Investigation report: Decontamination of surgical instruments

This investigation focuses on the work of sterile services departments (SSDs). SSDs are the departments in hospitals where reusable medical equipment is decontaminated (cleaned, disinfected and sterilised) to make it safe before it is used again. Effective decontamination of surgical instruments is essential for patient safety and to avoid delays and inefficiencies in hospital operating theatres.

In particular, the investigation looked at the regulatory framework within which SSDs work, and their use of assurance models, which provide evidence that a service is running according to the relevant policies and procedures. These mechanisms are designed to keep patients safe and enable NHS trusts to manage risk within their organisations.

SSDs are required to have a quality management system in place and many are accredited to the International Organization for Standardization (ISO) standard ‘ISO 13485 Medical devices – quality management’. ‘Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care’, which is produced by NHS England and NHS Improvement, explains the management of decontamination services and the various ways to sterilise reusable medical devices used in acute care.

To explore how SSDs operate and the related regulatory and assurance mechanisms, the investigation examined a real patient safety incident, referred to as ‘the reference event’. The incident involved a patient who had a procedure to remove a kidney stone. During the procedure foreign material was seen coming out of the end of a surgical instrument.

The investigation’s safety recommendations and safety observations aim to address regulatory and assurance gaps in infection control that prevent risks being identified and managed at an appropriate level, and to remove the confusion caused by the current regulatory structure. They also seek to address the lack of a national competency framework for sterile services staff.

A woman aged 56 (the Patient) was diagnosed with a kidney stone in her right kidney. She was seen by a consultant urologist (a doctor who specialises in conditions of the kidneys, bladder and urinary tract), who decided that the Patient needed to have the stone broken up and removed as it was unlikely to pass out of her kidney on its own. The Patient asked to have a procedure known as a percutaneous nephrolithotomy (PCNL) to remove the kidney stone. This involves making a small incision (cut) on a patient’s back and passing a surgical instrument into their kidney. The Patient gave her consent for an alternative procedure in case of any unforeseen problems with the PCNL.

The Patient was anaesthetised and prepared for the procedure. Once the kidney stone was located, the surgical equipment needed for the procedure was unpacked from its sterile wrappings and inspected by the nurses and the consultant urologist. The equipment looked clean.

An incision was made on the Patient’s skin and the surgical equipment was inserted into her kidney. Water (irrigation) was started, and “black stuff” was seen coming out of the end of the surgical equipment’s irrigation channel. The consultant urologist stopped the procedure immediately and the black material in the kidney was removed. It was later analysed and found to be dried blood. The kidney stone was successfully removed using the alternative procedure which the Patient had already consented to. As the Patient had been exposed to another person’s dried blood, she was tested for blood-borne viruses; the tests showed no evidence that she had contracted any.

The surgical equipment set used in the Patient’s procedure was classed as ‘reusable’ and therefore needed to be cleaned and decontaminated between each use. The set was made up of several items, including the cleaning brushes needed to make sure that the equipment could be cleaned. The set had been through a decontamination cycle in the SSD but several of its cleaning brushes were missing. This prevented the set (in particular the irrigation channel) from being cleaned in accordance with the manufacturer’s instructions for use. The importance of the brushes was not understood by operating theatre staff, who requested the equipment be removed from quarantine (where equipment that has been taken out of use is stored) and decontaminated for the Patient’s procedure. The investigation identified that there was not a robust assurance process for managing risks associated with the decontamination process and importantly for letting clinical staff know why equipment had been removed from use. The fact that there was only one set of this type of equipment was an additional factor in the decision to release it from quarantine for use in the Patient’s procedure.

The investigation identified several gaps in meeting the governance requirements relating to sterile services, more specifically the regulation and assurance frameworks that ensure people are kept safe. These gaps meant that there was a lack of direct regulatory oversight of SSDs and that NHS trust senior management across the healthcare system did not have systems in place to assure themselves that quality, risks and issues were being managed at an organisational level. While many individual SSDs did have quality management systems in place, NHS trust management did not have an active role in assuring the quality of these services.

The ability to decontaminate surgical equipment was also explored from a design perspective. There are clear requirements in place for decontamination to be considered during the design phase of a surgical instrument. These requirements sit in a complex system that has input from global stakeholders. The investigation heard that if the UK had different standards to the rest of the world, then the cost of equipment would increase.

Staff training and competence was another key area that the investigation considered. It was discovered that all training and training standards for decontamination are set locally by individual SSDs rather than set out in a national framework. This creates challenges for regulators, SSDs and NHS trusts as currently the system of safety relies on trained and experienced staff carrying out decontamination tasks to a set standard and identifying problems as they arise. If the standard of staff training varies across the country, then the standard of decontamination may also vary.

• There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the size of the issue is unknown and that the healthcare system does not fully understand the risks and issues it is holding.
• Risks and issues are held within individual SSDs and are not integrated within wider trust management systems.
• Trusts frequently focus on clinical risks and not on the risks that arise from non-clinical supporting departments but which present a patient safety risk.
• There is no national requirement for NHS trusts to have a formalised risk management system.
• All SSDs produce a similar product – decontaminated surgical instruments. The legal status of an SSD determines which national body regulates it (the Care Quality Commission (CQC) or the Medicines and Healthcare products Regulatory Agency (MHRA)).
• The CQC does not inspect SSDs for compliance with regulations and standards.
• The MHRA does not inspect SSDs for compliance with regulations and standards, but relies on external assurance bodies (known as Approved Bodies) to do so. It does undertake a small number of witnessed audits of Approved Bodies while that Approved Body audits an SSD to ensure that standards are being maintained.
• MHRA-regulated SSDs have in place quality management systems, managed at a local departmental level. ‘Top management’ are not involved in this quality management system, therefore risks and issues relating to SSD quality are not formally escalated to a trust organisational level.
• Escalation of SSD quality risks and issues relies on the integrity and professional behaviour of managers rather than being required by policy.
• There is a requirement for manufacturers to design reusable surgical equipment in such a way that it can be decontaminated.
• Surgical equipment can be difficult to decontaminate due to its complexity and size.
• Currently the MHRA regulates under the Medical Device Regulations 2002 which incorporate the European Union’s standards and regulations. The MHRA is restricted in developing its own standards due to market forces.
• To overcome design issues with surgical instruments that relate to decontamination, SSDs rely on decontamination processes to ensure equipment is suitable for use in operating theatres.
• It is difficult to change the design of equipment after it has been approved for use, so the success of the decontamination processes relies on trained and competent staff.
• There is no national competency framework for SSD staff to ensure consistency and standardisation.

1.1.1 Kidney stones are created by the grouping of deposits of minerals and salts in a person’s kidney. These waste materials can crystallise together, forming a hard lump. Kidney stones can develop in one or both kidneys and are more common in people aged between 30 and 60 years, with more than 1 in 10 people affected (NHS, 2019).

1.1.2 Kidney stones can be extremely painful and can lead to kidney infections or the kidney not working properly if left untreated. In many cases people can pass kidney stones in their urine with the assistance of medication and drinking plenty of fluids.

Treatment of larger stones

1.1.3 The main types of surgery for removing kidney stones are:

• shockwave lithotripsy
• ureteroscopy
• percutaneous nephrolithotomy (PCNL).

Ureteroscopy

1.1.4 Ureteroscopy (see figure 1) involves passing a long, thin telescope called a ureteroscope through a patient’s urethra (the tube urine passes through on its way out of the body) and into the bladder. It is then passed up into the ureter, which is the tube that connects the bladder to the kidney (NHS, 2019).

1.1.5 The surgeon may try to gently remove the stone using another instrument, or use laser energy to break it up into small pieces so it can be passed naturally in the patient’s urine.

1.1.6 Ureteroscopy is carried out under general anaesthetic.

Percutaneous nephrolithotomy (PCNL)

1.1.7 PCNL involves using a thin telescopic instrument called a nephroscope. The nephroscope is passed through a small cut (incision) in the patient’s back and into the kidney. The stone is either pulled out or broken into smaller pieces using a laser or air pressure. PCNL is always carried out under general anaesthetic (NHS, 2019).

