Product Overview

Summary: This Medical Facility Sterilisation Safe Operating Procedure sets out a clear, step-by-step method for safely cleaning, disinfecting and sterilising instruments, equipment and clinical areas in Australian healthcare settings. It helps prevent healthcare‑associated infections, protects staff and patients, and supports compliance with Australian WHS and infection prevention requirements.

Effective sterilisation in medical facilities is critical to preventing the spread of infection and safeguarding both patients and healthcare workers. This Medical Facility Sterilisation Safe Operating Procedure provides a structured, practical framework for managing the entire sterilisation lifecycle – from pre-cleaning and handling of soiled instruments, through disinfection and packaging, to steriliser operation, monitoring, storage and traceability. It is designed specifically for Australian healthcare environments, including hospitals, day surgeries, dental clinics, general practices, pathology and diagnostic services, and aged care facilities.

The SOP addresses the dual responsibility of infection prevention and workplace safety. It outlines how to manage contaminated sharps and instruments, select and use appropriate PPE, handle chemical disinfectants safely, and operate sterilisers in line with Australian Standards. Clear, repeatable steps help facilities standardise sterilisation practices across shifts, reduce variability between staff, and provide defensible evidence of due diligence under WHS legislation and clinical governance frameworks. By implementing this SOP, organisations can significantly reduce the risk of healthcare‑associated infections, non‑compliance findings in audits, and incidents that could lead to staff exposure, patient harm or regulatory action.

Key Benefits

• Reduce the risk of healthcare‑associated infections through consistent, validated sterilisation practices.
• Ensure compliance with key Australian Standards and infection prevention guidelines relevant to sterilisation services.
• Protect staff from exposure to biological hazards, sharps injuries and hazardous chemicals during cleaning and sterilisation tasks.
• Standardise sterilisation workflows across departments and sites, improving training, quality and audit readiness.
• Strengthen traceability and documentation to support incident investigations, accreditation and regulatory inspections.

Who is this for?

• Infection Prevention and Control Coordinators
• Sterilisation Technicians
• CSSD (Central Sterile Services Department) Managers
• Nurse Unit Managers
• Practice Managers (GP and Specialist Clinics)
• Dental Practice Owners and Practice Managers
• Day Surgery Centre Managers
• Aged Care Facility Managers
• WHS Managers in Healthcare
• Clinical Governance Managers

Hazards Addressed

• Exposure to bloodborne pathogens and other infectious agents from contaminated instruments and surfaces
• Sharps injuries during cleaning, sorting and packaging of instruments
• Thermal burns and scalds from hot water, steam sterilisers and heated equipment
• Chemical exposure from disinfectants, detergents and sterilant agents (skin contact, inhalation, eye exposure)
• Musculoskeletal injuries from repetitive tasks, awkward postures and manual handling of trays and equipment
• Slip, trip and fall hazards in wet or cluttered sterilisation and decontamination areas
• Equipment-related injuries from malfunctioning or incorrectly used sterilisers and washers
• Cross-contamination due to incorrect segregation of clean and dirty workflows

Included Sections

• 1.0 Purpose and Scope
• 2.0 Definitions and Key Terms
• 3.0 Roles and Responsibilities
• 4.0 Applicable Legislation, Standards and Guidelines
• 5.0 Required Facilities, Equipment and Materials
• 6.0 Personal Protective Equipment (PPE) Requirements
• 7.0 Workflow Design – Clean and Contaminated Zones
• 8.0 Instrument Reception and Initial Segregation
• 9.0 Pre-cleaning, Manual Cleaning and Ultrasonic Cleaning Procedures
• 10.0 Mechanical Washer-Disinfector Operation
• 11.0 Inspection, Assembly and Packaging of Instruments
• 12.0 Steriliser Operation (Steam, Low Temperature and Other Technologies)
• 13.0 Sterilisation Monitoring, Validation and Load Release Criteria
• 14.0 Cooling, Storage and Handling of Sterile Stock
• 15.0 Traceability, Labelling and Record Keeping
• 16.0 Handling of Single-use Items and Reusable Devices
• 17.0 Management of Non-conforming Loads and Recall of Sterile Stock
• 18.0 Hazard Identification and Risk Controls (Biological, Chemical, Thermal, Ergonomic)
• 19.0 Waste Management and Sharps Disposal
• 20.0 Environmental Cleaning of Sterilisation and Decontamination Areas
• 21.0 Incident Reporting, Exposure Management and First Aid
• 22.0 Training, Competency and Refresher Requirements
• 23.0 Inspection, Maintenance and Calibration of Sterilisation Equipment
• 24.0 Document Control, Review and Continuous Improvement

Legislation & References

• AS/NZS 4187: Reprocessing of reusable medical devices in health service organisations
• AS/NZS 4815: Office-based health care facilities – Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment
• AS/NZS 1715: Selection, use and maintenance of respiratory protective equipment
• AS/NZS 2243.1: Safety in laboratories – Planning and operational aspects (where applicable to decontamination areas)
• Australian Guidelines for the Prevention and Control of Infection in Healthcare (National Health and Medical Research Council)
• Model Work Health and Safety Regulations (Safe Work Australia)
• Safe Work Australia – Managing the Work Environment and Facilities Code of Practice
• Safe Work Australia – Hazardous Manual Tasks Code of Practice