AAMI ST46 pdf free download

AAMI ST46 pdf free download.Steam sterilization and sterility assurance in health care facilities.
2.62 sterilization: Process used to render a product free from viable microorganisms. NOTE—In a sterilization process, the nature of microbiological death is described by an exponential function. Therefore, the presence of microorganisms on any individual item can be expressed in terms of probability. While this probability can be reduced to a very low number, it can never be reduced to zero. 2.63 sterilization area: Area of a health care facility where sterilization activities take place. 2.64 sterilization cycle: See cycle, sterilization. 2.65 sterilizer: Apparatus used to sterilize medical devices, equipment, and supplies by direct exposure to the sterilizing agent. 2.66 sterilizer, steam: Sterilizing apparatus that uses saturated steam under pressure as the sterilant. 2.67 table-top sterilizer: Compact steam sterilizer that has a chamber volume of not more than 2 cubic feet and that generates its own steam when distilled or deionized water is added by the user. 2.68 validation: Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. NOTE—Validation covers three activities: installation qualification, operational qualification, and performance qualification.3 Design considerations 3.1 General rationale This section provides guidelines for the design and maintenance of the workplace to facilitate effective and efficient processing and personnel safety, minimize environmental contamination, and maintain the sterility of processed items. Whenever possible, centralized sterilization processing (i.e., sterilization processing in one department) is encouraged. Sterilization is a complex process requiring sophisticated equipment, adequate space, qualified personnel who are provided with ongoing training, and continuous monitoring for quality assurance. From both safety and cost-effectiveness standpoints, centralizing these functions is preferred to replicating them in several areas of the health care facility. Depending on the particular characteristics of the health care facility, there may be situations in which centralization of sterilization processing is not possible. If so, consistent policies and procedures should be maintained throughout the health care facility, sterilization processing should be under centralized control, and the work practices recommended here should be followed. NOTE—See ANSI/AAMI ST41 for design recommendations for ethylene oxide (EO) sterilization facilities. 3.2 Work area design and functional work flow 3.2.1 Definitions of work areas a) Central service department: Department within a health care facility that processes and controls medical supplies, devices, and equipment, both sterile and nonsterile, for some or all patient-care areas of the facility. b) Receiving, cleaning, and decontamination area: The area where reusable instruments, supplies, equipment, and carts are received, sorted, cleaned, and decontaminated. (The area for cleaning carts and associated equipment may be adjacent to the decontamination area.)NOTE—For reusable textiles, this area is the laundry. c) Decasing/breakout area: The area where products are removed from their external shipping containers prior to entry into the preparation and packaging area or sterile storage area. d) Personnel support area: The area providing toilet, shower, and locker facilities for employees. e) Preparation and packaging area: The area where decontaminated, clean instruments and other medical and surgical supplies are inspected, assembled into sets and trays, and wrapped, packaged, or placed into container systems for sterilization. f) Textile assembly area (pack room): The area where clean reusable textiles are inspected, patched, folded, assembled into packs, and wrapped. One or more of these functions may be performed in a central service or laundry facility. (See ANSI/AAMI ST65.) g) Sterilization area(s): The area(s) where sterilizers (steam, EO, and/or low-temperature gas plasma) are located, including the space for loading, unloading, and lining up carts and for cool-down.AAMI ST46 pdf download.