1.1.8 An ultra-mini percutaneous nephrolithotomy (UM-PCNL) (see figure 2) is a minimally invasive version of this procedure, which uses smaller instruments/components called an ultra-mini percutaneous nephrolithotomy (UMP) set (see figure 2). It requires only a 4mm-long incision on the patient’s skin. The advantages of this include a reduced risk of trauma and bleeding, less need for pain relief and a shorter hospital stay.

1.1.9 A UMP set (see figure 3) is the reusable surgical instrument that was used in the patient safety event described in this report (the reference event). The set contains the surgical instruments used in the procedure and several cleaning brushes which are required to comply with the cleaning procedures. In the NHS Trust where the reference event took place, if any component was missing or damaged, the UMP set could be removed from service (quarantined) until the problem was resolved.

1.1.10 The UMP set used in the reference event consisted of several items (similar to those shown in figure 3) including an inspection scope (camera), lithotripsy probe (used to break up the kidney stone) and water jet sheath (a stainless-steel tube approximately 150mm long). The water jet sheath had one larger channel to allow different probes (camera and lithotripsy probe) to be inserted into a patient’s body. In addition, there was a small fixed tube (an irrigation channel with an internal diameter of less than 2mm) that allowed water to be injected into the kidney (to assist stone removal). The UMP set also contained bungs for tubes and four cleaning brushes to ensure that the internal surfaces of the sheaths (known as lumen) were cleaned. Figure 4 shows examples of lumen cleaning brushes.

1.1.11 The cleaning procedure for the UMP set used in the reference event, as detailed in the manufacturer’s instructions for use, was:

• Place equipment in a cleaning solution as prescribed by the manufacturer.
• Place equipment (apart from nephroscope) in an ultrasonic bath. An ultrasonic bath creates micro bubbles that provide effective cleaning by agitating residual small particles on surfaces which then lift clear of those surfaces.
• Wipe external surfaces clean with fresh cloth.
• Brush cavities (including lumen) with provided brushes. (Figure 5 shows small lumen with 45-degree bend along its length.)
• Rinse with cleaning solution.
• Place in automatic washer/disinfector.

After the ultrasonic bath, the internal surfaces of the lumen were required to be brushed with the manufacturer’s provided brushes. If a brush was not passed through the lumen, it may be possible for bodily fluids to remain in the lumen and they may then congeal to form a solid material. Due to the 45-degree bend in the irrigation channel, inspection by sight or passing a light through the lumen was not possible.

1.2.1 Some people carry viruses in their blood, known as blood-borne viruses (BBVs). These include human immunodeficiency virus (HIV), hepatitis B and hepatitis C among others. People who have contracted a BBV may display few or no symptoms, but others may be seriously ill. BBVs can be transmitted through various routes, including contact with contaminated bodily fluid or contaminated surgical instruments. In healthcare, surgical instruments are decontaminated and sterilised (see 1.3) to ensure that BBVs are removed before the instruments are used again (Health and Safety Executive, n.d.a).

1.3.1 Within NHS hospitals, decontamination of surgical instruments is carried out by a sterile services department (SSD). This may be an NHS trust service or provided by a contracted third party.

1.3.2 The Health and Safety Executive (HSE) defines decontamination as follows:

‘Decontamination is a combination of processes that removes or destroys contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to initiate infection, or other harmful response.’
(Health and Safety Executive, n.d.b)

1.3.3 The document ‘Healthcare Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care. Part A’ (NHS, 2016) sets out the governance, regulatory and assurance framework for all SSDs, including NHS trust services and contracted services. Figure 6 describes the ‘reusable surgical instrument cycle’.

1.4.1 The purpose of assurance is to provide evidence that an organisation or department is compliant with policies, procedures and standards and is delivering products and services as required to its customers (International Organization for Standardization, 2015). In the context of healthcare, customers can be a patient, trust, operating theatre team, or any internal or external person or organisation in receipt of a service. This assurance, in many industries and safety-critical organisations, is managed within a formalised quality management system (see 1.7). Assurance also forms part of an organisation’s risk management system. This requires the organisation to provide evidence of compliance, but also to identify issues and risks.

1.4.2 The evidence that supports the assurance framework forms part of a trust’s mitigation plan for identified patient safety risks. The individual who ‘owns’ the identified risks for each organisation is its chief executive. In many safety-critical organisations these types of risk are known as ‘risk to life’. Risk owners seek to reduce risk to life to as low as reasonably practicable (ALARP).

1.5.1 The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in the UK. It does this under the Medical Devices Regulations 2002. While historically the Medical Device Regulations 2002 were the incorporation of EU directives into UK law, since 1 January 2020 the MHRA has been a sovereign regulator. In February 2021, with the passage of the Medicines and Medical Devices Act 2021, the Secretary of State for Health and Social Care obtained the powers necessary to amend the Medical Devices Regulations 2002 to establish a new regime for the UK. The MHRA has consulted on a new regulatory framework for medical devices, including on proposals to:

• set out more detailed requirements for Approved Bodies (bodies designated by the MHRA to assess medical devices) to drive improvements in their operation
• increase transparency of subsidiary companies used by Approved Bodies
• place additional requirements for the designation and monitoring of Approved Bodies to improve transparency of MHRA and Approved Body activity.

1.6.1 Risk management is an organised way of identifying, analysing and reacting to risk. Risk can be positive (upside) or negative (downside). Upside risks are those that an organisation may want to exploit because they could be of benefit to the organisation. Downside risks are those that threaten the organisation and its output (Association for Project Management, n.d.). Generally, in healthcare ‘risk’ is associated with poor outcomes for patients.

1.6.2 There are several types of risk:

• risk to life
• reputational
• financial
• operational (relating to the day-to-day delivery of services and owned by the operator responsible for the service delivery).

1.6.3 The intention of risk management is to predict risk before it is realised (and becomes an issue). An organisation with a mature risk management system will suffer less from uncertain events by undertaking risk analysis and then managing those risks. There are many sources that inform a risk management system, some of which are shown in figure 7. These sources include staff reporting problems, incident investigations or other management systems such as quality management systems (described in 1.7). For a risk management system to function efficiently, it must be integrated with other management systems to ensure that information is shared and understood.

1.6.4 Risks can be identified in the design of surgical instruments and in the operation and use of those instruments. In other safety-critical industries, the equipment design risks are formally documented and handed over to the operator of the equipment. Likewise, equipment operators will inform the manufacturer when they identify risks or when a piece of equipment is being used in a different way from the manufacturer’s original intent.

1.6.5 The term ‘issues’ has a specific meaning in risk management systems. Issues are things resulting from events that have happened (AXELOS, 2010). Issues management is a reactive management tool, but is separate to risk management. It is easy to blur the lines between risk and issues management, but practising issues management alone will not allow an organisation to progress and grow. A strong focus on predicting risk will increase organisational efficiency, reputation and, in the healthcare environment, increase patient safety.

1.6.6 Some organisations use analysis methods like PESTLE (Political, Economic, Social, Technological, Legal, Environmental), SWOT (Strengths, Weaknesses, Opportunities, Threats), horizon scanning, or stakeholder analysis to identify potential problems and then design actions to improve the process (AXELOS, 2010).

1.7.1 The quality standards that many SSDs are required to meet are set out in the International Organization for Standardization (ISO) standard ‘ISO 13485:2016 Medical devices – quality management’ (International Organization for Standardization, 2016). ISO 13485:2016 has its foundations set in the ISO 9001 series of standards for quality management systems, which requires that senior management (‘top management’) demonstrate their commitment to quality outcomes for customers and provides assurance to stakeholders that quality is being maintained.

1.7.2 The ISO (2015) defines quality as the ‘degree to which a set of inherent characteristics … of an object [service] … fulfils requirements’.

1.7.3 A quality management system is a formal means of continually monitoring and managing quality across an organisation in order to identify areas for improvement and meet customers’ needs.

