Investigation report: Suitability of equipment and technology used for continuous fetal heart rate monitoring

Concerns about patient safety in any area of NHS-funded healthcare in England can be referred to us by any person, group or organisation. We review these concerns against our investigation criteria to decide whether to conduct a national investigation. National investigation reports are published on our website and include safety recommendations for specific organisations. These organisations are requested to respond to our safety recommendations within 90 days, and we publish their responses on our website.

We investigate incidents in NHS maternity services that meet criteria set out within one of the following national maternity healthcare programmes:

• Royal College of Obstetricians and Gynaecologists’ ‘Each Baby Counts’ report
• MBRRACE-UK ‘Saving Lives, Improving Mothers’ Care’ report.

Incidents are referred to us by the NHS trust where the incident took place, and, where an incident meets the criteria, our investigation replaces the trust’s own local investigation. Our investigation report is shared with the family and trust, and the trust is responsible for carrying out any safety recommendations made in the report.

In addition, we identify and examine recurring themes that arise from trust-level investigations in order to make safety recommendations to local and national organisations for system-level improvements in maternity services.

For full information on our national and maternity investigations please visit our website.

This investigation focuses on the equipment that is used within maternity departments to conduct continuous fetal heart rate monitoring during labour and birth. While there are lots of different types of equipment used for monitoring the fetal heart, the main equipment used for continuous fetal heart rate monitoring is the cardiotocograph (CTG) machine.

The investigation looked at how CTG machines are used, problems that staff using them experienced, how the machines are purchased and how staff are trained and assessed as being competent to use them.

This summary uses the words fetal and fetus in place of baby’s and baby.

HSIB reviewed 39 investigations conducted by its maternity investigation programme into intrapartum stillbirths (where the fetus was thought to be alive at the start of labour but was born with no signs of life) and early neonatal death (when the fetus died within the first week of life (0 to 6 days)). This identified a theme relating to fetal monitoring. A further review of 138 completed HSIB maternity investigations from across the country identified 238 findings which referenced issues with CTG monitoring in some form. From these, one common theme was issues relating to CTG equipment.

The investigation team was formed of members of the HSIB national investigation programme and the HSIB maternity investigation programme, providing a balanced approach. During the investigation, issues relating to equipment involving procurement, staff training and culture were identified. The following observations and findings are based on visits to, and conversations with staff at, a number of NHS trusts.

Different trusts handled procurement in different ways, with some forming multidisciplinary teams to ensure staff with expertise in procurement and staff with expertise in the relevant clinical field were involved. However, there were also examples of procurement being led by single clinicians, with no expertise in procurement and without the involvement of other departments or other clinicians from their field. This led to equipment being purchased that was incompatible with existing equipment and staff having no knowledge that equipment was being replaced.

The introduction of equipment once purchased was also variable. Some trusts engaged with staff and kept them informed of decisions and plans, while others introduced equipment with almost no information being shared with the staff who were to use it. This led to obstructive behaviour from staff and a difficult roll-out of the equipment, resulting in financial losses in some cases.

While all members of staff displayed a good working knowledge of the basics of the CTG equipment, often staff could not demonstrate knowledge of certain functions or explain all the symbols or acronyms that were displayed on the machines.

There is a strong emphasis across maternity services on training staff on the interpretation of CTG traces (graphs that show fetal heart rate data). Correct interpretation of CTG traces is a common area of concern found during HSIB maternity investigations. There are also issues arising from a lack of in-depth understanding of the use of CTG equipment. However, the investigation found no evidence of any formal training being conducted by trusts to ensure that staff had in-depth knowledge of the equipment they were using.

Equipment was perceived as being fairly basic and similar, with the view that if you use it regularly then you must be competent and that all CTG machines are much the same.

The investigation found that some national guidance had affected procurement decision making, which was not the intent of the guidance. Phrases and terminology in guidance had resulted in trusts purchasing equipment without necessarily conducting full operational usage testing to ensure its compatibility with existing equipment or that the equipment met their specific needs.

• There is variation in the way trusts approach the procurement of equipment and in the use of multidisciplinary team working during the procurement process.
• There was a lack of use of change management processes by trusts to help ease new processes/equipment into service.
• Multiple manufacturers produce monitoring equipment with multiple specifications.
• There is no consistent approach to training for maternity staff on the equipment they use.
• There are no competency checks for maternity staff on the operation of CTG monitoring equipment (there are checks on their ability to analyse the output of CTG machines).
• Centralised monitoring is often installed and used with no clear understanding of its purpose or clearly defined roles and responsibilities for staff using it.
• National guidance has inadvertently influenced some trusts’ procurement decisions, which has in some cases resulted in financial costs.

1.3.1 There are two key stages of pregnancy where fetal heart rate monitoring (listening to the fetus’ heart rate) occurs: during the antenatal period (pregnancy, prenatal or maternity care are other terms used to describe this period) and during labour.

1.3.2 During antenatal care, a mother will have scheduled appointments to monitor both her and the fetus’ health. A number of tests are done at different times to assist in these assessments. If there are problems or suspected problems with the fetus and mother, such as reduced fetal movements, or bleeding from the mother’s vagina, then fetal heart rate monitoring should be carried out.

1.3.3 The fetal heart rate is regularly monitored through the different stages of labour. In the first stage of labour a midwife will listen to, and assess, the fetus’ heart rate at least every 15 minutes and for at least one minute after a contraction. In the second stage of labour it is expected they will do this at least every five minutes or after contractions. (National Institute for Health and Care Excellence, 2017). If there are any deviations from the normal heart rate the midwife will listen to the heart rate for the next three contractions. If there are any complications, or specific risk factors identified by the maternity team, continuous fetal heart rate monitoring should be advised.

1.4.1 The report ‘Each Baby Counts’ (Royal College of Obstetricians and Gynaecologists, 2015) states that ‘fetal monitoring, whether through intermittent auscultation or continuous cardiotocography (CTG) [see 1.5 and 1.6], requires a complex interplay of staff knowledge, use of equipment, team working and interpretation …’.

1.4.2 There are a multitude of methods and equipment that may be used to monitor (listen to, record, display or help analyse) a fetal heart rate; these are explained in detail later in this section. They include:

• Pinard stethoscope
• hand-held Doppler
• cardiotocography (CTG)
• ST analysis (STAN)
• ultrasound scan
• fetal scalp electrode (FSE)
• wired or wireless transducers.

1.5.1 Intermittent auscultation, or ‘listening in’, is the recommended method for monitoring a fetus’ heart rate in labour in pregnancies that are classed as low risk, where there are no anticipated complications. This is performed by using either a hand-held (Pinard) stethoscope or hand-held Doppler machine.

1.6.1 Cardiotocography (CTG) is an electronic means of recording the fetus’ heart rate pattern to assess their wellbeing. This is used both during the antenatal period, and during labour. During labour a mother’s contractions are also monitored by this machine which produces a printed or electronic record referred to as the CTG. It is usually performed externally, using two devices (transducers) placed on a mother’s abdomen.

1.7.1 CTG monitors receive signals from the mother and fetus from the transducers placed on the mother’s abdomen. The signals are received from the transducers by either a wired or wireless connection (telemetry). The monitor then converts these signals and traces them onto a graph.

1.7.2 There are a variety of CTG monitors in use across the healthcare system. Each one delivers similar functionality, differing mainly in design of the physical equipment and system menu layout, specifically the user screens.

1.7.3 All monitors produce a CTG trace, which allows for assessment of the fetal heart rate. This trace may be displayed on a screen, printed onto paper in a graph, or both.

1.8.1 A fetal scalp electrode (FSE) is a small clip placed on the unborn fetus’ head, if external monitoring produces a poor-quality heart rate recording. It is applied during a vaginal examination.

1.8.2 Because the electrode is placed directly on the fetus’ scalp, this method can only be used once the membranes (the sac containing the amniotic fluid that surrounds the baby in the womb) have been broken, and if there are no clinical reasons to avoid this method of monitoring, such as possible fetal bleeding disorders.

1.8.3 If the fetus is in the breech position (bottom first instead of head first) an FSE may be placed on the fetus’ buttocks.

