Can it work in your CSS D? |
Many hospitals in the Middle East are implementing a very high standards and following tough accreditation systems and protocols to ensure patient safety and the best services. Now, it is quite often to go to healthcare facility and find quality department, state of the art equipment, paperless documentation systems, pharmacy automation, pneumatic tube system, AGV and much more.
Is CSSD a part of the hospitaldevelopment? |
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CSSD is following every step of the modern setup of the hospitals. Now CSSD is equipped with state of the art Sterilizers, washers, automatic dosing system, traceability systems, multi-chambers washers and even automatic loading & unloading systems like air glide systems from Getinge. During my travels in the region I also witness some CSSDs are built with modular room solutions same as the OR. |
What is parametric release and what is ISO EN17665? |
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Parametric release is a fast system for the release of sterile loads. No need for biological indicators, no need for chemical indicators and no need to wait for load release. Parametric release is defined as the “Declaration that a product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances.” In other words, the decision to release a load of processed devices is based on the results of physical measurements. Understanding the concept of parametric release begins with an understanding of the sterilization process as used in health care facilities. It is common to think of the “sterilization process” as only the events that occur within the sterilizer itself. |
In reality, the sterilization process refers to any activity that may impact the outcome of the process and includes all of the steps required to reprocess a medical device.
These process steps include:
This concept of the total sterilization process demonstrates that the success of the sterilization depends on the successful completion of each of the elements of the process. |
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The fundamental requirements for setting up a parametric release system begin with the international standards that define the development and control of sterilization processes. The International Organization for Standardization (ISO) publishes these standards. The requirements for moist heat (steam) sterilization processes are defined in ISO 17665 with its three parts. This standard is applicable in both health care facilities and in industrial settings. Lot of people in the healthcare filed are thinking it is only for industrial setup but this is not true. This standard is quite comprehensive, and provide significant detail on a wide range of topics pertaining to all aspects of the sterilization process. |
Sounds interesting and Easy? |
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No, it is not easy but it is achievable. The ISO17665 is referring also to lot of quality and validation standards which should be implemented in order to reach the compliance with the requirements and ensures that this activity is both reliable and reproducible so that predictions can be made, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization. |
Consistency is the secret behind the parametric release. It is all about doing the same thing many times without any change so we will get always the same results. To ensure consistency we must have same procedures, materials, media supply, same patterns of loading, tested reference loads and validated equipment.
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The will result, all the time, a sterilized and dry load as long as these criteria are met. So in this case we don’t need to test the process by BI & CI every time we are repeating it. |
Which countries are releasing the load according to this standard?This is an international standard. Any country can adopt it but almost all CSSDs in western European countries are releasing the load based on physical parameters.
So let’s go back to our main topic:Are we ready for Parametric release?I believe the question should be rephrased and to be “Why we are late in adopting the parametric release in ME?” I believe many of the hospitals which trust its quality system and the consistency of the employees in doing their tasks can easily follow the ISO 17665. One thing will remain which will be the IQ, PQ and OQ of the equipment which will be covered in the next article.
“We are now ready to implement ISO 17665 as the stated requirements for documentation, a quality system and on-going validation are now realistic for many of health care facilities at the present time.”
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