1.7.4 An SSD that is required to have an ISO quality management system is internally audited by a quality manager and externally audited by an accredited body. The MHRA accredits external auditors (Approved Bodies) to undertake audits in MHRA-regulated SSDs, and the UK Accreditation Service (UKAS) accredits auditors to undertake external audits in non-MHRA-regulated SSDs (those regulated by the Care Quality Commission (CQC)).

1.7.5 A quality manager runs an SSD’s internal quality management system, but they have no part in carrying out its internal quality audits. These are carried out by a locally appointed auditor to ensure that the audits are independent. The internal audit focuses on departmental policies and processes to assure that the department is compliant with current standards and regulation, and that it is seeking continual improvement. These will include decontamination processes, training system requirements and customer feedback (normally issues that have been reported). An external quality audit should inspect the internal audits as well as carrying out independent audits to provide the parent organisation with assurance that the relevant standards are being maintained. Figure 8 shows a basic quality management system ‘as imagined’ (perception of how the assurance happens) by the regulatory bodies and illustrates some of the areas covered by its internal audit process.

1.8.1 The MHRA regulates medical devices using the quality requirements for medical devices set out by the UK government. The EU currently sets the regulations for medical devices, but there are plans in the coming years for the MHRA to operate fully under UK legislation and only cover the UK market.

1.8.2 Surgical instruments that are to be re-used are assessed by an Approved Body to ensure that they are compliant with essential quality requirements set out in European legislation. This includes evidence that decontamination is considered during the design phase of a medical device.

1.8.3 ‘ISO 17664:2017 Processing of health care products – information to be provided by the medical device manufacturer for the processing of medical devices’ (International Organization for Standardization, 2017) states that ‘Manufacturers of medical devices that are to be processed [prepared for re-use] have a responsibility to ensure that the design of the medical devices facilitates achievement of effective processing’.

1.8.4 Following the UK’s exit from the EU, manufacturers of medical devices need to comply with the UK’s Medical Devices Regulations (2002/618, as amended). The Medicines and Medical Devices Act 2021 provides powers to update the UK’s medical devices regulations. The MHRA’s public consultation on future medical device regulation in the UK closed on 25 November 2021. The consultation also sought views on proposed changes to the way Approved Bodies are designated and monitored, which are aimed at raising patient safety standards, including in the oversight of SSDs. The MHRA is currently finalising its response, which will outline new regulatory requirements and when these will come into force.

3.1.1 HSIB was notified of a patient safety concern relating to contaminated surgical equipment being used during a kidney stone removal procedure.

3.2.1 HSIB conducted an initial scoping investigation which determined that the patient safety concern met the criteria for investigation. HSIB’s Chief Investigator authorised a national investigation based on the criteria, which are described below.

Outcome impact – what was, or is, the impact of the safety issue on people and services across the healthcare system?

If not removed correctly, certain residue left on surgical instruments, such as bodily fluids and soft tissue, can put patients at risk of infection should the instrument be used during surgery. This could lead to patients becoming very ill and requiring further medical attention following the surgery.

When surgical instruments are opened in operating theatres before procedures, they are checked visually for cleanliness. If they are found to be dirty, and a replacement is not immediately available, this could result in procedures being cancelled.

Systemic risk – how widespread and how common a safety issue is this across the healthcare system?

Patients who undergo a surgical procedure are at risk of acquiring an infection. These infections may take some time to show and therefore may not always be tracked back to a surgical procedure.

There are many processes in place to ensure that the risk of infection is minimised. One of these processes is to ensure that the equipment needed has been decontaminated.

A search of national safety incident reporting systems revealed several instances of sterilised equipment being opened before procedures and found to be contaminated. It also showed used kits not being returned to sterilisation services in a timely manner, or with missing or additional items. This highlights the complexity of interactions when processing instruments, including those from operating theatres’ teams.

There seems to be minimal national reporting on decontamination incidents as many incidents are considered not serious, or because substitute equipment was available and therefore incidents were not reported. Many local healthcare providers do report incidents either formally or informally, but the scale of issues relating to decontamination nationally is not fully understood.

Learning potential – what is the potential for an HSIB investigation to lead to positive changes and improvements to patient safety across the healthcare system?

HSIB has explored the national issues arising from the reference event to consider how the existing regulation and assurance framework enables senior managers in healthcare to manage risk at an organisational level.

There is currently no other work being undertaken in this area.

3.3.1 Evidence was collected between April and November 2021.

3.3.2 A range of evidence was collected during visits to the healthcare organisation where the Patient received care and in other representative organisations. This included:

• the Patient’s medical records
• observation of sterile services departments (SSDs) and operating theatre processes
• interviews with senior management, sterile services, clinical and safety governance staff
• a review of local and national relevant guidance and policies
• meetings with key national bodies and stakeholders.

3.4.1 HSIB does not seek to apportion blame or liability in its investigations. It considers the healthcare system in its entirety to identify the factors that have contributed to the reference event. This was explained to staff and the family prior to collecting evidence.

3.4.2 A range of methods was used to collect and analyse evidence. The evidence gathering process adopted an iterative approach so that as further information was received, additional sources of evidence were identified.

4.1.1 The sterile services department (SSD) was located in a hospital trust building, two storeys underground. Figure 9 shows a representation of the layout of the SSD and flow (orange arrows) of equipment as it moves through the various stages of the decontamination cycle.

4.1.2 Contaminated surgical instruments arrived in the cleaning room, known locally as the ‘dirty area’, where they were initially processed. Every piece of equipment was delivered in its own metal container, was barcoded and contained a contents list. The ‘dirty area’ was a relatively small room containing sinks, cleaning equipment such as brushes, a ultrasonic bath and several washer/disinfectors. The washer/disinfectors created a wall between the ‘dirty area’ and the inspection and packing room, known locally as the ‘clean room’. There were no connecting doors or direct route for staff between the cleaning and inspection rooms. The ‘dirty area’ was poorly lit and “very tired feeling”. It also felt cramped. The SSD management stated that this had been reported and it was being managed by the facilities management team; plans were in place to refurbish this area.

4.1.3 When equipment had been manually cleaned, it was arranged on racks and placed in the washer/disinfectors and underwent a pre-set wash/disinfection cycle. Once this had finished, the equipment was removed from the inspection room side of the washer/disinfector. This meant that there was a physical separation between the two areas of the SSD to ensure no cross-contamination of unclean and disinfected equipment.

4.1.4 The inspection room was large, well lit and had areas for short-term storage of disinfected equipment, inspection desks and a sterile preparation packing area. In contrast to the ‘dirty area’, this area felt organised and staff said it was a “much nicer” working environment than the ‘dirty area’.

4.1.5 Staff worked to a schedule presented by an electronic tracking and management system so they knew which item needed to be inspected and packed for sterilisation next. The equipment was barcode scanned and the staff then scanned their own identity card so that the system could track which technician was involved at every stage. This then started an electronic timer so that staff performance could be managed. The timer was displayed to the staff on a computer screen in the form of a green/amber/red scaled indicator (similar in shape to a car speedometer).

4.1.6 Once a piece of equipment had been inspected, serviced and reassembled as required, it was barcode scanned again and taken to the packing area where it was wrapped in specialised material ready for sterilisation. The wrapped equipment was then placed in a steriliser machine and underwent a pre-set sterilisation cycle.

4.1.7 Equipment was placed in one side of the steriliser and removed from the other, which created a physical barrier between the inspection room and store area so that there was no cross-contamination. Outside the clean/inspection/sterilisation area there was a further storage area for sterilised equipment which included some equipment racks where equipment with identified issues could be quarantined.

4.2.1 During the reference event, the theatres team conducting the procedure were unable to check the internal surfaces of the surgical instrument used (the UMP set) because of the size and shape of its lumen (tubes). The lumen of this instrument was less than 2mm in diameter and had a 45-degree bend along its length. The team was able to confirm that the exterior surfaces were visibly clean. On identifying the black material, the team immediately stopped the procedure and assessed the best plan for moving forward. These actions prevented any further potential harm arising from the event.

4.2.2 As the Patient had given her consent for an alternative procedure to be carried out if there was a problem with her preferred procedure, the consultant was able to carry on with the alternative procedure and remove the remaining black material and the kidney stone.

