By the end of this month, health service organisations must have a plan in place for meeting the updated sterilisation standards for Australia and New Zealand. Peter Spryszynski of Q-bital Healthcare Solutions offers some practical advice for managing the process of upgrading the CSSD.

The ‘new’ standard – AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations – was introduced in 2016 and sets out more stringent requirements for the reprocessing of reusable medical devices in health service organisations, with the aim of making the standards more consistent with European and global sterilisation standards. Compliance is mandatory for approved accrediting agencies and health service organisations.

Due to the amount of work required to bring some facilities up to standard, the deadline for compliance has been extended to December 2022. In the meantime, organisations have to show they have an actionable plan for implementing changes to ensure compliance. The latest advisory was issued in July 2021, and outlined what is required, and by when.

To meet the requirements under the new standard, many Central Sterile Services Departments (CSSD) will have to make changes to the physical layout and design of the department, amend processes, implement new systems, or invest in new equipment – potentially causing temporary disruption to the provision of vital CSSD services.

Changes required by December 2021

Health service organisations which do not comply with the new requirements by the end of the year need to have in place a documented plan to address any gaps. This plan needs to detail the timeframes, milestones and deliverables in support of its implementation, and should also outline how any identified risks associated with the compliance gaps will be managed.

Organisations need to demonstrate progress towards implementing the plan, across four key areas:

  • Segregation of clean and dirty activities: ensuring unidirectional workflow and airflow to reduce the risk of cross contamination.
  • Design of storage areas for sterile stock: mitigating the risk of contamination of stock in storage.
  • Replacement of non-compliant cleaning, disinfecting and sterilising equipment: and a requirement to operate and maintain all equipment in accordance with the manufacturer’s instructions and relevant national or international standards.
  • Monitoring requirements for water quality: regular testing and monitoring of mineral content, pH value, ionic contaminants, microbial population and other elements.

The standard also requires each reusable medical device to be identifiable and traceable to the patient it was used on.

Healthcare Spaces asked Peter Spryszynski, Country Manager of Q-bital Healthcare Solutions in Australia, to take us through the key considerations for organisations that are working towards compliance.

What does that standard mean for health service organisations?

“Firstly, although the standard notes that the need for segregate clean and dirty activities does not automatically mean a hospital has to have separate rooms for each activity, in practice, it is likely that redesign of the floor space will be needed to physically segregate the reprocessing environment. This, in turn, could mean more space will be needed for the department.

“Hospitals will also need to review and monitor conditions, including temperature and humidity, in existing sterile storage facilities to ensure any contamination risk is mitigated. Sterile and non-sterile stock should not be stored in the same area. Facilities that are found to not be compliant may need to be refurbished or redesigned, or have their air conditioning systems upgraded.

“The new standard also requires instruments to be identifiable, as well as traceable to the patient. A tracing system is needed that can both identify the cleaning process applied to each RMD and trace the device to a patient – and ideally this system will be electronic.

“As well as implementing a tracing system, many hospitals will also need to replace or invest in new, compliant equipment for their CSSD. But simply replacing the equipment is not enough; wider changes to processes are likely to be needed. In practice, new procedures for using and operating the equipment will need to be developed, and training may also be needed. The more stringent requirements around water quality may mean new systems for monitoring water quality, and for water pre-processing, will need to be implemented. Departments which previously used filtration only for endoscopic cleaning, or those with single pass reverse osmosis plants, will need to upgrade.

“Although some of the changes needed to comply are major, many of these actions will bring significant benefit for health service organisation in the longer term. Instrument tracking, for example, can help improve patient safety, improve risk management and increase accountability.”

What have the biggest challenges been so far?

“Hospitals have faced a number of major challenges in attempting to reach compliance with AS/NZS 4187:2014, including how to finance the works and how to manage the potential disruption to services in the meantime. Limited access to capital affecting the ability to fund major refurbishment projects has been one barrier, and the lack of additional space available in many hospitals has been another. The cost of new equipment or infrastructure upgrades to improve air and water quality, or to implement an electronic tracking system, can also be substantial.

“The CSSD is one of the most critical departments within a hospital and it is imperative that hospitals have access to sterilised equipment at all times, so undertaking significant refurbishment works without disrupting key sterilisation and reprocessing services can present a major operational challenge. Retaining all sterilisation activity within the hospital building while undertaking major works has been known to extend, or even double, the timeline for the completing the project, and can lead to services being disrupted.

“As I mentioned, just buying new equipment is not going to solve the problem and making changes to key processes, implementing new systems, producing documentation and training staff all take time. A survey undertaken in 2020 by the Australian Commission on Safety and Quality in Health Care found that as many as 90% of all organisations had identified implementation issues when working towards compliance. This shows how much of a challenge meeting this standard has been for many organisations – and the pandemic hasn’t made things any easier.”