1.9.1 An ST analysis (STAN) may be used during labour. The system analyses the fetal electrocardiogram (ECG), which measures the heart’s electrical activity and the pattern of heartbeats. This can identify changes in the phases of the fetal ECG to help clinicians detect signs of hypoxia (low oxygen). STAN still requires clinicians to interpret the CTG. STAN requires an FSE to be placed.

1.10.1 An ultrasound scan uses high-frequency sound waves to create images of the inside of a patient’s body; in maternity care, it is used to create images of the fetus. Ultrasound scans are used during pregnancy to ‘date’ the fetus and assess them for growth or anomalies. During an ultrasound examination, Doppler measurements may be undertaken to explore the blood flow in the fetus and/or in the placenta. These Doppler measurements are different to those obtained using a handheld Doppler device, which is designed only to count the fetal heart rate. During an ultrasound scan the fetal heart will be found and observed for a short period of time; this is not continuous fetal heart rate monitoring.

1.11.1 Computerised CTG analysis is becoming more frequently used across maternity healthcare. It provides a computerised analysis of the fetal heart rate, based upon set criteria, and provides an assessment of the fetal heart rate pattern, to assess their wellbeing.

1.11.2 Dawes-Redman CTG analysis is one type of computerised fetal heart rate analysis. The method was developed at Oxford University and is based on data from thousands of fetuses. The system measures set ranges of the fetal heart rate and analyses them against set criteria.

1.11.3 This method can only be used during the antenatal (pre-labour) phase of pregnancy. A CTG from a healthy fetus would be expected to meet the Dawes-Redman criteria.

1.11.4 Dawes-Redman is the most well-known electronic fetal analysis software. However, other manufacturers of CTG machines have their own version. While all versions of computerised CTG analysis differ in their origin and the dataset on which they are based, they all provide an assessment of the fetus’ wellbeing.

1.12.1 A central monitoring station allows the combined display of more than one CTG on the same screen, usually situated on a labour ward. CTG monitors from the ward are connected to a central server allowing the CTG trace to be displayed on the central monitor.

1.12.2 The use of centralised monitoring has gained popularity within maternity departments. The system allows clinicians who are not in the birthing rooms to view and assess CTG traces. The monitors display either multiple or single CTG traces in real time.

1.13.1 A central server is an electronic means of archiving CTG traces. The servers are often linked to centralised monitoring systems, but this is not a requirement. Once archived the CTG traces are preserved and can be recalled at any point.

1.13.2 Saved CTG traces can be used for clinical review and training of clinicians. They may also be required for investigation, for use by coroner’s or for legal purposes and should be stored for 25 years.

1.14.1 In this report the term procurement refers to the overall process by which trusts choose, agree, purchase and implement new or replacement equipment.

1.14.2 Procurement of equipment in trusts is conducted in line with individual trust policies, formed from national guidance about procurement rules. The guidance and rules pertaining to procurement within the NHS are listed online (gov.uk, 2013) and include the following guidance relevant to this investigation:

• Procurement, patient choice and competition regulations: guidance (19 December 2013, Statutory Guidance)
• NHS healthcare providers: working with choice and competition (12 September 2014, Guidance).

1.14.3 There are numerous other guidance documents which set out information on improving procurement strategies, reducing costs and so on. NHS England had a ‘Best practice in procurement’ web page which described how clinical commissioning groups might approach procurement. There is nothing similar to this for trusts.

1.14.4 Additionally, the NHS procurement landscape was changed after the Carter review (2016). This resulted in the Procurement Transformation Programme, which in turn led to the Department of Health document ‘The Future Operating Model for NHS procurement’ (Department of Health, 2017). This laid out the plans for NHS Supply Chain (which manages the sourcing, delivery and supply of healthcare products to the NHS) to combine the buying power of NHS trusts, and use that to ensure that all trusts could buy equipment at the same cost, driving costs down by buying in bulk across the service.

1.15.1 The Clinical Negligence Scheme for Trusts (CNST) is a scheme run by NHS Resolution which ‘handles all clinical negligence claims against member NHS bodies where the incident in question took place on or after 1 April 1995 (or when the body joined the scheme, if that is later). Although membership of the scheme is voluntary, all NHS Trusts (including Foundation Trusts) in England currently belong to the scheme’ (NHS Resolution, 2020).

1.15.2 Trusts pay membership contributions to be part of the scheme. These contributions are assessed annually and are based on things such as claim history, number of staff and the trust’s compliance with safety actions (see 1.15.4). Compliance with the safety actions earns the trusts discounts on their contributions.

NHS Resolution maternity incentive scheme

1.15.3 The maternity incentive scheme (NHS Resolution, 2021) is part of the CNST. It aims to help provide safer maternity care.

1.15.4 The scheme is broken into 10 safety actions, which pose criteria to trusts, in the form of questions, which they must meet. The following safety actions are relevant to this investigation:

• Safety action 6: Can you demonstrate compliance with all five elements of the Saving Babies’ Lives care bundle version 2?
• Safety action 8: Can you evidence that at least 90% of each maternity unit staff group have attended an ‘in-house’ multi-professional maternity emergencies training session within the last training year?

1.15.5 Technical guidance is given in each section to help trusts to ensure that they are able to provide evidence that they are meeting each requirement. If the requirements are met, the trust will receive the financial incentive (discount) under the scheme. 

2.1.1 HSIB identified an issue relating to fetal heart rate monitoring within maternity care across the NHS. It conducted a review of 39 HSIB maternity investigations into cases of intrapartum stillbirth (where the fetus was thought to be alive at the start of labour but was born with no signs of life) or early neonatal death (when the fetus died within the first week of life (0 to 6 days)) of any cause. The review found multiple reports that identified issues associated with fetal monitoring during labour. The HSIB Maternity Team and its advisors confirmed that issues with fetal heart rate monitoring in labour is a recurrent theme in HSIB maternity investigations.

2.1.2 A further review of 138 completed HSIB maternity investigations, involving incidents from maternity departments across the country, identified 238 findings which referred to cardiotocography (CTG). There were also 87 recommendations within those reports which referred to CTG in some form. Not all of those findings and recommendations were relevant to CTG equipment; however, CTG equipment and its suitability and whether it was ‘fit for purpose’ was a common theme.

2.2.1 Following preliminary information gathering, HSIB concluded that the safety issues represented by the analysis of the completed maternity investigations met the criteria for investigation. HSIB’s Chief Investigator authorised a national investigation.

2.2.2 A summary of the analysis against HSIB’s investigation criteria is given below.

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

Issues regarding effective fetal monitoring in labour were a contributory factor in multiple HSIB maternity investigation reports (the initial 39 reports reviewed by the investigation). The outcomes relate to intrapartum stillbirth or early neonatal death. The fetal monitoring theme continued in the further 138 investigation reports reviewed by the investigation, which looked into incidents where the HSIB maternity investigation criteria had been met.

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

Issues with fetal monitoring during labour has been identified as a critical contributory factor in numerous reports looking into incidents of stillbirth, neonatal death or babies who suffered brain injury (National Perinatal Epidemiology Unit, 2019; Royal College of Obstetricians and Gynaecologists, 2018; 2017). The ‘Each Baby Counts’ report (Royal College of Obstetricians and Gynaecologists, 2017) identified 409 babies who were delivered in the UK during 2015 where different care may have led to a different outcome regarding fetal heart rate monitoring.

A recent report (National Perinatal Epidemiology Unit, 2019) listed fetal monitoring issues, including incorrect method, interpretation or management, that were identified as contributing to the death of the fetus in 19% of cases. Parents’ perspectives and concerns were described in the report. Of the comments collected from parents during the review process, 26% were regarding concerns around labour care and fetal monitoring was one of four subthemes.

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

Reports such as ‘Each Baby Counts’ (Royal College of Obstetricians and Gynaecologists, 2017), initially published in 2015, looked at incidents in maternity services and sought to reduce the stillbirth rate in the UK. This led to the launch of several maternity transformation programmes (National Maternity Review, 2016; NHS England, 2016). ‘Saving Babies’ Lives care bundle’ version 1 (NHS England, 2016) and version 2 (NHS England, 2019) provide detailed guidance for providers and commissioners of maternity care on how to reduce cases of intrapartum stillbirth and early neonatal deaths across England. The maternity transformation programmes centre on ensuring staff receive training and are competent to interpret fetal heart rate data, that they use a buddy system for review, and escalate issues when concerns arise. The improvement programmes do not consider equipment, technology or tools used to interpret fetal monitoring.

