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Process Validation
Principles of validation

It is not possible to individually control each medical device being reprocessed. Instead, each reprocessing step (from point of use processing to aseptic presentation)  undergoes validation to minimize the risk of a non-sterile product.

Initial validation takes place before a new process or equipment is implemented. Revalidation ensures that process effectiveness is maintained over time. It takes place periodically (often annually) or after a major event (for example, voluntary modification or breakdown)

Between validations  (initial validation and revalidation) periodic or systematic routine controls preserve process effectiveness over time.

The validation plan defines the operations, methods and schedules of the initial validations, revalidation and routine controls as well as the responsibilities, training and, as needed, accreditations of the personal in charge.

Validation includes the qualification  of the equipments used by the process. Qualifications of equipment consist of installation qualification (IQ) , operational qualification (OQ) ,performance qualifications (PQ) and requalifications (rQ).


     In the present guidelines it will be considered that all processes, including those predominently manual, require equipment (for example a bench with sink possibly equipped with pumps for manual cleaning) and will hence consist of IQ, OQ, PQ. Validation of manual processes such as point of use processing or manual cleaning is key to minimize human dependance. Risks of deviance is however inevitably be higher than for a validated automated process

Installation qualification (IQ) is intended to confirm that the services associated with the equipment (water, electricity, etc.) and any accessories and safety devices are installed in accordance with the manufacturer’s instructions.

Documentary verification  may be considered as a prerequisit to qualification operations or as being part of IQ.

 

The documents to be made available by the manufacturer vary according to the type of equipment but have some common points.

Before  installation, the supplier:

  1. communicates the characteristics of the equipment and its accessories (weight, dimensions, noise level) in order, if necessary to allow the user to adapt the access and the space around the equipment, if necessary to reinforce supporting structures.
  2. specifies the associated service needs: electricity, chemical and possibly microbiological characteristics of the water, drainage, extraction, temperature and humidity control.
  3. stresses the requirements of safe use and protection of personnel.

In return, the future user specifies any installation constraints (eg quality of the water available), the requirements in terms of the test method to be used.

 

After installation, the user checks:

  1. conformity of marking and availability of certificates: calibration of the measurement system, verification of safety devices, compliance with applicable standards and, where applicable, certificate of essential tests.
  2. the availability of commissioning and use instructions (with description of the functions and cycles of the equipment, of the anomaly detection systems and the measures to be applied, the list of consumables and accessories, cleaning instructions and disinfection).
  3. availability of the maintenance manual (with electrical and hydraulic diagrams, safety functions, list of spare parts, instructions for preventive maintenance, periodic checks and calibration of equipment, software checks), warranty certificates and maintenance or technical assistance contract and contacts.

 

Language in which the user and service manual must be made available is defined by local regulation.

 

Operational qualification (OQ) is carried after successful IQ. It is intended to verify that the equipment performs according to manufacturer design specifications and international standards respectively. OQ tests are performed with empty equipment or test loads.

Additionally, the calibration status of all instruments (including test instruments) used for monitoring, control, indication or recording should be confirmed.

Performance qualification (PQ) takes place after successful IQ  and OQ on an equipment in normal operating conditions. All factors that may have an influence (operators, methods, materials and the environment) should be taken into account.

Requalification is usually performed annually periodically or earlier in case of an event that may affect the efficacy of the process.

 

Examples of events justifying a requalification:

• Change in equipment and installation that may impact process performance (e.g. modification of cycle parameters, new load carriers or cleaning products).

• New load, unless it has been shown to be equivalent to another load already validated.

• Failure detected during a routine control

• Relocation of the equipment or technical intervention with change of critical elements in the PLC (or intervention on control elements)

 

The contents of the initial IQ, OQ and PQ and scheduled requalifications  are predefined. Scheduled requalifications may be simplified compared to initial qualifications (for example IQ will not be repeated).

The content of the unscheduled validation is event related (for example IQ may be partially or totally repeated after a relocation of the equipment).

Validation and requalifications operations are supervised by the sterilization department or the technical department of the healthcare facility. The healthcare facility may however contract with the supplier of the equipment or third parties. A detailed written description of the  scope, objectives and respective assignments must be made produced.

