01 · Compliance party

AS 5369 Compliance & Regulation

AS 5369:2023 is the official Australian Standard for cleaning, disinfecting and sterilising reusable medical devices. It regulates safe and effective reprocessing of reusable medical devices and other reusable items in healthcare.

It tells dental and healthcare practices how to clean, disinfect, sterilise, store and handle reusable instruments and equipment safely, including requirements for procedures, staff training, equipment and documentation. It ensures reusable dental instruments and equipment are reprocessed correctly and safely between patients.

While the standard is published by Standards Australia, compliance and clinical enforcement are governed by the Australian Commission on Safety and Quality in Health Care (ACSQHC).

• Disinfectants and sterilisers used on medical equipment must be explicitly registered with the Therapeutic Goods Administration (TGA) as Class IIb Medical Devices. Standard “Hospital Grade” hard-surface disinfectants do not meet this requirement for medical equipment.
• Reprocessing workflows should strictly adhere to national infection-control frameworks and the Australian Dental Association (ADA) Guidelines.

02 · Compliance party

TGA Compliance and Regulation

The Therapeutic Goods Administration (TGA) is the Australian Government agency responsible for regulating therapeutic goods. Products are assessed for safety, efficacy and quality and are included in the Australian Register of Therapeutic Goods (ARTG) for a specific intended use.

A product registered as a hospital-grade disinfectant, for example, is not automatically authorised for use as a medical device disinfectant. Products should therefore only be used for the purpose and applications for which they are TGA-approved, to comply with the TGA.

03 · Compliance party

ADA Guidelines

The Australian Dental Association (ADA) provides practical guidelines to help dental practices implement TGA requirements and national infection control standards.