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Packaging
Objectives of packaging

Packaging is intended to preserve the sterility of the reusable medical devices (RMD) until its use. To meet this objective, the packaging system

  1. Is a microbial barrier 
  2. Protects an RMD and microbial barrier integrity from handling, transport and storage risks.
  3.  



Precautions must be taken to protect fragile parts of an RMD and avoid breach of the microbial barrier. For instance, sharp edges of RMD’s are shielded, and RMD’s are methodically installed in a basket, tray or instrument organizers
The size and resistance of the packaging system are adapted to the configuration and weight of an RMD or RMD composition. As needed, the physical resistance of the packaging is reinforced by additional protective layers.
Protective layers may also be used to prevent the accumulation of excessive environmental dust on outside surfaces of the packaging.
Transport and storage processes and equipments (e.g., cabinets and shelves) are key contributors to preservation of RMD’s and packaging integrity.



  1. Is compatible with the sterilization process.



Compatibility concerns all packaging components installed before sterilization, means :

  1. Preservation of microbial barrier properties 
  2. Free diffusion of the sterilizing agent to all RMD surfaces as well as free evacuation of condensate or sterilization residues.
  3. Physical resistance to pressure variation and high temperature (when applicable).
  4. No toxic by-products resulting from interaction with the sterilizing agent
  5. No particles release 



  1. Alllows the aseptic presentation of the RMD 



Aseptic presentation is defined by international standard ISO 11607-1 as:

“Transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination”.

To minimize risks during aseptic presentation:

  1. The personal in charge of aseptic presentation received appropriate training and was consulted for implementation of the packaging process. 
  2. During aseptic presentation, an RMD does not make contact with non-sterile surfaces of the packaging system and appropriate sterile techniques are applied.
  3. Sterile fields are adequately prepared. As needed contaminated protective packaging is withdrawn before entry in any sterile area
  4. If handling by sterile personal is required, the Sterile Barrier System (SBS) is itself inserted in an SBS and aseptically presented to sterile staff 




      International standard ISO 11607-11,2 defines packaging functions as follows :

The Sterile Barrier System (SBS) is “the minimum package that minimizes the ingress of microorganism and allows aseptic presentation of the sterile contents at the point of use”.
The protective packaging (PP) if “the configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use”.
The packaging system (PS) is “the combination of a sterile barrier system and protective packaging”

Choice of the packaging method

Sterile barriers technologies available on the market are as follows

  1. Single use wraps are made of woven or nonwoven cellulose, synthetic or mixed cellulose/synthetic sheets. Wraps are commonly used for basket and instrument sets. Wraps manufacturers define the number of wrap layers required for compliance to resistance and microbial barrier criteria defined by international standards. Wraps layers may be independent (sequential) or pre-bonded.
    Various folding methods are used (e.g., envelope, square or parcel or parallel, roll or pasteur). Name or preference for methods, may vary according to regions, habits or both. Folding is secured by adhesive tapes which usually serve also as sterilization indicators. Training of operators in charge of folding is key. Tutorials are available in different languages.
  1. Single use pouches or reels are made of 2 sheets pre-sealed on 3 sides (pouches) or 2 sides (reels).
    Pouches and reels are available in various dimensions and strengths. Rolls of reels are cut at the desired length.
    At least, one side of the pouch or reel is permeable to the sterilizing agent. The permeable side is made of nonwoven cellulose, synthetic or mixed cellulose/synthetic material. The other side is a transparent film (usually not permeable to the sterilizing agent).
    Pouches and reels are commonly used for light weight instruments or trays.
    heat sealing is the preferred way to close pouches or reels. Closure of pouches or reel is preferably by heat sealing. By default, when heat sealing equipment is not available, pouches with self-sealing adhesive can be used. 



Heatsealers are calibrated at temperature and pressure as defined by a pouch manufacturer. Minimum strength and minimum width of seals are defined by international standards. Maximum strength must be defined such that aseptic presentation is not compromised. An arrow (chevron) indicate peel direction.
RMD handles are on the opening side to ease extraction. Sharp edges are on the opposite side to avoid injuries.
1/3 of an internal surface (within seal limits) remains free to allow the packaging to absorb pressure variations.
Before sealing, air is forced from the pouch to avoid bulging.
Sealing is at a minimum distance of 3 cm of pouch side to make opening easier.
Integrity and continuity of the sealing is visually controlled .
Seal integrity tests are available on the market to periodically check that thermosealers are correctly used and calibrated (using, for example, the ink test).