 

In practice IQ is performed by the supplier of the equipment (manufacturer or distributor) or a service provider accredited by the supplier.
Some or all OQ operations may be performed by the user, by a qualified third party or by the supplier as part of a service contract (or a service provider accredited by the supplier)
PQ may be performed by the user, by a third party or by the supplier (or a service provider accredited by the supplier)
Routine controls are usually carried out by the user in accordance with his documented procedures

 


  International standards do not assign responsibilities but they say that the responsibilities and party accepting the responsibilities must be defined and recorded.

Validation and requalification reports are approved and kept for record by the healthcare facility.They are grouped in a process validation report confirming:

  • The existence of up-to-date procedures,
  • The availability of up-to-date documentation
  • The existence of a validation plan and its execution.

 

for equipment, the validation (or revalidation) report includes

  • the identification of the equipment and its location,
  • the confirmation of a maintenance plan and its execution,
  • the confirmation that the calibration of the test equipment and measuring system was verified,
  • IQ reports (if applicable), OQ, PQ with data, reports of periodic tests carried out or at least confirmation of their execution and success,
  • for washer-disinfectors (WD) and sterilizers, the characteristics of the loads: product families able to be treated, configurations. For sterilizers: description of packaging systems,
  • the identity and training certificates of all staff involved in validation and routine checks,
  • the analysis of validation / qualification results. Indication and justification of any deviations from the validation plan,
the approval of the validation.

 

Validation of automated cleaning and disinfection processes and manual cleaning processes
  •  Cleaning processes can be automated (with washer-disinfectors), manual or assisted by ultrasonic cleaners. Validation (IQ, OQ, PQ) of processes in automated washer-disinfectors is performed according to ISO 15883-12 and subsequent parts 3,4,5,6,7
  • There is no ISO standard for manual cleaning and ultrasonic cleaners but ISO 15883-1 principles may be applied.  

  The validation of Automated Endoscope Reprocessor will be added in a future update of the guidelines. Washer-disinfector includes a disinfection phase, which in some case


  The validation of Automated washer-Disinfector includes the validation of a disinfection stage (thermal or chemical). For some devices the disinfection stage might be the last step before use


  Some local guidelines say that validation of Washer-Disinfector complying to ISO 15883-6 and ISO 15883-7 can be simplified as they pertain to non-critical items

IQ verifies that the connections and utilities (power, water, drain, dosing systems etc..) and Washer disinfector, ultrasonic bath or manual cleaning workstation are installed according to manufacturer specifications, that the equipment is safe for use and that equipment and consumables documentation is available.

OQ verifies that the equipment operates as specified by the manufacturer (for example, absences of leaks, chemistry dosing, temperature for thermal washer-disinfector, cavitation for ultrasonic baths, drying). Cleaning test are performed with test soils.
Controls are visual for visible surface and quantitative (e.g. protein tests) for complex device with hidden surfaces. Test methods, test soils and acceptance criteria are described in ISO 15883-58 (see below)

PQ is intended to control that reproducible results are obtained in conditions fully representative of real life. Control tests are performed with actual loads or devices contaminated by clinical use. Validated surrogate devices and test soils may however be used when real devices are difficult to sample.
Prior to PQ, load or devices are grouped in families presenting common processing characteristics. Load or device used for PQ are selected to present the highest cleaning challenge for a given family.
Controls are visual for external surface, carriers and loads and quantitative for complex devices with hidden surfaces. Test methods, test soils and acceptance criteria are described in ISO 15883-5,8 (see below)

The contents of the initial IQ, OQ and PQ and scheduled requalifications  are predefined.

Operational and Performance requalifications are commonly annual. Scheduled requalifications may be simplified compared to initial qualifications.


  Scheduled requalifications may be simplified compared to initial qualifications. For example some national guidelines may suggest to test the most challenging program and load carrier configurations instead of testing all program/load configurations.

The content of the unscheduled validation is event related (for example IQ may be partially or totally repeated after a relocation of the equipment).

