Chemical sterilization and high-level disinfection in health care facilities
|Publication Date:||1 January 2013|
This recommended practice provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/highlevel disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other health care facilities.1 These guidelines are intended to assist health care personnel in the safe and effective use of gaseous chemical sterilizing systems, LCSs/HLDs, and associated equipment.
Chemical sterilants can be classified into two basic categories:
a) LCSs/HLDs in which the items to be processed are immersed manually or processed in an automated system under defined conditions
b) Gaseous chemical sterilants that are used in a sterilizer under defined cycle conditions
Processes that use liquid chemical sterilization/high-l
NOTE 1-The information provided in this recommended practice was accurate at the time the document was approved for publication. However, sterilization and high-level disinfection processes evolve over time, and FDA-cleared manufacturers' label claims and written instructions for use (IFU) change accordingly. Therefore, it is essential that health care personnel obtain up-todate information for the products that they use-or are considering using-and refer to manufacturers' current label directions and written IFU.
NOTE 2-The information provided in this recommended practice and its annexes is for general reference and is not intended to imply endorsement of individual products.
This recommended practice specifically addresses
a) work area design considerations for processing areas in which liquid chemical sterilization/high-l
b) staff qualifications, education, and other personnel considerations;
c) criteria for selecting liquid chemical sterilization/high-l
d) decontamination and preparation of instruments;
e) safety and efficacy considerations in the use of liquid chemical sterilization/high-l
f) storage and transport of sterilized or disinfected devices;
g) quality control methods; and
h) quality process improvement.
This recommended practice also includes definitions of terms and informative annexes on microbial lethality, materials compatibility, and toxicity (Annex A); glutaraldehyde solutions (Annex B); hydrogen peroxide solutions (Annex C); ortho-phthalaldehyde
This recommended practice does not cover
a) steam sterilization (see ANSI/AAMI ST79 and ANSI/AAMI ST8);
b) ethylene oxide sterilization (see ANSI/AAMI ST41, ANSI/AAMI ST24, and Danielson );
c) gaseous chemical sterilization systems and liquid chemical sterilization/high-l
d) the reprocessing of medical devices intended for single use (see FDA [2000c]); or
e) the processing of devices that might have been exposed to prions, such as the prion that causes Creutzfeldt-Jakob disease (CJD).
NOTE-For information about processing devices exposed to prions, see AORN (2010a), Favero and Bond (2001), Rutala and Weber (2010), ANSI/AAMI ST79, and the recommendations of the Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov)
1This recommended practice covers LCSs/HLDs and gaseous chemical sterilization systems known to be commercially available at the time of this writing. For up-to-date information on gaseous chemical sterilization systems and LCSs/HLDs cleared by FDA, check the Center for Devices and Radiological Health (CDRH), FDA's web site at http:www.fda.gov/cdr