Sterile Services Departments (SSDs) – the importance of risk management

A presentation to the Central Sterilising Club¹ from leading experts in microbiology and clinical sciences found that although steam sterilisation standards throughout the NHS were high, it is often difficult to sterilise instruments as they are designed for function, not with reprocessing in mind.

This problem is particularly acute for instruments such as transoesophageal echocardiogram (TOE) probes, where only part of the device is suitable for immersion in sterilisation fluids.

The difficulty, however, is that it can be impossible to modify the design of an instrument once it has gone through the necessary regulatory approvals. As a result, surgical teams depend heavily on the expertise of SSD staff, the rigour with which they follow decontamination processes and the reliability of decontamination equipment, including the efficiency of water purification systems.

A further issue identified at the conference was that training for staff in SSDs was often variable, increasing the risks of errors occurring due to limited knowledge or experience with procedures and equipment, some of which such as water purification units they may only interact with occasionally. This point is also reflected in a report published earlier this year by the independent Healthcare Safety Investigation Branch (HSIB), which found that there is no national competency framework for SSD staff to ensure consistency and standardisation.

The report also highlighted inconsistencies in the way in which SSDs were regulated. Depending on their legal status SSDs are regulated either by the Care Quality Commission (CQC), in which case they are not normally inspected for compliance with regulations and standards, or by the Medicines and Healthcare Products Regulatory Agency (MHRA), where compliance is managed by external ‘Approved Bodies’. Additionally, MHRA regulated SSDs may have quality management systems in place but do not generally have a formal process that automatically escalates issues upwards to senior NHS managers in the event of a problem occurring.

The report made a number of recommendations, including the need to develop a single assurance and regulatory framework for SSDs, with both a competency framework and the requirement to involve senior management in sterilisation policies and incidents being incorporated into HTM 01-01.

The recommendations noted by the HSIB², together with the wider issue of instrument design to eliminate the risk of incomplete decontamination, will clearly take time to implement. In the meantime, SSD teams are becoming increasingly stretched as the NHS struggles to meet ever-growing demands while battling with staff shortages and dwindling levels of funding.

This is where new technologies and refinements to processing techniques can make a considerable difference. Clearly, these must comply with HTM 01-01 and be easy to integrate safely into existing decontamination processes. These essential requirements aside, the adoption of simple techniques such as assessing peak water flow requirements, can significantly reduce cycle times and productivity without affecting quality or safety. For more on reducing cycle times see our blog post: The washer disinfector cycle time dilemma.

It’s also worth remembering that there is a wealth of knowledge and experience available from key equipment suppliers. That this can often help SSD staff increase the performance and efficiency of sterilisation and decontamination systems. For example, our team of water purification specialists can offer insight into ways to reduce water and energy consumption, improve throughput and enhance water safety. Alternatively, we are able to offer water purification system upgrades that provide greater traceability, share our experiences of best practice that we see from our work with public and private sector hospitals around the UK, and provide training for water purification system optimisation.

Please get in touch if we can help with your SSD challenges.