Routine controls include periodic tests (part of OQ or PQ) and systematic controls (each cycle) Validation of Automated Washer-Disinfector processes consist of IQ, OQ and PQ as defined by ISO 15883-1 and annexes applicable to the specific type of washer-disinfector (Thermal or chemical, critical and semi-critical or non critical devices). Tests applicable to automated endoscope reprocess will be added in a future update of WFHSS guidelines.

 

The 2005 version of ISO 15883-5 listed soils and test methods developped by different countries. ISO 15883-5 ( 2021), lists chemical substance (analytes) contained in artificial or clinical soils.
  • ISO 15883-5 is a significant progress for the objective evaluation and validation of cleaning processes. Like for any new standard some time might be needed to translate the normative requirement into practice and adapt the guideline according to return on operating experience.
Analytes (for example protein) shall be used for quantitative control of cleanliness. For each analytes alert levels and action levels are provided (for exemple 3 μg/cm2 and 6,4 μg/cm2. Respectively for protein). The alert level provides early warning of a deviation. The action level necessitates immediate action. Annex  C of ISO 15883-5 describes methods (modified OPA, BCA)  which may be used to sample the device and measure residual protein. Test soils must contain a quantity of analyte representative of clinical soils. Examples of test soils are provided for various applications (for example coagulated blood for general surgery). Examples of analytes with corresponding alert and action levels are displayed below Example of test soils (coagulated blood, 2 components blood test, Edinburgh, ATS2015, BTS, biofilm) for various procedures (general surgery, gastroinstestinal, flexible endoscopy) are provided in annex A of ISO 15883-5

 

Annex B of ISO 15883-1 explains the A0 concept.

 

 

A0 is the equivalent value in seconds at 80 ° C to produce a given disinfection effect on a specified microorganism. When the microorganism is a bacterial spore (the most resistant) we speak of A0.
A0 = ∑ 10 ((T - 80) / Z) ∆t
 
T is the temperature
Z is specific to each microorganism. The Z value indicates the increase in T ° C allowing to accelerate the reduction of the population by a factor of 10 (in other words a change in the D of the microorganism by a factor of 10). For bacterial spores the z is 10 ° C.
∆ t is the holding time at a temperature ≥ T
Standard ISO 15883-1 imposes a minimum A0 of 600 s corresponding to 10 min at 80 ° C or 1 min at 90 ° C. It adds that any washer-disinfector must offer at least one cycle capable of achieving an A0 of at least 3000 s (i.e. 5 minutes at 90 ° C, 2 mins 30 at 93 ° C).
The recommendations of the standard on the positioning of sensors are detailed below:

 


 ISO 15883-1 recommends to perform thermometric and cleaning efficiency controls for each cycle and type of carriers. This represents a large number of tests. Simplifications might be considered after appropriate risk analysis or per national guidance.

  ISO 15883-1 is being adapted according to ISO 15883-5 and recent evolution. As experience is acquired with the new standard framework, adaptations may be proposed by local guidelines


  Local regulations may impose some specific requirements. For example UK and Austria have  defined cleaniless target per device, instead of per cm2

An example of Manual cleaning processes validation inspired by ISO 15883-1 and ISO 15883-5 principles may be as follows


  The “guideline for validation of manual cleaning and manual chemical of medical devices 9 published in Germany is an example of a validation plan for manual cleaning processes

 

 

Validation of ultrasonic cleaning bath must be adapted to the use of the type and objective of the ultrasonic cleaning process.  

  • If the ultrasonic bath is used in preparation to Manual cleaning, it will be considered as a preparation to manual cleaning process and cleaning efficacy control do not have to be performed.
  • If the ultrasonic bath is the final stage before dsinfection or sterilization of the Medical device the procedure shoud be according to ultrasonics system features. 

