Prevention of Future Deaths reports · 2025
Regulation 28 report to prevent future deaths, reference 2025-0044, written 24 Jan 2025. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 24 Jan 2025 |
|---|---|
| Reference | 2025-0044 |
| Deceased | Neville McKenzie |
| Coroner | Emma Brown |
| Coroner area | Birmingham and Solihull Districts |
| Category | Care Home Health related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
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) Birmingham and Solihull Integrated Care Board 2) The Health and Safety Executive CORONER I am Emma Brown, Area Coroner for Birmingham and Solihull Districts 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. INVESTIGATION and INQUEST On 6 September 2024 I commenced an investigation into the death of Neville Daniel Elisha MCKENZIE. The investigation concluded at the end of the inquest. The conclusion of the inquest was that death was due to accidental choking as a consequence of cognitive impairment. CIRCUMSTANCES OF THE DEATH Mr McKenzie died at City Hospital, Birmingham on the 25th August 2024 as a result of the effects of a cardiac arrest caused by an incident of choking on the 13th August 2024 at his care home. Mr McKenzie was recognised to be at risk of choking because his dementia meant he would eat quickly and put too much food in his mouth. Consequently, his care plan was for him to be supervised eating and encouraged to sit and eat slowly. On this occasion he had eaten his lunch under the general supervision of staff and left the dining room without giving any cause for concern. A short time later he was witnessed to be choking by staff who immediately commenced manoeuvres to try and remove the food from his airway but this was unsuccessful and he went into cardiac arrest. He received CPR and was successfully resuscitated by paramedics and transferred to hospital but had suffered an un-survivable brain injury. Based on information from the Deceased’s treating clinicians the medical cause of death was determined to be: 1 2 3 4 1a Hypoxic brain injury 1b Cardio respiratory arrest 1c Choking 1d II Dementia 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 will occur unless action is taken. In the circumstances it is my statutory duty to report to you. 5 The MATTERS OF CONCERN are as follows. – 1. The inquest heard evidence from , Director of Operations for 1st explained that since Mr McKenzie's death they have Care Limited, the company which owns Acorn Care Home where Mr McKenzie was a resident. purchased a number of anti choking devices and provided training to all staff on the use of them as part of their first aid training. This arose from investigations and research carried out by 1st Care Limited to try and avoid a fatal incident occurring again. Prior to Mr McKenzie's death 1st Care Limited had no knowledge of the availability of these devices. regulatory requirement for Care or Nursing Homes to have these devices available. explained that there is no legal or 2. , who has considerable experience working in health and social care, said she was concerned that there was not wider knowledge of the existence of these devices particularly for homes that have a high volume of residents with choking risks like Acorn Care Home. 3. I heard evidence that the devices are relatively inexpensive and do not require extensive training. 4. ' evidence was that she felt the devices could save lives in the event of choking incidents and the fact that most homes would not have them, even those with a high risk resident cohort, was creating an avoidable risk of deaths. 5. It was my finding that there is not wide knowledge of the availability of these devices in care settings and if more homes had them it is likely that deaths from choking could be reduced. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe you have the power to take such action. YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely by 21 March 2025. 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. COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons: (daughter of the deceased and Acorn Care Home. I have also sent it to the NHS England and the CQC who may find it useful or of interest. I am also under a duty to send the Chief Coroner a copy of your response. 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 by the Chief Coroner. 24 January 2025 6 7 8 9 Signature: Emma Brown Area Coroner for Birmingham and Solihull
2 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.
