AU 
NZ 
October 23, 2025
The Role of CSSD in Ensuring Patient Safety: Best Practices and Standards in ANZ
In modern healthcare, patient safety is paramount – and nowhere is this more evident than in the Central Sterile Services Department (CSSD). Responsible for the cleaning, disinfection, and sterilisation of reusable medical devices (RMDs), CSSDs play a critical role in infection prevention and control across hospitals, day surgeries, and clinics throughout Australia and New Zealand.
Why CSSD Matters for Patient Safety
Healthcare-associated infections (HAIs) remain a significant risk in clinical settings. According to the Australian Commission on Safety and Quality in Health Care (ACSQHC), over 170,000 HAIs occur annually in Australian public hospitals alone. Many of these are preventable through rigorous sterilisation protocols and adherence to standards in CSSD operations.
Key Standards Governing CSSD in ANZ
AS/NZS 4187:2014 (Superseded)
Previously the cornerstone standard for CSSD operations, AS/NZS 4187:2014 outlined requirements for the reprocessing of RMDs in health service organisations. It mandated physical segregation of clean and dirty zones, validated sterilisation processes, and traceability systems.
AS 5369:2023 (Current Standard)
Superseding AS/NZS 4187:2014, AS 5369:2023 expands its scope to include office-based and non-healthcare facilities. It introduces:
- Product Families based on steam penetration resistance (SPR)
- Spaulding Classification for device risk levels
- Performance Qualification (PQ) testing for sterilisation validation
- Annual staff training in infection prevention and control
ISO 15883 (Parts 1-7)
The ISO 15883 standards provide global benchmarks for washer-disinfectors used in CSSDs. These include:
- Part 1 General requirements and validation methods
- Part 2-7 Specific requirements for surgical instruments, endoscopes, human waste containers, and thermolabile devices.
Compliance with ISO 15883 ensures consistent cleaning and disinfection outcomes, supporting both AS 5369 and NSQHS mandates.
Best Practices for CSSD in ANZ Healthcare
To meet accreditation and safety goals, CSSDs should implement the following:
Segregation of Zones
Maintain physical separation between dirty and clean areas to prevent cross-contamination. AS 5369 mandates dedicated reprocessing zones with unidirectional workflow.
Cleaning Processes: Manual and Automated
Effective cleaning is the foundation of safe sterilisation. In ANZ CSSDs, a combination of manual pre-cleaning at the sink and automated washer-disinfectors is widely practiced. Manual cleaning plays a vital role in removing gross soil and preparing instruments for automated cycles, especially for complex or delicate devices. This step often involves the use of validated manual cleaning chemistries, such as enzymatic detergents, designed specifically for medical device pre-cleaning.
Following manual cleaning, instruments are typically processed in washer-disinfectors compliant with ISO 15883, which ensure consistent, validated cleaning and thermal disinfection. These machines support standardised outcomes and reduce variability, particularly for high-throughput CSSDs.
Together, manual and automated cleaning form a complementary workflow that aligns with AS 5369:2023 and ISO 15883 standards, supporting best practice in infection prevention.
Traceability Systems
Implement electronic tracking of instruments to link devices to patients and procedures. This supports recalls and enhances accountability.
Staff Training
Annual training in infection control and sterilisation protocols is recommended under AS 5369 and NSQHS.
Regulatory and Accreditation Bodies in ANZ
Several organisations oversee CSSD compliance and patient safety:
- Therapeutic Goods Administration (TGA): Regulates medical devices and sterilisation validation.
- MTANZ: Advocates for ethical standards and innovation in medical technology.
- ACSQHC: Sets the NSQHS Standards, including infection control and equipment reprocessing.
- ACHS: Accredits healthcare organisations against NSQHS and EQuIP7 standards, ensuring continuous quality improvement.
The CSSD is a linchpin in the healthcare safety chain. By adhering to AS 5369:2023, ISO 15883, and NSQHS standards, and engaging with bodies like TGA, MTANZ, and ACHS, healthcare organisations in ANZ can ensure their sterilisation practices meet the highest standards—protecting patients and staff alike.
Take the Next Step Toward Safer Reprocessing
Ensuring patient safety starts with robust CSSD practices. Whether you’re upgrading your sterilisation protocols, validating washer-disinfectors, or reviewing compliance with AS 5369 and ISO 15883, now is the time to act.
Partner with Ecolab Healthcare ANZ to access expert guidance, validated manual cleaning chemistries, and solutions that support best practice across every stage of the reprocessing workflow.
Let’s work together to elevate patient safety – one instrument at a time.
AU: 1300 425 529
NZ: 0800 425 529
www.healthcare-au.ecolab.com