2.3.1 The investigation was completed between December 2019 and May 2021. It was extended due to the COVID-19 pandemic, which restricted observational visits and caused delays in speaking to staff and organisations.

2.3.2 The HSIB investigation team consisted of a mix of staff from both the national and maternity investigation programmes. The backgrounds of team members included:

• human factors investigation
• engineering
• midwifery
• obstetrics.

2.3.3 The investigation engaged with five NHS trusts that deliver maternity care to conduct observational visits and interviews with staff. The trusts were selected to ensure that evidence was gathered about different equipment types, from different sized trusts and from different regions across the country.

2.3.4 Evidence was collected from HSIB maternity investigation reports and the experience of HSIB maternity investigators, which reflected maternity departments across the country. The investigation team had a combined total of over 100 years of maternity care experience.

2.3.5 Stakeholders were approached from across maternity services, including:

• NHS England and NHS Improvement
• National Institute for Health and Care Excellence
• NHS Supply Chain
• three manufacturers of maternity healthcare equipment.

2.4.1 The investigation used the Systems Engineering Initiative for Patient Safety (Carayon et al, 2006). This approach classifies evidence into categories (person, organisation, tools and technology, task, internal environment, external environment) (see figure 1), enabling easy analysis of evidence while ensuring that all aspects of a system are investigated.

2.4.2 The investigation’s interview and observation schedules were informed by SEIPS. Interview data was recorded in note form, which was then thematically coded, based on the SEIPS framework.

2.5.1 Following the initial analysis of completed maternity reports, the investigation scope was set to ensure that realistic and valuable results could be achieved within a timeframe of approximately one year. To ensure the investigation’s objectives were met, only equipment used to monitor fetal heart rate were considered in scope.

3.1.1 Trusts wishing to purchase monitoring equipment approach NHS Supply Chain (NHS SC) and choose one of two methods of purchasing: a pricing exercise or a call off purchase. These are explained in more detail below. Whichever route is chosen, NHS SC will then assist the trust in the purchase and guide them through the process.

3.1.2 For patient monitoring equipment in England, NHS SC is the only centrally appointed supply organisation; however, there are other organisations that can supply equipment to the NHS. The systems in place are all similar.

Pricing exercise

3.1.3 Trusts that do not know exactly which equipment they wish to buy would ask for a pricing exercise to be carried out. This is an alternative to the trust ‘going out to tender’. It would usually involve the following steps, but can be tailored to suit individual trust requirements:

• The trust completes a ‘statement of requirement’ (SoR) form, which is sent to the trust by NHS SC.
• NHS SC forwards the SoR to manufacturers.
• Manufacturers who could meet the SoR respond.
• The trust develops clear evaluation criteria against which it will assess the equipment.
• The trust holds a demonstration day, at which manufacturers demonstrate their equipment.
• Preferred manufacturers then supply some equipment for a period of time (normally two weeks per supplier) for the trust to conduct an operational assessment using its evaluation criteria.
• Following the trust’s evaluation of the clinical operational assessments, NHS SC requests best and final prices from the manufacturers and presents them to the trust, which then completes a final evaluation and makes an award decision.
• NHS SC provides the trust with details about how to complete the order. NHS SC issues a unique reference number with address details for the order. The details can vary, therefore trusts are required to check the document prior to raising a purchase order.
• A purchase order is raised and the procurement process is complete.

Call off purchase

3.1.4 This approach is used where trusts know which equipment they wish to purchase. The trust approaches NHS SC and gives it the details of the manufacturer and the specifications. NHS SC then approaches the manufacturer and asks for a quote. The quote is presented to the trust, along with a ‘points to consider’ communication about the purchase (see safety action A/2021/045), and the purchase is agreed. The procurement process is complete.

3.1.5 With the call off purchase route, trusts should ensure that they have completed all the due diligence required by their local procurement team. However, for various reasons (knowledge of the process, expertise in procurement, team make up) the levels of due diligence vary across NHS trust teams.

3.1.6 NHS SC can also conduct a ‘multi trust aggregate’. This happens when a number of trusts wish to purchase the same equipment from a manufacturer. The orders are combined into a single order resulting in greater numbers of units and enabling NHS SC to negotiate a reduced price for trusts.

3.1.7 Approximately 80% of trusts that purchase fetal monitoring equipment through NHS SC do so via the call off route. However, the investigation has identified problems that have arisen through this route. These are explored later in this section.

3.2.1 Trusts use teams that are specifically formed to procure and introduce equipment into the operational environment, such as the antenatal assessment unit. These teams should have staff from departments with the expertise to advise on all aspects of the procurement. This multidisciplinary team should include stakeholders such as representatives from medical engineering/medical physics, the designated medical devices safety officer and staff from the area of care for which the equipment is being bought. In the case of cardiotocography (CTG) equipment, the team should include members of the medical engineering department, IT and staff from the maternity department who use the equipment, as a minimum.

3.2.2 The investigation found that the composition and membership of procurement teams varied considerably. Some trusts involved staff who use the equipment, compiling a list of desired requirements, and understanding what functionality the equipment offered. One trust had a team led and directed by a senior clinician who individually decided on the best purchase which was then taken forward. Staff in the maternity department were not involved in the procurement process, which led to problems with their acceptance of the new CTG machines. To compound the problems, the trust’s medical devices department was not involved until the process was almost complete and a decision about which equipment to purchase had been made. Interoperability issues (issues relating to the ability of different IT systems to communicate and share data) were not fully considered. This had a knock-on effect and meant the trust had to decide whether to spend more money to replace their existing central monitoring system (see 1.12).

3.2.3 The investigation saw another example where a single piece of equipment was bought under the direction of an individual; this person moved on and the item was not used again, thus wasting finances and time.

3.2.4 Long-term planning for procurement of equipment was also seen to be varied among trusts and influenced by staff at various levels. One trust informed the investigation that it had been a considerable way along the procurement process, with the first items already bought as a pilot phase. Senior members of the midwifery team changed, and the incoming staff did not like the equipment and stopped the replacement programme. This cost the trust time and money. At the other end of the scale, the investigation spoke with a trust that had identified the functionality it wanted/needed, drawn up a procurement plan, involved the staff and enacted it. The process took two years to roll out, but the trust has reaped the benefits since that point, with good staff engagement, equipment that has fulfilled the trust’s stated requirements and the generation of a large cache of data which was being used to analyse incidents to learn and improve care.

3.2.5 Due to the varied levels of multidisciplinary team working during procurement that was reported to the investigation, and the negative impact of poor team construction in the process, HSIB makes the following safety observation.

3.3.1 In a standard procurement process a trust might invite manufacturers to demonstrate their equipment, as part of a sales pitch, and the manufacturers may allow the trust to assess the equipment for a period of time in the environment in which it will be used. The investigation saw varying levels of this, from a full assessment of new equipment through to a trust placing equipment in the staff room for midwives to ‘play with’ during their breaks. The investigation heard from staff that they found this an infringement as they valued their breaks for relaxation and to attend to personal matters. Therefore, the equipment was ignored and the intention of getting staff to acquaint themselves with it was unsuccessful.

3.3.2 A full operational assessment process should identify the benefits and expose the drawbacks of a new piece of equipment, allowing evidence-based decisions to be made and the best equipment for that trust to be purchased. The investigation was told that some trusts compiled a requirements list for new equipment, with input from both the procurement team and the clinical staff who would use the equipment. Assessments were then completed to establish the suitability of the different equipment types, before selecting the equipment which was the best fit for them and their existing systems. In one case the investigation heard that a trust made the decision about ‘best fit’ without taking the cost of the equipment into consideration, as the financial differences were not deemed sufficiently important to impact on the process.