  1. Reusable containers (box and lid) are made of aluminum, stainless steel or high-density polymers. Containers are available in various standardized sizes and often used with multiple basket or set compositions. A sterilizing agent penetrates through a filter, single use (most frequent) or reusable. Cleaning and disinfection of containers is as defined by a container’s manufacturer IFU, and requires organization, supplies and equipment. Maintenance plans are in place.
    Before reprocessing, disposable items  are discarded, and reusable accessories are disassembled. Container gaskets, mating surfaces, and latching mechanisms are visually inspected very carefully for cleanliness, distortion, impact, defect (which could impair the sealing), filtering, and locking functions. Dirty containers are cleaned again. Damaged containers are sent for repair.
    Many manufacturers recommend single use filters.  Reusable filters are inspected and discarded if defective. If manufacturers specify a maximum number of reprocessing cycles, the filters are discarded when this number is reached.
  1. Reusable textiles are made of cotton or polyester. Like single use wraps, they are mainly used for basket and instrument sets.
    Barrier performances of traditional cotton wraps are poor and deteriorate by repeated laundering and sterilization. Visual inspection for holes, and tears, are at risk for human error, which is not reliable. Textile release particles may pollute an RMD or spread in a sterile area during extraction.
    Polyester reusable wraps have better initial barrier performance than cotton. Evidence must be provided by the manufacturer that the sterile barrier performance remains satisfactory over the allowed number of reuses. Means must be provided to control the number of reuses. Controls should be performed by trained personal in conditions that minimize the risks of errors.

SBS and SBS material performance must conform to international standards. Except for cotton textile, international standards define performances of SBS materials.


      International standards ISO 11607-1 and -2 describe criteria and methods to test the packaging design, material and closure (e.g., resistance, permeability to air, biocompatibility, and aging, etc..). For several criteria, different methods may be proposed. For instance, there is no unique universally accepted test for sterile barrier performances. A manufacturer may use one or several methods and test internally, or preferably with support of external independent laboratories. At least one methods that uses a pass or fail criteria should be utilized.

There is no unique way to adequately package a given RMD or RMD composition. A packaging process is defined in partnership with surgical or medical users. A packaging process is adapted to the organization of the sterilization department and healthcare facility. Local recommendations or regulations may be applicable.

For each packaging configuration, a risk analysis should address the following hazards and hazardous situations:

  • The conformity with a packaging manufacturer’s IFU and international standards
  • The compatibility with the sterilization process (pressure changes, temperature, chemical impact)
  • The worst case scenarios regarding transport and storage conditions and their potential impact on the SBS and RMD.
  • The achievement of aseptic presentation objectives 
  • Expiration date determination. Expiration dates are event-related (i.e. related to transport and storage risks). Expiry dates are always more pessimistic than aging tests performed by packaging and packaging manufacturers.


Multiple layers of SBS are commonly used (double pouch or reel, double-wrapping or wrap in a container). Risk analysis should confirm the need for multiple layers in an SBS. In any case, it must be checked that:

  • Multiple layers in an SBS are compatible with the sterilization process
  • For pouch and reels : space left around an internal SBS is sufficient. Criteria for space around an internal SBS are the same as for an RMD. Internal pouches or reels are not folded to fit into an external SBS. Internal seals are not crossed by sealing of an external SBS
  • For wraps: that double wrapping is not an incentive to minimize attention paid to folding
  • Multiple SBS’s does not increase extraction risks
The packaging process

Packaging takes place in a controlled environment. The space allocated to packaging operations is separated from the cleaning area. Air quality  is determined by local regulations or best practices

There is no unique way to correctly package a given RMD. A packaging process is defined in partnership with a surgical or medical user, according to RMD characteristics, organization, and experience of the sterilization department. For example, a general hospital with an internal sterilization department will not have the same imperative as a specialized surgery center with outsourced reprocessing. Local recommendations or regulations may apply.

Written SOP’s describe each step of the packaging process. SOP’s include RMD and packaging manufacturers’ IFU’s.

  • Expiration dates (for single use packages) or maximum number of reuse (for reusable containers) are checked. Expired wraps, pouches or reels are discarded according to waste management procedures, and/or manufacturers’ IFU’s,  local regulations, or all three entities. Margins above an expiration date of single use items provided by the manufacturer (wrap, pouch and filter) estimates longest expectable storage period.
  • Packaging is visually controlled.

Wraps, pouches and reels are controlled for integrity(i.e. by detecting holes or pinches). Damaged items are discarded according to manufacturers’ IFU’s and local regulations.

Container gaskets, mating surfaces, and latching mechanisms are inspected for cleanliness, distortion, impact, defect (which could impair the sealing), filtering or locking functions. Dirty containers are re-cleaned. Damaged containers are sent for repair. Reusable filters are inspected and discarded if defective.

  • Before insertion in an SBS, RMD’s are, as needed, equipped with protection accessories, and installed in a basket, tray or organizers. Protection and organizers ease aseptic presentation and limit the risk of operators injuries. For pouches and reels, handles are on opening side, and sharp edges are on the opposite side.

