Frequently Asked Questions about Sterequip.
What is AS/NZ 4187:2014?
AS/NZS 4187:2014 is the Australian standard for reprocessing of reusable medical devices in health service organisations.
It is part of the National Safety and Quality Health Service Standard: Preventing and Controlling Healthcare Associated Infections published by the Australian Commission on Safety and Quality in Health Care.
Reprocessing is a multi-step process that includes cleaning, disinfection, inspection and assembly, testing, packaging and sterilisation of used items to make them safe for reuse.
There are several components of the new standard which will affect each health service in a unique way. All health services in Australia will need to consider:
- Space, layout and design
- Product families
- Water quality
- New equipment
- Instrument identification and traceability
Space, layout and design
This means physically segregating the reprocessing environment and equipment by redesigning your floor plan and allocating more space to your central sterile services department.
This is the most significant change. Reusable medical devices (RMDs) are grouped according to their materials, intended use, design characteristics, physical weight and thermal conductivity.
Grouping devices in to product families addresses some of the challenges posed by the increased range of RMDs available and the variety of design, complexity and reprocessing requirements.
You are required to:
- understand and document the product family for each individual device used
- correctly reprocess and sterilise each device according to its product family and the manufacturer’s instructions.
Water quality is a critical consideration in all stages of the reprocessing of reusable medical devices. The new standard sets out requirements for water supplied to a CSSD and used for reprocessing RMDs including monitoring schedules and reporting.
To meet the requirements of the new standard, most CSSDs will need the following new equipment:
- A pass-through washer disinfector (compliant with ISO 15883)
- A pass-through steriliser (compliant with EN 285 or EN 13060)
- A water system capable of providing water of the quality laid out in table 7.2 of AS/NZS 4187:2014.
All new equipment must undergo installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). These tests must be documented and meet the applicable national and international standards.
All CSSD equipment must also be compatible with the detailed specifications provided by RMD manufacturers.
Instrument identification and traceability
The new standard requires that all instruments be traceable. Your CSSD should have a system which can identify the cleaning process applied to each RMD, including an ability to track a device to a patient, and allow a recall if required.
Instrument tracking has several benefits including increased traceability, improved patient safety, enhanced risk management and increased accountability.
Why is it changing?
Effective and safe reprocessing of reusable medical devices in health services is a critical aspect of infection prevention, patient safety and the delivery of high quality health care.
Evolving surgical techniques and advances in engineering have resulted in an increase in the range of reusable medical devices used in healthcare today.
Devices vary in design, complexity and reprocessing requirements, which create various challenges for health services in ensuring devices are effectively cleaned, disinfected and sterilised.
The new standard reflects these challenges, advances and the evolution of surgical techniques, with patient safety being the main driver.
When is the change happening?
A new version of this standard was released in December 2014.
All health services must demonstrate compliance to the new standard by 2021.
Accrediting bodies will be assessing early planning and progress towards implementation over a five-year period commencing December 2016.
Has your health service completed a gap analysis? Can you demonstrate progress towards implementation of changes to meet the new standard?
Sterequip’s comprehensive central sterile services department evaluation service can help you get on track.
What is the impact for my health service’s CSSD?
The new standard introduces important changes and requirements which will pose a range of challenges for health services.
To meet the requirements of the new standard, health services will need to make adjustments to their central sterile services department.
These adjustments will bring challenges in relation to design, layout, floor space, equipment and staff training.
Compliance with the new standard will take long-term planning and significant capital outlay.
How does this impact my health service’s license?
In order to meet your state or territory licensing requirements, your health service must demonstrate that your central sterile services department meets the requirements of the new standard.
How do I ensure that my health service will meet the new standard?
- complete a gap analysis to determine the current level of compliance
- use findings from the gap analysis to develop a transition plan
- develop a detailed implementation plan
- implement the plan
- demonstrate progress toward implementation.
Accrediting bodies will be assessing each health service organisation’s early planning and progress towards implementation.
Your detailed implementation plan should use quality improvement principles and specify timeframes, milestones and deliverables to enable full implementation over a five-year period commencing December 2016.
Your transition plan should considers the required changes in the following areas:
- floor space
- upfront fixed costs
- ongoing costs
- time to implement the above changes.
What are the cost implications of the new standard?
Meeting the requirements of the new standard will require significant upfront capital outlay and increased ongoing costs.
What are the options?
Considering the space, cost and staffing implications, an external partner to deliver sterilisation services may be your best option.
Sterequip’s managed sterilisation solution offers compliance and patient safety with maximum efficiency and minimal cost.
Sterequip is the most reliable, cost effective way to meet the new standard
The benefits and reasons to use Sterequip’s managed sterilisation solution include:
1. It’s our core business
Sterilisation is an essential part of running your health service and ensuring patient safety – but it’s not your core business. It’s ours. Partner with Sterequip so you can focus on quality patient care.
2. Space = money
Should you redesign and expand your CSSD – or repurpose that floor space? Could your current CSSD area be converted into an operating theatre?
3. Reduce your costs
Our managed sterilisation solution is the most reliable, cost effective way to meet the new standard – and without the upfront costs of redesigning your CSSD. You will also save on staff training and education.
4. Quality you can trust
Our professional, reliable sterilisation services are the quality you can trust to meet the new Australian standard.
5. Improved efficiency
Our world-class facilities achieve efficiencies not possible in individual central sterile services departments.
6. Reduced risk
If the standard changes in the future, we will adjust our managed sterilisation solution to ensure your health service is always compliant.
Where can I advice and more information?
Sterequip can help you get ready for the new standard.
As part of our commitment to world-class sterilisation services and patient safety, we provide a comprehensive central sterile services department evaluation service.
Our experienced sterilisation consultants can work with you to:
- audit your existing CSSD equipment and processes
- provide a report on what you need to do to meet the new standard
- make recommendations to help you achieve efficiencies and cost savings (while also meeting the new standard).
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