Dear Coroner,

Re: Regulation 28 Report to Prevent Future Deaths – Reginald Edwin Bourn who died on 24 February 2022.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 8 August 2023 concerning the death of Reginald Edwin Bourn on 24 February 2022. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Reginald’s family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Reginald’s care have been listened to and reflected upon.

In your Report, some of your concerns related to the lack of instructions, national guidance, and protocols/training on the insertion of nasogastric decompression tubes. I will address these within the realms of NHS England’s statutory powers, roles and responsibilities. Where I am unable to assist, I hope to provide you with some direction on either where such information can be obtained or from what organisation.

Whilst NHS England would not routinely provide national guidance on the insertion of nasogastric decompression tubes, there is existing national guidance in the form of the Royal Marsden Manual, who have particular expertise in this area. The manual has a section on ‘Insertion of a nasogastric drainage tube’ which contains background information and specific procedural guidance for the insertion and removal of these tubes, including around pH testing. This is aimed at clinical nursing staff who would routinely be the staff responsible for placing nasogastric tubes in patients. The Manual is a well-known guide for nurses to deliver clinically effective, patient-focused, and evidence-based care.

You raised concern about some nasogastric tubes having product instructions and others not. Product instructions for the use of nasogastric decompression/drainage tubes would not sit within the remit of NHS England. The Coroner may wish to refer this concern to the Medicines and Healthcare products Regulatory Agency (MHRA) as they would be the organisation responsible for issuing the relevant instructions. NHS England will be happy to support the MHRA with the dissemination of any new instructions/guidance to relevant healthcare professionals.

In your Report, you also raised the concern that a Healthcare Safety Investigation Branch independent report 12019/006 found that the use of pH strips is potentially unreliable and incorrect X-ray confirmation and interpretation is the most common National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

27 December 2023

cause of nasogastric tube misplacement incidents. It recommended national standardised competency-based training for nasogastric tube placement and confirmation by pH testing.

The National Institute of Health and Care Excellence (NICE) are the statutory body who lead on developing and disseminating clinical guidance and I note that you have also sent your Report to them. NHS England will carefully consider NICE’s response to you and any actions that may be required from us as a result.

As to national training provisions around insertion of nasogastric tubes, I asked my colleagues from the national Workforce, Training and Education (WTE) Directorate at NHS England to consider your Report and the concerns raised. They advised that such a training programme would not come under NHS England’s remit. Individual NHS Trusts are responsible for the implementation of locally recommended practice and protocols, including the staffing and availability of workforce. You may wish to engage with Frimley Health NHS Foundation Trust for further information on their specific practice and protocols regarding placement of nasogastric tubes.

What is clear from your Report is that there does appear to be some inconsistency of understanding and awareness around instructions or guidance on the insertion of nasogastric decompression tubes. Considering this, NHS England has asked regional colleagues to ensure that they raise awareness of what happened in Reginald’s care, the concerns raised in your Repot and the learnings with their regional Integrated Care Boards (ICBs). ICBs are responsible for planning and commissioning health services for their local populations and will be able to engage with their respective local NHS Trusts and NHS providers on this matter to ensure that there is understanding of guidance and information available.

I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Ms Topping,

I write in response to your regulation 28 report regarding the sad death of Reginald Edwin Bourn. I would like to express my sincerest condolences to his family.

We have considered the circumstances surrounding Mr Bourn’s death and I have addressed below the matters of concern on which NICE can comment.

Lack of national guidance on the placement of nasogastric decompression tubes

In your report you explained that while there is national guidance in relation to the placement of nasogastric feeding tubes, there is not the same for nasogastric decompression tubes.

NICE has not published guidance on the management of small bowel obstruction, and so has not made recommendations on nasogastric decompression. Your report has been shared with our topic selection and prioritisation team to consider the need for NICE guidance in this area.

Healthcare Safety Investigation Branch (HSIB) report on the placement of nasogastric feeding tubes

You expressed concern that the HSIB made recommendations on the placement of nasogastric feeding tubes, having found that the use of pH strips is potentially unreliable and that incorrect X-ray confirmation and interpretation is the most common cause of misplacement incidents.

In the NICE guideline on nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition [CG32] we recommend that:

The position of all nasogastric tubes should be confirmed after placement and before each use by aspiration and pH graded paper (with X-ray if necessary) as per the advice from the National Patient Safety Agency (2011); further patient safety alerts for nasogastric tubes have also been issued in 2013 and 2016. Local protocols should address the clinical criteria that permit enteral tube feeding. These criteria include how to proceed when the ability to make repeat checks of the tube position is

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limited by the inability to aspirate the tube, or the checking of pH is invalid because of gastric acid suppression. (Recommendation 1.7.17)

Both the HSIB’s report on the placement of nasogastric tubes and your report concerning the death of Mr Bourn have been shared with NICE’s guideline surveillance team to see if an update to this recommendation is required.

Instructions for nasogastric decompression tubes

On your point that ‘feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed [while] decompression tubes have neither’, we believe the Medicines and Healthcare products Regulatory Agency (MHRA) would be best placed to consider this issue as the UK’s regulator of medical devices.

Dear Ms Topping,

: Regulation 28 Report - Reginald Edwin Bourn

I would like to thank you for your email dated 1 November 2023 regarding the Regulation 28 Report for the death of Reginald Edwin Bourn and the subsequent response from

Chief Executive, NICE, regarding instructions for nasogastric decompression tubes. I would like to express our condolences to the Bourn family and hope that the information provided below may help at this difficult time.

Firstly, it may be helpful if to provide background information relating to the MHRA and the work we carry out. The MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment, including medical devices, are used safely and meet appropriate standards of safety, quality, performance, and effectiveness. The MHRA assesses the balance of risks and benefits of medical devices throughout their use in clinical practice in a process known as vigilance. This involves the collection of information and assessment of any potential risks, followed, when necessary, with communications and regulatory action to minimise those risks. Where serious incidents involving medical devices have been reported to other authorities including the Police, Coroners and the Health and Safety Executive (HSE), the MHRA provides technical expertise and facilitates independent testing if required. The MHRA ensures any concerns raised from these investigations are disseminated to the health service to prevent further incidents or taken up with the manufacturer.

Following receipt of the Regulation 28 Report we have considered point two in the matters of concern: “Feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. The decompression tubes have neither”. We have reached out to the manufacturers of nasogastric tubing to confirm their primary intended use and to review their instructions for use (IFU) for both feeding and decompression tube placement.

We expect to complete the initial review of the IFUs by 4 January 2024. Following this review, we will work with manufacturers to update their IFU where applicable. If updates are made, the MHRA is of the opinion that they should issue a Field Safety Notice (FSN) to highlight the changes to clinicians, and ensure that their staff are fully trained in the changes so that they can provide advice to clinicians where necessary.

I would like to thank you once again for raising this important safety issue to our attention and I hope the information provided is useful and I will provide a summary of any planned actions by 4 January 2024. In the meantime, please do not hesitate to contact me if I can be of further assistance.