02 July 2024
Implementing new standards and guidelines
Change can be daunting and compliance to AS5369:2023 appears to be consuming many in practice. As AS5369:2023 does not state an implementation timeframe, the following provides guidance and examples to assist you in your considerations and hopefully alleviate some of your concerns.
Guidance and tips on transitioning to new standards and guidelines.
Change can be daunting, and it is evident by the enquiries we are receiving at ADAVB that compliance to AS5369:2023 is consuming many in practice.
The following provides guidance and tips to assist you in your considerations and hopefully alleviate some of your concerns.
It is recommended that you:
- Familiarise yourself with the changes. The member edition of the ADA Guidelines for IPC 5th Ed. notes changes in blue.
- As you work through the requirements, document any gaps identified and consider listing these in order of risk or priority.
- Ask yourself does this require my immediate attention or do I have an opportunity to make this change?
Here are some examples of changes and insight into how and when you might implement them. These examples are not exhaustive but are reference to our most frequently asked questions.
Annual validation [Performance Qualification PQ] of your steriliser
AS5369:2023
- Now requires the service provider [technician] to complete the entire validation process including the three consecutive loads using biological indicators. This component of PQ should no longer be performed by practice staff. Except in exceptional circumstance eg: remote locations without access service providers onsite.
Practice response
- Implement at your next opportunity – when validation is due. All service providers will be validating units to the new Standard AS5369:2023. The implications of delaying validation [PQ] and tracking to a unit where validation has lapsed should be avoided.
Segregation, ventilation and environmental controls in reprocessing [steri] areas
AS5369:2023
- Physical or spatial segregation, flows including air flows, temperature and humidity controls, amongst others.
Practice response
- Identify gaps, document these with a note of when you may address these in the future
- Adopt changes in your plans if you are planning a renovation or new build now.
Performance testing sterilisers – Air removal steam penetration tests for units that utilise a vacuum for air removal in the pre sterilisation stage of a cycle.
AS5369:2023
- Practices are to perform a B&D type test daily [exceptions: units processing only solid non packaged reusable medical devices [RMDs] in units using Type N or some Type S cycles]
- Steriliser specifications should indicate the type of test device suitable for the unit
- Test devices used in small steam steriliser to test air removal and steam penetration shall conform to ISO 11140-6. This standard refers to the required criteria for devices and chemical indicators, despite the form the device takes.
- The use of a PCD used as a batch monitor in units that do not have an air detector fitted is recommended but optional as per AS5369:2023 Table 8.2
Practice response
- Industry [ device manufacturers] are in the process of updating their websites, product labelling and guidance. Therefore, it is the exception currently to see new references on products, brochures and websites.
- It is not expected that you dispose of current product and purchase new ones.
- It is recommended that you continue to test in accordance with previous compliance and practise and transition to the new recommendations at the time of your next purchase.
- If you are uncertain, seek advice from the steriliser company or distributor. They may indicate that transition to the new requires is not yet complete.
The ADA Guideline for infection prevention and control 5th Edition discusses the changes in detail. In addition, the release of new and revised ADA Practical Guidelines and webinars will assist with the implementation of the new requirements.
It is important to understand transition will look different depending on your current circumstances and compliance is neither expected nor achievable immediately.