NHS Birmingham and Solihull Integrated Care Board First Floor Wesleyan Colmore Circus Birmingham B4 6AR Telephone: 0121 203 3300 www.birminghamsolihull.icb.nhs.uk 21 March 2025 Miss Emma Brown Area Coroner for Birmingham and Solihull Districts By way of email only: Dear Miss Brown, Inquest into the death of Neville Daniel Elisha McKenzie. Response to Regulation 28 and 29 of the Coroners (Investigations) Regulations 2013. I am writing in response to the Regulation 28 and 29 notice issued following the inquest on 23 January 2025 into the death of Mr Neville Daniel Elisha McKenzie at City Hospital on 24th August 2024. We offer our sincere condolences to Mr McKenzie’s family and friends. We acknowledge the concerns raised regarding the awareness and availability of anti-choking devices in care settings and the need for action to prevent future deaths. ICB Interventions to Mitigate Future Risk The ICB does not directly purchase anti-choking devices for care homes. However, we are committed to ensuring that care homes have the information and support they need to make informed decisions about whether to purchase and use these devices, in alignment with Resuscitation Council UK (RCUK) guidelines. The ICB adheres to the RCUK guideline which emphasises that any use of anti-choking devices should be adjunctive to, and not a replacement for, the established techniques recommended by the RCUK for manag- ing choking, which include encouraging coughing, back blows, and abdominal thrusts. The ICB has reviewed current practices and is implementing the following measures: • Providing training and resources: The ICB has: • Commissioned training for nursing homes, including a guest speaker on choking prevention for the Birmingham and Solihull Nurses and Clinical Leads Network on March 20, 2025. • Provided free training on modified diets and choking risk, including the use of recommended International Dysphagia Standardisation Initiative (IDDSI). • Shared information on the NHS E-Learning for Health platform, including dysphagia e-learning developed by speech and language therapy experts. • Offered free training on Learning from Events to all Nursing Homes. • Ensuring best practice and compliance: The ICB is monitoring compliance with dysphagia guide- lines, conducting a review of choking incidents with Safeguarding and Learning from lives and deaths of people with a learning disability and autistic people (LeDeR) teams, and sharing findings with Speech and Language Services to discuss further support. • Conducting assessments and investigations: The ICB is updating the nursing home quality team assessment tool for a more in-depth review of dysphagia management. This includes developing a root cause analysis tool to improve the investigation of choking incidents. • Facilitating learning and dissemination: The ICB has shared the clinical learning alert, included choking and dysphagia management, in NHS contractual meetings and the new Nursing Home Man- agers Development Programme. • Promoting support and collaboration: The ICB is working with the Support to Care Homes Team in Solihull and exploring the current provision of support from commissioned Speech and Language community services. The ICB takes the recommendations within the Regulation 28 report extremely seriously. The actions outlined above demonstrate our commitment to learning from Mr. McKenzie’s death and working to prevent future similar incidents. We will continue to build on these actions and provide support and advice through evi- dence-based literature and guidance. Yours sincerely ICB Chief Executive NHS Birmingham and Solihull Appendix 1 Anti Choking Devise evidence 1.1 NICE Guidelines: At present, there are no specific guidelines from the National Institute for Health and Care Excellence (NICE) that mandate the use of anti-choking devices in nursing homes. NICE guidelines focus on evidence-based practices, and currently, there is insufficient evidence to support the routine use of these devices in such settings. 1.2 Resuscitation Council UK (RCUK) Guidelines: The Resuscitation Council UK does not support the use of suction-based airway clearance devices (anti-choking devices) due to a lack of sufficient research and evidence on their safety and effectiveness. The RCUK emphasises established choking management tech- niques, such as encouraging coughing, back blows, and abdominal thrusts, which are well-supported by clinical evidence. For more information, please refer to the RCUK's position on the use of suction-based airway clearance devices here RCUK’s position on the use of suction-based airway clearance devices on choking individuals | Resuscitation Council UK 1.3 Resuscitation Council UK (RCUK) has reviewed this statement in light of the ILCOR systematic review on removal of foreign body airway obstruction (April 2021) Removal of foreign body airway obstruction (BLS 368): Systematic Review (ilcor.org) and the ILCOR 2022 Evidence Update. No new evidence was identified to alter ILCOR’s or RCUK position on suction-based air- way clearance devices. RCUK recommendations therefore remain unchanged. RCUK welcomes ILCOR’s call for high-quality clinical research focused on assessing the potential benefits and harms of suction-based airway clearance devices. Removal of foreign body airway obstruction (BLS 368): Systematic Review For more information, please refer to the RCUK's position on the use of suction-based airway clearance devices here RCUK’s position on the use of suction-based airway clearance devices on choking individuals | Resuscitation Council UK which are supported by clinical evidence 1.4 CQC Guidelines: The Care Quality Commission (CQC) provides guidance on caring for people at risk of choking. This guidance emphasises the importance of individualised care plans and proper training for staff to manage choking risks effectively. For more information, please refer to the CQC's guidance here Issue 6: Caring for people at risk of choking - Care Quality Commission 1.5 GOV.UK Guidance: According to GOV.UK, anti-choking devices, also known as airway clearance de- vices, are intended for use in the management of choking incidents by removing obstructions from the air- ways via manual suction after other approaches have failed. These devices are classified under the Medical Devices Regulations 2002 and Regulation (EU) 2017/745 as class I devices. The Medicines and Healthcare products Regulatory Agency (MHRA) has investigated concerns about the evidence supporting the quality, safety, and performance of these devices. The MHRA recommends that users follow established Basic Life Support protocols when managing a choking incident and that anti-choking devices should only be used by healthcare professionals trained in advanced life support. For more information, please refer to the MHRA's guidance on medical devices here Medical devices: information for users and patients - GOV.UK and DSI here Device_Safety_Information_-_counterfeit_Anti-Choking_Devices.pdf 1.6 Initial analysis: In response to the inconclusive evidence regarding anti choking devices the ICB have a number of concerns listed below: • Safety and Effectiveness: The primary concern with anti-choking devices is the potential delay in administering established choking treatments. There is also a risk that these devices could worsen the situation by pushing obstructions further into the airway. • Training and Implementation: Effective use of anti-choking devices requires effective training and regular practice. Without adequate training, there is a risk of improper use, which could lead to ad- verse outcomes. • Regulatory Compliance: The MHRA has highlighted issues with counterfeit and unbranded anti- choking devices that do not comply with UK Medical Device Regulations. These devices, which do not have a valid UKCA or CE mark, may pose a significant risk of worsening choking if used. They should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.