4.3.1 The black material that was recovered during the procedure was confirmed to be dried blood and could not have come from the Patient. If the blood had come from the Patient, it would be in a fluid form rather than black and flaky material. Therefore, the dried blood must have been left behind from a previous procedure.

4.3.2 The manufacturer’s instructions for use detailed that the UMP set had four brushes, including two small brushes for the purposes of cleaning small-diameter lumen. As the two smaller brushes were missing from the set, the SSD decided to quarantine it because the set could not be cleaned without them. The set was removed from circulation and placed on an equipment rack in the SSD which contained other equipment that required servicing or replacement items. This rack was known as the quarantine area.

4.3.3 The authority to release surgical instruments from quarantine lay with the Trust’s theatres team, despite the quarantine process being managed by the SSD. There was only one UMP set available in the Trust, and while used infrequently, it was required for the percutaneous nephrolithotomy procedure described in the reference event. The theatres team understood that the brushes were missing, and said they did not need the brushes to carry out the procedure. They released the set from quarantine without fully understanding the consequences of the missing cleaning brushes.

4.3.4 The missing brushes had been noted on the SSD’s electronic equipment records system, but there was no description of the consequences of processing the set without them. The consequence was that the UMP set could not be cleaned correctly and therefore not decontaminated in accordance with the manufacturer’s instructions for use. This posed a significant patient safety hazard in terms of infection control. Theatres team had access to the equipment records system and if the consequences of the missing brushes had been described, then they would have had more information upon which to base a decision to release the UMP set. Therefore, the theatres team could not easily know the implications of the missing brushes. The investigation concluded that had the theatres team been aware that there was a risk of cross-infection, they would not have requested the equipment to be removed from quarantine.

4.3.5 The local process to release equipment from quarantine was done by the theatres team sending an email to the SSD making the request. On receiving the email from the theatres team, the SSD released the set without further challenge. The SSD did not inform the theatres team that the set could not be cleaned properly. The communications between SSD and the theatres team, either by electronic recording systems or email, were all one way without check and challenge or decision rationale being recorded.

4.3.6 The SSD management and staff understood the implications of the missing brushes (that is, that it was impossible to clean the set in line with the manufacturer’s instructions for use). The Trust stated that the staff member who carried out the cleaning without the brushes said that they knew the brushes were missing, that the set had been in quarantine and that it had been authorised by the SSD management for release from quarantine. The SSD staff member who carried out the cleaning of the UMP set therefore made the assumption that management had released the set knowing that it could not be cleaned correctly, and therefore implicitly authorised the cleaning of the set without the use of the brushes.

4.3.7 The SSD procedure for quarantining surgical equipment stated that only ‘Supervisors or Managers may remove items from quarantine’. It did not state what interaction was needed between the theatres team and the SSD to release a piece of equipment. Therefore, it was not clear how supervisors or management made the decision to release the UMP set from quarantine knowing that it had missing brushes and that the set could not be cleaned in accordance with the manufacturer’s instructions for use.

4.3.8 The missing brushes meant that staff could not follow the manufacturer’s instructions for use, but the SSD management and theatres team still expected the UMP set to undergo a full decontamination cycle. The investigation was not able to find evidence that a deviation from the manufacturer’s instructions for use was authorised and communicated to the staff member undertaking the cleaning procedure. The system relied entirely on individual staff to identify risks and issues, rather than this being done within a layered management system. This meant that risk was being held at the cleaning staff member level rather than at a management level, where it could be mitigated and understood in a wider context.

4.3.9 The investigation heard that the staff member who had cleaned the UMP set had been disciplined for not cleaning it in accordance with the manufacturer’s instructions for use. If the staff member had declined to clean the UMP set because of the missing brushes, the UMP set would potentially have been re-quarantined and would have been stuck in a loop of quarantine, release from quarantine and back to quarantine without a plan to resolve the problem. The wider system placed this individual in a situation where they felt compelled to process the UMP set. Improved safety systems and processes would have resulted in individuals not being required to make assumptions and use their personal judgement.

Conclusion

4.3.10 The investigation determined that the most likely reason for the dried blood being left behind during the previous decontamination cycle was because a cleaning brush was not passed through the irrigation channel. Both the SSD and theatres team had a significant role to play in the SSD’s quarantine process. Neither the SSD nor theatres team understood each other’s needs and processes and the theatres team were not aware of the implications of the missing cleaning brushes. SSD and theatres team told the investigation that while they have a good relationship, they do not hold regular meetings to discuss issues. There was not a robust quarantine process in place that accounted for releasing previously quarantined equipment and its reprocessing when nothing had changed with the equipment.

4.3.11 The management of the risk in this instance fell to the SSD technician rather than being managed at a departmental and organisational (Trust) level.

4.4.1 The Trust had a policy for infection prevention control, environmental cleaning and decontamination of medical and non-medical devices. This stated that any surgical equipment undergoing decontamination must be processed in accordance with the manufacturer’s instructions for use. It also stated that ‘All instruments will be inspected by normal vision’.

4.4.2 In the case of the UMP set, it is not possible to visually inspect the internal surfaces of the irrigation channel because it is less than 2mm in diameter and has a 45-degree bend in its length. In light of the reference event, the Trust had decided that it was unable to decontaminate any such equipment and told the investigation that it no longer did so. The investigation was not able to establish how this had affected the wider Trust and availability of surgical instruments at the time of the investigation.

4.4.3 The Trust had a quality strategy and a policy for clinical audit and quality improvement. The investigation found that the focus of the quality strategy was on clinical quality outcomes. As such, it did not include a quality management system that provided assurance for decontamination of all surgical instruments. The investigation also found that the policy did not provide senior leadership assurance for compliance with the standards set out in ISO 13485:2016 (International Organization for Standardization, 2016). This would enable senior leadership to monitor assurance in all areas of the Trust, including support services, and that they are compliant with policy and procedures, are ‘customer’ (patient) focused and are committed to continuous improvement as would be the case in a formalised standard quality management system (International Organization for Standardization, 2015).

4.4.4 The Trust had a risk management system in place despite there being no national requirement to do so. The Trust had identified that it needed a Trust-wide integrated risk management system, as it was keen to improve its internal risk management processes. At the time of the investigation, the Trust was developing an integrated risk management policy and strategy, supported by a Trust director and risk management professional, and was committed to publishing this in 2022.

4.4.5 The SSD did report the incident to the MHRA and received a reply stating that the risks had been assessed and added to its trending and surveillance database.

4.5.1 The UMP set used in the reference event had been placed in quarantine several times because of missing brushes. The investigation was told that the Trust theatres team had a significant part to play in the release of equipment from quarantine. The investigation found no evidence of policies or systems in place that consider the release of equipment from quarantine when it cannot undergo a full cleaning and decontamination cycle. Therefore, residual risks resulting from releasing equipment from quarantine are not identified or understood and therefore cannot be managed.

4.5.2 The theatres team made the request for the UMP sets release from quarantine and the SSD complied without challenge. This demonstrated that the theatres team has a significant influence over the operation of the SSD. The theatres team are not fully conversant with the quarantine process, nor do they provide any assurance over that process despite being intrinsically involved in it.

4.5.3 During a visit to the Trust, the investigation was told by the theatres team that it was not uncommon to open a surgical pack and find items missing, extra items or dirty items. They said that in the case of general surgical instruments (such as forceps and scissors), this could be managed by selecting a new pack from the storage area. This type of incident would go unreported. If the surgical equipment was specialised, such as the UMP set used in the reference event, there was not always a backup piece of equipment and any problem with the set may have resulted in a procedure being cancelled, with a subsequent incident report being submitted by the theatres team.

4.5.4 An example where staff had opened a sterile surgical pack and found that there was an additional item was discussed with the investigation. This involved a cleaning brush that was protruding from the end of a tube. The brush should not have been in the surgical pack and the SSD’s quality control procedures had not identified this before the pack had been prepared for sterilisation.

