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 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; and

b) Gaseous chemical sterilants that are used in a sterilizer under defined cycle conditions.

Processes that use LCSs/HLDs and gaseous chemical sterilization processes are validated by different methods. Therefore, they do not provide the same level of sterility assurance. Medical devices undergoing gaseous chemical sterilization can be packaged to maintain product sterility indefinitely. However, devices processed with LCSs/HLDs are not packaged. Liquid chemical sterilants 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 gas plasma, 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 instructions change accordingly. Therefore, it is essential that health care personnel obtain up-to-date information for the products that they use-or are considering using-and refer to manufacturers' current label directions and instructions for use.

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.

¹This recommended practice covers those 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, contact the Chief, Infection Control Devices Branch (HFZ-480), CDRH, FDA, 9200 Corporate Blvd, Rockville, MD 20850 (301/443-8913); or refer to FDA's web site at http://www.fda.gov. A list of LCSs/HLDs provided at FDA's web site (http://www.fda.gov/cdrh/ode/germlab.html) 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.