AS 5369:2023 is a critical standard focusing on the reprocessing of reusable medical devices in both health and non-health-related facilities. This standard provides guidelines to help ensure reusable medical devices are cleaned, disinfected, and sterilised properly to prevent infections and improve patient safety.
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Why the standard is changing

AS 4187 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities was first published 29 years ago as a response to a serious incident in 1989 where five patients contracted HIV following procedures in an office-based practice setting. This incident highlighted the need for a standardised approach to reprocessing reusable medical devices, leading to the development of AS/NZS 4187.

Nearly 30 years later, AS 5369:2023 has replaced AS/NZS 4187:2014. The transition from AS/NZS 4187:2014 to AS 5369:2023 introduces significant changes, with AS 5369:2023 offering updated guidance along with a supporting flowchart, enhancing the foundational principles of AS/NZS 4187:2014.
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Understanding AS 5369:2023

AS 5369:2023 provides important guidelines for the reprocessing of reusable medical devices. The standard outlines the important steps and procedures to help ensure that devices are effectively cleaned, disinfected, and sterilised. It covers a wide range of devices used in medical and non-medical settings.

Key updates in AS 5369:2023 include:

• Product families: The new standard introduces a preliminary step for grouping devices into Product Families based on steam penetration resistance (SPR). This step involves determining the device's SPR, identifying the most challenging device to sterilise, and grouping devices accordingly.

• Spaulding classification: Devices are classified based on their intended use (Critical, Semi-critical, or Non-critical) before being assigned to a Product Family. Critical devices must be sterilised. Semi-critical devices, which come into contact with mucous membranes or non-intact skin, should be sterilised or high-level disinfected depending on the risk of infection and the nature of the device. Non-critical devices require cleaning and low-level disinfection.

• Validation and monitoring: The standard emphasises the importance of conducting test loads to evaluate steam penetration and identify the master product for each Product Family. Performance qualification (PQ) tests should be conducted on groups of devices to help ensure effective sterilisation.
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Benefits of AS 5369:2023

The implementation of AS 5369:2023 offers numerous benefits for health and non-health-related facilities:

• Enhanced patient safety: Adhering to stringent reprocessing guidelines can significantly reduce the risk of infection and contamination, protecting patients from potential harm.

• Industry guidelines: Compliance with AS 5369:2023 helps ensure that facilities adhere to industry guideline, including the Australian Dental Association’s Infection Prevention and Control (IPC) Guidelines.

• Operational efficiency: The standard provides clear and structured procedures for reprocessing, helping facilities streamline operations and improve efficiency.

• Quality assurance: Consistent adherence to the standard helps ensure that reusable medical devices meet high-quality standards, enhancing the overall reliability of medical procedures.

• Cost savings: Proper reprocessing extends the life of reusable medical devices, reducing the need for frequent replacements and lowering costs.
  

Who is the standard for?

AS 5369:2023 is designed for a wide range of facilities involved in the reprocessing of reusable medical devices and other devices. These include:

• Hospitals and healthcare facilities: The standard is crucial for hospitals and clinics that rely on reusable medical devices for various procedures.

• Dental practices: Dental clinics benefit from the guidelines to help ensure that their instruments are properly sterilised.

• Veterinary clinics: Veterinary practices also use reusable medical devices that require stringent reprocessing to help ensure animal safety.

• Non-medical facilities: Facilities such as beauty salons and tattoo parlors that use reusable instruments can also adhere to the standard to maintain high hygiene standards.
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AS 5369:2023 is a vital standard that provides a framework for the reprocessing of reusable medical devices and other devices. By following this standard, facilities can help ensure patient safety, regulatory compliance, and operational efficiency.  

Its implementation is important for maintaining high-quality healthcare services and protecting public health in various settings. The guidance and flowchart provided in the standard are helpful tools for navigating the complex process of Product Family assignment, so that every device can be processed safely and effectively.

AS 5369:2023 is available via the Standards Australia Store.