Comprehensive guide to steam sterilization and sterility assurance in health care facilities
|Publication Date:||1 January 2017|
This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation.
This recommended practice specifically addresses
a) functional and physical design criteria for sterilization processing areas;
b) staff qualifications, education, and other personnel considerations;
c) processing recommendations;
d) installation, care, and maintenance of steam sterilizers;
e) quality control;
f) product evaluation; and
g) quality process improvement.
Definitions of terms, a bibliography, and informative annexes also are provided.
This recommended practice does not cover
a) specific construction and performance criteria for steam sterilizers (see ANSI/AAMI ST8 and ANSI/AAMI ST55), rigid sterilization container systems (see ANSI/AAMI ST77), or rigid, protective organizing cases that require wrapping before sterilization (see ANSI/AAMI ST77);
b) the use of containment devices for packaging items other than instrument sets or procedural trays;
c) procedures and techniques for handling and laundering contaminated reusable surgical textiles (see ANSI/AAMI ST65), reusable laboratory items, food service items, and items assigned to a patient for the length of stay (e.g., bedpans, thermometers);
d) decontamination of hemodialysis machines, hemodialyzers, and hemodialyzer blood tubing (see ANSI/AAMI/IEC 60601-2-16, ANSI/AAMI RD47, and ANSI/AAMI/ISO 8638, respectively);
e) the use of dry heat for decontamination purposes or for terminal sterilization of reusable medical devices (see ANSI/AAMI ST40);
f) the use of ethylene oxide sterilization in health care facilities for other than decontamination purposes (see ANSI/AAMI ST41);
g) the use of chemical sterilization and high-level disinfection in health care facilities for other than decontamination purposes (see ANSI/AAMI ST58);
h) the reprocessing of devices labeled for single use only (see Food and Drug Administration [FDA], 2000c); and
i) aseptic presentation.
NOTE-For more information on the subjects excluded from the scope of this recommended practice, and for additional background information on the inclusions, refer to the references listed in the bibliography.