4.5.5 The investigation found that incidents relating to the decontamination of surgical equipment were under-reported. The theatres team stated that they had a good working relationship with the SSD and incidents of this type were managed by the electronic equipment management system, emails and phone calls between the two departments. Such incidents did not show up on any serious incident reporting systems as they were dealt with at a local level, therefore the number of incidences of these types were not truly known or understood within the Trust.

4.5.6 The Trust management told the investigation that they are responsible for the clinical risk resulting from the Trust’s services. In the case of operational risk resulting from contracted-in support services, they stated that they had transferred all risk to the contractor; in the reference event this was the SSD. Risk in this case was managed through the contract that was in place, relying on the SSD to report against key performance indicators. The SSD did not have links into the Trust’s risk management system nor was there a requirement for it to do so.

4.5.7 The investigation found that the Trust had started to put in place a formalised risk management system with the intent of holistically managing risk across the Trust in all areas, including clinical and support services such as the SSD, facilities management and engineering. At the time of the reference event, the Trust’s assurance method was to rely on the SSD being externally audited, as per the requirements of the Health Technical Memorandum 01-01 (NHS, 2016) and ISO 13485:2016 (International Organization for Standardization, 2016). However, this external audit was only reported back to the SSD, and the Trust only became aware of its outcome after it carried out an internal investigation into the reference event.

4.5.8 Therefore, the Trust’s risk mitigation strategy for the SSD was that it was externally assured, without management systems in place to assure the Trust that risks were being managed. The lack of an integrated governance structure that considers risk and quality of services across the organisation may have left the Trust’s management unaware of the risks it was holding relating to patient safety.

4.5.9 In addition to there not being an integrated risk management system in place, the Trust said there was not a consistent way of managing quality across the interface between clinical and non-clinical areas. Quality outcomes are managed in the clinical services that the Trust delivers and this is done through various committees and policies. The main focus of quality was on the delivery of services and the targets that were required to be met that had been set by external agencies. While quality is not managed centrally for support services, in the case of the SSD it was managed internally within the department under a formal quality management system. The Trust did not have a way to look at quality from a perspective of customer (patient) outcomes across the Trust for all its areas of activity.

4.5.10 The SSD is accredited to and operates within the ISO 13485:2016 (International Organization for Standardization, 2016). The standard requires that internal audits are carried out regularly by a qualified quality manager, and that external audits are carried out by an independent external body which provides assurance that the quality management system is being run in accordance with the ISO. The SSD stated that the independent external body would only report audit findings to the MHRA by exception.

Conclusion

4.5.11 While incidents of incorrectly decontaminated surgical instruments are managed directly between the theatres team and the SSD, the Trust management had no system in place to assess the magnitude of the problem, and was not able to manage such incidents at an organisational level.

4.5.12 The absence of cross-departmental/organisational risk and quality management systems prevented the Trust from fully understanding the risks and issues that it held. In the case of contracted services (including the SSD), there was a Trust expectation that those contracted services would own and manage their risks despite them not being able to do so, as they were not responsible for the final use of equipment during a procedure.

4.5.13 The lack of these management systems and assurance oversight of non-clinical services means that the Trust may have been “blind” to the holistic patient safety risks (including clinical and non-clinical) that it was holding.

4.6.1 The SSD was located in a basement alongside the catering department’s wash area. This created a feeling among staff that they were a hidden service and that no one really understood what they did. Staff stated that this “downstairs” culture meant that as long as the service produced sterile equipment as required, it only received management focus from the Trust when things went visibly wrong.

4.6.2 SSD staff believed that the general view of an SSD was that it was a “dish-washing service” where staff just loaded equipment into racks and placed them in a dishwasher. This perception supported the “downstairs” culture and led to a wider misunderstanding of their value in the system. Because of this perception SSD staff said that their roles attracted minimal training or registration requirements for an essential service. Theatres team and SSD staff stated that when a piece of incorrectly decontaminated equipment slipped through the system, it could cause frustration for clinical staff, harm to patients and potentially cancelled procedures. When this happened, it was immediately obvious that the SSD was vital to ensure the smooth running of the Trust’s operating theatres.

4.6.3 The Trust was not able to tell the investigation how many different surgical sets it had, but the SSD stated that it reprocessed approximately 6.2 million sets/surgical instruments per year.

4.6.4 Trust staff told the investigation that SSD technicians (contracted services) were on the entry-level pay band (Agenda for Change Band 2) and that applicants did not require formal qualifications and training. SSD management told the investigation that technicians had to undergo locally set numeracy and literacy tests before they were employed. This was followed by locally defined training on the use of SSD equipment and cleaning, inspection and packing techniques.

4.6.5 When new staff joined from other SSDs, the SSD management stated that these new staff had to undergo localised training. This was because the SSD management was not sure to what standards they had been working before, or how the training they had previously received related to the new SSD. This increased the training burden by potentially retraining staff who had already achieved a certain level of competence in a previous organisation. The SSD management said that there was not a national qualification, training or competence framework to which they could refer, and therefore they had to develop their own, specific to that SSD.

4.6.6 The SSD did have a quality management system which tracked staff training and competence, and this was audited externally during regular required assurance visits by auditors.

4.6.7 When there were SSD staff shortages, the SSD relied on agency staff. However, the SSD management did not set the training, qualification and competency levels of these staff and had to accept the staff that were sent to them. The SSD management said that many agency staff did not have English as their first language and may not have been able to read technical documents such as a manufacturer’s instructions for use, which must be followed to ensure that equipment is decontaminated correctly. This often meant that agency staff were confined to the ‘dirty area’ of the SSD, where they undertook the initial manual cleaning and loading of the surgical instrument washers. The SSD management stated that agency staff could sometimes require additional supervision and assistance.

4.6.8 The investigation observed that the role of an SSD technician involved:

• identifying a wide variety and significant number of surgical instruments
• following manufacturers’ instructions for use
• dismantling, cleaning, inspecting, reassembling and packing said surgical instruments
• identifying faults or missing items and reporting them to line management
• carrying out basic servicing such as lubrication of surgical instruments.

4.6.9 A significant part of a technician’s role is to follow manufacturers’ instructions for use, and this forms part of the overall risk and assurance system that has been put in place by the SSD. The SSD management told the investigation that SSD technicians and agency staff were not required to read manufacturers’ instructions for use because decontamination processes are covered by training.

Conclusion

4.6.10 SSD staff were trained in line with locally set requirements. There is not a national competence framework.

4.6.11 Staff’s ability to decontaminate a large number of different equipment types, in vast numbers, to a set quality and standard, is purely reliant on individuals following manufacturers’ instructions for use (which they are not required to access), their professionalism, integrity, training, skill and competence. The investigation concluded that currently staff were the strongest barrier to prevention of incorrectly decontaminated equipment being sent to operating theatres for use.

Nigel had been on an NHS waiting list for a shoulder replacement. To speed up the waiting list, he was offered to have the procedure carried out at a private hospital by an NHS surgical team. On the day of the procedure, Nigel was waiting in his surgical gown and all administrative tasks had been carried out. Ten minutes before he was due to go into the operating theatre, the surgical team informed Nigel that the surgical kit was found to have several items that were visibly dirty. This resulted in the procedure being cancelled as no other kit was available.

The operation was rescheduled for the following month, but again was cancelled just before the procedure due to dirty equipment. Again, Nigel was fully prepared for surgery, and was informed approximately 10 minutes before the scheduled start time. The operation finally took place the following month, but 5 weeks after the surgery Nigel became very unwell and was admitted to an NHS hospital. After exploratory surgery, it was found that he had an infection in his shoulder.

As a result of this infection, Nigel required corrective shoulder surgery in the NHS hospital. During this operation, the surgical equipment was seen to be dirty again. To allow the procedure to go ahead, the surgeon decided to clean and disinfect the dirty equipment in the operating theatre using iodine.

Nigel said that the impact on him was one of “deflation and disappointment”, but he understood that the problem did not lie with the surgical team or the hospital. Nigel was concerned

“that such a seemingly simple quality control issue could lead to an unnecessary waste of time and resources for all concerned especially during a period that the NHS was trying to deal with an unprecedented backlog of surgical procedures”.