    In all cases cavitation efficacy should be controlled

 

Cavitations test can be performed using:

  • An aluminum foil (according to the international technical rule IEC / TR 60886: 1987-03), Assessment of the effectiveness of the waves is according to the deteriorations and perforations observed in the aluminum foil. This test is only indicative and is not reproducible.
  • Commercialized colorimetric tests.
  • Ultrasonic analyzer
  • Cavitometer

An example of ultrasonic cleaning processes validation inspired by ISO 15883-1 and ISO 15883-5 principles may be as follows

 

 

Validation of packaging process

Packaging validations is governed by standards ISO 11607-110 (packaging system), 11607-211 (packaging process) and guided by ISO 1677512


  ISO 11607-2 concerns packaging processes such as forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. ISO 16775 provides guidance on ISO 11607-1 and -2 and suggests validations plans and checklists for each type of packaging (wraps, pouches and reels and containers).

The packaging validation plan lists the types of packaging and packaging equipment and determines, for each type of packaging (wraps, pouches, reels, containers), those that will be subject to validation.  

The installation qualification (IQ) controls that:

  • The packaging workstations and environment are adequate: layout, ergonomics (operator position), light appropriate for visual controls, air quality, temperature and humidity level,
  • The documentation is available for each type of packaging (brand, model): user documentation, marking and certificates of compliance with applicable standards, compatibility with the sterilization cycle planned for the DMR, storage conditions.
  • Maintenance plans are in place for equipment, in particular heat sealers.
  • Operating procedures are available for each type of packaging and operator training are up to date. Cleaning and disinfection procedures are in place for the workstations and environment.

  The user is not expected to repeat the type tests already performed by the manufacturer. Instead, certificates of compliance to the tests listed in the appendix to NF EN ISO 11607-1 and recommended by the applicable NF EN 868 standard should be requested (867-213 for wraps, 867-514 for Pouches and reels, 867-813 for containers). The chemical indicators affixed to the packaging should comply with NF EN ISO 11140-1.

The operational qualification (OQ verifies the correct implementation of various packaging, controls that heat sealers meet manufacturer specifications and control containers are operational and were maintained according to plans. PQ test are performed with the most challenging load for each type of packaging.

 

For wraps: controls of correction execution

  • For container: Visual controls, absence of deformation and control of gaskets. Control that maintenance plans are in place and executed. Optionnally water leak test according to AFNOR FD S98-053
  • For pouches and reels: Control of heat sealer setting, verification of Calibration, Dye and peel tests

    Sealing controls are carried out at the upper and lower limits of the T ° C range given by the manufacturer of the packaging. It is checked that the seal is intact over its entire length and width, absence of visible deterioration, grooves, or openings of delamination or separation of the material (ISO 11607-2 5.3.2 b).

    The sealing control is carried out with dyes (according to the ASTM 1929 method cited in informative appendix B of standard NF EN ISO 11607-1)

    Commercial tests allow the temperature and pressure of the rollers to be evaluated.

    The seal resistance test is carried out according to the principles of standard 868-5 appendix E

.

 

The performance qualification controls the entire packaging circuit from preparation to aseptic presentation (article 6.3 ISO 11607-1 January 2018)). Performance validation is performed with performed with actual content representing the most challenging packaging and handling, transport and storage conditions. It confirms, through practice, the risk analyzes carried out when defining the packaging system suitable for each RMD or family of DMRRMD’s.


  Within each family of packaging (sheets, sachets / sheaths, containers) several variants, specific to each hospital, may exist (according to the type of DMR, sterilization methods, size, brand etc…) . In practice, it is accepted to limit operational and performance validations after apropriate risk analysis. ISO 16775 provide guidance to determine the size of OQ samples. ISO 16775 suggests 3 evaluations for each type of packaging (i.e. 3 loads and 3 sterilization cycles. One of them corresponds to the conditions considered to be the most penalizing. If destructive checks are carried out (dye test or peel test), the number of samples tested is increased accordingly.

Requalification is annual. It may be simplified compared to the initial validation. A risk analysis will determine if a requalification is required after an incident or a voluntary modification (e.g. change of supplier).  

