With the deadline for compliance with the new sterilisation standards for Australia and New Zealand fast approaching, what options are there for hospitals unable to extend the space taken up by the central sterilisation services department (CSSD) in the short term?

What are the requirements?

The new standard, AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations, which became operational in December 2016 and requires compliance, or a plan for achieving compliance, to be in place by the end of 2021. It is mandatory for approved accrediting agencies and health service organisations.

The document 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 standards for sterilisation processes.

In practice, the need for segregating clean and dirty activities may mean redesigning floor space and physically segregating the reprocessing environment, which in turn could mean more space is needed. Hospitals will also need to review conditions in existing storage facilities, such as temperature, humidity and contamination risk, and if facilities are found to not be compliant, this could mean re-design of the facility or investment in upgrading air conditioning systems is required.

The new standard also requires that instruments are traceable to the patient. A tracing system – ideally electronic – that can identify the cleaning process applied to each reusable medical device, and have the ability to track a device to a patient to allow for a recall, is required.

What does it mean for hospitals?

In terms of equipment needed, it is expected that many hospitals will need to replace or invest in new equipment for their central sterile services departments, including washer disinfectors (compliant with ISO 15883) and sterilisers (compliant with EN 285 or EN 13060).

However, simply replacing the equipment is not enough; wider changes to processes are likely to be needed as operational complexity increases. In practice, health service organisations will need to develop new procedures for operational use of the equipment, and training may also be required. This is likely to mean a higher level of expertise will be required, costing time, money and resources.

Why has the deadline been extended?

A survey undertaken last year by the Australian Commission on Safety and Quality in Health Care found that only 30% of organisations reported compliance with the standard, and 50% expected to be compliant by 2021. As many as 90% of all organisations also identified implementation issues.

A number of major challenges have been identified. From a management perspective, the largest challenges for health service organisations in meeting the AS/NZS 4187:2014 standard are likely to be limitations to capital and ability to fund major refurbishments; and the availability of additional space. The cost of new equipment or infrastructure upgrades to improve air and water quality, or implement an electronic tracing system, can also be substantial.

Since it is critical that the hospital has access to sterilised equipment at all times, and that sterilisation and reprocessing services are not disrupted, undertaking refurbishment works also presents a major operational challenge in the short to medium term.

One option for hospitals is to set up a temporary internal department by repurposing existing space, while making longer term changes or to achieve compliance in the short term. However, this can present logistical issues and introducing the new processes and ways of working required for compliance can also be difficult.

Maintaining all sterilisation activity within the hospital while undertaking major refurbishment can more than double project time for the construction work, and can cause significant disruption which can lead to indirect costs.

What other options are available?

For some hospitals, the requirement for separating all dirty and clean activities, and the need to house additional equipment or to meet demands for compliant storage facilities, will mean more space is needed. However, extending the department is not always an option and finding a new location requires long-term planning.

For hospitals with space constraints or difficulty in achieving compliance, outsourcing the device reprocessing service to another hospital or an external provider, or insourcing capacity by bringing external facilities onto the hospital site, provide viable compliant options. Using the facilities of a nearby hospital can also be an option, but can bring a number of logistical challenges.

These options offer a number of advantages, such as minimal disruption to existing workflows, providing continuity of service and ensuring surgical schedules are not impacted. Compliance is ensured by the external provider reducing risk for the hospital. Facilities are likely to already have unidirectional flows, ensuring a clear separation from soiled, clean and sterile zones, systems ensuring compliance with water and air quality requirements, and compliant equipment in place.

Maintenance or repair is also taken care of by the external provider, further reducing risk to the hospital, while equipment tracing systems can integrate with the hospitals’ existing system without requiring substantial investment in IT. When used long-term, these options can also free up both capital resource and space within health service organisations; and provide opportunities for repurposing the existing space.


Outsourcing to an external provider

While outsourcing provides a viable option, and allows an element of risk to be transferred to an external provider, it does come with some loss of control for the hospital, in terms of processes and workflows, and this can actually increase risk for the hospital.

In many cases the outsourcing option requires long journeys to larger central facilities, which can add to reprocessing time, and the transfer of hospital equipment off the hospital site – or in some cases the transfer of ownership of surgical devices to the outsourcing organisation.

Often, these large central facilities serve a number of customers and require hospitals to adopt their systems for equipment tracing, rather than allowing hospitals to select their own and maintain ownership of the full sterilisation cycle. The outsourcing option 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.

Insourcing mobile or modular capacity

The insourcing of additional capacity, in the form of a purpose built modular or mobile CSSD unit, means all sterilisation activity can be maintained at the hospital site, or in a nearby convenient location.

This is likely to minimise delays, while keeping devices on site at all times, reducing risk. 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.

Mobile or modular CSSD units can be equipped to integrate with the hospitals’ existing equipment tracing and IT systems.

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. In addition, refurbishment or construction 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.

One downside of this option is that the number of mobile facilities available is limited and with demand rising as the deadline looms nearer, hospitals will need to act quickly to secure such a facility ahead of the compliance deadline.

Having appropriate compliant facilities, such as Q-bital Healthcare Solutions’ mobile CSSD units or endoscopy decontamination units, which allow activity to continue without disruption, in place is essential while long-term changes take place.