Understanding the size of the problem

5.2 It has not been possible to determine the size of the issue of incorrectly decontaminated surgical instruments as there is not a national requirement to centrally report all incidents. Some individual sterile services departments (SSDs) record incidents of incorrectly decontaminated equipment within their own quality management systems.

5.3 The consequences of cancelling procedures can be far reaching for patients and the healthcare system. These range from physical harm and psychological trauma for patients through to frustration for staff and waste of valuable resources.

5.4 As in the reference event, SSD and the theatres team from a number of hospitals said that it is not uncommon for surgical equipment to be dirty or have additional or missing equipment when opened in the operating theatre. In the case of general surgical instruments such as scalpels and forceps, the problem is not seen to be significant as spares may be readily available. In many cases this problem is not reported and is therefore hidden. Staff said that the most frustrating problems occur when the item that has not been decontaminated properly is a specialised piece of surgical equipment and a procedure is cancelled because there is not a spare available.

5.5 SSD and the theatres team stated that many of these issues are reported verbally, by email or by internal electronic reporting systems. This reflects what was found in the reference event. While this allows local investigations to be carried out, it means the issues are not recognised nationally. Therefore, the harm to patients and the full cost to the NHS of cancelled procedures due to incorrectly decontaminated surgical instruments is not known. In quarter 3 of 2021 (October to December 2021) (NHS, 2021), 19,338 elective operations were cancelled for non-clinical reasons; however, the data is not split into cancellation categories.

5.6 The number of patients who have contracted a blood-borne virus (BBV) from contaminated surgical instruments is difficult to assess. This is because it may take some time for an infection to develop and patients to show symptoms, or patients may be asymptomatic. If a patient did eventually develop a BBV infection, due to the time that had passed, it may not be obvious that the BBV was a result of a surgical procedure using contaminated surgical instruments. Healthcare staff told the investigation that the current systems that they work within are not mature or integrated enough to identify whether the source of a BBV was a contaminated surgical instrument.

5.7 Faults or incidents with medical devices (including surgical instruments) used in the NHS may be reported to the MHRA by the end user (normally by theatres team and SSD staff). These reports are recorded on a trending and surveillance database. In the reference event the incident was reported, but the MHRA stated that it would not undertake any further investigation into this type of incident as it related to the operational function of an SSD rather than the design of a medical device. This means that while SSDs have a requirement to report operational issues, the reports are not being reviewed, and that there is no national body to undertake active monitoring of operational risks and issues being identified.

5.8 Therefore, the lack of reporting of issues relating to decontamination of surgical instruments, or inconsistencies in reviewing reports that have been submitted, as in the reference event, means that risks may not have been identified nor issues managed.

5.14 The Health Technical Memorandum (HTM) 01-01 (NHS, 2016) sets out the framework for how SSDs are run and governed. NHS England and NHS Improvement produces the HTM 01-01 on behalf of the Department of Health and Social Care but neither have a role in checking compliance with it. Figure 10 demonstrates the regulatory and assurance framework for SSDs.

5.15 Within this framework, there are two regulatory routes for SSDs. The regulatory route depends on whether an SSD is providing sterile services for a single legal entity (only providing services to a single organisation) or to multiple legal entities (providing services to multiple organisations or that add equipment to preformed surgical kits). SSDs that serve a single legal entity are regulated and assured by the Care Quality Commission (CQC) (right side of figure 10). SSDs that provide services to multiple legal entities are regulated by the MHRA and assured by an independent external auditor (left side of figure 10).

5.16 The international standard for medical device quality management system is ISO 13485:2016 (International Organization for Standardization, 2016). Only those SSDs that provide services external to their own organisation ‘will have a quality system against which they are independently audited’ (NHS, 2016), meaning ISO 13485:2016.

Single legal entity SSDs

5.17 The CQC is responsible under the Health and Social Care Act 2008 for regulating NHS services against current legislation, regulations and standards (Care Quality Commission, n.d.).

5.18 The CQC told the investigation that it does not audit SSDs, and never has. It relies on NHS trusts identifying risks and issues internally and informing the CQC of them when it carries out its inspections.

5.19 The CQC stated that it had undertaken checks to ensure that endoscopy decontamination units were accredited by the Joint Advisory Group on GI Endoscopy (JAG), which is part of the Royal College of Physicians (Royal College of Physicians, n.d.). To gain accreditation, services must provide evidence that they meet the JAG standards; the evidence is reviewed and a site assessment is undertaken.

5.20 During inspection visits of endoscopy decontamination units, the CQC stated that it only asked to view evidence of the JAG accreditation and did not inspect or assure the service. It did not ask to see the results of the JAG inspection. This approach relies on an external body assuring the service and reporting new risks and issues, which are not specifically viewed by the CQC. The investigation did not explore this issue as it was outside the terms of reference of the investigation.

5.21 The CQC told the investigation that it is changing its strategy to a risk-based inspection regime and no longer carries out full-service inspections (Care Quality Commission, 2021).

5.22 SSDs that are regulated by the CQC are advised by the HTM 01-01 that they must have a quality management system (NHS, 2016). However, the HTM it does not define what this quality management system should look like or how it should be achieved, or require that the quality management system be independently audited. Many SSDs have adopted the ISO 13485:2016 standard (International Organization for Standardization, 2016).

5.23 As the CQC does not inspect SSDs, it is unable to inspect the management systems that are in place to check that processes for quality assurance and control are in place, nor are they able to gather information on risks and issues identified by these management systems. Therefore, the CQC does not have any mechanisms to identify emergent risks from SSDs.

5.24 In SSDs that are regulated by the MHRA, the CQC maintains no oversight of patient safety risks that may result from those SSDs.

Multiple legal entity SSDs

5.25 Under the Medical Devices Regulations 2002, the MHRA regulates SSDs that provide to multiple legal entities and that ‘place’ products on the market (meaning that they offer services outside their own organisation or add additional equipment to preformed surgical kits). The MHRA does this by appointing Approved Bodies to carry out external independent audits. These audits are normally undertaken by means of the ISO standards (International Organization for Standardization, 2016), which is a requirement of the Medical Devices Regulations 2002. The MHRA has started a period of consultation which will include the services that it regulates.

5.26 The MHRA told the investigation that ISO 13485:2016 (International Organization for Standardization, 2016) requires that the quality management system is externally audited to provide system assurance that the sterile services are compliant with current standards. The MHRA regulates these SSDs with reliance on the abilities and skills of the Approved Bodies. While it is clear from the HTM 01-01 (NHS, 2016) that the MHRA is required to regulate these SSDs, it told the investigation that it did not have any practical role in this.

5.27 To assure that Approved Bodies are performing as required, the MHRA witnesses a small number of audits being carried out on SSDs by Approved Bodies to ensure that they are maintaining its standards.

Consistency of regulation

5.28 The two regulatory and assurance frameworks described in the HTM 01-01 (NHS, 2016) require two regulators, which are working to different standards of assurance and different evidence-based audit systems. Both regulators rely on external checks but do not assure themselves that these are being carried out to the required standards and do not assure that patient safety concerns are being escalated to NHS trust risk owners.

5.29 The input to an SSD is a piece of non-sterile equipment and the output is a piece of equipment which has undergone a full decontamination cycle. Therefore, to ensure consistency of the application and assurance of standards, leaders in the sterile services sector stated that it would be beneficial if there was a single regulatory framework, irrespective of the legal entity status of an individual SSD.

5.30 A single regulatory framework for all SSDs would be simpler and enable the provision of clear and unambiguous guidance. It would provide a single assurance model and assurance to the healthcare system that all SSDs were being managed and operated in a consistent manner and that risks and issues were being managed appropriately, with oversight from a single regulator.

Assurance requirements for ISO 13485:2016 compliant SSDs

5.31 In the reference event, there was a quarantine process in place that did not include input from the theatres team, despite them being considered as the authority to release the ultra-mini percutaneous nephrolithotomy (UMP) set. The lack of an integrated process and record of decisions had a significant bearing on the use of an incorrectly decontaminated piece of surgical equipment. The purpose of a quality management system in this instance would be to identify that there was a significant process happening that had not been assured end to end. Once this process was identified, a quality management system would be able to recommend that the owner of the process formally document it and then check that it was fit for purpose.

