Advisory DI21/04: Disinfection requirements for reusable medical devices

Advisory details

Purpose

To advise medical imaging providers of the reprocessing requirements for reusable medical devices (RMDs).

Issue

Medical imaging providers have requested clarification about the reprocessing requirements for reusable medical devices including ultrasound transducers.

Requirements

Medical imaging providers should read this advisory along with Standard 1.6: Health-care Associated Infection. the Australian Guidelines of the Prevention and Control of Infection in Health Care

Classification of reusable medical devices

Medical imaging providers are to classify and reprocess their RMDs based on the Spaulding classification, which outlines the level of reprocessing necessary, intended use, and the risk of infection.

Reprocessing of reusable medical devices

Medical imaging providers must clean and then disinfect or sterilise their RMDs after each use, in line with their risk classification.

Medical imaging providers must have appropriate validation and control mechanisms for their cleaning, disinfection, packaging and sterilising processes. The imaging provider needs to demonstrate they have a quality control system, systems for staff training and assessment of competency, and processes for monitoring conformance to reprocessing procedures.

The imaging provider must have sufficient devices and reprocessing equipment available to ensure the continuance of safe clinical care and account for the time required to clean, disinfect or appropriately sterilise RMDs.

Under the Diagnostic Imaging Accreditation Scheme, if a medical imaging provider fails to clean, disinfect, or sterilise their RMDs after each use in a manner consistent with the manufacturer’s instructions, the requirements of the standards are not met. 

Cleaning

All RMDs must be cleaned, as soon as practical, after use to remove foreign material. Cleaning must occur prior to any subsequent disinfection or sterilisation and must follow the manufacturers guidelines.

The Australian Register of Therapeutic Goods (ARTG) lists appropriate cleaning agents as Class I medical devices. The cleaning agent and method must follow the manufacturer’s instructions and comply with AS 5369:2023.

Non-critical RMDs must be stored in a clean, dry place to minimise environmental contamination.

High-level disinfection

Semi-critical RMDs must undergo at least a high‐level disinfection, which kills all microbial pathogens, except when there are large numbers of bacterial endospores.

For high-level disinfection, the disinfectant must be labelled as an ‘instrument grade disinfectant’, listed in the ARTG as a Class IIb medical device, and validated for use on the RMD. The disinfectant may be a liquid, spray, wipe, or aerosol. Medical imaging providers must follow the RMD’s and disinfectant’s manufacturer's instructions when completing the high-level disinfection process.

After reprocessing, the semi-critical RMDs are stored in a designated dry storage system to prevent environmental contamination.

Sterilisation

Critical RMDs, must undergo sterilisation. Sterilisation renders the RMD free from viable microorganisms. Moist heat, low temperature, and dry heat sterilisation are the principal processes, with moist heat sterilisation is preferred for items that can withstand it. Where a RMD is not compatible with moist heat sterilisation, it is sterilised using a validated low-temperature sterilisation process after each clinical use.

Medical imaging providers must maintain the sterility of critical RMDs after re-processing and store them to prevent environmental contamination.

Traceability of reusable medical devices

Medical imaging practices must have a traceability process to enable patient recall if decontamination fails. The process is to trace and log on each clinical occasion, the patient, the procedure, the semi-critical and critical RMD used for the procedure, the batch number and expiry dates of the disinfectant, and the re-processing method used for that piece of equipment.

Ultrasound transducers

Ultrasound transducers used in percutaneous procedures are classified as non-invasive medical devices as the transducer does not penetrate inside the body, either through a body orifice or through the surface of the body. Ultrasound transducers that penetrate inside the body through areas of non-intact skin (e.g. burns sites, open wounds, skin ulcers) or contact areas with mucous membranes (e.g. rectum, vagina), are classified as invasive medical devices. Note: If an uncovered transducer (i.e. no sheath has been used) comes into direct contact with the puncture site, then it has become an “invasive medical device” during the procedure. 

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 cleaning and disinfection of ultrasound transducers, see the:

• AS 5369:2023 Reprocessing of reusable medical devices in health and non-health related facilities
• Australian Commission on Safety and Quality in Health Care's Cleaning and disinfection of ultrasound transducers fact sheet

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