A new set of sterilisation standards for Australia and New Zealand became operational in 2016, with compliance by hospitals required by the end of 2021. However, in response to concerns raised by health service organisations and state and territory health departments, the implementation requirements and the compliance timeframe have been revised by the issuer, the joint Standards Australia/ Standards New Zealand Committee.

This article explores how the timeline has been impacted, what the changes mean for hospitals and how the new requirements can most effectively be met.

About the Standard

The ‘new’ standard, AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations, was released in 2014 and became operational in December 2016. It sets out more stringent requirements for 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. It is mandatory for approved accrediting agencies and health service organisations to implement the new standard.

The basic requirements for accreditation are that, where reusable equipment, instruments and devices are used, the health service organisation should have:

  1. Processes for reprocessing that are consistent with relevant national and international standards, in conjunction with manufacturers’ guidelines
  2. A traceability process for critical and semi-critical equipment, instruments and devices that is capable of identifying the patient, the procedure, and the reusable equipment, instruments and devices that were used for the procedure.

Since the Standard was issued, there have been a number of revisions to the related Advisory document, AS18/07, which sets out the minimum requirements for health service organisations’ compliance. The revisions have been mainly concerning the timeframe, and a revised timeline of what is required – and by when – was included in the most recent update, released in July 2020.

Though there have been discussions about allowing more time, either full compliance or a robust plan and timeframe for reaching compliance will still be required by December 2021. The latest Advisory update states that to comply with Action 3.14 in the related standard National Safety and Quality Health Service (NSQHS) Standards (second edition), health service organisations will need to, as a minimum:

  1. Complete a gap analysis to determine its current level of compliance by June 2021
  2. Develop and document an implementation plan using a quality improvement framework specifying timeframes, milestones and deliverables to support implementation by December 2021
  3. Demonstrate progress toward implementing the plan.

The Australian Standard AS/NZS 4187 is the national standard most commonly used to meet the requirements in Action 3.14 of the NSQHS.

What are the key requirements?

As a minimum, there are four key areas within which compliance is essential.

  1. Segregation of clean and dirty activities

The Advisory states that compliance with AS/NZS 4187:2014 requirements for effective segregation of clean and dirty activities can be achieved by implementing strategies that ensure sufficient segregation of activities, including unidirectional work and airflows being implemented to reduce the risk of cross-contamination.

These must be accompanied by a detailed risk analysis and include a process map or flow diagram to indicate how risks of cross contamination are being identified and managed.

All health service organisations are expected to be compliant with requirements to segregate clean and dirty activities by December 2023, through refurbishment and redevelopment of existing sterilising services, endoscopy reprocessing units and satellite services, while all future new builds should be planned to be compliant from the outset.

  1. Design of storage areas for sterile stock

To meet the AS/NZS 4187:2014 requirements for storage of sterile stock, organisations need to assess the risk of humidity and temperature on stored sterile stock, and ensure risks of contamination are mitigated wherever sterile stock is stored.

All sterile stock should be stored in compliant shelving, and a risk analysis is required if sterile stock and non-sterile stock are co-located in a storage area.

For organisations that do not currently comply, compliance can be achieved by developing a plan, endorsed by the organisation’s executive, that includes realistic timeframes, costings and options for funding to achieve full compliance by 31 December 2022. In the meantime, a risk assessment, including mitigation strategies, and documented evidence of a regular review process will need to be prepared.

  1. Replacement of non-compliant cleaning, disinfecting and sterilising equipment

Whenever an organisation replaces cleaning, disinfecting and/or sterilising equipment, it must install equipment that is compliant with AS/NZS 4187:2014 and the relevant applicable ISO standard. The equipment should be operated and maintained in accordance with the standard, as well as the manufacturer’s requirements, including for water quality and water monitoring.

Equipment and design of all new builds, refurbishments and redevelopments of sterilising services units are required to comply with the Standard by 31 December 2022.

For health service organisations that will not be fully compliant by this date, compliance can be achieved by developing and implementing a detailed plan that includes realistic timeframes, costings and options for funding to move to full compliance. There should also be a risk assessment, mitigation strategies and evidence of regular review and reports to the executive on progress. This detailed plan, inclusive of executive endorsement, must be in place by 31 December 2021.

In practice, health service organisations will also need to develop procedures for operational use of this equipment that are compliant with the standard, and training may also be required. All new equipment must also undergo installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) tests. These must be documented in a way that meets the applicable national and international standards.

  1. Monitoring requirements for water quality

Health service organisations are required to comply with water monitoring requirements set out in AS/NZS 4187:2014 for all reprocessing equipment compliant with the applicable ISO standards. Compliance is required by 31 December 2022 but can also be achieved by developing and implementing a detailed plan, as above, by 31 December 2021.