5.32 Having policies and procedures in place may help to mitigate risks and provide assurance to the healthcare system. However, policies and procedures sometimes expire, situations change, and they rely on staff following them. While policies and guidelines are important, HSIB has identified issues with staff following them in previous investigations (Healthcare Safety Investigation Branch, 2019). Checking the currency of policies and procedures, identifying gaps in processes and checking that staff are able to follow them is a key part of a formalised quality management system.

5.33 A quality management system should not just be restricted to the individual department that is managing it. It should be integrated within the overall organisation’s management systems to ensure that senior leadership are involved in the quality assurance and output of services.

5.34 The HTM 01-01 states that healthcare providers are ‘able to demonstrate evidence of an appropriate quality management system and audit system’. It also states that commissioners of services (this could be a clinical commissioning group (CCG) or an individual trust) are to ensure that SSDs are ‘registered with a notified body’ and have ‘an appropriate quality system in place’ (NHS, 2016). A decontamination subject matter advisor told the investigation that the intent of these statements is to ensure that top management have oversight of the quality management system and quality output of their SSD.

5.35 The commissioners of the service can also ask to see evidence of (NHS, 2016):

• 'non-conformances picked up in the audit;
• required corrective actions that have been agreed; and
• evidence of corrective actions being implemented'

5.36 The investigation found that the term ‘commissioner’ was frequently interpreted to mean a CCG. In relation to the term used in the HTM 01-01 (NHS, 2016), NHS England and NHS Improvement told the investigation that it means the organisation that either puts a contract in place to deliver the service or is responsible for managing and delivering the service.

5.37 As in the reference event, during observation visits the investigation found that ‘commissioners’ of services (NHS trusts) did not seek evidence of SSD audit outcomes at a senior management level. The investigation did not find a framework within which trusts operate to ensure that ‘top management’ are involved in the requirement for a quality management system and informed of the outputs of internal and external audits (risk and issues). Figure 8 (see 1.7.5) describes a quality management system working ‘as imagined/prescribed’ by the regulatory bodies (Hollnagel et al, 2015). Figure 11 describes quality management systems working ‘as done’ in SSDs that the investigation visited. There was no formal link between the SSD local quality management system, regulatory body (MHRA/CQC) or NHS trust ‘top management’. The escalation of SSD risks and issues relies on conscientious and professional SSD managers to ensure that the HTM 01-01 (NHS, 2016) is complied with and that their managers are kept informed.

5.38 Another reason for top management to be involved in a quality management system is that it demonstrates commitment to the quality of the service provided and also ensures risks and issues are managed appropriately (International Organization for Standardization, 2015).

5.39 The HTM 01-01 (NHS, 2016) does not set out an accountability structure for SSDs. The investigation found that SSDs sat within different trust directorates, some clinical and others non-clinical. One SSD may sit in an anaesthetics directorate, others in operating theatres or engineering and estates management. SSD managers that the investigation spoke to had varying opinions on whether they should be accountable to a clinical or non-clinical directorate; however, they all stated that it would be beneficial if all SSDs operated under a consistent accountability structure.

Conclusion

5.40 The system for reporting non-conformities (deviation from a standard or specification), issues and risks relies on professional SSD managers to inform top management of non-conformities rather than there being a system in place required by national policy. Trust risk owners and those in senior management roles responsible for the delivery of sterile services are not involved in the quality management system. Furthermore, there is no feedback loop from an external audit to the top management (normally an executive) to ensure that risks (in the form of non-conformities) are being escalated and considered at NHS trust board level.

Design of equipment

5.41 The evidence that surgical equipment design is compliant with current regulations is gathered by Approved Bodies that have been appointed by the MHRA or another EU-notified body, which allows that medical device to carry a CE (quality) mark. The MHRA said that it can carry out checks on Approved Bodies to ensure that they are maintaining the required assurance standards and are compliant with the regulations.

Inspection of surgical equipment

5.42 In the reference event, the investigation identified that many items could be cleaned but then could not be inspected due to their design. Sterile services staff and other leaders in this field told the investigation that they feel that medical devices are designed wholly with the surgical team in mind and the requirement for decontamination is an afterthought. They said that equipment can be delicate, complicated, and difficult to dismantle, reassemble and decontaminate. They see this problem increasing as equipment is miniaturised. Therefore, conflict exists between the surgical team’s needs and the SSD’s ability to dismantle equipment and decontaminate it.

5.43 In the hierarchy of controls (Stolzer and Goglia, 2015), the strongest safety barrier is to eliminate the problem. However, this is not always practical and therefore another way to reduce operational risk is to ‘design out’ the problem. In the context of ensuring that surgical instruments can be decontaminated correctly, this would mean designing them in a way that makes it possible to easily dismantle, clean, inspect and sterilise them.

5.44 The MHRA stated that it recognised that the SSD community had challenges inspecting internal small-diameter surfaces or openings with the same rigour as external surfaces, conceding that some are impossible to inspect. To compensate for these design challenges, the system for managing decontamination relies on decontamination processes and the validation of such processes rather than engineering design.

5.45 The MHRA said that some manufacturers, particularly of complicated surgical equipment, undertake the decontamination of their own equipment under a supply contract arrangement. A significant advantage of this approach is that complicated equipment is decontaminated, serviced and managed by the “equipment experts”. The investigation found that in these cases the manufacturer was more involved in the ongoing care of equipment. However, the ownership of operational risk still sits with the NHS trust using the surgical equipment in a procedure.

5.46 The Medical Devices Regulations 2002 state that residual design risks should be described to the end user (staff who use/decontaminate the equipment); however, the investigation found no evidence that this was the case. For example, in the reference event the residual risk was that a patient may become infected with a BBV because a lumen of less than 2mm could not be inspected to ensure it was clear of material from previous use. If the risk had been described, the SSD may have been able to put additional cleaning/inspection processes in place to mitigate this risk.

5.47 In other high-reliability industries, risk is separated into operational risks (owned by the operator, in this case the NHS trust) and equipment design risks (owned by the manufacturer). The risks are identified and managed in a formalised manner using documents such as safety cases (written demonstrations of evidence and due diligence to show that an organisation is able to operate safely) and systems such as risk, quality and safety management systems.

5.48 In the current requirements for surgical equipment design there are elements of a safety case. These include consideration of decontamination during the design and certification process and in the manufacturer’s instructions for use. The investigation did not explore this subject further as it is outside the scope of the investigation.

UK-specific design standards

5.49 Currently, all surgical equipment in use in the UK must have the European Conformity (CE) mark. Any equipment that carries the CE mark can be used in the UK, irrespective of the country of manufacture or which EU country acted as the Notified Body (the body authorised to assess the equipment and issue the CE mark). For example, a piece of equipment manufactured in Italy and CE-certified in Germany can be used in the UK without the MHRA’s involvement in certification.

5.50 As the UK currently must comply with the European directive concerning medical devices (Council Directive 93/42/EEC (1993)), if the UK adopted more stringent standards it would have to do so on top of current requirements. The UK has the ability to set its own standards and the MHRA is consulted on this. If standards were different to the EU, the MHRA (via Approved Bodies) would have to carry out additional checks on all CE-marked equipment being used in the UK that has not been certified by MHRA, which it currently does not do. Addressing the specific issue of cleaning and inspecting small internal surfaces, the MHRA stated that if the UK tightened the regulations, it would create a significant issue and incur additional costs in the design process which would be passed on to the NHS. Therefore, market forces may exclude the UK from having standards and requirements for manufacturers of medical devices that are vastly different to those of other countries.

5.51 The MHRA told the investigation that there are several possible options that would help to overcome these issues. These include the development of single-use or part-reusable and part-single-use surgical equipment. These options would prevent cross-contamination and reduce or remove decontamination requirements, but would come with a significant cost to the healthcare system.

Cleaning process

5.52 In the reference event, the manufacturer’s instructions for use required a cleaning brush to be passed through the small-diameter tube (lumen). The decontamination cycle relies on processes assured and certified by the manufacturer to make sure that equipment is correctly decontaminated.

