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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
Go to packaging process →
2 of 12 RMD in packaging systemRMD ready for transport and storage and aseptic extraction
Go to packaging process →
3 of 12 RMD in packaging systemPackaging system ready for transport and storage and extraction
Go to packaging process →
4 of 12 Reusable textilesReusable Cotton textile to be avoided
Go to choice of the packaging method →
Implementation according to SOP
Go to Packaging process →
5 of 12 Reusable containersContainers 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 reelsPouches 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 wrapsWraps 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 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
Go to packaging process →
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”
“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”
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)
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.