3.3.3 The investigation was told by a trust that one type of CTG machine had been purchased because “it was the latest and heralded as the best”, yet the equipment was expensive and was different to most CTG machines. A full operational assessment was not completed prior to the purchase and the full impact on the trust, in terms of resource, training and finances, was not properly determined. The trust invested in one machine, which was “barely, if ever, used”, the machine was eventually taken out of service.

3.3.4 The availability of pre-tendered equipment through NHS SC was identified as an influencing factor in the variation between assessments. Trusts are able to shop from a catalogue of equipment that has been ‘pre-tendered’, providing equipment at lower cost to smaller trusts. However, this enables trusts to ‘buy off the shelf’ and may result in local trials or assessments not being conducted. The investigation was told that the availability of pre-tendered equipment could encourage procurement steps to be ‘skipped’, therefore shortening the process. By not completing an assessment, issues such as compatibility with existing equipment or the environment the equipment will be used in may be missed, as the staff who are involved in the purchasing may have made assumptions about how the equipment will be used.

3.3.5 The pre-tendered approach is a valid approach with many benefits. It provides valuable standardisation of costs and legal overview of contracts, while also saving trusts time and money by satisfying the requirements of the Standing Financial Instructions (which set out the financial responsibilities, policies and procedures to be adopted by trusts). However, the investigation identified examples of issues encountered by trusts when procuring equipment without completing a full operational assessment. These included:

• Machines that could not be moved with a mother when she was transferred between wards in the maternity department because they were “too bulky” and therefore not fit for the environment in which they were to be used.
• Machines with no battery back-up (or limited back-up), which prevented the machine from being unplugged while a mother was transferred between wards in the maternity department. This resulted in monitoring of the fetal heart rate being lost or interrupted during the move.
• Equipment purchased because of national advice/guidance/recommendations (NHS England, 2019; National Institute for Health and Care Excellence, 2017), which was not suitable for the environment or compatible with existing technologies at the trusts.

3.3.6 The World Health Organization (WHO) has produced guidance on the use of tools to support a ‘health technology assessment of medical devices’ (World Health Organization, 2011). Figure 2 outlines the WHO’s assessment process for deciding to introduce new technology into a healthcare system. Importantly, the WHO guidance sets out the remit of regulation and limits this to ‘technical performance’ and ‘efficacy’. The investigation did not identify issues associated with the ‘technical performance’ of CTG devices. However, issues with location, environment and use were shared with the investigation and are dealt with later in this report.

3.3.7 Although the majority of the equipment was being procured due to obsolescence of existing equipment, trusts were looking at the latest technology with enhanced functionality, so the equipment was not replaced on a like-for-like basis. The process should have encompassed questions such as, ‘Should the technology be implemented in this setting?’ and ‘How should the technology be implemented?’ as described in the WHO health technology assessment (see figure 2).

3.4.1 The investigation found that access to the Dawes-Redman computerised analysis of CTG (see 1.11.2 to 1.11.4) was exclusive to one manufacturer; other manufactures have their own version of electronic analysis. The manufacturers with exclusive rights has two main types of CTG machine, covering both antepartum (before birth) and intrapartum (during birth), which have the Dawes-Redman software package available.

3.4.2 Machines that have the Dawes-Redman analysis software package may be connected to any centralised monitoring system and server. However, the Dawes-Redman analysis data cannot be shared with the server unless it is connected to the same manufacturer’s server. The CTG trace can be printed from the bedside machine and may also be exported to a hospital information system (electronic patient records system) in a number of formats, such as pdf (non-modifiable document) or png (image) files.

3.4.3 The manufacturer with exclusive rights to Dawes-Redman also produces a viewing and archiving system (a combined central monitoring system and server) but this necessitates a dedicated server. While other CTG machines could connect to this server system, due to licensing agreements, it is not possible to connect any other manufacturers’ CTG machines to the system and benefit from the Dawes-Redman analysis software.

3.4.4 Trusts were not always aware of the Dawes-Redman licensing constraints. The investigation identified that, apart from one trust that the investigation spoke with, there was no knowledge of how this would affect the interoperability and compatibility of trusts’ electronic equipment, such as centralised monitoring central servers.

3.4.5 The investigation spoke with a trust that was in the process of procuring new CTG machines, as their current machines were at the end of their operating life. The procurement was being led by the trust’s medical devices department, which had considered interoperability of the equipment and how the trust’s existing IT infrastructure would cope with the purchase. It had considered essential requirements of the system and had canvassed opinion from staff within the maternity department to ensure that their requirements were met during the procurement. All aspects appeared to be covered; however, during conversations between the medical devices department and the investigation, a technical conflict was uncovered that the trust was unaware of. The intent was that the CTG machines would feed data directly into the trust’s current maternity electronic patient record system. It was considering, as one of its options, the machines with Dawes-Redman installed. If the trust were to purchase the Dawes-Redman enabled CTG machine, it would not be able to use it in the intended manner. However, it would be able to import the CTG trace (as an image or pdf document) and, therefore, the Dawes-Redman assessment data would be displayed on the trace.

3.4.6 This issue had already been experienced by another trust the investigation spoke with. It had set up two independent centralised monitoring (viewing) and archiving systems. One system was running the Dawes-Redman licensed equipment in the antenatal areas, while the other system (used in the intrapartum areas of the unit) was running a separate system. Both systems were purchased as full suites, in order to ensure that there were no compatibility issues, and the trust extracted the maximum level of functionality from the systems. This set-up was more expensive but was driven by necessity due to the licensing and compatibility issues.

3.5.1 Interoperability was a significant issue for all the trusts that the investigation visited and spoke with, impacting on them all to varying degrees. This ranged from trusts that had already felt the burden of systems being incompatible, to others that were in the process of purchasing new equipment and were either not aware of compatibility issues, or were having to make decisions based around their existing equipment.

3.5.2 One example the investigation observed typified this scenario. A maternity department was using seven different IT systems:

• the trust electronic patient record system
• a maternity information system
• a centralised monitoring and archiving system
• an electronic patient record system for the neonatal intensive care unit
• an electronic digital management system for archiving notes
• a system for viewing and archiving test results (blood tests, X-rays and so on)
• the trust was planning to adopt another system for documenting patient observations.

3.5.3 In addition, the trust had separate electronic patient record systems for mother and baby. This resulted in a complex and sometimes confusing route to documenting and providing care in an already extremely busy maternity department. The investigation was told that none of the IT systems that were in use had any interoperability, so there was always an element of repetition when it came to updating notes.

3.5.4 While trusts can identify interoperability issues with IT equipment during equipment operational assessments or during conversations with manufacturers, interoperability is an ongoing problem with IT systems that HSIB has seen in many other investigations. In particular two investigations, ‘Procurement, usability and adoption of ‘smart’ infusion pumps’ (Healthcare Safety Investigation Branch 2020) and ‘Electronic prescribing and medicines administration systems and safe discharge’ (Healthcare Safety Investigation Branch, 2018), noted issues around the interoperability of equipment. The latter highlighted that ‘staff switching between electronic and paper records increases the likelihood of missing crucial information’; this is also true when switching between IT systems and was a concern for all staff that this investigation spoke with.

3.6.1 The Health Foundation (2012) defines a safety case as a ‘structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is acceptably safe for a given application in a given context’.

3.6.2 HSIB has previously highlighted the benefit of using safety cases when introducing new equipment. Within ‘Procurement, usability and adoption of ‘smart’ infusion pumps’, HSIB stated that:

‘Safety cases can provide a means of promoting structured thinking about risk that facilitates a consensus between managers, healthcare staff and device manufacturers. The evidence gathered to support the safety case is used to demonstrate that risks within the system have been identified and can be managed by the processes that have been designed to ensure a safe implementation.’
(Healthcare Safety Investigation Branch, 2020)

3.6.3 The investigation noted that safety cases would have benefited trusts by encouraging them to look at the risks related to the introduction of new equipment. None of the trusts that the investigation spoke with had placed the introduction of new CTG equipment onto their risk register. Given the importance of these machines, there is a clear case for identifying the deployment of new CTG equipment as a risk to the safe delivery of care in the maternity department.

