scope:

This Technical Information Report (TIR) is intended for reference and use by all healthcare personnel who perform low and intermediate-level disinfection processes on patient care medical devices, medical equipment, and their accessories, and who have responsibility for cleaning and disinfecting environmental surfaces in medical device processing areas. This TIR provides guidance on the selection and use of low and intermediate-level disinfectants and disinfection processes for safe and effective use.

Inclusions

This TIR includes:

a) cleaning and disinfection of non-critical patient care items, devices and patient care equipment and accessories, cleaning and disinfection of electronic accessories for devices, and other non-critical devices (e.g., MR coils, MR/CT tables, X-ray detector plates, NICU incubators, cables, smaller console equipment, IV pumps and poles);

b) processes for categories of items that are terminally processed with low or intermediate disinfection;

c) chemical disinfection of items that are made safe to handle through low or intermediate disinfection to proceed to further processing, e.g. critical medical devices that will be terminally sterilized or semi-critical items that will be high-level disinfected;

d) recommendations for cleaning and disinfection of environmental surfaces in the sterile processing area; and

e) guidance on use of disinfectants and disinfection processes intended for items that:

1) undergo final processing prior to reuse

2) items that undergo processing to be made safe to handle prior to further processing (high-level disinfection or sterilization)

3) environmental surfaces in medical device processing areas.

Exclusions

Non-critical environmental surfaces, (e.g., table tops, bed rails, privacy curtains) outside the sterilization or high level disinfection processing areas. This document also excludes high level disinfection and thermal disinfection processes for semi-critical devices, and disinfection achieved by physical means. Disinfection by a physical means would include methods such as pasteurization.

High level disinfection of endoscopes is covered by ANSI/AAMI ST91 and is outside the scope of this document. Similarly, sterilization processes, including steam sterilization, high level disinfection/chemical sterilization, and ethylene oxide sterilization, which are covered in ANSI/AAMI ST79, ANSI/AAMI ST58 and ANSI/AAMI ST41, respectively, are excluded from this document.