AS 5369:2023 – Safeguarding Smaller Healthcare Facilities

Date: 6/11/2024
Read Time: 5 minutes
Author: Dr Surani McCaw, B.E. (Chemical), Ph. D.

Key points:

• Smaller healthcare facilities, such as day hospitals and dental clinics, must now adhere to the same rigorous standards as larger healthcare settings.
• A well-designed RO system is crucial for ensuring water quality and safety. By effectively removing contaminants and controlling microbial growth, RO systems help prevent infections and maintain compliance.
• While compliance with AS 5369:2023 may involve initial investments, the long-term benefits, such as reduced operational costs, improved patient safety, and enhanced facility reputation, far outweigh the expenses.

The National Safety and Quality Health Service (NSQHS) Standards emphasise the need to minimise infection risks associated with reusable medical devices (RMDs). With the introduction of AS 5369:2023, which supersedes AS/NZS 4187:2014 (Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities) and AS/NZS 4815:2006 (Office-based health care facilities – Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment), all healthcare and non-healthcare facilities must implement effective measures for the safe reprocessing, storage, and handling of RMDs. This article examines the critical role of Reverse Osmosis (RO) plant design in day hospitals and dental facilities, focusing on compliance with safety standards, while maintaining a strong Return on Investment (ROI).

Implementation of AS 5369:2023 is required in all healthcare settings as well as other non-healthcare settings where RMDs and other devices are in use.

The NSQHS Standards, particularly Action 3.17, require healthcare organisations to establish comprehensive processes for reprocessing reusable equipment. Key requirements include:

• Adherence to Standards – Processes must comply with national and international guidelines and manufacturers’ specifications.
• Traceability – Systems should enable tracking of critical and semi-critical equipment back to patients and procedures.
• Managing Reprocessing Needs – Strategies must address the challenges posed by emerging infections.

Smaller facilities often seek cost-effective solutions, but compromising on safety and compliance can lead to lower ROI.

The design elements necessary for compliance with AS 5369:2023 in larger healthcare settings are equally relevant for smaller facilities. While smaller facilities may not engage in complex patient procedures, the infection risks associated with reusable RMDs remain significant. To effectively manage the challenges posed by emerging infections, a unified national standard is critical.

Some of these points were addressed in my previous white paper, Legionella Safety in Building Water Systems. Although that paper specifically targets Legionella control, the same factors, such as temperature, disinfectant type and levels, hydraulic conditions, nutrient presence, scale and sediments, and pipe material, also influence the growth of other gram-negative bacteria and biofilms.

To manage and mitigate bacterial proliferation, consider the following technical aspects when selecting a design for your RO System:

Regular disinfection is crucial for meeting microbial limits in healthcare settings. While chemical and ozone sanitisation may appear cost-effective, their implementation can be challenging, especially in smaller applications. The aggressive nature of these sanitants may increase the porosity of internal surfaces in piping systems/networks, heightening the risk of bacterial growth. Various Occupational Health and Safety (OHSE) risks associated with their use, must be carefully considered as well. For instance, ozone gas is an irritant, hence requires air purification systems in treatment rooms, while fumes from chemical sanitants like chlorine, chlorine dioxide and peracetic acid, pose health risks.

RO systems should keep supply water temperatures below 20°C or above 65°C to inhibit bacterial growth. For day hospitals and dental facilities, consistently maintaining these temperature limits can be costly; therefore, using ambient temperatures with daily thermal disinfection is advisable.

Properly sized heating elements are essential for maintaining supply and return temperatures above 80°C, ensuring effective thermal disinfection.

Incorrectly sized heating elements and lengthy pipe runs can create temperature variations that promote bacterial growth. Proper sizing helps mitigate these issues.

Maintaining temperatures between 80°C and 90°C for at least 60 minutes is vital for thermal disinfection. A monitoring system is essential for ensuring compliance.

Effective pipe insulation reduces heat loss and maintains consistent water temperatures, minimising the risk of bacterial growth.

Adequate water velocity is crucial to prevent stagnation. Proper pump selection and pipe diameter should maintain a minimum velocity of 1 m/s, while avoiding excessive velocities above 1.5 m/s, even during peak operations in the Central Sterilising Services Department (CSSD).

These considerations apply to all water treatment systems designed to control pathogenic bacteria. While meeting AS 5369:2024 standards may incur significant costs for smaller facilities, maintaining a robust design is essential for maximising ROI.

Investing in a well-designed water purification system can significantly optimise ROI. Key strategies include:

• Assess Incoming Water Quality – Understanding the quality of incoming water is critical for tailoring effective treatment processes.
• Avoid De-ionised (DI) Resin Beds – DI resins can increase bio-burden levels. Instead, focus on single or two-pass reverse osmosis systems for enhanced safety and compliance.
• Utilise RO for Final Rinse and Sterilisation – RO technology serves as an effective barrier against microbial contamination, ensuring higher safety standards.
• Base Selections on Evidence and Best Practices – Prioritising scientific evidence in process selection enhances safety and compliance, ultimately protecting patient health.

Non-compliance can lead to significant repercussions, including:

• Retesting and potential surgery cancellations can incur substantial costs. Additionally, failure to achieve accreditation can increase the facility’s operational expenses.
• Compliance issues may impact resource allocation, diverting staff and resources, from core operations.
• Non-compliance erodes trust, and damages facility reputation.
• Ongoing compliance challenges can lead to frustration and reduced productivity, impacting staff morale.

These repercussions can ultimately diminish ROI.

A well-designed purified water unit is essential for day hospitals and dental facilities to ensure AS 5369:2023 compliance. The long lifecycle of these systems, typically exceeding 10 years, often justifies the initial investment. Balancing regulatory adherence with operational efficiency is key to successful water treatment in healthcare environments. By prioritising safety and compliance, day hospitals and dental facilities can protect patients and staff while maximising ROI.