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Healthcare watchdog, HSIB, has published its latest national learning report into maternity safety, focussing on the suitability of continuous fetal heart rate monitoring equipment used in pregnancy and labour.
HSIB’s report, Suitability of equipment and technology used for continuous fetal heart rate monitoring, raises concerns about NHS trusts’ procurement (choosing, sourcing, buying and replacing) of CTG monitoring equipment, and lack of midwife competency testing and training.
What is fetal heart monitoring?
During pregnancy and labour the fetal (unborn baby’s) heart rate is an important indicator of their health and wellbeing. The baby’s heart rate may be monitored to check their condition as part of their mother’s antenatal (pregnancy) care, particularly if there are concerns, risks or complications. The fetal heart rate is also monitored regularly, and in high risk labours continuously, throughout the first and second stages of labour. Safe childbirth and effective fetal heart monitoring depend on a combination of staff knowledge, team working, and correct use of equipment and interpretation.
The fetal heart rate is monitored in many different ways and using different types of equipment.
Intermittent Auscultation or IA
In low-risk pregnancies, with no complications, the unborn baby’s heart rate may be monitored in labour by IA or intermittent auscultation (listening) using a Pinard stethoscope or a hand-held Doppler machine.
Cardiotocography or CTG
CTG monitoring electronically records the fetal heart rate and the mother’s contractions. Transducers are placed on the mother’s abdomen and send signals to the CTG monitor which records the fetal heart rate pattern and the mother’s contractions onto the screen or on a paper graph (CTG trace). The NHS uses various different types of CTG monitors across the healthcare system.
Fetal scalp electrode or FSE and STAN
If external monitoring via a transducer produces a poor quality trace, a fetal scalp electrode may be directly applied (during vaginal examination) to the unborn baby’s scalp (or buttock if the baby is in breech position). A FSE can only be used after the membranes (waters) are broken, and where there are no clinical reasons to avoid FSE monitoring. FSE may be used together with an ST analysis (STAN) to analyse the baby’s ECG (which measures the heart’s electrical activity and heartbeats). STAN is not a replacement for skilled clinicians, who must interpret the information produced by the CTG, but can help identify signs of hypoxia (oxygen deprivation).
Ultrasound scans use high-frequency sound waves to create images of the unborn baby which help with assessing their age, growth, and checking for abnormalities. During an ultrasound examination the blood flow in the baby or placenta over a short period of time may be measured by Doppler. Ultrasound Doppler measurements are different from those obtained by hand-held Doppler devices, which can only count the fetal heart rate.
Computerised CTG analysis
Computerised CTG analysis uses electronic fetal analysis software to provide a computerised analysis of the fetal heart rate pattern, based upon set criteria. There are many different types of computerised CTG analysis system, the best known being Dawes-Redman, which can only be used in the pre-labour phase of pregnancy.
A central monitoring system connects the CTG monitors from the ward via a central server and displays more than one CTG on the same screen. This is usually situated on a station on the labour ward, allowing clinicians to view and assess CTG traces without entering the mother’s delivery room.
Why is fetal heart rate monitoring important?
When carried out properly, as part of an overall assessment of the mother and baby’s condition during pregnancy and labour, fetal heart rate monitoring provides vital information to the maternity team. In most cases, the CTG trace provides welcome reassurance about the unborn baby’s wellbeing, but the main purpose of CTG monitoring is to provide early warning of danger signs (fetal distress) which can lead to life-saving intervention.
HSIB’s previous review of 39 HSIB maternity investigations into stillbirths, neonatal deaths and babies born with suspected brain injury identified common issues with fetal monitoring and the suitability of equipment and technology used to monitor the baby’s heart rate in labour. HSIB say a further review of 138 completed HSIB maternity investigations identified 238 findings which referred to issues with CTG monitoring (including CTG equipment). Issues with fetal monitoring have also been identified in other reports relating to maternity safety, including the RCOG’s Each Baby Counts programme.
