Comments on WFHSS guidelines

Please fill the form

Click words or phrases color for definitions and descriptions

When a word or phrase is the title of a chapter, a link is provided to give direct access to the chapter

Close or expand to hide or show functions :

Display a window with additional information
Close a window

Using icons :

Provides explanations or examples
Provides additional indications on international standards
Are regulatory insights
Provides WFHSS advice or recommendations

In the flowchart

Move the cursor on colored cells to open an explanation or tool tips.

Click a link for direct access to a paragraph

Partners
Transport
Transport of RMD – key principles

Tranport of Reusable Medical Devices (RMD) takes place:

  1. After point of use processing. An RMD is transferred to the sterilization department or to a reprocessing room for disinfection. The contaminated RMD’s are enclosed in a container. Precautions are taken to avoid RMD damages.
  2. After sterilization or disinfection. After terminal sterilization, sterile RMD’s protected by packaging are transported to the storage area, or if intended for immediate use, to the point of use. After non-terminal sterilization or disinfection, unprotected RMD’s are transferred to the point of use or temporary storage. Transfer takes place within a certain time frame and under conditions that limit the risks of recontamination

In countries with prion measures, at risk RMD’s are separated from other instruments, clearly identified and transferred according to local regulation.

Contaminated transport containers: RMD’s are visibly differentiated from sterile or disinfected items. Whatever the type of transport, contaminated items do not use the same transport pathway as of sterile or disinfected items.

  • On-site transport by hand, or on trolley or transport cart : contaminated devices containers follow designated routes to avoid high-traffic and patient care areas. Transport carts and tables are large enough for all packages to be placed flat without extending beyond the edge of the cart shelf or table surface. Contaminated and sterile or disinfected items are never placed together on a cart or trolley. When trolleys are used alternately to transport contaminated and decontaminated items, they are reprocessed between each use according to a trolley manufacturer’s instructions for use (IFU). Carts are designed and made of material that allow easy, preferably automated cleaning. If trolleys leave an air controlled area, they are to be closed and under supervision. Reusable covers for carts or other transport vehicles are cleaned after each use and have a reclosable opening.
  • On site automated cart distribution systems and pneumatic systems : By design, contaminated routes and sterile routes are different. Operation is supervised by authorized staff. Equipment is cleaned and disinfected according to manufacturer’s IFU’s.
  • On site transport in lifts : Lifts are dedicated to either contaminated RMD or sterile and disinfected RMD. Lifts are large enough to allow the containers to be positioned securely. Lifts are designed for easy cleaning and cleaned on a routine basis, according to the organization’s policy. Dedicated, clean lifts should be located in areas designated as “clean.” Sterile packages are contained in a closed bin, a closed case cart, or a plastic bag.
  • Off-site transport : Vehicles are preferentially dedicated to RMD transport. If the vehicle is being used to transport both contaminated and decontaminated devices, contaminated and decontaminated devices are placed in separate, secure areas of the vehicle. The design and materials used in the construction of all transport vehicles (motorized or manual) allow appropriate cleaning and disinfection. The storage compartment is completely enclosed. Vehicles are customized for ease of loading and unloading. Carts are secured within the vehicle to prevent damage or contamination by spills. Vehicles that are loaded and ready for transport are not left unattended in unsecured areas.

All RMD’s are transported with care. Containers used to transport contaminated items by hand are carried  parallel to the floor to avoid spills and RMD shifting.

Transport operators are appropriately educated on risks related to handling of loads.

Transport of RMD after use

Transport operators in charge of contaminated items receive appropriate education on risks related to the contaminated content of transport containers.

Personal protection equipment and biohazardous spill kits are available in transportation vehicles. 


Local regulation may apply for off-site transportation of hazardous material and infectious substances.

Transport after disinfection or sterilization

After disinfection or non-terminal sterilization, RMD’s are not protected from environmental and handling contamination. Transfer occurs in controlled conditions. Level of precaution is linked to the intended use of the RMD according to Spaulding classification principles

After terminal sterilization, sterile RMD’s are protected by their packaging. Precautions are taken to avoid breach or damages of the packaging. Damages are systematically reported.

Transport and quality

Transport standard operating procedures (SOP’s) are prepared in accordance with quality management principles. 

risk analysis is performed. Packaging is adapted to transport conditions. Risk analysis also evaluates transport challenges such as excessive humidity, condensation caused by exposure to temperature extremes, dust and dirt, excessive air pressures, and microorganisms. 

Transport process validation manages that :

  • Training is executed, and training certificates are available for both internal and external staff (if transport is outsourced).
  • Occupational health and safety measures are in place; in particular for transport of contaminated RMD’s
  • SOP’s are up to date and include risk analysis outcomes.
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS recommendations for transport

  1. Contaminated and sterile or disinfected items follow different routes
  2. Transport personal (employed by the healthcare facility or external) receives appropriate occupational health and safety education on contamination and load handling risks
  3. Transport  is implemented according to quality management principles and undergoes process validation. A risk analysis is driven to adapt packaging to transport conditions.
Transport flowchart

Switch in landscape mode to use the flowchart

RMD at point of use

RMD after point of use processing

Go to Transport– Key principles

1 of 12
Transport of soiled RMD

By trained operators personal aware of contamination risks

Go to Transport of RMD after use

2 of 12
RMD in reprocessing unit

RMD after point of use processing

Go to Transport – Key principles

3 of 12
RMD in reprocessing unit

Packaged sterile RMD or disinfected RMD

Go to Transport– Key principles

4 of 12
Transport of sterile or disinfected RMD

By trained operators personal

Go to transport of RMD after disinfection or sterilization

5 of 12
Storage area

RMD in sterile packaging

Go to transport key principles

6 of 12
Reprocessing at point of use

Care unit or operating theatre

Go to Transport key principles

7 of 12

According to transport SOP

Go to WFHSS recommendation for transport 

8 of 12

Traceability and controls

Go to Transport and quality

9 of 12

According to SOP’s

Go to WFHSS recommendation for transport 

10 of 12

According to SOP’s

Go to transport of RMD after disinfection or sterilization 

11 of 12

Traceability and controls

Go to Transport and quality

12 of 12
Bibliographic references - Transport
  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”  

Play Video

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.