3.6.4 While CTG equipment was not viewed by end users as a digital technology, it was being procured with the functionality of sharing information over a telecommunications network, providing a central monitoring functionality or central archiving functionality. NHS Digital publishes standards for introducing digital systems – DCB0129 (NHS Digital, 2018a) and DCB0160 (NHS Digital, 2018b).

3.6.5 These standards could provide a suitable framework and prompt an organisation to consider whether or not a system is safe to ‘go live’, meaning that risks that may lead to patient harm have been documented and processes have been developed to manage/mitigate these risks.

3.6.6 The investigation heard from manufacturers who had considered and complied with DCB0129 (which requires manufacturers to conduct a risk assessment based on documented assumptions that have been made about clinical use). However, organisations employing the new equipment should be compliant with DCB0160; the investigation found limited evidence of this. DCB0160 mandates that the NHS organisation conducts a further risk assessment, based on the manufacturer’s risk assessment, and documents additional risks associated with the local customisation needed for the system to go live.

3.6.7 Both standards also require ongoing clinical risk management activities to be defined so that processes can be revised and documented in response to newly identified risks after the system goes live. Risk management activities need to continue when the system is live and should be used to inform future procurements.

3.6.8 It is also important that both financial and resource risks are considered. The investigation saw examples where both financial and human resources were wasted. This could have been minimised or prevented completely through the use of change management systems (see 3.7) and safety cases.

3.6.9 The investigation observed trusts that had encountered difficulties with procurement, some that had completed very successful procurement projects and some that were embarking on new procurement projects but were unaware of key factors. With this in mind, HSIB makes the following safety observation.

3.6.10 As part of the investigation, NHS SC identified that there were two actions it could take that would help to reduce issues during the existing procurement process. The actions relate to the statement of requirement, which is sent out to trusts and manufacturers as part of the procurement process (see 3.1), in terms of the detail it contains about compatibility and connectivity, and a ‘points to consider’ communication prior to purchase.

3.6.11 NHS SC has completed the following safety actions.

3.7.1 Change management is an essential part of the process of introducing new equipment or processes to organisations or individuals. Changing systems or equipment is a complex and challenging process and needs to be managed carefully in order to ensure success. There are many models that have been created to support change management, including Kotter’s Change Model (Mind Tools, n.d.) and the Prosci ADKAR model (Prosci, n.d.). All models concentrate on some key phases of the change process, which include:

• identifying the need for change
• communicating the need and forming the team to implement the change
• obtaining buy-in from those affected by the change
• introducing the tools or training required to facilitate the change
• completing the change and any training or system modifications the change requires
• reinforcing the change, either through monitoring, supervision or further training.

3.7.2 All stages of a change management process will smooth the process of rolling out the implementation of new equipment, potentially saving trusts money by reducing the likelihood of project failure and the amount of time it takes to enable the change to be made. It will also ensure that staff are brought along the journey of the change and equipped with the right skills and attitude to assist in the implementation of the equipment or process.

3.7.3 The investigation saw equipment which had been introduced with no communication to staff, either about the need for the change or which equipment was going to replace their existing stock. During the roll-out trusts experienced resistance to change from staff who did not understand why the change was happening and found fault with the new equipment. The key phase of gaining staff buy-in had not taken place; they were not involved in any discussions or asked about key requirements for the machines.

3.7.4 It is also recognised that trusts are likely to have more than one project being initiated at the same time. However, with good change management and communication there is evidence that this can be successfully managed with good results. If change management is not considered, then the projects may clash and priorities can become mixed. The investigation was informed that this was an issue at one trust where an electronic patient record system was being introduced at the same time as a new suite of CTG machines.

3.7.5 During a meeting with the trust, the investigation was told about plans to integrate the CTG machines with the electronic patient record system for the maternity department. The capability would allow them to “automatically upload CTG traces onto the system”, which was currently completed manually. This had not been communicated to staff and the senior staff that were in the meeting were not aware that it was being planned.

3.7.6 A good example of change management was a planned roll-out by one trust of new CTG machines. The process had staff buy-in as they had been kept informed of decisions and the reasons for change, and there was a phased roll-out of the equipment and training for staff. The trust completed the roll-out over a two-year period, with all staff trained and brought along on the journey. The trust has now been operating the equipment for 18 years and reaped huge benefits in terms of staff satisfaction with the equipment, knowledge of the equipment and use of the technology to learn from incidents, which all started with a smooth transition to the new equipment.

3.7.7 The investigation saw variation in trusts’ approach to change management. The trusts that had used good change management techniques had more success than those that had not. Therefore, HSIB makes the following safety observation.

3.8.1 The investigation observed that once new CTG equipment had been purchased and supplied to trusts, the training of staff on the new equipment was similar across different trusts. An initial group training session was delivered by representatives from the manufacturer, which lasted between 30 minutes and 45 minutes. Trusts reported that there were one or two training sessions, which aimed to include as many of the midwives at the trust as possible.

3.8.2 The manufacturers’ training sessions covered the basic functions of the CTG machines. Staff reported that the training was not comprehensive.

3.8.3 In some trusts the manufacturer conducted one-to-one training with some midwives who had not been able to attend the group sessions.

3.8.4 Additionally, as stated in 3.3.1, one trust placed a couple of machines in the staff room, so that the staff could ‘play’ with and become acquainted with the machines during their breaks. It was reported to the investigation that this was not popular with the staff.

3.8.5 Trusts that the investigation spoke with stated that none of the manufacturers’ training included leaving any training booklets or guidance on the use of the machines. This was disputed by multiple manufacturers and the investigation was supplied with electronic versions of ‘quick start’ guides and more comprehensive user manuals. Once the manufacturers’ training was complete, other than having a representative to call and discuss problems with, their role in training staff ended.

3.8.6 Manufacturers told the investigation that they ask trusts to identify a ‘super user’. The manufacturer provides additional training to the super user, who can then train other midwives. This provides the trusts with a train-the-trainer capability, so any staff that did not receive the manufacturers’ training can be trained.

3.8.7 After the roll-out of the equipment was complete, trusts were then responsible for training midwives as required via the super user. The investigation was told by a trust that the fetal monitoring lead (known in the trust as the CTG midwife), a fairly recent role created as a result of a recommendation in ‘Saving Babies’ Lives care bundle version 2’ (NHS England, 2019), conducted some initial training for new midwives. All initial training after roll-out was conducted as in-house or train-the-trainer style training. It should also be noted that not every trust has implemented the ‘Saving Babies’ Lives care bundle version 2’ recommendation and created a fetal monitoring lead role.

3.9.1 Midwives are trained to use CTG equipment during their university training. The type of equipment they are trained to use will depend on the equipment in use at their placement hospital. After completion of their course and qualification as a midwife, they will use whichever equipment is being used by the trust they move on to. This may not be the same equipment they have been trained on.

3.9.2 Trusts approach the arrival of newly qualified midwives in different ways; however, at all the trusts the investigation engaged with there was no formalised training for new arrivals. A midwife told the investigation that they had completed their training at a university in a different region. They spent a couple of years at the trust they had trained at, using machines they were familiar with, but had then moved to their current trust. The new trust used different machines, but they had no recollection of receiving any training upon arrival. They said “I think I just picked it up”, which reflected what the investigation found elsewhere.

3.10.1 There was no evidence during any of the investigation visits that trusts were conducting competency training for midwives or doctors on the functionality of the CTG machines. The general thinking was that midwives were competent by virtue of the fact that they were using the machines daily. The investigation was told that conducting further competency training on the equipment was something that staff did not have time to do.

3.10.2 During observational visits the investigation noted that there were several functions or capabilities of CTG machines that midwives were not familiar with. The in-depth knowledge of the CTG machines was found to be poor in each site that was visited. Midwives understood how to operate the machines but beyond that their knowledge was limited, including their knowledge of the machines’ alarms (see 3.16). Examples observed by the investigation included midwives being unable to correctly state what acronyms displayed on the machines stood for, how to start the computerised electronic analysis tool, and confusion over whether alarm parameters reset when the machine was turned on/off.