Health and Safety Executive Head of Health and Public Services Sector Engagement & Policy Division Health and Safety Executive Redgrave Court Bootle Merseyside L20 7HS Emma Brown Area Coroner for Birmingham and Solihull Coroner's Court Steelhouse Lane Birmingham B4 6BJ By email to: , PA to HM Senior Coroner Date: 19 March 2025 Dear Ms. Brown NEVILLE MCKENZIE: PREVENTION OF FUTURE DEATHS REPORT Thank you for your Regulation 28 report dated 24/01/2025, issued following the inquest into the death of Neville McKenzie. I am replying as the Head of HSE’s Health and Public Services Sector. I would like to express my sincere condolences to Mr McKenzie’s family and loved ones. Matters of concern I understand that Mr McKenzie died at the City Hospital, Birmingham on 25/08/2024, as a result of a choking incident at Acorn Care Home (provided and run by 1st Care Limited) on 13/08/2024. During the inquest the Director of Operations for 1st Care Limited expressed the view that anti-choking devices could save lives in the event of choking incidents. Your report raises the concern that there is not wide knowledge of the availability of these devices in care settings and if more care homes had them it is likely that deaths from choking could be reduced. In preparing this response, I have considered: • • the respective responsibilities of regulators in England when dealing with health and safety incidents in the health and adult social care sectors the regulation of medical devices. Following consideration of these factors, I respectfully advise that HSE is not the appropriate regulator or policy lead to address this concern relating to anti-choking devices because: • 1st Care Limited are a service provider registered with the Care Quality Commission (CQC), and therefore regulation of this and similar care providers falls under their enforcement responsibility • anti-choking devices are medical devices for which the Medicines & Healthcare products • Regulatory Agency (MHRA) are the UK regulator the Department of Health and Social Care (DHSC) are the government department that leads on health and social care policy and delivery in England. These bodies will therefore be better placed to address your concerns about the use of anti-choking devices in health care premises. To provide further clarification, I have set out below more detailed information on how health and safety incidents are regulated in the health and adult social care sectors in England and on regulatory responsibility in respect of medical devices. Regulation in England of health and safety incidents in the health and adult social care sectors In England, the regulation of health and safety in adult and social care sectors is shared between HSE/Local Authorities and the CQC. This is set out in a Memorandum of Understanding (MoU) that outlines each regulator’s respective responsibilities. In summary, in respect of patient safety: • CQC is the lead inspection and enforcement body under the Health and Social Care Act 2008 for safety and quality of treatment and care matters involving patients and service users in receipt of a health or adult social care service from a provider registered with CQC. • HSE/LAs (depending on the type of premises) are the lead inspection and enforcement bodies for health and safety matters involving workers, and patients and service users who are in receipt of a health or care service from providers not registered with CQC. I draw your attention to Annex 1 of this MOU that gives illustrative examples of incidents where CQC take the lead (i.e. where the provider is registered with the CQC), including a patient/service user being seriously injured or dying as a consequence of choking. As mentioned, 1st Care Limited are a service provider registered with CQC, and therefore fall under their enforcement remit. Regulation of medical devices MHRA are the regulator of medicines, medical devices and blood components for transfusion in the UK. Anti-choking devices are classed as medical devices by MHRA, and they have published guidance on this issue: guidance on anti-choking devices. This agency’s responsibilities include: • ensuring medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy 2 • securing safe supply chain for medicines, medical devices and blood components • educating the public and healthcare professionals about the risks and benefits of medicines, medical devices and blood components, leading to safer and more effective use • enabling innovation and research and development that is beneficial to public health • collaborating with partners in the UK and internationally to support the mission to enable the earliest access to safe medicines and medical devices and to protect public health. Additionally, the Department of Health and Social Care (DHSC) are the government department that leads on health and social care policy and delivery in England. Its responsibilities include making sure that legislative and policy frameworks are fit for purpose. MHRA is an executive agency of DHSC. I understand you have already copied your Regulation 28 report to the CQC as an interested party. You may also wish to refer your concerns to MHRA who can be contacted at DHSC, who have a dedicated inbox to receive coronial correspondence at and to . Yours sincerely, Head of Health and Public Services Sector 3
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