scope:

General

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-level disinfection and gaseous chemical sterilization processes are validated by different methods. Therefore, they may or may not provide the same level of sterility assurance. Medical devices undergoing gaseous chemical sterilization can be packaged to maintain product sterility. However, devices processed with liquid chemical sterilization/high-level disinfection are not packaged. LCSs/HLDs are most often used for high-level disinfection of semicritical medical devices or for sterilization of critical or semicritical medical devices that are not amenable to physical sterilization processes (e.g., steam, dry heat, radiation) or gaseous chemical sterilization processes (e.g., ethylene oxide [EO], hydrogen peroxide, ozone).

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.

Inclusions

This recommended practice specifically addresses

a) work area design considerations for processing areas in which liquid chemical sterilization/high-level disinfection and gaseous chemical sterilization systems are used;

b) staff qualifications, education, and other personnel considerations;

c) criteria for selecting liquid chemical sterilization/high-level disinfection and gaseous chemical sterilization systems;

d) decontamination and preparation of instruments;

e) safety and efficacy considerations in the use of liquid chemical sterilization/high-level disinfection and gaseous chemical sterilization systems;

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 solutions (Annex D); peracetic acid-hydrogen peroxide solutions (Annex E); sodium hypochlorite solutions (Annex F); chemical vapor sterilants using alcohol and formaldehyde (Annex G); hydrogen peroxide gas plasma sterilization (Annex H); ozone sterilization (Annex I); government regulation (Annex J); the Occupational Safety and Health Administration (OSHA) bloodborne pathogen regulation (Annex K); user verification of cleaning (Annex L), load release documentation (Annex M); gas and vapor monitoring (Annex N); and relevant literature (Annex O).

Exclusions

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 [1998]);

c) gaseous chemical sterilization systems and liquid chemical sterilization/high-level disinfection systems not cleared by the FDA at the time this document was published;

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) and the International Association of Healthcare Central Service Materiel Management (http://www.iahcsmm.org).

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/cdrh; or contact the Chief of the Infection Control Devices Branch, Office of Device Evaluation (ODE), CDRH, FDA, White Oak, Building 66, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002; 301-796-5580. A list of LCSs/HLDs provided at the FDA web site: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/UCM133514 identifies the products cleared by FDA in a 510(k) with general claims for processing reusable medical and dental devices. This list does not include preamendment products (products that were on the market before 1976 and that have not been modified since that time); FDA-cleared germicides dedicated to specific devices, such as hemodialyzers or hemodialysis machines; or gaseous chemical sterilization systems.