3.10.3 Additionally, there was a common false belief that the function that was being referred to was the Dawes-Redman computerised analysis function. The machine was not licensed to have Dawes-Redman software installed – the function was a variant, or alternative method to Dawes-Redman. Just as a Dyson vacuum cleaner is often referred to as a Hoover, Dawes-Redman has become a common term for computerised analysis of CTGs, regardless of the manufacturer or the method of computerised analysis.

3.10.4 The investigation spoke with staff at the observation sites and midwives from HSIB’s maternity programme, and across many maternity departments there is a false belief that all CTG machines that have computerised analysis of the fetal heart rate are using Dawes-Redman. The terms Dawes-Redman and computerised analysis were used interchangeably in conversation. This shows that beyond the basic functions of the machines, there is a lack of knowledge among staff about the functionality of the equipment they are using.

3.10.5 The fetal monitoring lead, a role introduced by ‘Saving Babies’ Lives care bundle version 2’, conducts competency assessments and training on the assessment of CTG traces. The assessments do not cover the machines and the care bundle does not refer to competency on use of the equipment. Not all trusts have a fetal monitoring lead, but they do conduct annual continuing professional development (CPD) training, which has an assessment of midwives competence at interpreting CTG traces.

3.10.6 During the investigation, the HSIB maternity investigation programme continued to investigate incidents where user interaction with CTG machines had an effect. Some of these incidents involved the paper feed speed being set incorrectly, resulting in a trace that did not reflect the patterns that staff would expect. Another example was the ‘+20bpm’ function, which is used to separate the heart rates of twins, being switched on accidentally and not noticed. This gave the appearance that the fetus had an unexpectedly high heart rate, indicating stress and a fetus that is struggling.

3.10.7 A trust that had recently purchased new equipment told the investigation that training logs were being kept for training received on the new equipment, however, they were “not great” and not all staff had one. Training records were being kept by most trusts to ensure that staff were conducting their annual CPD training, which included assessment of their ability to interpret CTG traces, but the records did not include the manufacturers’ training on new equipment.

3.10.8 Manufacturers supplied competency training sheets with new equipment so trusts could conduct training themselves. However, they were more of a training checklist for the trust super users, rather than a sheet with areas to assess staff competency on an annual basis. Some trusts told the investigation that they did not use the competency sheets left by the manufacturers as they believed they were not helpful. The trusts viewed them as a ‘tick-box exercise’ as opposed to a useful training or competency assessment tool.

3.10.9 Competency checks were conducted in some trusts on all point-of-care testing equipment, which includes the glucometer (blood sugar) testing kit. However, there were no competency checks for CTG machines, which are key pieces of equipment. In three of the trusts visited, there was a belief that staff were competent on the CTG machines as they used them daily. This conflicted with the evidence found by the investigation, which showed that staff did not have a complete understanding of all the functions of the equipment and, as reported by the trusts, made mistakes as a result of a lack of knowledge or understanding of certain functions.

3.10.10 The Nursing and Midwifery Council (NMC) dictates that midwives ‘must have undertaken 35 hours of continuing professional development (CPD) relevant to your scope of practice as a nurse, midwife, nursing associate or combination in the three year period since your registration was last renewed’, but it does not prescribe what that training has to consist of. The NMC specifically states that ‘It’s important to remember that the NMC doesn’t prescribe any particular type of CPD; we leave it up to you to decide what activity is most useful for your development as a professional’ (Nursing and Midwifery Council, 2021).

3.10.11 During one visit, the investigation was shown how to operate a function of one of the CTG machines. However, the staff could not get the function to work. It was discovered by the investigation, during discussion with the manufacturer, that the staff were carrying out the procedure incorrectly and were missing an essential piece of information to enable the function to operate. This was an example of information that would be known to staff if they were properly assessed for their competence on the equipment each year and provided with the requisite training to arm them with that knowledge.

3.10.12 The trusts had put systems in place to supervise newly qualified midwives in all aspects of their training and integration into the unit. One system which was described to the investigation included:

• an induction programme (one week), which involved spending time in all maternity department areas/wards
• a two-week period of 100% supervision
• a ‘buddy’ system where midwives have an experienced colleague they can turn to for advice.

3.10.13 In June 2014 the Medicines and Healthcare products Regulatory Agency (MHRA) produced a document titled ‘Devices in practice’ (Medicines and Healthcare products Regulatory Agency, 2014). The document covers, among other areas, the safe use of medical devices, responsibilities of users and carers, and record keeping. Under safe use of medical devices there is a ‘Before use: knowledge of device’ checklist. Two questions on this list are:

• Have you been trained in its use?
• How was your competency to use this device assessed?

In the responsibilities of users and carers section, the document asks:

• Has the user or carer been trained to use the device and assessed as competent?

3.10.14 Midwives are assessed for competence in many areas of their practice, but there are no competency checks on the most complicated and widely used piece of equipment.

3.10.15 Manufacturers have put other training methods in place for staff, some of which were introduced due to the COVID-19 pandemic. These include e-learning packages with modules for both doctors and midwives, online guides, and YouTube videos on how to conduct certain operations on the machines. The investigation was informed by a manufacturer about the YouTube videos. There was no mention of these videos when the investigation asked trust staff about training resources.

3.11.1 The maternity incentive scheme (NHS Resolution, 2021) safety action 6 (see 1.15.4) sets out to ensure that trusts are complying with ‘Saving Babies’ Lives care bundle version 2’ (NHS England, 2019). Element 4 of the safety action states that trusts must evidence that at least 90% of staff (obstetric consultant (specialising in care for women during pregnancy and childbirth), all other obstetric doctors, and midwives) receive training on fetal monitoring, including:

• intermittent auscultation
• electronic fetal monitoring
• human factors
• situational awareness.

3.11.2 In the ‘further guidance’ section it states:

‘The Royal College of Midwives (RCM) and RCOG [Royal College of Obstetricians and Gynaecologists] are introducing a national intrapartum fetal surveillance training package that can be used locally and will comply with Element four of the SBLCBv2 [‘Saving Babies’ Lives care bundle version 2’].’
(NHS Resolution, 2021)

3.11.3 There is no mention in any of the sections of training on the equipment; the main thrust of all training on CTG is based on interpretation.

3.11.4 Safety action 8 of ‘Saving Babies’ Lives care bundle version 2’ states that trusts must evidence that 90% of maternity staff have attended ‘in-house’ multi-professional maternity emergencies training. Within the technical guidance it states that the training ‘should include fetal monitoring’. The technical guidance expands further, stating:

‘Fetal monitoring training should be based on the previously recommended: multi-professional case history discussions that demonstrate the use of local fetal monitoring tools and resources for risk assessment, classification and escalation.’
(NHS Resolution, 2021)

3.11.5 There is no reference in the maternity incentive scheme to any specific requirement for staff to be trained or have their competency assessed on CTG equipment.

3.12.1 The investigation found a culture that existed around CTG machines, including training and their use. On multiple visits the investigation was told that “a CTG machine is a CTG machine”, and there was a general perception that if you can use one then you can use them all. There was very little consideration of the nuances of the machines and that with some machines there were significant differences in what they were measuring.

3.12.2 Other phrases the investigation heard were “they’re a pretty simple machine, just turn them on and away they go” and “we use the machines all the time, they’re not particularly complicated”. On those visits the investigation was also informed that midwives regularly forgot to carry out certain steps in processes, resulting in loss of information or poor CTG traces. This was reported in trusts that had recently changed their CTG machines and in trusts that had the same machines for years.

3.12.3 When it came to training, it was apparent that most training was conducted as part of annual CPD. The investigation was told that there was an imbalance when training was conducted; typically midwives attended as instructed, but doctors were regularly too busy to attend.

3.12.4 There was an emphasis on the interpretation of CTG traces, which is an area that is widely recognised as needing improvement. However, the investigation identified a lack of knowledge of the equipment in multiple trusts, with no plans in place at any level to address the shortfall of knowledge of the functionality, capability and terminology of CTG equipment.

Equipment

3.13 Staff at each of the trusts raised issues about the usability of all types of equipment purchased for continuous fetal heart rate monitoring. The investigation has captured these issues; however, fundamentally the investigation found that these issues could have been identified as part of a robust procurement process.