Routine and periodic tests include:

  • systematic visual checks of packaging, before sterilization, after sterilization and before opening
  • periodic checks of the execution quality of packaging systems and in particular checks on the effectiveness of the seals

 

 

Validation of Steam sterilization

Validation of steam sterilization process is carried out according to ISO 17665-114 and guided by ISO 17665-215 and ISO 17665-316


 ISO 17665-1 specifies the implementation requirements for large steam sterilizers. Technical specification ISO 17665-2 provide guidance for implementation of ISO 17665 -1. Technical specification ISO 17665-3 provide guidance to assign device in product families presenting common characteristics. These 3 texts refer to the criteria and test methods applicable to steam sterilizers complying to  EN 28517.


 ISO 17665-1, -2 and -3  cover hospital and industry applications of steam sterilization. Annex D of EN ISO 17665-2 refers to considerations specific to healthcare establishments.


 ISO 17665-1 can also be used, by analogy, for small steam sterilizers conforming to standard EN 1306018 (sterilizers intended for loads smaller than one sterilization unit)

IQ verifies and documents the compliance of the services (water supply, steam supply if applicable, power, supporting structure, etc.) with the manufacturer’s specifications. IQ also checks the availability of documentation (Instruction for use, maintenance, calibration certificates, certificates of essential type tests) as well as statement of conformities to local, regional, or national regulations for emissions into the environment from the equipment. The installation and documentation checks may need to be repeated, in part, after risk assessment, after a relocation of the equipment or a major modification / repair to the installation.


 Paragraph 24 of EN 285 defines the documentation to be supplied with the sterilizer (measurement system calibration certificate, proof of control of the safety functions, settings of the automatic control device, declaration of compliance with standards). Paragraph 25 of EN 285 lists the information required to prepare the installation, operate the sterilizer and ensure routine maintenance. It details the information to be communicated before installation (25.2), upon delivery (25.3) and before installation qualification (25.3).

 Local regulation define safety measure and  periodic inspection against the risk related to te safety of pressure vessels

OQ verifies that the equipment operates as specified by the manufacturer:  OQ tests include steam quality, air leakage flow rate, thermometric test, air detector if fitted, steam penetration, load dryness, thermometric tests hollow load and Bowie-Dick test,  

PQ is intended to control that reproducible results are obtained in conditions representative of real life.

Thermometric tests are performed with the most challenging load among product families and loading configurations that the sterilizing process may treat.

Advice on characterizing for difficulty should be available from the medical device manufacturer(s) and/or sterilizer manufacturer. Element to be considered when defining the most challenging load are mass (tray or container with the highest mass, the material and geometry (hollow devices), packaging (wrap, pouches, container).

Experience has shown that for a typical health care sterilization load and chamber usable space (ca. 400 l), 5 to 12 temperature sensors may be sufficient. Some sensor are placed on parts of the medical device from which is assumed (or known) that stelm penetration/air removal is most difficult to achieve.

If a process challenge device is used the challenge must be equivalent to the medical device(s).

Operational and Performance requalifications are commonly annual. The contents of the initial IQ, OQ and PQ and scheduled requalifications  are predefined.

The content of the unscheduled validation is event related (for example IQ may be partially or totally repeated after a relocation of the equipment or a major repair).


 Other examples of event requiring a requalification are a modification of the sterilization program or packaging A revalidation may be required  (for example, modification of the pre-treatment or sterilization phase, change of the duration), after modification of a packaging. Following a load modification, revalidation can be avoided if it has been shown that the new load is equivalent to another load already validated.

Routine controls are performed at each cycle, daily, weekly or quarterly

  • Each cycle: dryness and integrity of all packaging and chemical indicators (if used). Control that cycle parameters are in accordance with validation data.
  • Daily: visual control of corrosion and stain in chamber, gaskets, control of operating means and recorders, Bowie Dick test (chemical or electronic)
  • Weekly: Air leakage flow rate in some countries and calibration of air detector (if fitted)
  • At least quarterly: Air leakage flow rate (if not specified by country guidelines and unless the sterilizer is fitted with an automated leak tests active at each cycle)

 

 

 

Validation of Low temperature sterilization vaporized H202 processes (vH2O2)

in waiting for the development of ISO and EN vH2O2 standards , ISO 149371 and ISO 11138-120 remains the references for the validation of vH2O2 processes. 


