Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0288, written 8 Aug 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 8 Aug 2023 |
|---|---|
| Reference | 2023-0288 |
| Deceased | Reginald Bourn |
| Coroner | Caroline Topping |
| Coroner area | Surrey |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. 2. , Chief Executive, Health Education England , Chief Executive, National Institute for Health and Care Excellence 1 CORONER I am Caroline Topping assistant coroner, for the coroner area of Surrey. 2 CORONER’S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. 3 INVESTIGATION and INQUEST An inquest into the death of Mr Reginald Edwin Bourn was opened on the 12th May 2022 and on the 19th June 2023. The inquest was concluded on the 27th June 2023. Reginald Bourn died at Frimley Park Hospital on the 24th February 2022. The cause of death was: I a Aspiration of Gastrointestinal Content I b Small Bowel Obstruction caused by either a Peritoneal Adhesion or Incarceration of an Inguinal Hernia (Resolved) The narrative conclusion was: Reginald Bourn was admitted to Frimley Park Hospital with acute abdominal pain and a distended stomach. Investigations revealed prominent small bowel loops but no transition point. He began to vomit. He was treated conservatively, and a nasogastric tube was used to decompress his stomach. On the 24th February 2022 the tube had fallen out by 4.30 by which time he no longer felt nauseous. He began to vomit again, and staff were advised to reinsert the nasogastric tube at 7.02. He was seen at a surgical ward round at 9.45 by which time the tube had not been reinserted. The plan remained for conservative treatment and decompression with a nasogastric tube. He was admitted to a surgical ward with a NEWS score of 3 at 10.20. Insertion of the nasogastric tube was effected by 11.40. The tube was misplaced into his left lung. Prior to 12.00 he suffered an acute event resulting in the aspiration of one and a half litres of stomach content into his lungs. His condition significantly worsened, his 1 NEWS score was 10 and his blood oxygen level deteriorated to 88%. He died from the aspiration of gastrointestinal content. The misplacement of the nasogastric tube more than minimally contributed to the death. Misplacement of nasogastric tubes into the lungs is a known complication of a necessary medical procedure. 4 CIRCUMSTANCES OF THE DEATH Mr Bourn had an intestinal blockage on admission to hospital which required the placement of a nasogastric draining tube to decompress his stomach. The first tube came out and a second one was placed by an experienced nurse. Shortly thereafter he suffered an acute event and aspirated one and a half litres of gastrointestinal content into his left lung. A chest X ray was taken. He died shortly thereafter. When read the X ray revealed that the tube had been misplaced in the left lung. He died as a consequence of the aspiration of gastrointestinal content which was in part attributable to the fact that the misplaced tube enabled ingress to the lung of the aspirate, and in part because the stomach content had not been drained. 5 CORONER’S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows: 1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus. 2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The 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. 3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes. However, as exemplified by this case, misplacement of either can prove fatal. 4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed. 5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents. 2 6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing. 7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes. 6 ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you [AND/OR your organisation] have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 3rd October 2023. I, the coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise, you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: Mr Bourn’s Family Frimley Park Hospital I am also under a duty to send a copy of your response to the Chief Coroner and all interested persons who in my opinion should receive it. I may also send a copy of your response to any other person who I believe may find it useful or of interest. The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me, the coroner, at the time of your response, about the release or the publication of your response. 9 Caroline Topping, 8th August 2023 3
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra Ms Caroline Topping HM Assistant Coroner 27 November 2023 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. Yours sincerely, Chief Safety Officer Medicines and Healthcare products Regulatory Agency
Caroline Topping
Surrey HM Coroner’s Court
Station Approach
Woking
GU22 7AP
Dear Coroner,
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
27 December 2023
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
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.
Yours sincerely,
National Medical Director
2nd Floor
2 Redmond Place
London
E20 1JQ
United Kingdom
27 October 2023
Caroline Topping
HM Coroner’s Court
Station Approach
Woking
Surrey
GU22 7AP
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
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.
Yours sincerely,
Chief executive
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