Whenever an organisation replaces equipment that is used in the cleaning, disinfecting or sterilisation process, water quality requirements should be included in the planning and risk assessment undertaken.

Source: Advisory AS18/07 – July 2020 update

Implications for hospitals

The requirements in the standard are mandatory. Accreditation is necessary, and is awarded on a three or four-year cycle, depending on the accrediting agency.

Australian hospitals are required to be licensed in the relevant State and Territory and must comply with all relevant safety and quality requirements. While individual health departments regulate which services must undertake accreditation, all States and Territories have agreed that hospitals and day procedure services will be accredited to the NSQHS Standards from January 2013. This is also a requirement for private health insurance.

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 may need to be allocated to the sterile services department. It is possible that a major rebuild or refurbishment programme will be needed.

Hospitals will 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 a re-design of the facility or investment in upgrading air conditioning systems is required.

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). As a result, significant investment may be needed and the hospital also needs to develop or update operating procedures and train staff.

Water quality is a critical for sterile reprocessing, and hospitals may need to make infrastructure changes to ensure a water supply that is capable of providing water of the quality outlined in the standard, as well as to the specifications given by equipment manufacturers. It may be necessary to treat water before using it for reprocessing and sterilisation, for example to soften, filter, demineralise or distil the water, or undertake reverse osmosis, depending on the relevant recommendations.

The AS/NZS 4187:2014 standard also requires that instruments are traceable to the patient. A system is required that can identify the cleaning process applied to each reusable medical device, including an ability to track a device to a patient to allow for a recall if required. The Standard states that health service organisations should be working towards an electronic tracking process and record system.

What are the key challenges?

When the new standard was first introduced, reports in the media suggested that Australian hospitals may face an estimated $1 billion cost to overhaul central sterilisation departments to meet the new requirements.

In any case, it is clear that a number of health service operators do not currently meet the new standards and that upgrading existing facilities to a compliant level could be expensive. It may also take a long time with works difficult to schedule, given that the sterile services department is critical for the continuity of surgical procedures. The new water quality standard also presents a particular challenge, as it can have a wider impact on hospitals’ entire infrastructure.

The trigger for the most recent set of revisions was a workshop held by the Australian Commission on Safety and Quality in Health Care in September 2019 with participants from the public and private sector across the acute, community, dental sectors and policy areas, specifically to discuss the issues health service organisation had identified with the implementation of the new standard.

If not already compliant, hospital operators should already be assessing their compliance with the new standards and implementing plans for compliance. However, a recent survey by the Commission found that, while over 90% of respondents had completed a gap analysis as required, 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.

Workshop participants recognised the need for updating the standards and that current sterilisation practices do not meet best practice, but had identified a need for simplified guidance and clearer documentation to assist health service organisations in accurately interpreting and applying the standards, as well as improved access to training. It was also recommended that a risk-management approach to implementation be adopted to enable prioritisation of high-risk areas, and this has influenced the more lenient wording of the latest revision to the Advisory.

From a management perspective, the largest challenges for health service organisations in meeting the AS/NZS 4187:2014 standard is likely to be limitations to capital; as in the ability to fund major refurbishments; and physical capacity or space available. The cost of new equipment or infrastructure upgrades to improve air or water quality can be substantial. In addition, electronic tracing systems can be costly and challenging to implement.

For hospitals that do not already meet the requirement for separating all dirty and clean activities, this is likely to mean the sterile services department may need to be expanded and, in some cases, will require more space than is currently available. Additional space may also be needed for new equipment or to meet the new demands for the correct storage of sterile devices.

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 any refurbishment works also presents a challenge in the short to medium term. How will the department ensure continuity of service while improvements are being undertaken?

Meeting the new standard

Health service organisations typically undertake the reprocessing of reusable medical devices within the facility, but alternative solutions are becoming more common. For many hospitals with space constraints or difficulty in achieving compliance, outsourcing the device reprocessing service to another hospital or an external provider, or insourcing of capacity in the shape of external facilities and staff to support the hospital on site, provide viable compliant options.

Both provide 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, while facilities 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, reducing risk to the hospital, while track and 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.

While outsourcing provides a viable option, it does come with an element of risk. 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.

The insourcing of additional capacity, however, 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 another convenient location, minimising any delays, while keeping devices on site at all times, reducing risk.

The revised timescale that was recently announced will be welcomed and allows for more time for implementing robust, strategic plans for major refurbishment work, rather than a need to opt for an interim solution in order to achieve compliance. However, implementing the changes will provide a challenge and appropriate compliant facilities, such as Q-bital Healthcare Solutions’ mobile CSSD units, where activities can continue without disruption are essential while these changes take place.