Overview – Reprocessing reusable medical devices
Note on standards: The current Australian standard applicable to reprocessing reusable medical devices (AS/NZS 4815:2006 Office-based health care facilities—Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment) is under review and will be superseded by the new standard: AS 5369 Reprocessing of reusable medical devices and other devices in health and non-health related facilities. This guidance will be updated after the new standard comes into effect.
Reusable medical devices that require reprocessing to achieve the required level of asepsis (standard or surgical) include surgical instruments, medical devices, and other equipment.
Practices can choose to reduce the volume of medical devices that require reprocessing by replacing some or most categories with disposable alternatives. However, practices need to be mindful of their environmental impact and to reduce waste, reprocess and correctly recycle where practical to do so.
Practices that reuse medical devices that require sterilisation, such as surgical instruments, can choose either to do all reprocessing on site, or outsource to an off-site provider (eg hospital) for sterilisation. Reprocessing of items that require sterilisation should only occur within the practice if the current relevant standard can be met.
For each reusable medical device, practices need to check information provided by the manufacturer on the validated processes for cleaning, disinfection, packaging (if required), and sterilisation.
Practices must ensure that staff involved in reprocessing have received adequate education (eg a course), training and regular competency assessment, and that these are documented.
Practices should have a designated area for processing reusable medical devices, and must establish a workflow pattern that prevents the packaging, sterilisation and storage areas becoming contaminated. This involves systematically moving from ‘dirty’ to ‘clean’ within the designated area. The reprocessing area must be segregated from treatment and administration areas. Ideally, there is a dedicated room for reprocessing. In shared spaces, a practice could demonstrate what physical methods or barriers they use for segregation of reprocessing activities (eg locating the patient bed away from the sterilizing area, not processing equipment while the treatment room is occupied by patient/s).
Personal protective equipment must be worn during reprocessing, and may require changing between stages.
Immediately after use, reusable medical devices should be initially wiped/rinsed to remove visible soiling, then thoroughly cleaned in the equipment reprocessing area before sterilisation. This process can involve:
- manual cleaning
- the use of an ultrasonic cleaner followed by manual cleaning, or
- the use of a washer/disinfector that may incorporate an ultrasonic cycle.
Ultrasonic cleaners and washer/disinfectors require performance monitoring and validation. Ultrasonic cleaners and washer/disinfectors are not mandatory. They are an optional precleaning step.
If an item cannot be cleaned, it cannot be further processed or reused.
Steam under pressure is the most reliable method for sterilising cleaned reusable medical devices, and is recommended in general practices and other office- and community-based practices.
Using the correct sterile barrier system (pack, pouch, wrap or rigid container) for each item or set of items is important to ensure that they are effectively sterilised and remain sterile. Packages for sterilising should be labelled to enable monitoring, appropriate stock rotation, and other affected items to be identified if a problem with a processed item is later discovered.
Correct loading of the steriliser is important to ensure air is removed and steam can penetrate the load. The correct processing and drying times must be used, according to the load to be sterilised. Correct handling of the sterile load when it is taken out of the steriliser is vital to ensure items remain sterile. If an item contained in a sterile barrier system emerges from the steriliser wet or damaged in any way, it cannot be considered sterile. Correct storage of sterilised packs is also vital.
Every time the steriliser is used, the process must be documented for quality assurance and review purposes.
Routine monitoring of every sterilisation cycle is required to check that the selected cycle parameters (including time, temperature, and pressure) are met. These must be recorded as evidence that the cycle has achieved sterilising conditions.
Chemical indicators are used in addition to physical monitoring, to provide evidence that the load has reached the correct temperature.
Regular routine maintenance is required for all reprocessing equipment, including sterilisers, ultrasonic cleaners, washer-disinfectors with or without ultrasonic capacity, drying cabinets and incubators, and biological indicator readers.
Validation of steriliser cycles must be performed annually and as needed (eg after any major repairs and if the practice changes the type of loads sterilised).
Practices that perform procedures in other locations, such as aged care facilities, home visits and at sporting events, must develop policies and procedures to ensure sterility of equipment during transport, and safe handling of used equipment, including correct pre-cleaning/treatment immediately after use.