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After sterilization or disinfection, Reusable Medical Device (RMD) may be immediately used or stored until use.
Storage conditions depend on the level of risk of the RMD under Spaulding classification principles.
In some countries, the temporary storage of semi-critical flexible endoscopes may be prolonged by using a storage cabinet. Maximum storage time is defined by local regulation or guidelines. Valves must be removed and stored separately, under dry and dust free conditions.
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Storage take place in a room adjacent to the central sterilization department or at point of use.
Items have been removed from the external shipping containers in a breakout space external to the storage area. The access to the storage area is restricted to authorized personnel. |
Open evacuation, water supply, ducts are avoided. In case they exist, sterile items, including those packaged in rigid sterilization container systems, are not stored next to or under sinks, under exposed water or sewer pipes, or in any location where they could become wet. Packaging are not exposed to direct sun light. UV accelerate material aging. Temperature and humidity variations are avoided to prevent the acccumulation of moisture (condensate) on instruments surfaces. Major temperature fluctuations are avoided to prevent the accumulations of moisture (condensate). Recommended T°C and relative humidity ranges vary according to local guidelines (from 15°C or 18°C and 25°C for temperature, around 60 % or between 40 and 75% for RH). For some sensitive supply, manufacturer IFU's may require specific humidity ranges. There are no standardized air quality or aero-contamination limits for storage area. Local recommendations may apply. |
Open shelves (wire or solid shelves) are adapted for confined storage area, where traffic, ventilation are controlled. Closed or covered cabinets are needed for high trafic areas where dust might acccumulate. The bottom shelf of storage carts or shelving is preferably solid. Transport trays with solid or perforated bottoms may be used to prevent tears in wraps or pouches during handling. Pouches and reels are stored vertically or flat in baskets. Compression can force air and microorganisms onto the package content, cause seal to burst, or puncture the packaging. Wraps are not stacked. Wrapped packages are not stored beneath rigid sterilization containers on the same shelf. |
The shelf life of sterile RMD is event-related and based on the quality of the packaging material, the storage conditions, the methods and conditions of transport, and the amount and conditions of handling. The probability of damages increases over time and with number of handling. |
Written storage standard operating procedures (SOP’s) are prepared in accordance with quality management principles.
Process validation of storage controls that:
Sterile in packaging or sterilized but not packaged or disinfected
Go to Storage – Key principles →
1 of 8 Ino storage - immediate useTransfer under controlled conditions
Go to Storage – Key principles →
2 of 8 Storage of non critical itemsAccording to type of RMD and hospital policy
Go to Storage – Key principles →
3 of 8 Storage of semi critical RMDMaximum storage times according to local regulation
Might be prolonged with flexible scopes storage cabinets
Go to Storage – Key principles →
4 of 8 Storage of sterile itemsIn storage area under controlled conditions
Go to Storage of sterile items →
5 of 8 RMD safe for useRMD safe for delivery to final users
Go to Storage – Key principles →
6 of 8According to SOP’s
Go to WFHSS recommendation for storage →
House keeping of storage area and control of expiration dates according to SOP’s
Go to Storage and quality →
8 of 8“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.