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Reusable medical device
Processing of reusable medical devices (RMD's)

For the purpose of this guide a Reusable Medical Device (RMD) means:

  • An item that is not intended by its manufacturer for single-use.
  • A medical device designated or intended by the manufacturer as suitable for reprocessing.

      Reprocessing of single use medical devices is outside the scope of these guidelines

RMD’s may be :

  • Medical or surgical items in contact with skin, mucous, or are inserted into the human body (e.g., surgical instruments, flexible endoscopes, dental instrumentation).
  • Diagnosis, monitoring, treatment equipment components in contact with a patient.
  • Items used for conveying body fluids, tissues or preparation for subsequent use in humans (e.g., hemodialysis).
  1.  

      Medical device regulations vary between regions. Some items may not be registered as medical device in some regions.

Reprocessing means all operations performed on a used RMD to allow its safe reuse


      The European Medical Device Regulation defines reprocessing as a: 

process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilization and related procedures, as well as testing and restoring the technical and functional safety of the used device”. 

The US food and drug administration (FDA) defines reprocessing as a:

 “validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent single use. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. Reprocessing of reusable devices encompasses appropriate steps that begin in close proximity to the point of use of the device and, in general, involves the following three steps in sequence: point-of-use processing…., thorough cleaning….. Disinfection or sterilization……”

Reprocessing may be performed by a health care facility or shared with an external organization under an outsourcing contract.
Reprocessing applies to all RMD’s that were removed from packagingeven if they were not used.

Reprocessing may also be undertaken on:

  • A loaned or deposited RMD,
  • An RMD returned from repair,
  • A new RMD delivered non-sterile. Specific reprocessing may be recommended by RMD manufacturer to eliminate manufacturing residuals from a new device and/or to sterilize the device before first use.

An RMD returned for maintenance must be cleaned and disinfected for the safety of maintenance staff (a reprocessing certificate is provided)

Spaulding classification principles

Instruments and items for patient care were categorized by E.H. Spaulding in the late 1960’s according to the risk for infection involved in their use.

  1. Critical: An item that contacts sterile tissue or the vascular system. A critical RMD presents a high risk for infection if it is contaminated by any microorganism. Thus, an object that enters in sterile tissue or in the vascular system must be sterile. Any microbial contamination could transmit disease. Surgical instruments, surgical implants, endoscopes or ultrasound probes  (such as choledochoscopes) used in sterile body cavities are examples of critical RMD’s.
  2. Semicritical: An item that contacts mucous membranes or non‐intact skin. Mucous might be an efficient barrier against small quantity of common bacterial spores. However, other organisms are at risk, such as bacteria, mycobacteria, and viruses. Examples of semi-critical items are respiratory therapy and anesthesia equipment, and some flexible endoscopes.
  3. Noncritical: An item that contacts intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms. Examples of noncritical patient-care items are bedpans and blood pressure cuffs. Non-critical environmental surfaces include bed rails, some food utensils, bedside tables, patient furniture, and floors. In some regions keyboards and consoles forming part of imaging systems may also be classed as medical devices and these will also be non-critical.

The core principles of the Spaulding classification remains valid, however, changes have occurred over time. For example: 

  • Minimally invasive surgery increased the average complexity of RMD. Cleaning of lumen and sophisticated devices can be difficult. Heavily soiled and contaminated flexible duodenoscopes are a good illustration where the complexity of cleaning increases the risk and sterilization may be advocated to support effective cleaning.

  • Choice of sterilization and disinfection methods has increased, is more difficult, and subject to local interpretations. 



Heat sensitive RMD’s require a range of cycles adapted to their material and geometrical specificities.

Some heat compatible, minimally invasive surgery instruments are subject to accelerated aging (e.g., laparoscopy devices). Some countries offer the flexibility to use low temperature sterilization; other countries do not.

More recently, overlaps have appeared between critical and semi-critical categories. For example, an endoscope used for upper gastrointestinal tract investigation with sterile biopsy forceps.

The 3 levels of disinfection defined below are not used by all guidelines.