In trays, instruments with concave surfaces are positioned on their side to ease to ease diffusion of a sterilizing agent, and allow for moisture to collects in the concave portion to drain (for moist heat sterilization)

  • SBS’s are hermetically closed. A container lid is fastened with temper-evident indicators. Wraps are folded. Pouches and reels are sealed. If required per the risk analysis, additional layers of pouch, reels or wrap are implemented with similar precautions.
  • An SBS carries individual labeling. Labels are visible (i.e. on an external wrap, in case of double wrap). If a protective package (PP) contains several SBS’s, means are provided to identify the SBS enclosed in the PP. For pouches and reels, a label is placed on the non-permeable side. Writing or printing on the porous web is not allowed, as ink could seep through the packaging. Conversely, writing or printing on the porous web which does not come in direct contact with the medical device is allowed.  Each container carries a traceability tag. Labels are compatible with the sterilization process. Expiration dates are defined according to SOP’s.
  • After sterilization, each item is visually controlled. Damages, non-conformities and missing or incomplete labels are reported and analyzed. Visible damage on an external pouch, reel or wrap is an incentive to check damages of the internal SBS. As needed, RMD’s are repackaged and sterilized or cleaned and sterilized. A root cause analysis should be performed and the risk control measures should be adapted accordingly.
  • As needed, protective packaging (post sterilization) is implemented. If a protective packaging includes several SBS’s, contents of the protective packaging is visibly indicated.
  • Transport and storage of packages are performed with care.
  • At point-of-use, packages are visually inspected. An RMD is aseptically extracted by trained operators.
Packaging and quality

Written packaging standard operating procedures (SOP) are prepared in accordance with Quality Management principles.

An SOP is available for each group of RMD’s sharing a common packaging process (i.e. same sterilization procedure, same type of SBS, protective measures for transport and storage). Each SOP is based on a thorough step-by-step risk analysis from package preparation to aseptic presentation. A risk analysis is challenged by a real life test in worst case conditions for each type of representative packaging.

Packaging process validation controls: 

  • The packaging area of the sterilization facilities is adequately designed and installed  (e.g. including lighting, packaging workstation etc.) and that air quality  is appropriate and monitored.
  • Sealing equipment is properly installed and calibrated.
  • Manufacturer’s  instructions for use (IFU) for SBS and heat sealing equipments are available.
  • Packaging Certificates of compliance with international standards and certificates of tests performed to claim compliance are provided.
  • SOP’s are up to date
  • Occupational health and safety considerations are included. Packaging facilities and workstations are adequately designed, installed and equipped; precautions are taken against injuries by sharp RMD’s or excessive loads. The maximum total weight of a packaged items does not exceed 10 kg (including the container, if that type of reusable SBS is used)
  • Training is executed and certificates are available. 



All operators involved in packaging preparation, transport, storage and extraction receive appropriate training. A packaging process, involves many manual or semi-manual operations, and correct execution of these operation is critical. No protection is enough against improper handling during transport or storage. Finally, all efforts to bring a sterile RMD to the point of use (i.e., operating theater) are ruined if aseptic presentation is not done with care.



Validation is repeated each year, and before a change that justifies a partial or total validation has occurred. Procedure and training are updated as needed. 

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

WFHSS key recommendations for packaging

  1. The packaging process is key for efficient sterilization and preservation of sterility  until use of an RMD. A risk analysis checks that all packaging configurations:
    • Meet sterile barrier criteria
    • are compatible with the sterilization process
    • adequately preserve the SBS and its contents against worst case transport and storage events
    • achieve aseptic presentation objectives.
  2. Packaging process validation checks that
    • SBS IFU, and certificates of compliance to international standards are available. When there is no unique standardized test methods for a given criteria (e.g., microbial barrier), methods using a clear pass and fail threshold are preferred. Tests performed by independent test laboratories are preferred to internal testing by a manufacturer. Non-compliant SBS’s and, in particular, cotton textiles are not used.
    • Packaging equipments and workstations are adequately designed, installed and maintained.
    • SOP’s are up to date
    • That expiration dates are event related
    • All operators involved in the packaging chain, including logistic and point of use staff, receive adequate training and are conscious of their contribution to the delivery of safe and functional RMD’s and patient safety.
Packaging flowchart
Cleaned, dry, assemble RMD

RMD ready to be packaged in preparation for sterilization

Go to objectives of packaging

1 of 12
Sterillized RMD

RMD sterility preserved by SBS

Go to packaging process

2 of 12
RMD in packaging system

RMD ready for transport and storage and aseptic extraction

Go to packaging process

3 of 12
RMD in packaging system

Packaging system ready for transport and storage and extraction

Go to packaging process

4 of 12
Reusable textiles

Reusable Cotton textile to be avoided

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

5 of 12
Reusable containers

Containers compliant to international std cleaned and disinfected and controlled

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

6 of 12
Single use pouches or reels

Pouches and reels compliant to international std

Validated sealing

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

7 of 12
Single use wraps

Wraps compliant to international std

Folding according to validated practices

Go to choice of the packaging method


Implementation according to SOP

Go to Packaging process

8 of 12

According to SOP defined after risk analysis

Go to  WFHSS recommendations for packaging

9 of 12

Visual controls

Go to Packaging and quality

10 of 12

Packaging compatible with sterilization process

Go to Objectives of packaging

11 of 12

As needed installation of protective packaging

Go to packaging process

12 of 12
Bibliographic references - Packaging
  1. ISO 11607-1 : Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (2019) 
  2. ISO 11607-2 : Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (2019)
  3. ISO/NP TS 16775 : Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
  4. EN 868 2 to 10 Packaging for terminally sterilized medical devices – Part 2 to 10.
  5. Decontamination and reprocessing of medical devices for health-care facilities – WHO (2016)
  6. ISO 17664 : 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.