Dental practices required to conduct an AS5369 gap analysis by 30 June 2025

The Australian Commission on Safety and Quality in Health Care has released Advisory PCHS24/01, outlining updated requirements for reprocessing reusable medical devices (RMDs) under Action 3.13 of the National Safety and Quality Primary and Community Healthcare (NSQPCH) Standards.

With the transition to AS 5369:2023, practices involved with accreditation must review, assess, and update their infection prevention and control processes — particularly for those seeking or wishing to remain accredited.

If you are not involved with accreditation, it could be useful to know how far removed your practice is against the new Standard.

Just because you are not involved with accreditation does not mean that accepted infection prevention and control approaches in Australia do not apply to you.

Understanding the new requirements

1. Action 3.13 and AS 5369:2023

Action 3.13 requires healthcare services to have:

• Reprocessing processes that align with AS 5369:2023 and manufacturers' guidelines.

• A tracking system for critical equipment, instruments, and devices used during procedures.

• A structured approach to reprocessing that includes additional controls for novel and emerging infections.

  
  

2. AS 5369:2023: What’s changed?

On 15 December 2023, Standards Australia released AS 5369:2023, which supersedes AS/NZS 4815:2006 and AS/NZS 4187:2014.

This standard establishes uniform minimum requirements for the cleaning, disinfection, and sterilisation of reusable medical devices (RMDs) to ensure patient and practitioner safety.

While no fixed compliance timeframes are stated in the standard, Advisory PCHS24/01 requires a gap analysis by 30 June 2025 to support transition arrangements.

Key steps for practices

1. Perform a gap analysis

Healthcare services using critical and semi-critical RMDs must assess their current reprocessing practices against AS 5369:2023 to determine compliance. You could do this yourself, or get some help.

For practices involved with accreditation, assessors will verify that:

✔ A gap analysis has been completed by the second accreditation cycle.

✔ An action plan is being implemented to address non-compliance.

2. Implement risk mitigation strategies

If gaps or risks are identified, practices must develop risk mitigation strategies, ensuring:

✔ Routine monitoring and reporting to senior leadership - this could be a practice owner

✔ Processes to separate clean and dirty activities.

✔ Appropriate storage, cleaning, disinfection, and sterilisation of medical devices.

Assessors will check that risk assessments have been conducted, monitoring is in place, and corrective actions are being, or plan to be, implemented.

3. Why this matters for dental practices

While accreditation remains voluntary for dental practices, dental practitioners are still expected to comply with approved standards, codes, and guidelines, ensuring infection risks are minimised.

Get ahead with an AS5369:2023 gap analysis

A comprehensive gap analysis is the first step to ensuring compliance and best-practice alignment. You could do this yourself, or get help.

My onsite IPC gap analysis service helps practices:

✔ Identify risks and any gaps that need addressing

✔ Develop a clear action plan for AS 5369:2023 alignment.

✔ Strengthen team confidence in IPC best practice.

If you are approaching your second accreditation cycle against the PCH Standards, your 30 June 2025 deadline to have conducted your AS5369 gap analysis is approaching.

Email me at kylie@niche.dental or call 0438 628 664 for help.