  • High-level disinfection: Process that kills all microbial organisms but not all bacterial spores. Variants of this definition are : kill all microorganisms except large numbers of bacterial spores, or kill microorganisms except for small numbers of bacterial spores.
  • Intermediate-level disinfection: Process that kills viruses, mycobacteria, fungi, and vegetative bacteria, but not necessarily bacterial spores. Variants of this definition are : kill mycobacteria, vegetative bacteria, most viruses, and most fungi but not necessarily bacterial spores or vegetative microorganisms.
  • Low-level disinfection: Process that kills most vegetative bacteria, some viruses, and some fungi, but not mycobacteria or bacterial spores.

Some countries have additional criteria for high level disinfection. For instance, the US FDA definition is: sterilant used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacteriumspecies. In other countries there is no efficacy threshold between intermediate and high-level disinfection and the sterilant concept is not used.

National or regional regulations should be consulted with respect to use of the above categories of disinfection.



  • Prion, outbreak and patient susceptibility (e.g., immunocompromised patients) have highlighted the need for communication between care units and infection control. 
  • Regulators and international standard have increased the pressure on medical device manufacturers for improved, validated instructions for reprocessing. 



International standard ISO 17664-11 describes the information to be provided by RMD manufacturer for reprocessing of critical and semi-critical medical devices. RMD manufacturers’ guidance are supported by risk analysis and tests, as needed. RMD manufacturers check that the recommended reprocessing methods are available in countries where an RMD is marketed.



  • Occupational health and safety and environmental considerations became key factors. For example, automated cleaning methods are preferred as they are more consistent and safer for operators. Waste management rules are applied.
Prion risk

Prion is a small proteinaceous infectious unit that appears in a variety of human and animal neurodegenerative diseases, including Creutzfeldt-Jakob disease (CJd), bovine spongiform encephalopathy (BSE, also known as the mad cow disease), and scrapie. 

Prion diseases have always existed but usually very rare. Prion proteins derive from a normal body protein that becomes irreversibly mis-folded. Prion proteins proliferates primarily in the central nervous system (CNS). 

In the 1980’s  beef became infected by BSE in some Western European countries. A variant of Creutzfeld-Jakob disease spread among human who had consumed infected beef. 

 

Prions are highly resistant to disinfection and sterilization. Their resistance can be increased by fixative agents. 

 

Anti-prion regulations or guidelines were hence implemented by some countries to deal with the removal or inactivation of prion proteins from RMD’s. Such regulations or guidelines are country specific. The following paragraphs provide high level information on prion recommendations (when such national or regional recommendations or rules exist).

Strategy is commonly  based on patient screening and specific attention to CNS surgeries (brain, spinal cord or posterior of the eye).

Example of measures for at risk patient or surgeries are :

  • When possible, prefer single use surgery devices.
  • Extended hold period of an RMD until the absence of risk can be confirmed.
  • Processes which experimentally showed an ability to inactivate prion (i.e., destruction of the protein and not only elimination). 


Evaluation of prion inactivation is based on complex in vivo experiments. Example of processes which show efficient are sodium hypochlorite, sodium hydroxde, high pH alkaline detergent, some low temperature sterilization cycles, combination of cleaners and low temperature cycles. Efficacy is obtained in accurately defined conditions (i.e., concentration, temperature and exposure times, etc.) and are only valid for these specific conditions. Steam cycles at 134°C 18 minutes have a high efficacy. (although inactivation is not complete)
 

Prion regulation or guidelines insist on precaution to avoid drying of soils on RMD’s and include warnings on risks linked to the use of fixative processes



Some sterilizing, cleaning and disinfecting formulations are known to reinforce the fixation of proteins, including prion, on RMD surfaces. For instance, dry heat, ethylene oxide, aldehyde based sterilizing and disinfecting agent such formaldehyde or glutaraldehyde or  alcohol. Countries with prion regulation may forbid or discourage the use of fixative formulation or require a thorough cleaning with a non-fixative process before implementation of a potentially fixative formulation.


 

In addition some regions may set their own standards for residual protein levels on RMD and apply additional precautions for RMD used in particular procedures such as those relating to the brain, spinal cord or posterior of the eye

As prion Management is country specific Management of prion risk is management by national regulation

Medical Device vigilance

Medical Device Vigilance Systems are used to improve patient safety, provide for the protection of health and safety of  healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a RMD. 

Countries have regulations in place to collect and analyse incidents report. 

Some risks may be related to reprocessing. Reprocessing department must contribute.



