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Suitability of equipment and technology for continuous fetal monitoring during labour and birth

The latest HSIB report findings surrounding CTG monitoring, including recommendations for Trusts

HSIB (Healthcare Safety Investigation Branch, which conducts independent investigations of patient safety in NHS funded care) has undertaken an investigation on the suitability of equipment and technology for continuous fetal monitoring during labour and birth, often referred to as CTG monitoring. A CTG is a machine used during pregnancy/birth to monitor the fetal heart rate and uterine contractions. It is commonly used in the third trimester and its purpose is to monitor fetal wellbeing and allow early detection of distress. For instance, an abnormal CTG may indicate the need for further investigations and/or intervention.

The investigation does not focus on interpretation of CTG monitoring, which, although progress is being made to improve this, has been identified as a longstanding problem for clinical staff who may not recognise problems in a timely way and escalate appropriately to avoid harm at birth, and you will see that the report does make reference to this. Instead, this investigation has focused on the suitability of equipment and technology used to monitor the baby’s heart rate in labour. It looked at how CTG machines are used, problems that staff using them experienced, how the machines are purchased and how the staff are trained and assessed as being competent to use them.

The report identified that multiple methods and types of equipment are used to continuously monitor fetal wellbeing during labour and birth. This can cause complexity and safety issues. Common safety issues have been identified with equipment availability and functionality, inability to interpret the fetal heart rate and staff understanding of equipment and its purpose. As a consequence, HSIB made two safety recommendations aimed at NHS England/Improvement and one aimed at NICE, along with three actions for local level learning, which is summarised below.

The local level learning is referred to initially below, as it is likely to be of most relevance in Trusts, as an approach to inform decision-making and processes when purchasing equipment and how the use of the equipment can be implemented to ensure safe staff usability and the safety of patients.

The recommendations for NHSE/I and NICE highlight the need to continuously review and improve how trusts can best use this type of equipment effectively for the safety of the fetus and mother in pregnancy/birth to reduce harm.

Safety observation

For local level learning:

  • It may be beneficial for Trusts to ensure that when procuring new equipment, they form a multidisciplinary team, which incorporates staff with the requisite skills in procurement and the clinical environment in which the new equipment will be used. If the new equipment has additional functionality, then stakeholders from these areas should be included – for example, if the equipment is to be networked, the IT department should be included.
  • It may be beneficial if a single procurement guidance document were produced for trusts to use when purchasing clinical equipment, with all relevant information included.
  • It may be beneficial for Trusts to use a change management system when implementing new systems or introducing new equipment.

The main findings, investigation summary and safety recommendations taken from the full HSIB report are summarised below:

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 (although 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.

Investigation summary

  • Identified the factors that influence the choice of continuous fetal heart rate monitoring equipment.
  • Identified the variations of continuous fetal heart rate monitoring equipment found in clinical practice.
  • Identified barriers to reliable continuous heart rate monitoring and escalation of concerns noted when using technology.
  • Reviewed the factors that need to be considered when using continuous electronic fetal heart rate monitoring equipment. These factors include training, equipment support and engineering usability, with a focus on centralised monitoring.

Safety Recommendations

HSIB recommend that they amend the ‘Saving Babies’ Lives Care Bundle Version 2’ to:

  • Enhance the role of the ‘fetal monitoring lead’ to include, training and competency checks of all maternity staff on the use and functionality of cardiotocograph (CTG) equipment and
  • Remove specific references to Dawes-Redman and instead use a generic term such as ‘computerised cardiotocograph (CTG) analysis’.

HSIB recommend that they consider reviewing their telemetry recommendation as part of the current update of clinical guideline CG190, taking into account the existing evidence and the findings of this report.

Conclusion

Although the report is focused around continuous fetal monitoring, the safety observations identified at local level in particular are likely to apply more broadly to any equipment that is purchased for patient monitoring and can be aligned across services with the Trust in adopting a standard approach when procuring equipment, to establish a clear approach, decision-making and implementation to ensure relevant information is available and that there is an ongoing process to support appropriate usability of the equipment and maintain patient safety.

The findings, investigation summary and safety recommendations are also likely to help inform and identify any gaps in both procuring equipment and its safe use.

For further support or guidance, please contact our healthcare solicitors.

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