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

HSIB Legacy Published
Published 8 April 2022 · Launched 22 July 2020
Maternity Medical devices

This national patient safety investigation looks into the suitability of equipment and technology used for continuous fetal heart rate monitoring during labour and birth.

3 recommendations
3 observations
2 actions
3 of 3 responded

Safety Recommendations (3)

NHS England R/2021/136
HSIB recommends that NHS England and NHS Improvement amends 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.
NHS England agrees on the need for staff CTG training and competency checks. They have included this in a Maternity Incentive Scheme safety action and will add it to the core competency framework. They will update SBLCBv2 by March 2022, allowing Trusts to determine the specific role.
NHS England and NHS Improvement welcome this report. We agree that all relevant maternity staff should be trained and competent in the use and functionality of CTG equipment. We have included this in the minimum requirements for this year’s Clinical Negligence Scheme for Trusts Maternity Incentive Scheme safety action 8 and this is also being added to the next iteration of the core competency framework. We will update SBLCBv2 to reflect the HSIB recommendation but we think Trusts should decide the best way of ensuring staff are trained rather than specifically stipulating that this is the role of the ‘fetal monitoring lead’. Timeline: March 2022 Response received on 4 October 2021.
NHS England R/2021/137
HSIB recommends that NHS England and NHS Improvement amends the ‘Saving Babies’ Lives care bundle version 2’ to remove specific references to Dawes-Redman and instead use a generic term such as ‘computerised cardiotocograph (CTG) analysis’.
NHS England agrees to amend ‘Saving Babies’ Lives care bundle version 2’ by removing the specific reference to Dawes-Redman and replacing it with ‘computerised CTG analysis’ by March 2022.
We note that Dawes Redman criteria are only referenced once in the document and that is in the in the introductory section of the Care Bundle and not in the element section which describe the recommended pathways. We do however agree to make this change. We will remove the specific reference to Dawes-Redman and instead use a generic term such as ‘computerised CTG analysis’. Timeline: March 2022. Response received on 4 October 2021.
National Institute for Health and Care Excellence R/2021/138
HSIB recommends that the National Institute for Health and Care Excellence considers reviewing its telemetry recommendation as part of the current update of clinical guideline CG190, taking into account the existing evidence and the findings of this report.
NICE will review its telemetry recommendation (1.10.9) as part of the ongoing update of clinical guideline CG190, considering existing evidence and the HSIB report findings. A timeline for review, public consultation, and publication is provided, concluding March 2023.
In its guideline on intrapartum care for healthy women and babies [CG190], the National Institute for Health and Care Excellence (NICE) recommends that any woman who needs continuous cardiotocography during labour (monitoring of the baby’s heart rate) should be offered telemetry, which allows the woman to move around and change position (see recommendation 1.10.9). NICE is currently updating CG190 and will review recommendation 1.10.9 as part of this. Action: Review recommendation 1.10.9 as part of current update of CG190. Timeline: Present to July 2022. Action: Public consultation on guideline update. Timeline: 27 September 2022 to 8 November 2022. Action: Publication of guideline update. Timeline: 22 March 2023. Response received on 8 October 2021.

Safety Observations (3)

– 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.
– local-level learning: It may be beneficial for trusts to use a change management system when implementing new systems or introducing new equipment.

Safety Actions (2)

NHS Supply Chain has amended its statement of requirements document and expanded the section on compatibility and connectivity to allow trusts to identify key areas and existing equipment that purchases must be compatible with or able to connect to.
NHS Supply Chain has amended its processes to include a ‘points to consider’ communication with all trusts that opt for the ‘call off’ purchase route. This will allow trusts to ensure that they have considered all requirements and possible conflicts when purchasing new equipment.