be non hazardous, infectious, or toxic. Waste management regulation limits impact on environment and protects staff. Waste management rules are country dependent.

Traceability

Traceability is the ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.

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.