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Packaging is intended to preserve the sterility of the reusable medical devices (RMD) until its use. To meet this objective, the packaging system:
Precautions must be taken to protect fragile parts of a RMD and avoid breach of the microbial barrier. For instance, sharp edges of RMD are shielded, and RMD are methodically installed in a basket, tray or instrument organizers. |
Compatibility concerns all packaging components installed before sterilization, means :
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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:
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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) is “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”. s
Sterile barriers technologies available on the market are as follows;
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. 75% 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). |
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 method 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:
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:
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.
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.
In trays, instruments with concave surfaces are positioned on their side to ease diffusion of the sterilizing agent, and allow for moisture to collect in the concave portion to drain (for moist heat sterilization)
Written packaging standard operating procedures (SOP) are prepared in accordance with Quality Management principles.
A 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:
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 or after a change that justifies a partial or total revalidation . Procedure and training are updated as needed.
RMD ready to be packaged in preparation for sterilization
Go to objectives of packaging →
1 of 12 Sterillized RMDRMD sterility preserved by SBS
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2 of 12 RMD in packaging systemRMD ready for transport and storage and aseptic extraction
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3 of 12 RMD in packaging systemPackaging system ready for transport and storage and extraction
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4 of 12 Reusable textilesReusable Cotton textile to be avoided
Go to choice of the packaging method →
Implementation according to SOP
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5 of 12 Reusable containersContainers compliant to international std cleaned and disinfected and controlled
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Implementation according to SOP
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6 of 12 Single use pouches or reelsPouches and reels compliant to international std
Validated sealing
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Implementation according to SOP
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7 of 12 Single use wrapsWraps compliant to international std
Folding according to validated practices
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Implementation according to SOP
Go to Packaging process →
8 of 12According to SOP defined after risk analysis
Go to WFHSS recommendations for packaging →
Visual controls
Go to Packaging and quality →
10 of 12Packaging compatible with sterilization process
Go to Objectives of packaging →
11 of 12As needed installation of protective packaging
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12 of 12“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”
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 is intended to preserve the sterility of teh reusable medical device (RMD) until its use.
Rigid sterile barrier system designed to be repeatedly used (ISO 11607-1 2018)
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 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
Some sterilizing, cleaning and disinfecting formulations are known to favor the adherence and resistance of proteins, including prion on RMD surfaces.
Levels of purity of ambient air and compressed air used for drying.
Chemical, physical, biological, and radiological characteristics of water used for cleaning, disinfection, rinsing and steam sterilization of RMD.
Processing operation performed at point of use of the Reusable Medical Device (i.e. operating theatre or care unit)
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 →
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.
OHS deals with all aspects of health and safety in the workplace and has a strong focus on primary prevention of hazards (WHO : 2016)
For the present guidlelines reusable medical device (RMD) means:
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 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)
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.
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)
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 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.
Go to Sterilization chapter →
Process whereby product is sterilized within its sterile barrier system (ISO 11139 : 2018)
Go to Sterilization chapter →
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.
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 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
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)
Ability to trace the history, application, use and location of an item (products, parts, materials, and services) or its characteristics through recorded identification data.
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 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 →
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.
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 concerns mainly sterile medical device. Storage of disinfected devices may be allowed by local regulation in defined conditions.
Transport includes:
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 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 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.