 How can these challenges be addressed?

“The requirement for separating all dirty and clean activities, and the need to house additional equipment or to meet demands for compliant storage facilities, can mean more space is needed – but extending the department may not be an option at some sites.

“Hospitals with space constraints or difficulty in achieving compliance could consider outsourcing the device reprocessing service to another hospital or an external provider, or insourcing capacity by bringing external facilities onto the hospital site. Compliance is then ensured by the external provider, reducing risk for the hospital. There are other benefits too; the facilities used are likely to already have unidirectional flows, separation between soiled, clean and sterile zones, systems ensuring compliance with water and air quality requirements and compliant equipment in situ. Maintenance and repair is also taken care of by the external provider.

Both provide viable compliant options for decanting the sterile services department. They ensure minimal disruption to existing workflows and provide continuity of service, ensuring that surgical schedules are not impacted and when used longer-term, these options also free up both capital resource and space within health service organisations and provide opportunities for repurposing the existing space.

“However, the outsourcing option comes with some loss of control over processes and workflows, and this can actually increase risk for the hospital instead of decreasing it. In many cases, outsourcing involves long journeys to large, central facilities, which can add to reprocessing time, and hospital equipment is transferred off the hospital site. In some cases the transfer of ownership of surgical devices to the outsourcing organisation is also necessary.

“Outsourcing may also require the purchase of additional equipment to cover for that which is off-site, which in the case of endoscopes, for example, can be very costly. Something else to consider is that, if the need is temporary, this will lead to in-house staff and service being unutilised for the duration of the refurbishment period, while continuing to incur cost.”

How does insourcing of mobile or modular capacity work?

“Additional capacity – in the form of a purpose built modular or mobile CSSD unit – is brought onto the site or to a nearby convenient location”, explains Peter.

“This means the existing CSSD can be decanted while the ownership of all sterilisation activity, all processes and equipment can be retained on site. Existing hospital CSSD staff can be utilised effectively during the refurbishment period, and there is no need to purchase additional surgical equipment. Aside from set-up costs related to connecting utilities and undertaking any enabling works, there are no construction costs. Equipment tracing systems can integrate with the hospitals’ existing system without the need for substantial investment in IT.

“All this reduces risk. With activity and staff moved to a facility that is already compliant with the new standards, new processes can be implemented at an earlier stage, and timescales for work done to the inside of the hospital can be reduced, meaning the risk of not meeting the standard by the deadline is significantly lowered.”

“Having appropriate compliant facilities, such as Q-bital Healthcare Solutions’ mobile CSSD units or endoscopy decontamination units, in place to decant the existing sterilising activity to is guaranteed to minimise disruption while long-term changes take place.”

Are there any other considerations?

According to Peter, looking longer-term and considering future capacity needs is also essential. He continues:

“This is an ideal time to ensure sterile services departments are future proof. It makes little sense to invest in upgrading the CSSD to meet the standard, only to find a rise in demand is likely to mean capacity will not be sufficient in 5 or 10 years’ time.

“Hospitals are under pressure to meet the needs of a growing and ageing population,  and the numbers – and types – of operations undertaken in hospitals are increasing demand for CSSD reprocessing services. Just like it provides an opportunity to replace equipment that was coming to its end of life anyway, it is also an opportunity to look at sterile services provision as a whole, including the capacity issue.

“Rather than place strain on other departments, or temporarily relocate complex equipment, hospitals are choosing to invest in our temporary mobile CSSDs – either to ensure vital services can continue during refurbishment, or to run alongside existing departments, allowing them to go beyond 100% capacity at busy times.”

About Q-bital

Q-bital’s mobile and modular CSSDs are used in hospitals across both Europe and Australia, providing reliable, temporary solutions to meet the exacting regulatory standards. Q-bital takes a partnership approach, working closely with health service organisations and offering 24/7 technical support.

In the words of Sarah Nixon, Nurse Unit Manager for surgical services at Grafton Hospital in NSW, who recently worked with Q-bital to temporarily decant its CSSD:

“I would like to state how impressed I have been with Q Bital’s professional approach and communication. As with any project of scale, there have been challenges. However as each challenge arose, we were able to work together collaboratively to establish suitable solutions quickly without compromising the end result. This has minimised risk and impact on service delivery.“


Contact Peter Spryszynski at Q-bital Healthcare Solutions for advice on reaching compliance and options for decanting the CSSD department during essential works, on +61 (0) 7 3554 1022.