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International water standards for hospitals have been established since 1958, ensuring purified water of a specified quality is delivered to the point of use. From sterilising medical instruments and decontaminating hands to lab experiments and dentistry, water has many uses in today’s hospitals.
Quality water supply to healthcare facilities is not only essential for safe patient care – it also presents a manageable source of healthcare-associated infections (HAI). In many low to middle income countries where quality standards are still unmet, HAI outbreaks from water sources are not uncommon. Infrastructure is often damaged or inadequate, contaminated through broken water systems.
As a global engineering partner in the life sciences sector, we recognise the undisputed importance of water purification systems which include devices, associated piping, pumps, valves and gauges.
Looking through a global lens, we’re seeing regulatory change in Australia.
Here’s what’s changing…
In December 2023, AS/NZS 4187 was superseded by AS 5369 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.
This change broadens the scope of reprocessing water quality and risk management system requirements, requires segregated reprocessing environments and places greater emphasis on the requirement for suitably qualified and competent personnel to be engaged for validation, quality and operational tasks.
There are implications in the new standard for Central Sterilisation Services Department (CSSD) facility design, specification and validation including the documenting of water as an ‘agent involved in reprocessing’. Process maps or flow diagrams of CSSD systems, including water purification, are mandatory and to be used in a formal risk evaluation and management system. The developed risk assessment is then recommended to be reviewed annually or whenever a change is made to the process.
Around the world, hospital water units and systems can have a limited expected plant life of ten years. System replacement becomes necessary once routine sanitisation cycles become less effective against the build-up of biofilm.
Increased frequency of chemical sanitisation and thermal disinfection become necessary to counter the effects of an established biofilm and meet regulatory compliance requirements for water quality. Poor water quality performance and unscheduled maintenance events therefore increase the operational costs of the water system and raise questions about system reliability.
Patient outcomes are known to improve with the quality of the water used in renal dialysis and the CSSD processes for reusable medical devices and endoscopes.
Avoiding the build-up of biofilm through investigation of compliance issues, system performance issues and a focus on addressing their root causes can support an improved plant life.
While we may be seeing regional regulatory standards change in certain regions, we believe best practice is international.
We’ve outlined practical strategies that hospital water system owners can use to prioritise maintenance activities and improvement projects, benefitting system performance, patient outcomes and sustainability.
Monitoring starts at mains water connection. The chemical, microbiological and physical properties of the feed water will have seasonal variation. Consequently, this has an impact on the performance of the water purification equipment.
Regular sampling and water quality data collection throughout the water system, including incoming water supply at each step of the purification process and at the user outlets, are essential to identify trends and early indication of performance issues. Whilst the water quality requirements for a dialysis ward will be different to the CSSD, we can use the same methodical approach for investigation and troubleshooting any excursions from the acceptable quality limits.
But how and where can you gather water quality data?
This step requires input from several sources and a supportive open path of communication with maintenance contractors, suppliers and internal customers or medical departments. For a holistic view of RO water system performance, you’ll need to engage with the right people.
Maintenance contractor | Water testing laboratory | Data acquisition system | Medical directors/ward staff |
Adequate water sampling points Detailed service reports including unusual alarm events or unscheduled replacement of any components In-house engineering attendance during service visits to gain insights about the system operation and inspect the condition inside any open systems System operation training for in-house engineering personnel and system users | Adequate frequency of sampling and testing Test result reports including trend analysis of chemical, microbial count and endotoxin levels Notifications from Water Authority on expected changes to water supply quality | Adequate in-line instrumentation with data output capability Adequate trend reporting from the available in-line instrumentation Access to data in a format that allows comparison of multiple parameters for trend identification IT support to gain remote access to historical trend data for desktop reviews | Record and investigate all reports of water quality issues Record and investigate all complaints from system users that could indicate system performance issues |
Once the available data has been reviewed and a root cause of any adverse quality event(s) has been identified, the output of these investigations can be introduced to the risk assessment process.
