Advisory DI21/04: Disinfection requirements for reusable semi critical medical devices - Standard 1.6: Healthcare Associated Infection

Advisory details

Purpose

To advise diagnostic imaging practices of the requirements for Diagnostic Imaging Accreditation Scheme Standard 1.6: Health-care Associated Infection. Specifically, the requirements for high-level disinfection of semi-critical reusable medical devices in diagnostic imaging.

Issue

Diagnostic imaging practices may use semi-critical reusable medical devices such as ultrasound probes, in the delivery of services.

Semi-critical reusable medical devices are those that come into contact with broken skin, mucous membranes, blood or body fluids. These devices must undergo high‐level disinfection using a high level disinfectant approved by the Therapeutic Goods Administration and an instrument grade disinfection method, consistent with the manufacturer's instructions for use.

This advisory should be read in conjunction with Standard 1.6: Health-care Associated Infection which states:

The diagnostic imaging practice must mitigate the risk of the transmission of infectious agents to patients, carers, healthcare workers, support staff and other visitors, by:

1. Identifying, assessing, and managing and reporting the risk of the transmission of infectious agents
2. Meeting the requirements specified in infection control guidelines/policies produced by Commonwealth, State and Territory government authorities
3. Reporting, investigating, and responding to incidents at the diagnostic imaging practice arising from the transmission of infectious agents; and
4. Ensuring consumer-specific information on the management and reduction of healthcare associated infections is available at the point of care.

Requirements

Reprocessing a semi-critical device requires cleaning followed by disinfection using a high-level disinfectant listed on the Australian Register of Therapeutic Goods (ARTG) and a method that is consistent with the manufacturer’s instructions.

High-level disinfectants kill all microbial pathogens, except large numbers of bacterial endospores, when used as recommended by manufacturer. High –level disinfectants include:

• Liquid, high-level instrument grade chemical disinfectants
• Automated, high-level disinfection systems either, chemical or light-based
• High-level instrument grade disinfectant wipes.

The following are not high-level disinfectants:

• Alcohol wipes
• Anti-bacterial tablets, solutions, or units specific to infant feeding items
• Stain removing powders or solutions.

In addition to cleaning and disinfection, there are other measures for reducing the risk of transmission of infectious agents. In relation to semi-critical reusable medical devices, these measures include information about infection prevention and control practice, such as:

• How and where semi-critical reusable medical devices are stored after cleaning and high-level disinfection
• Use and disposal of single-use components of a semi-critical reusable medical device. For example, manufacturer approved transducer covers when transvaginal and transrectal procedures are performed.
• A process to trace and log, on each occasion, the patient, the procedure the re-usable equipment used for the procedure and the re-processing method used for that piece of equipment.

Under the DIAS, if a diagnostic imaging practice fails to use a high-level disinfectant or complete a high-level disinfection consistent with the manufacturer’s instructions, the requirements of the standards are not met.

For more information

For more information on a risk-based approach to reprocessing medical devices, see the Australian Guidelines for the prevention and control of infection in Healthcare.

For guidance on high-level disinfection of ultrasound transducers, see the Australasian Society for Ultrasound in Medicine and Australian College for infection Prevention and Control’s Guidelines for Reprocessing Ultrasound Transducers.

For guidance on evidentiary requirements for Standard 1.6, see the DIAS User Guide for Practices Applying for Accreditation.

Diagnostic Imaging Accreditation Scheme – User guide for practices applying for accreditation

2022

Guide, user guide or guidelines