The new era of flash sterilization

AORN Journal,  July, 2007  by Arlene Carlo

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Although managers are responsible for providing the education, perioperative staff members also have responsibilities in regard to flash sterilization. Each staff member who performs flash sterilization is responsible for

* acquiring and maintaining the knowledge necessary to perform flash sterilization properly,

* demonstrating competence in all aspects of the flash sterilization process, and

* demonstrating consistent performance in accordance with established procedures.

STANDARDS, RECOMMENDED PRACTICES, AND GUIDELINES

One of the most frequently referenced resources for sterilization is the Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities (ANSI/AAMI St79:2006). (1) The recently published version is a consolidation of five previous recommended practices that were reviewed, revised, and incorporated into the new standard, and it includes recommended practices for steam sterilization, tabletop sterilizers, flash sterilization, decontamination, and rigid sterilization container systems. According to the AAMI, the ST79:2006 reflects the conscientious efforts of health care professionals, in cooperation with medical device and equipment manufacturers, to develop recommendations for optimal performance levels in the processing of reusable medical devices to be steam sterilized. These recommended practices, approved by the ANSI, reflect optimum performance levels and are viewed as best-practice information. Adherence to the AAMI recommended practices is voluntary, unless they have been adopted into regulation. For instance, New Jersey state law mandates that methods for processing reusable medical devices conform to current AAMI standards.

The ANSI/AAMI's ST79:2006 recommends that flash sterilization be performed only if all the following conditions are met: (1(p3))

* Work practices ensure proper cleaning, inspection, and arrangement of instruments before sterilization.

* The physical layout of the department or work area ensures direct delivery of sterilized items to the point of use (eg, the sterilizer opens into an area either within or directly adjacent to the procedure room).

* Procedures are developed, followed, and audited to ensure aseptic handling and personnel safety during transfer of the sterilized items from the sterilizer to the point of use.

* Items are needed for use immediately following flash sterilization.

The guidelines presented in the ANSI/AAMI's ST79:2006 for cleaning and decontamination, assembly, packaging, sterilization, process controls, and staff member qualifications and education are considered recommendations for optimal performance levels for processing reusable medical devices in a health care setting to ensure safe and effective patient care. Optimal performance levels might not be immediately achievable and should be used to guide personnel toward desirable performance objectives. (1)

Another frequently referenced resource is AORN's Standards, Recommended Practices, and Guidelines. AORN recommended practices include recommendations for sterilization in the perioperative practice setting, (5) care and cleaning of instruments and powered equipment, (6) and selection and use of packaging systems, (7) which are intended to serve as the basis for policy and procedure development in perioperative settings. Compliance with AORN's recommended practices is voluntary. Facilities are mandated to comply with applicable regulatory agencies affecting sterilization. For example, the US Food and Drug Administration (FDA) requires device manufacturers to validate sterilization parameters and provide documentation for users to follow.