Pay particular attention to the microbiological results. This will provide an indication of the locations within the water system that have biofilm growth potential. A biofilm forms when bacterial cells attach to the internal wet surfaces. Low bacterial and endotoxin levels are therefore desirable throughout the system to minimise the development of a biofilm. Biofilm growth is the typical indicator for replacing dialysis RO plant after 10 years. Excitingly, opportunities to limit the biofilm growth are opportunities to extend plant life.
A water system operating at low temperature and using clean design principles will have a significantly lower bioburden as compared to a system operating closer to 36°C with dead legs of stagnant water, a low recirculating velocity and with piping systems, fittings and joints that contain crevices.
How to identify areas of concern
Taking the common issue of a deadleg of stagnant water in a typical RO water system pre-treatment piping as an example, we can develop a risk assessment for the biological hazard of high bioburden in the pre-treatment piping causing biofilm development and microbiological load on the RO membranes.
Process step | Hazard or threat | Risk Assessment | Total | ||
Likelihood | Frequency | Impact to patient | |||
Pre-treatment piping | Microbial growth in stagnant water within a deadleg section of piping (biological) | 10 (high) | 10 (all the time) | 1 (mild) | 21 (short term) |
10 (high) | 10 (all the time) | 5 (moderate) | 25 (long term) |
In this example, the indirect impact to patient is mild in the short term but becomes moderate as the biofilm develops and the hazard persists. System availability may be compromised in the long term by increased sanitisation frequency as fouling of the RO membranes starts to impact system performance.
In both the short term and long term, the risk score ranking for stagnant water in the pre-treatment piping is categorised a severe high risk (15-30) as defined in AS 5369 Appendix B. The piping dead leg risk is consequently required to be documented and the control measures in place to manage the defined risk and the assigned corrective actions. The ranking of identified hazards in the established risk assessment document becomes a guide to the prioritisation of maintenance budget expenditure and justification for capital improvement projects.
Risk evaluated priorities for improved compliance and performance can also make RO water systems more sustainable. The key aspects of sustainability applicable to RO water systems are water efficiency, waste and materials.
Sustainability category | Key principles | RO water application |
Water efficiency | Minimise water consumption | A low bioburden RO water system requires a lower frequency of sanitisation Avoiding or minimising chemical sanitisation procedures significantly reduces the flushing water volume required to remove residual chemical prior to the system resuming normal operation |
Waste | Aim for zero waste during building construction and operation Implement waste management initiatives (eliminate, reduce, recover / recycle waste, engage employees, etc) | Strategies to adopt clean design principles and avoid microbiological loading of the system extends the plant life of piping and replaceable system components such as filter cartridges and RO membranes |
Materials and resources | Avoid using materials which damage the environment Minimise use of materials which increase concentrations of substances in the earth’s crust or ecosphere | Strategies that extend plant life instead of demolishing and replacing it reduce the embodied carbon of the system The need to use chemical sanitising agents and energy for thermal disinfection can be minimised in a low bioburden RO water system |
The introduction of mandatory risk assessments for the performance monitoring and maintenance of CSSD system, as required by AS 5369: 2023 in Australia, is an opportunity for facility owners to proactively manage water system performance.
Using the risk assessment framework to capture findings from regular review of water quality data allows for the prioritisation and allocation of budget to improvement projects that return the greatest benefits.
Whilst the objective is to improve water quality compliance and patient outcomes, there are measurable sustainability benefits with improved water efficiency, extended plant life and reduced consumption of chemicals and replaceable components.
We place sustainability and reliability at front of mind when designing water systems for leading life science and pharmaceutical companies. Our meticulous, thorough designs and predictable, reliable project delivery are what make us a partner of choice to many hospitals and Government health departments across the globe.
From concept to start-up, we’re supporting some of the largest pharmaceutical, healthcare and life sciences companies on their unique facilities.