There are different vigilance systems in operation in many regions. As an example, in the European Union, the medical device regulations place a legal responsibility on device manufacturers to report adverse incidents and Field Safety Corrective Actions (FSCAs) to EU Competent Authorities. Users of medical devices can also report incidents to the Competent Authority on their own jurisdiction. These reports contribute to a central database called EUDAMED. The US food and drug administration (FDA) operate a similar system and have their own database called the Manufacturer and User Facility Device Experience (MAUDE) database which contains all the medical device reports reported to the FDA since Aug 1996. 

Other countries such as Canada, Japan and Australia operate similar systems.  Many of the regions now co-operate on regulation for medical devices via the International Medical Device Regulators Forum (IMDRF).



RMD reprocessing and quality

Safe reprocessing is obtained by application of quality management principles by :

  1. RMD manufacturers: IFU’s include validated instructions for reprocessing. If needed, the maximum number of reuse is specified.
  2. Manufacturers of reprocessing equipment and consumables: Sterilizers, washer-disinfectors, cleaning and disinfecting agents, etc… comply to international standards and applicable regulation.
  3. Healthcare facilities: Detailed  standard operating procedures (SOP’s) are defined for all reprocessing steps. All reprocessing chain links are key for patient safety: soils that are given time to dry on an RMD are more difficult to clean, an improperly cleaned RMD cannot be sterilized or disinfected, deficient packaging, transport, storage, or aseptic presentation may mean a contamination or damage of an RMD.

By process validation, a user verifies that: 

  • Installation of reprocessing equipment conforms to manufacturer’s recommendations
  • IFU, test and calibration certificates are available.
  • SOP’s are up to date. Il applicable, management of specific risk such as prion is included.
  • Routine controls are in place.
  • Training is executed. Training certificates are available.
  • Occupational health and safety precautions are known and implemented.
  • Medical devices vigilance obligations are known and enforced.
  • Waste management measures are known and applied.
  • Maintenance plans are in place for reprocessing equipment.
  • Traceability is operational. 
Screenshot-2019-09-07-at-13.22.20-e1567939504403

WFHSS recommendations for reprocessing of RMD's

  1. Persons in charge of reprocessing are consulted before purchase of a new RMD. It is verified that reprocessing methods recommended by RMD manufacturers are available to the health care facility. Specific attention is paid to complex RMD’s.
  2. Reprocessing Standard Operating Procedures (SOP’s) follow RMD IFU’s and applicable guidelines. If adaptations to an RMD manufacturer’s IFU are required they are to be justified, risk assessed and documented. When doubt exists between Spaulding categories, the highest available is chosen. If deficiencies are detected, they are reported according to applicable medical devices vigilance rules.
  1. RMD reprocessing is organized and implemented in partnership with care units and infection control. Implementation is clear from point of use to aseptic presentation. Prion risk, outbreaks and fragile patients are taken into consideration.
  1. Quality management and process validation are in place
RMD reprocessing flowchart
RMD soiled

SOP’s according to Spaulding classification principles, Manufacturers IFU’s and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

1 of 13
Non-critical

contact with intact skin

Go to Spaulding classification principles

2 of 13
Semi-critical

contact with mucous or injured skin

Go to Spaulding classification principles

3 of 13
Critical

Contact with sterile tissue and vascular system

Go to Spaulding classification principles

4 of 13
Evaluation of risk according to previous use (outbreak - prion)

In partnership with care or surgical user and infection control

Go to Recommendations of WFHSS for reprocessing of RMD’s

5 of 13
Point of use processing, cleaning, packaging (for terminal sterilization) and controls

Thorough cleaning and preparation of RMD

Go to recommendation of WFHSS for RMD

6 of 13
◁ Disinfection ▷

Level of disinfection according to risk

Go to recommendation of WFHSS for RMD

7 of 13
◁ Sterilization ▷

Sterilization method according to RMD manufacturer IFU and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

8 of 13
Prion measures

According to applicable regulation

Go to prion risk

9 of 13
RMD safe for use

Functional, reprocessed according to manufacturer IFU’s and applicable regulation

Go to Recommendations of WFHSS for reprocessing of RMD’s

10 of 13

Consult services in charge of reprocessing before purchase of a new RDM

Go to Recommendations of WFHSS for reprocessing of RMD’s

11 of 13

Validated processes

Go to recommendation of WFHSS for reprocessing of RMD’s

12 of 13

Controls

Go to RMD and quality

13 of 13
Bibliographic references - Reusable Medical Devices (RMD)
  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.