Steam sterilization
are we applying recent
advances in control and validation process?
ABSTRACT
Currently, sterilization processing is at the dawn of a new era of quality improvement. There are many new technologies demonstrated to be effective that will contribute to improved patient care. The efficiency, reliability, and performance monitoring of modern equipment is continually improving; however, the fundamental process remains essentially the same in most health care settings. This article emphasizes the steam sterilization process commonly available in countries with limited resources because it is a simple, efficient, reliable, fast and inexpensive way to sterilize reusable medical devices. Universally accepted approaches to validation or process approval have been introduced as a suitable standard to measure conformity for which an international standard (ISO) has been published that identifies requirements for sterilization processes. The ISO should provide a format for establishing a common standard for the acceptance or rejection of sterilizing processes. A national guideline defines all the correct processes of sterilization to insure all medical devices are properly processed and safe for reuse on patients by implementing the following: correct cleaning; packaging; loading; proper use of sterilization equipment; monitoring; and storage. Therefore, all health care settings in Libya, should adopt central sterile service department system and all relevant factors must be taken into consideration, including instrument characteristics, design of the load carrier, process controls, water qualities and the computability of washer-disinfector and detergent, as it is the key solution that will increase safety for patients and staff.
INTRODUCTION
Sterilization, as a specificdiscipline,hasbeenwith us for over a century, since the invention of the steam autoclave. Since that time, there has been progressive refinementofsteamsterilizers.Sterilization processes have been altered by new organisms and resistances, different products to be sterilized and new techniques and methods of practice. Sterilization processes that employ physical agents are preferred because of their
relative simplicity. In addition, the conditions required to achieve sterility can be closely definedandmeasureddirectly(1). Althoughmany sterilization methods have been developed during last century such as ethylene oxide, and hydrogen peroxide gas plasma, each of these technologies has a combination of desirable and undesirable characteristics that can affect materials, assembly methods, adhesives, packaging and shelf life (2). In contrast steam is still the preferred and most cost-effective medium for the sterilization of re-usable medical devices worldwide and especially in limited resources countries. In such countries there is no other process that is more efficient,flexiblyemployed,easy to monitor and control, non-poisonous and economical. Despite these positive aspects, it would be wrong to think that steam sterilization can be used without a minimum knowledge of how it works and the need for compliance with certain regulations. Guidelines for steam sterilization are laid down in the European standards. This trend has been promoted by the current harmonization of European standards (CEN) and international standards, International Standardization Organization (ISO) (3).
advances in control and validation process?
ABSTRACT
Currently, sterilization processing is at the dawn of a new era of quality improvement. There are many new technologies demonstrated to be effective that will contribute to improved patient care. The efficiency, reliability, and performance monitoring of modern equipment is continually improving; however, the fundamental process remains essentially the same in most health care settings. This article emphasizes the steam sterilization process commonly available in countries with limited resources because it is a simple, efficient, reliable, fast and inexpensive way to sterilize reusable medical devices. Universally accepted approaches to validation or process approval have been introduced as a suitable standard to measure conformity for which an international standard (ISO) has been published that identifies requirements for sterilization processes. The ISO should provide a format for establishing a common standard for the acceptance or rejection of sterilizing processes. A national guideline defines all the correct processes of sterilization to insure all medical devices are properly processed and safe for reuse on patients by implementing the following: correct cleaning; packaging; loading; proper use of sterilization equipment; monitoring; and storage. Therefore, all health care settings in Libya, should adopt central sterile service department system and all relevant factors must be taken into consideration, including instrument characteristics, design of the load carrier, process controls, water qualities and the computability of washer-disinfector and detergent, as it is the key solution that will increase safety for patients and staff.
INTRODUCTION
Sterilization, as a specificdiscipline,hasbeenwith us for over a century, since the invention of the steam autoclave. Since that time, there has been progressive refinementofsteamsterilizers.Sterilization processes have been altered by new organisms and resistances, different products to be sterilized and new techniques and methods of practice. Sterilization processes that employ physical agents are preferred because of their
relative simplicity. In addition, the conditions required to achieve sterility can be closely definedandmeasureddirectly(1). Althoughmany sterilization methods have been developed during last century such as ethylene oxide, and hydrogen peroxide gas plasma, each of these technologies has a combination of desirable and undesirable characteristics that can affect materials, assembly methods, adhesives, packaging and shelf life (2). In contrast steam is still the preferred and most cost-effective medium for the sterilization of re-usable medical devices worldwide and especially in limited resources countries. In such countries there is no other process that is more efficient,flexiblyemployed,easy to monitor and control, non-poisonous and economical. Despite these positive aspects, it would be wrong to think that steam sterilization can be used without a minimum knowledge of how it works and the need for compliance with certain regulations. Guidelines for steam sterilization are laid down in the European standards. This trend has been promoted by the current harmonization of European standards (CEN) and international standards, International Standardization Organization (ISO) (3).
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