Boyes Turner’s cerebral palsy team have acted for countless children whose brain injury and associated claims arose from negligent failure to use, interpret or act on the information provided by CTG monitoring.
Findings from HSIB’s investigation into fetal monitoring (CTG) equipment
HSIB’s investigation focussed specifically on CTG monitoring equipment used in maternity units to carry out continuous fetal heart rate monitoring during labour and birth. The investigation looked at how CTG machines are procured by NHS trusts, problems with their use, and how staff are trained and assessed as competent to use them.
Intermittent auscultation (IA) and the interpretation of CTG traces are specifically excluded from the scope of this report but may be the focus of a future HSIB investigation.
HSIB found that multiple manufacturers produce CTG monitoring equipment with multiple specifications. The process by which NHS trusts choose, agree, purchase, and implement new or replacement CTG equipment is known as procurement.
Different trusts handled procurement in different ways. Whilst some formed multidisciplinary teams with expertise in procurement and in the relevant clinical field, in some trusts CTG equipment was procured by a single clinician, who had no expertise in procurement and with no involvement from other departments or clinicians in the relevant field.
Poor procurement processes led to problems including:
- equipment being bought that was incompatible with existing equipment;
- staff being unaware that equipment was being replaced;
- machines were bought:
- which were too bulky to be moved with a mother when she was transferred between maternity unit wards;
- which had limited or no battery back-up, preventing the machine from being unplugged while a mother was transferred between wards, resulting in fetal heart rate monitoring being lost or interrupted;
- relying on national guidance which was unsuitable for the environment or incompatible with existing technology at the trust;
- equipment was introduced with almost no information given to the staff who were to use it, leading to obstructive behaviour from staff, difficult roll-outs, equipment not being used, and financial loss.
- centralised monitoring was often installed and used with no clear understanding of its purpose, or clearly defined roles and responsibilities for the staff who use it.
In addition, HSIB found that the wording of some national guidance had unintentionally affected procurement decision making, resulting in trusts buying equipment without properly ensuring its compatibility with existing equipment or that the equipment met their specific needs.
Lack of maternity staff knowledge, competence and training
HSIB recognised that correct interpretation of CTG traces is a common area of concern found during HSIB maternity investigations and referred to the NHS’s strong emphasis on training maternity staff in the interpretation of CTG traces. Despite this, they found issues related to staff knowledge of equipment, including a lack of in-depth understanding of the use of CTG equipment.
They found that there was:
- no evidence of any formal training being carried out by trusts to ensure that staff had in-depth knowledge of the equipment they were using;
- no consistent approach to training for maternity staff on the equipment they use;
- no competency checks for maternity staff on the operation (rather than interpretation) of CTG monitoring equipment;
- lack of staff knowledge of certain functions, symbols or acronyms displayed on the machines;
- an assumption that the CTG machines were all fairly basic and much the same, and that those who use them regularly must be competent.
Boyes Turner help families whose babies have been severely harmed by maternity mistakes
Whilst it is disappointing that HSIB’s report into fetal heart monitoring fails to explore intermittent auscultation and CTG misinterpretation, HSIB’s latest report demonstrates that, even in the area of fetal heart monitoring equipment, maternity safety incidents are often caused by more than one individual’s mistake. National guidance, adequate resources, multidisciplinary training and trust culture all play an important role in keeping maternity patients and their babies free from harm.
Injuries to babies from failings in maternity safety are undoubtedly amongst the most severe that we experience as medical negligence lawyers. Families are devastated and lives are destroyed. Whilst the disability that is suffered by these children can never be undone, we remain committed to helping them recover full compensation to give them the best quality of life and the opportunity to achieve their own individual potential.
If you are caring for a child or young adult with cerebral palsy or severe neurological disability and would like to find out more about making a claim, you can talk to one of our specialist solicitors, free and confidentially, by contacting us here.
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