The first mentions of sterilisation in history began in ancient Egypt when pitch and tar were used as antiseptics. Centuries later inventors used sulphur fumes to clean infectious material from objects. Steam was first recorded in cleansing items in 1679 by Deni Papin using a pressure cooker, a device he called a steam digester. The concept of sterilisation grew in importance in the 1860s when famous French microbiologist and chemist Luis Pasteur wrote about the connection between germs and disease. Soon after in 1879, one of Pasteur’s first associates Charles Chamberland designed and built the first Autoclave.
While today's sterilisers still operate on the same principles, medical-grade sterilisers, called autoclaves, can sterilise items much more efficiently, effectively, and predictably in controlled environments. Autoclaves adhere to quality assurance guidelines and must guarantee that instruments are correctly sterilised before reuse. Standards Australia updated its standards for reprocessing reusable medical devices in health related facilities in 2023.
Australian Standards for Reprocessing
AS 5369:2023 sets out guidelines and best practices to ensure the effective and safe management of reusable medical devices and other healthcare-related items throughout their lifecycle, from reprocessing to how it is moved, stored and handled.
AS 5369:2023 superseded AS/NZS 4187:2014 with a raft of changes. These updates included more detailed information on steam penetration resistance to help define product classifications. The Spaulding classification identifies items as non-critical, semi-critical or critical, so they can be assigned to a product family and cleaned accordingly.
Regular testing of water quality is required as some water might need to be treated before use and new washing and sterilisation equipment must be compliant with ISO 15883, EN 285 or EN 13060 and be installed according to Performance Qualifications (PQ), Installation Qualifications (IQ), and Operational Qualifications (OQ).
Australian Standard 5369:2023 also defines the space, layout and design of sterilisation rooms in medical facilities. This involves physically separating each reprocessing area and their equipment which could require facilities to designate more space for sterilisation procedures. A unidirectional airflow and workflow greatly reduce the risk of cross-contamination.
Latest Trends in Instrument Reprocessing
There are four key areas identified by steriliser manufacturers that are important this year:
Digitalization: The demand for full-colour intuitive smart touch displays and efficient documentation sharing via USB or networks is increasing as autoclave manufacturers improve their digital offerings. Newer features include integrated software for documentation approval, labelling traceability, and ease of inbuilt label printing.
Sustainability: Sterilisers are inherently better for the environment than traditional cleaning methods due to the efficient use of water under pressure. Autoclaves that offer reduced cleaning and drying cycle times use less power and water which is more environmentally friendly. In some cases, autoclaves can be recycled as a whole or working parts can be transferred to other machines to keep them operational.
Experts Shortage: The healthcare industry needs more staff, and the sterilisation sector is no exception. The shortage of skilled technicians and lack of standardised training programs is a constant problem for sterilisation businesses of all sizes.
Inflation and Increases in Pricing: Post-pandemic manufacturing has become more expensive as refining raw materials, staff wages and increased transportation costs flow down to the end consumer.
Upcoming Educational Webinar on Reprocessing for Medical Devices
Run by SSS Australia and Presented by Dr Greg Whiteley, Executive Chairman of the Whiteley Corporation. This webinar will discuss some fundamentals of reprocessing devices including Spaulding’s classification for medical and other devices, AS 5369:2023 and its implications, as well as water testing requirements for facilities. Get more info and book now.
Autoclaves Supported by SSS Australia
Melag series of Class S autoclaves
The latest Melag Pro-Line S Autoclaves come in 17 and 23 litre models and are competitively priced and stacked in features. Key highlights include smart-touch displays, and integrated USB and network interfaces for simplified data logging and are designed and made in Germany. With a full load taking under 25 minutes, the 17 Litre version can handle 5 trays and up to 4kg of instruments while the 23 litre version can sterilise 5 long trays (45cm) and 5 kg loads.
Kronos series of Class B and Class S autoclaves
Reach out to our Personal Account Managers if you need help choosing the right steriliser for your business.