The packaging area is for inspecting, assembling, and packaging clean, but not sterile, material. The American Institute of Architects 959recommends negative pressure and no fewer than six air exchanges per hour in the decontamination area (AAMI recommends 10 air changes per hour) and 10 air changes per hour with positive pressure in the sterilizer equipment room. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. In the decontamination area reusable contaminatedsupplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Items processed during the three evaluation cycles should be quarantined until the test results are negative. When three consecutive cycles show negative biological indicators and chemical indicators with a correct end point response, you can put the change made into routine use 811-814, 958. Biological and chemical indicators are placed in products, which are processed in a full load. The sterilizer is not put back into use until all biological indicators are negative and chemical indicators show a correct end-point response 811-814, 819, 958.īiological and chemical indicator testing is also done for ongoing quality assurance testing of representative samples of actual products being sterilized and product testing when major changes are made in packaging, wraps, or load configuration. In a prevacuum steam sterilizer three consecutive empty cycles are also run with a Bowie-Dick test. Each type of steam cycle used for sterilization (e.g., vacuum-assisted, gravity) is tested separately. Three consecutive empty steam cycles are run with a biological and chemical indicator in an appropriate test package or tray. All steam, ETO, and other low-temperature sterilizers are tested with biological and chemical indicators upon installation, when the sterilizer is relocated, redesigned, after major repair and after a sterilization failure has occurred to ensure they are functioning prior to placing them into routine use. Furthermore, care must be consistent from an infection prevention standpoint in all patient-care settings, such as hospital and outpatient facilities.Ī sterilization process should be verified before it is put into use in healthcare settings. Healthcare facilities should promote the same level of efficiency and safety in the preparation of supplies in other areas (e.g., operating room, respiratory therapy) as is practiced in central processing.Įnsuring consistency of sterilization practices requires a comprehensive program that ensures operator competence and proper methods of cleaning and wrapping instruments, loading the sterilizer, operating the sterilizer, and monitoring of the entire process. The aim of central processing is the orderly processing of medical and surgical instruments to protect patients from infections while minimizing risks to staff and preserving the value of the items being reprocessed 957. Healthcare personnel should perform most cleaning, disinfecting, and sterilizing of patient-care supplies in a central processing department in order to more easily control quality. The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycle for the load contents, and other aspects of device reprocessing.
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