Implementation
The hospitals in Libya should designate well trained qualifiedpersonnelresponsibleforsupplying, preparing, distributing and managing the sterile medical devices. The authorization of any activity in sterilization, from cleaning to storage, is required. A guide to good sterilization practices, defininghowtoperformsterilizationfrom beginning to end, should be available for implementing quality assurance: procedures from the use of the instrument to its storage; the necessity of validation of every sterilization process; staff education; core training and regular updating.
The development of more complex instruments for use in minimally invasive surgery has resulted in more cleaning and disinfection challenges, therefore cleaning plays an immensely important role in this process.The majority of our hospitals adopted manual cleaning, using low quality detergents/cleaning agents and brushes. Above all water quality is essential and has a great influenceontheresult of the cleaning process. Quality control in cleaning is currently a topic that is heavily under review and various test methods are being developed in order to verify the adequate cleaning. According to the new standard for automatic washer/disinfectors (ISO 15883) the cleaning performance has to be validated for each type of load. This resulted in the development of standard test soils and process challenge devices for cleaning process.
ISO 17665 describes the requirements for ensuring that the activities associated with the process of moist heat sterilization are performed properly (9). These activities are described in documented work programmes designed to demonstrate that the moist heat sterilization process consistently yields sterile products on treatment with process variables falling within the predetermined limits. Compliance with the requirements ensures this process is both reliable and reproducible so that predictions can be made, with reasonable confidence,thatthere is a low level of probability of there being a viable microorganism present on product after sterilization. Specificationofthisprobabilityisa matter to be handled by regulatory authorities and can vary from country to country.
The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Bacillus stearothermophilus. Positive spore test results are a relatively rare event (10) and can be attributed to operator error, inadequate steam delivery (11), or equipment malfunction. Biological indicators are now definedinISO14937asorganismspossessinga greater resistance to the sterilizing agent than the intrinsic bioburden of the product to be sterilized, irrespective of species or form (3,12). Currently, no Libyan hospital is using a biological indicator, wireless loggers nor Boie and Dick test for routine monitoring and to validate the performance of the steam sterilizer according to ISO 17665. Libyan hospitals rely on traditional process indictors such as tapes. In addition, non of the hospitals is using chemical
The development of more complex instruments for use in minimally invasive surgery has resulted in more cleaning and disinfection challenges, therefore cleaning plays an immensely important role in this process.The majority of our hospitals adopted manual cleaning, using low quality detergents/cleaning agents and brushes. Above all water quality is essential and has a great influenceontheresult of the cleaning process. Quality control in cleaning is currently a topic that is heavily under review and various test methods are being developed in order to verify the adequate cleaning. According to the new standard for automatic washer/disinfectors (ISO 15883) the cleaning performance has to be validated for each type of load. This resulted in the development of standard test soils and process challenge devices for cleaning process.
ISO 17665 describes the requirements for ensuring that the activities associated with the process of moist heat sterilization are performed properly (9). These activities are described in documented work programmes designed to demonstrate that the moist heat sterilization process consistently yields sterile products on treatment with process variables falling within the predetermined limits. Compliance with the requirements ensures this process is both reliable and reproducible so that predictions can be made, with reasonable confidence,thatthere is a low level of probability of there being a viable microorganism present on product after sterilization. Specificationofthisprobabilityisa matter to be handled by regulatory authorities and can vary from country to country.
The effectiveness of steam sterilization is monitored with a biological indicator containing spores of Bacillus stearothermophilus. Positive spore test results are a relatively rare event (10) and can be attributed to operator error, inadequate steam delivery (11), or equipment malfunction. Biological indicators are now definedinISO14937asorganismspossessinga greater resistance to the sterilizing agent than the intrinsic bioburden of the product to be sterilized, irrespective of species or form (3,12). Currently, no Libyan hospital is using a biological indicator, wireless loggers nor Boie and Dick test for routine monitoring and to validate the performance of the steam sterilizer according to ISO 17665. Libyan hospitals rely on traditional process indictors such as tapes. In addition, non of the hospitals is using chemical
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