3.14.1 Monitors were noted as generally being fixed, normally to a trolley of some description and occasionally mounted on walls. This meant there was little flexibility for positioning of the monitor screen. One midwife said: “Imagine trying to see the trace, either on the paper or the screen, when you’re holding the sensor onto a woman who is laid on a bouncy ball on the floor.”

3.14.2 The investigation was told that with the current IT infrastructure it was difficult to maintain monitoring if the mother needed to be moved between wards. Machines were connected to the centralised monitoring system via leads to internet ports on the walls. In addition, some monitors were too bulky to move between wards and so mothers had to be disconnected from the monitoring equipment, moved, then reconnected. During the period the machine was not connected to the wall, the centralised monitoring was not working, which meant the display on the centralised monitoring station would not display the trace, plus the archiving system would not be recording the trace.

3.15.1 Wireless transducers, which many manufacturers have introduced as an additional option, were found to be problematic. The introduction of wireless transducers was aimed at allowing the mother to move about while still maintaining the continuous monitoring of the fetal heart, with the data transmitted using a process known as telemetry. However, the telemetry would fail due to the distance between the transducer and the machine, and the loss of signal often resulted in having to start the monitoring again. Staff reported that the telemetry also failed if the mother went into the en-suite bathroom, regardless of how thin the walls of the bathroom were.

3.15.2 Each transducer is paired with a monitor. Transducers can be moved between monitors but require pairing with the new machine. This could be beneficial if the transducers with the machine were low on battery power, for example. However, the investigation was also told that this had resulted in transducers being placed with machines and not paired. In an emergency scenario, monitoring could be delayed while the midwife paired the transducer to the machine.

3.15.3 The investigation asked members of staff how long a fully charged transducer battery would last. None of the staff could provide a definitive response. The staff told the investigation that they felt the charge didn’t last as long as required in practice. The transducers charge when placed into their housing on the machines. This became problematic when machines were stored in corridors and not plugged in; without power to the machines the transducers would not charge and this may have contributed to the battery life issues cited by staff.

3.15.4 Staff reported that they had noticed an increase in loss of contact with the fetus (reading of the fetal heart rate) with the wireless transducers when compared to the wired versions. They also noted that the wireless transducers were not as reliable as the wired version when it came to monitoring mothers with a high body mass index (BMI).

3.15.5 Trusts also reported that the transducers were expensive and that they had experienced problems with some going missing. It was thought that several had been thrown out with dirty bed linen. Transducers were damaged when dropped, resulting in significant replacement costs. While one trust had stopped replacing them, another stated that they had initially bought upgraded machines with wireless transducers, but then decided to replace their equipment with wired transducer machines.

3.16.1 All the CTG machines observed by the investigation were fitted with alarms, set for various parameters and settings. Each alarm had a default (manufacturer’s) setting which could be adjusted by the clinician who was using the machine. The alarms reverted back to the default setting when the machine was turned off and back on again. However, it was noted that when staff were asked whether this was the case they were unclear in their responses. Several staff had to turn the machines off and on to give the answer as they were unsure whether the alarm parameters did reset or not.

3.16.2 The purpose of most alarms on the machines was to alert the user to a breach of the clinical parameters of the heart rates being monitored. There were no alarms to notify staff that trace paper had jammed or run out. It was reported that some of the machines jammed more regularly than others. Some machines were able to print the history of the trace; not all machines had this capability. Staff told the investigation they were not aware which machines had this capability.

3.16.3 The CTG trace paper that was being used by the trusts had a red line as a visual indicator that the paper was reaching the end of its roll. There was no audible alarm for the paper running out.

3.16.4 Staff at one trust stated that the older wireless transducers had caused issues as they ‘alarmed’ more often than the wired transducers. After investigation into the alarm there was regularly no issue and the alarm parameters had not been reached (that is, they were false alarms). This resulted in the normalisation of alarm cancellation among staff as they assumed that the alarms were incorrect. The latest models were reported to have been “not so bad” when it came to false alarms.

3.17.1 Centralised monitoring stations were observed in most trusts the investigation visited. Trusts had experienced several problems with their centralised monitoring systems. One trust’s system was not in use due to the many issues it had experienced (external management, update reliability and IT problems). The trust reported that after financing the installation of the system, it had reportedly been used infrequently and the trust was now replacing it with another manufacturer’s system. The monitoring screens that had been fitted around the maternity department were all turned off.

3.17.2 Centralised monitoring systems all used wired connections from the CTG machines to their associated servers. The conventional types of CTG machines were on wheels, allowing staff to move the machines around the room/ward according to the position of the mother. This resulted in issues with centralised monitoring system leads being accidentally “ripped out of the walls”. The leads also suffered from wear over time as they were constantly being connected/disconnected from the socket in the wall.

3.17.3 An additional problem that was encountered was the system not being available in all areas, such as operating theatres. This resulted in sections of the CTG being missing from the archived CTG traces.

3.18.1 At trusts observed by the investigation, not all CTG machines had a form of electronic fetal heart rate analysis software installed. The availability varied between trusts. Some had bought machines exclusively with software as part of the package, while others had a mix of machines, both with and without the software, on their wards.

3.18.2 Often this meant that staff would use a machine based on whether they liked using it, they were familiar with it, or the machine had the software installed. This would inevitably result in occasions where the preferred machine, either by midwife preference or scenario preference (that is, if computerised analysis was required), would not be available to the midwife.

3.18.3 The investigation was told about a case where computerised analysis of the CTG was not available after 20:00 hours because the day assessment unit, which housed the CTG machines with this capability, was closed.

3.19.1 Staff raised very few concerns about machine faults. The investigation heard about only one incidence of a machine fault, where wireless transducers, when used in conjunction with a fetal scalp electrode (FSE) (see 1.8), had only printed the fetal heart rate and not the maternal (mother’s) heart rate. However, a trust informed the investigation that on one occasion the maternal heart rate was printed and not the fetal heart rate. This was only noted after the fetus had died and the machine was still printing a heart rate.

3.20.1 There was considerable variability in the methods used within trusts to log faults with equipment. The processes differed depending on whether the fault had harmed patients or not. If patient harm had occurred then a report may be submitted to the Medical and Healthcare products Regulatory Agency (MHRA) through its Yellow Card Scheme, although this is voluntary. A report would be submitted to the Strategic Executive Information System (a national database of serious incidents in healthcare) and an associated investigation would take place. The HSIB investigation found that reporting through the MHRA was variable across maternity services. Manufacturers stated that they were notified about incidents involving their equipment by both the MHRA and by trust contacts – sometimes by both but often by one or the other. All manufacturers told the investigation that if they were notified by trust staff directly then they would notify the MHRA of any reportable incidents to ensure they were captured.

3.20.2 A trust informed the investigation that faults were logged with the electronic patient record midwife (EPRM) as they had the contacts with the manufacturers. The EPRM kept a spreadsheet of all ‘tickets’ logged with faults that had been escalated to the manufacturer. However, this spreadsheet was kept on a shared device within the maternity department and was therefore not visible to anyone outside of the department, including IT or medical engineering staff.

3.20.3 In addition, there was often a single point of contact within the maternity department for the trust to use to communicate with the manufacturer. All corporate knowledge sat with that individual, with little or no resilience in the system if that person was absent. The potential loss of knowledge included system knowledge, process knowledge, contact information and knowledge of the customer relationship.

3.21.1 Trusts were keen to emphasise the continuous use of the equipment, with monitoring taking place somewhere within the department 24 hours a day. This meant that normal wear and tear on the equipment could be significant, with some issues being repairable by the trusts and some requiring the purchase of new equipment or maintenance by the manufacturer.

3.21.2 The ability of trusts’ medical devices departments to repair certain equipment faults influenced the availability of equipment and the confidence of staff in using the equipment. While one trust regularly had its machines repaired by its medical devices department and confidence in the equipment was high, another trust had printer issues which needed to be repaired by the manufacturer. The trust concerned had 32 machines, of which 22 required the print functionality to be fixed by the manufacturer; coupled with other issues, this had resulted in a lack of confidence in the machines.