  3 vH2O2 standards are currently in development. ISO 22441: Sterilization of health care products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices” will have the same structure as ISO 14937. Links will be made to EN 17180sterilizers for medical purposes – low temperature vaporized hydrogen peroxide sterilizers-requirements and testing” the future vH2O2 standard for manufacturer of H2O2 sterilizers. EN17180 will use the structure of ISO 22421(not to be mixed with ISO 22441) . ISO 11138-6: Sterilization of healthcare products – biological indicators – Part 6 – biological indicators for hydrogen peroxide sterilization processes” will confirm Geobacillus Stearothermophillus will remain the reference test microorganisms for hospital applications. Both ISO 22441 and EN 17180 drafts have agreed on the minimal variables to be measured by a vH2O2 process: Pressure, Time, Temperature and vH2O2 concentration. vH2O2 concentration can be measured by an H2O2 or deducted by other means such as pressure dynamic.

 

 

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

WFHSS key recommendations for cleaning & disinfection

  1. As sterility of each RMD cannot be individually controlled, the validation of all reprocessing steps (from point of use cleaning to storage) is essential to minimize the risk of a non sterile device. The validation is a key component of the quality management system.
  2. International ISO standards detail the validation of automated cleaning and disinfection and most sterilization processes. Although no standardized guidance is provided for manual processes, they must also be validated. The validation manual cleaning process may follow the principles of washer-difector standards.
  3. A validation plan describes the initial validation (for a new process or equipment), requalifications and routine controls. Initial validation consists of installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Requalifcation (rQ) is usually annual. It may be simplified compared to initial validation (for example no need for an rIQ). The content of unscheduled requalification are event related.
  4. Requalification may be required after an event  (for example, relocation of an equipment, amajor change in the process or major repair). The content of the requalification is event related.
  5. The results of the qualifications are recorded in the validation reports submitted for formal approval.
flowchart
Solide and stérile RMD

Validation of all steps of the sterilization processes from point of use processing to aseptic presentation is key to minimize the risk of a non sterile RMD

Go to WFHSS Recommandations for process validation 

1 of 5
Validation of Steam sterilization

For an example of validation of sterilization process  

Go to Validation of steam sterilization

2 of 5
Validation of packaging process

For details on validations on packaging process

Go to Validation of packaging process  

3 of 5
Process validation

For generale explanation on principles of validations 

Go to Principles of validations 

4 of 5
Validation of cleaning process

For details on validations on automated manual and ultrasonic assisted cleaning process 

Go to Validation of cleaning process  

5 of 5
Bibliographic references - Validation
  1. ISO 14937: Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices – 2009
  2. ISO 15883-1 : Washer-disinfectors — Part 1: General requirements, terms and definitions and tests (2006)
  3. ISO 15883-2 : Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (2006)
  4. ISO 15883-3 : Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (2006)
  5. ISO 15883-4 : Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (2018)
  6. ISO 15883-6 : Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (2011)
  7. ISO 15883-7: Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (2016)
  8. ISO 15883-5: Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (2021)
  9. Guideline for validation of manual cleaning and manual chemical disinfection of medical devices – DGSV/DGKH/AKI (2013)
  10. ISO 11607-1: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (2019) 
  11. ISO 11607-2: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (2019)
  12. ISO/NP TS 16775 : Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
  13. EN 868 2 to 10 Packaging for terminally sterilized medical devices – Part 2 to 10.
  14. ISO 17665-1: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices – 2006
  15. ISO 17665-2: Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1 – 2009
  16. ISO 17665-3: Sterilization of health care products – Moist heat – Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization – 2013
  17. EN 285: Sterilization – Steam sterilizers – Large sterilizers – 2016
  18. EN 13060: Sterilization – Steam sterilizers – Small steam sterilizers – 2018
  19. ISO/TS 22421: Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities (2021)
  20. ISO 11138-1 Sterilization of health care products — Biological indicators — Part 1: General requirements (2017)

Copyright 2020 Ⓒ WFHSS / Development by Benedetto.S

“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)

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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.