5.53 A decontamination subject matter advisor told the investigation that just passing a brush through a small lumen may not completely remove any residual material from a previous procedure. They also said that the inspection of these internal surfaces was difficult, if not in many cases impossible.

5.54 The investigation observed cleaning processes at several SSDs where some tubes as small as 0.04mm were cleaned in an ultrasonic bath. An ultrasonic bath uses sound waves to create micro bubbles which agitate debris on all surfaces submerged in the bath, providing effective cleaning. Tubes that are connected directly to the ultrasonic bath via an adapter have water forced through them to ensure they are cleaned prior to disinfection. On completion of this ultrasonic bath process, one SSD stated that it then also passes high-pressure air through the tube to ensure no debris remains.

5.55 Some manufacturers already detail this type of procedure in the cleaning process. The decontamination subject matter advisor told the investigation that there may be reasons that this process is not suitable for some surgical equipment due to the materials used in their construction. Some chemicals, and the way that the micro bubbles in the ultrasonic bath agitate the surfaces of surgical equipment, may be corrosive or harmful to surfaces and therefore may not be appropriate. The decontamination subject matter advisor also said that if a manufacturer’s instructions for use did not explicitly say an ultrasonic bath and high-pressure air could not be used, then using either of these may help to ensure as much material was removed as possible before disinfection and sterilisation.

SSD staff training and qualifications

5.56 The staff who work in the operational side of an SSD are known as technicians. The investigation observed that SSD technicians undertook the decontamination processes with minimal supervision, but when supervision was needed it was provided by team leaders.

Reliance on staff

5.57 The investigation found that some SSDs were located away from the main hospital site, or if on the main site were not easy to find, some being several floors underground. SSD staff told the investigation that they felt that they were a forgotten service and that the importance of their work was not appreciated by the wider healthcare system.

5.58 One senior leader in sterile services said that “sterile services are like the engine of a car for theatres, when it runs fine no-one knows it’s there, but when it breaks all hell breaks loose”. SSD managers also said that if an SSD failed to deliver sterile equipment, procedures and operations could be cancelled and that this places enormous pressure on the healthcare system.

5.59 The investigation observed that many of the decontamination tasks were manual and required skill of hand, but also needed numeracy and literacy skills. SSD managers told the investigation that there is a heavy reliance on SSD technicians to ensure that the decontamination processes were followed and that they had the necessary skills to do so.

5.60 The SSD technicians who undertake these tasks start on the lowest pay band in the NHS. SSD managers stated that this banding could make it difficult to recruit SSD technicians, although they recognised that once SSD technicians were experienced, they felt pride in the work they carried out.

5.61 The MHRA stated that essential decontamination services (SSDs), such as those delivered at an endoscopy unit, are not considered as specialised. SSDs:

• decontaminate on a large scale
• are not specific to one type or piece of equipment. Therefore sensitive, uncommon, specialised equipment may be decontaminated to different standards depending on the experience and competence of the decontamination technician.

5.62 The investigation found that the most relied-on safety barrier within the SSD to ensure that equipment is decontaminated to the required standard, was the professionalism, competency, skills and knowledge of SSD technicians.

SSD task analysis

5.63 The investigation observed technicians in several SSDs at all stages of the decontamination cycle, working with minimal supervision. The tasks they carried out included:

• accessing IT systems
• reading instructions for use when required and carrying out mathematical calculations
• identify missing items
• skill of hand to dismantle equipment
• manual cleaning of equipment
• understanding the use of automatic washers (including ultrasonic baths) and how to connect equipment to them
• stacking equipment correctly before it is placed in automatic washers and disinfectors
• inspecting for cleanliness after equipment had been washed and disinfected
• understanding rejection criteria when a piece of equipment has not been decontaminated correctly, and how to escalate these issues
• carrying out lubrication and basic servicing as required
• skill of hand to reassemble equipment (many hundreds of different pieces of equipment, some extremely complicated and intricate)
• packing equipment for sterilisation
• operating sterilisers.

5.64 To be able to undertake these tasks, SSD managers told the investigation that staff needed the following skills and knowledge:

• numeracy and literacy
• basic understanding of the science behind decontamination to enable efficient and successful decontamination
• skill of hand
• knowledge of processes required to decontaminate
• awareness of risks and issues
• ability to use IT.

5.65 In order to achieve the skills and competency to carry out the decontamination tasks, SSDs train technicians locally. The investigation heard that the requirement for basic numeracy and literacy was set at a local level; there was no national standardised requirement that could be used in the recruitment process. SSD managers said that training needs are generally determined based on the local SSD’s needs rather than a national standard.

5.66 Some SSDs take an approach that after staff members have gained experience and their competency has been assessed, they may progress to a higher pay band in recognition of this achievement.

5.67 The investigation heard from SSD managers that when technicians move from SSD to SSD, they may need extra training to bring them up to the new SSD’s standards. This is because there is not a recognised national competency framework for managers to refer to. Such a framework would ensure consistency for all SSD technicians, would increase the knowledge and training standards of staff, and therefore increase the consistency and quality of the SSD output.

5.68 For those SSDs that have a formal quality management system (International Organization for Standardization, 2016), staff training and competencies are recorded and audited within that system. The Institute of Decontamination Sciences (IDSc) told the investigation that it had developed a competency framework in the early 2000s and a have route to professional registration for SSD technicians in place; however, it had not been unable to have this adopted nationally. Adopting a formalised quality management system which records training and competency and professional registration are voluntary and are not a national requirement.

5.69 The HTM 01-01 (NHS, 2016) sets out the regulatory and governance framework for SSDs. It does not state the training and competency requirements for any staff involved in the decontamination process. NHS England and NHS Improvement stated that this is a known gap in the governance structure of SSDs.

5.70 The investigation found no evidence of any national standardised SSD technician competencies that ensure that all technicians have the base level of knowledge and skills to be able to undertake the decontamination of surgical instruments.

5.71 Given the importance of the work that SSD technicians do, the complexities of the equipment and processes, and the minimal supervision of their work, the investigation makes the following safety recommendation.

There is no requirement to report issues nationally relating to incorrectly decontaminated surgical instruments. This means that the size of the issue is unknown and that the healthcare system does not fully understand the risks and issues it is holding.

• Risks and issues are held within individual SSDs and are not integrated within wider trust management systems.
• Trusts frequently focus on clinical risks and not on the risks that arise from non-clinical supporting departments but which present a patient safety risk.
• There is no national requirement for NHS trusts to have a formalised risk management system.
• All SSDs produce a similar product – decontaminated surgical instruments. The legal status of an SSD determines which national body regulates it (the Care Quality Commission (CQC) or the Medicines and Healthcare products Regulatory Agency (MHRA)).
• The CQC does not inspect SSDs for compliance with regulations and standards.
• The MHRA does not inspect SSDs for compliance with regulations and standards, but relies on external assurance bodies (known as Approved Bodies) to do so. It does undertake a small number of witnessed audits of Approved Bodies while that Approved Body audits an SSD to ensure that standards are being maintained.
• MHRA-regulated SSDs have in place quality management systems, managed at a local departmental level. ‘Top management’ are not involved in this quality management system, therefore risks and issues relating to SSD quality are not formally escalated to a trust organisational level.
• Escalation of SSD quality risks and issues relies on the integrity and professional behaviour of managers rather than being required by policy.
• There is a requirement for manufacturers to design reusable surgical equipment in such a way that it can be decontaminated.
• Surgical equipment can be difficult to decontaminate due to its complexity and size.
• Currently the MHRA regulates under the Medical Device Regulations 2002 which incorporate the European Union’s standards and regulations. The MHRA is restricted in developing its own standards due to market forces.
• To overcome design issues with surgical instruments that relate to decontamination, SSDs rely on decontamination processes to ensure equipment is suitable for use in operating theatres.
• It is difficult to change the design of equipment after it has been approved for use, so the success of the decontamination processes relies on trained and competent staff.
• There is no national competency framework for SSD staff to ensure consistency and standardisation.