3.22.1 Linked to the number of repairs required, the robustness of some items of equipment also raised concerns among staff. Common complaints centred on the robustness of the leads supplied with the equipment. Problems with leads meant staff often had to switch leads between machines, which inevitably resulted in machines being left without the required leads.

3.22.2 The investigation also heard that there were issues with the quality of the FSE clips, with staff reporting that they would continually break during the process of applying them to the fetus’ head. Some staff reported that entire batches of these clips were brittle and parts of the clip broke easily when it was being attached to the fetus. However, the investigation was also informed by trusts, including one that uses FSEs regularly, that there was no issue with the clips and that unfamiliarity with the process may be a factor in clips breaking. The trusts that reported issues with the FSE clips did not, in comparison, use them very often.

3.23.1 After describing the issues that they had experienced with their equipment, some trusts told the investigation that the relationship they had with manufacturers and their representatives had become tense. The investigation was informed of disagreements about equipment reliability, functionality and suggested repairs. It was evident that a lot of problems were caused by lack of knowledge of equipment and contractual agreements made as part of the procurement process.

3.23.2 In trusts where machines had been introduced to staff in a way that was controlled and well communicated, with an element of training, or where familiar machine types had been upgraded to newer models, the investigation noted fewer issues. In those cases, generally the relationships with the manufacturers were good, with effective communication between the trusts and the manufacturers’ representatives.

3.24.1 Staff confidence was a significant factor in the success of the roll-out of new machines. Staff trusted monitors with familiar appearance, symbols and terminology; they had a knowledge base of the basic functions and how to operate them, which they could transfer easily to the new machines. If the machines had slightly different processes, such as having to initiate the print function instead of it starting automatically, they were aware of them. These processes had become second nature to staff, which allowed them to use the equipment in the manner intended. This did not address the previously stated issues of having a comprehensive knowledge of the machines; there were still the aforementioned knowledge gaps (see 3.10).

3.24.2 The investigation found that when equipment was purchased without staff knowledge and/or without staff being involved in the decision-making process, it engendered a sense of distrust. Whether this affected the reporting of faults, with staff looking for things to go wrong with the machines, could not be determined. However, after speaking to manufacturers, the investigation found that there was a reciprocal level of distrust or scepticism in the issues that were being reported.

3.25.1 A theme that was identified through HSIB’s maternity programme was a lack of clarity about, or existence of, centralised monitoring policies. The investigation found that none of the trusts it visited or spoke with had a centralised monitoring policy.

3.25.2 The investigation attempted to determine what roles and responsibilities were set out by trusts for the use of centralised monitoring systems. When one member of staff was asked about trust policies, they told the investigation: “I think it’s in the CTG policy.” This was a common response from staff when the question was asked. Each time the policy was requested and supplied, it was found to make little or no reference to the centralised monitoring system.

3.25.3 One trust informed the investigation that it had a centralised monitoring system standard operating procedure, which set out staff roles and responsibilities, and what the system was to be used for. However, when it tried to supply the document to the investigation it found it was mistaken and there was no such document.

3.25.4 It also became apparent from the investigation’s conversations with staff that there were conflicting views about who was responsible for the overview of the system. One senior staff member stated: “It’s everyone’s responsibility, isn’t it?” This was also evident during HSIB maternity investigations, where the installation of centralised monitoring systems gave staff false assurances. Staff thought that someone senior was looking at the central screens and monitoring situations, and that therefore if something was wrong, they would be informed. This was often an incorrect assumption. There were also incidents that occurred where the centralised monitoring station was used to conduct reviews of the CTG. One incident that was shared with the investigation, where the fetus died during labour, involved a mother at high risk of birth complications and a fetus with a known genetic disorder. The CTG trace reviews were being conducted outside of the labour room and resulted in the loss of a holistic view of the mother and fetus, culminating in the assessments not considering all the relevant risk factors.

3.25.5 While the main staff-facing aspect of the installed systems are the central monitoring screens, these are mainly a by-product of the machines’ original purpose. The manufacturers refer to these systems as ‘central archiving and monitoring systems’, where the main intent and purpose was to supply an archiving system for CTG traces, for review and evidence.

3.25.6 A trust that had been using the archiving and monitoring system for 18 years showed the investigation the benefits it had provided. The trust used the system to review cases, regularly looking at recent cases and learning as a department. It used the system for instructional and reflection purposes, which the staff understood and had bought into. This process had been integrated into the trust training regime and was documented. However, when it came to the monitoring aspect of the system, there was no policy which described the roles, responsibilities and intended use.

3.26.1 A number of national guidance documents make recommendations for trusts to follow. Particularly relevant to this investigation are: NHS England’s ‘Saving Babies’ Lives care bundle version 2’ (SBLCB2) (NHS England, 2019); NHS Resolution’s maternity incentive scheme (NHS Resolution, 2021); and the National Institute for Health and Care Excellence (NICE) ‘Intrapartum care for healthy women and babies’ (CG190) (National Institute for Health and Care Excellence, 2017).

‘Saving Babies’ Lives care bundle version 2’

3.26.2 SBLCB2 refers to reducing human error through the use of antepartum (pre-birth) computerised CTG, stating:

‘A failure to meet the Dawes/Redman criteria usually prompts even the most experienced clinician to re-evaluate their clinical assessment. It provides a second line of defence when a less experienced doctor or midwife interprets a CTG. Therefore, with a recognition that the evidence is inconclusive, SBLCBv2 recommends the antepartum use of computerised CTG over and above visualised CTG due to the potential to reduce the risks of human error.’
(NHS England, 2019)

3.26.3 It is clear at the end of this extract that this means any computerised analysis method has the potential to reduce the risk of human error. At the start of the extract it mentions failing to meet the Dawes-Redman criteria; this is not a direct recommendation to trusts that they must use Dawes-Redman, but by mentioning it the SBLCB2 has inadvertently guided trusts in their procurement strategy.

3.26.4 The investigation has already highlighted that the most common term used in midwifery for computerised analysis of CTG is Dawes-Redman (see 3.10.3). The mention of the term in the SBLCB2 has increased the use and reinforces a misconception that all computerised CTG analysis is Dawes-Redman.

3.26.5 The investigation spoke with trusts that were in the process of replacing ageing equipment. The trusts had identified that if they wanted to buy CTG machines that had Dawes-Redman, as specified in the SBLCB2, there was only one machine they could purchase. This was a clear indication that the procurement process and staff mindset was being swayed towards one manufacturer because of the reference to a specific version of CTG electronic analysis software.

3.26.6 The investigation has identified that trusts have been influenced during procurement processes by the appearance of Dawes-Redman in the SBLCB2 text.

NICE guidance

3.26.7 The NICE guidance, ‘Intrapartum care for healthy women and babies’ (CG190), gives clinical recommendations and ‘has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding’ (National Institute for Health and Care Excellence, 2017).

3.26.8 In the section on ‘Measuring fetal heart rate’ the guidance has the following line under telemetry:

3.26.9 Trusts procuring new CTG machines had read the line and placed telemetry as a requirement for the new equipment. This then led them to purchasing equipment that they described as expensive. As described in 3.15, after purchase trusts then discovered issues. The guidance was seen by trusts as being prescriptive and they thought that to ensure they were meeting/reflecting NICE guidance they would need to have telemetry capability.

3.26.10 NICE has already begun a review of its CG190 guidance document; a review of its telemetry statement is not included in the scope of the review.

3.26.11 Based on the impact on trusts and the influence that the guidance has had on procurement processes, particularly financially but also operationally, HSIB makes the following recommendation.

• There is variation in the way trusts approach the procurement of equipment and in the use of multidisciplinary team working during the procurement process.
• There was a lack of use of change management processes by trusts to help ease new processes/equipment into service.
• Multiple manufacturers produce monitoring equipment with multiple specifications.
• There is no consistent approach to training for maternity staff on the equipment they use.
• There are no competency checks for maternity staff on the operation of CTG monitoring equipment (there are checks on their ability to analyse the output of CTG machines).
• Centralised monitoring is often installed and used with no clear understanding of its purpose or clearly defined roles and responsibilities for staff using it.
• National guidance has inadvertently influenced some trusts’ procurement decisions, which has in some cases resulted in financial costs.