Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0109, written 29 Mar 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 29 Mar 2023 |
|---|---|
| Reference | 2023-0109 |
| Deceased | Angela Kearn |
| Coroner | Caroline Topping |
| Coroner area | Surrey |
| Category | Other related deaths · Product 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. 2. 3. 4. Accidents 1 CORONER , Chair of the General Medical Council. , Chair of National Trading Standards , Chief Executive of the Royal Society for the Prevention of , Chief Executive Officer, Decathlon UK 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 Following an investigation opened on the 2nd March 2020 and an inquest opened on the 5th March 2020 the inquest was concluded on the 20th December 2022. The cause of death was: 1a.) Immersion Pulmonary Oedema II.) Hypertension and Menopause treated by Hormone Replacement Therapy The narrative conclusion was: Angela Jean Kearn was suffering from hypertension and taking hormone replacement therapy. On the 13th January 2020 she was snorkelling using a full face mask. She developed immersion pulmonary oedema and died at the Nile Hospial, Hurghada Egypt. Hypertension, hormone replacement therapy and the use of the full face mask each more than minimally contributed to the death 4 CIRCUMSTANCES OF THE DEATH i.) ii.) iii.) iv.) v.) Angela Kearn was aged 63 when she died. She had recently been diagnosed with hypertension which was being treated with atenolol. She was also taking hormone replacement therapy. For the previous 5 years she had been using a Decathlon Easybreath full face snorkel mask when on holiday. On the 13th January 2020 she was snorkelling using the full face mask when she expressed concerns and was accompanied back to the beach. She collapsed and died. Expert evidence at the inquest identified immersion pulmonary oedema as the cause of the death. This is caused by the build-up of fluid in the lungs as a result of an increase in pulmonary capillary pressure caused by water pressure when the chest is submerged. This is exacerbated by hypertension and hormone replacement therapy. Negative pressure in the lungs causes fluid from the blood vessels to be drawn into the lungs. The use of a full face snorkel mask contributed to the death in two ways: a.) because negative pressure in the lungs is increased as a result of the increased effort of breathing caused by inhalation through the snorkel tube and mask, and b.) because respiratory effort is increased by the inhalation of elevated carbon dioxide levels caused by inhaling air drawn through a dead space in the mask. 1 Both exacerbate the negative pressure in the lungs and increase the effects of immersion pulmonary oedema. 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: Awareness of Immersion Pulmonary Oedema in the medical profession: i.) Concerns were raised by the medical witnesses that there is very little awareness of Immersion Pulmonary Oedema in the medical profession and that it is not addressed in medical training, as a consequence, it can be missed by those treating the condition and is often mistaken for drowning. The Full Face Mask At the time that the Easybreath full face snorkel mask was developed by Decathlon there were no United Kingdom or European Standards which were applicable to a full face snorkelling mask. In the course of its development, Decathlon commissioned a number of tests to be undertaken on it, but it was accepted in evidence that the tests undertaken did not replicate the conditions of the use of the mask by the general public. Decathlon have sold over 16 million of the masks. Other such masks are also on the market. The Decathlon usage instructions for the full face mask, contained in small print, have been amended over time. From the 17th August 2015 the instructions included a warning that you must make sure that you are in good physical condition before snorkelling and that the mask is not suitable for swimming. Further tests were undertaken and an Ergomedical report considered the issue of whether use of the mask and inhalation through the mask’s dead space gave rise to excess carbon dioxide inhalation. The report concluded “we strongly recommend to advise against wearing Easybreath masks to people who suffer from underlying cardio-respiratory conditions.” As a result, Decathlon amended their instructions for use to include that the mask should not be used if the user has unstable cardio-respiratory pathologies, that the mask is to be used under conditions of submaximal exercise (mild to moderate) and that it is not suitable for active swimming. Development of a United Kingdom standard in relation to this type of mask is now being put in train but has not yet begun and is likely to take some time. Decathlon have recently updated their website in the United Kingdom to include the following, “It is not recommended to use this product if you have any ongoing respiratory or cardiovascular issues including but not limited to chest infection, asthma, high/raised blood pressure (hypertension), heart disease or angina etc. If you have any doubts or questions relating to this please check with your medical practitioner." The same additional wording is being translated and added to all websites of the company. The packaging of the mask has been revised to show a pictogram to warn against use of the mask by those with heart or other cardiovascular conditions. The concern is that many million of the full face masks have been sold and the safety concerns about their use by those with ongoing cardiovascular and respiratory issues has not been widely publicised or brought to the attention of those who already own the masks. Those purchased before 2017 had no warning is relation to these matters and the warning included in the instructions from 2017 inwards was not prominent nor sufficient to alert prospective purchasers to the hazards of use which have now been identified. ii.) iii.) iv.) v.) vi.) vii.) viii.) ix.) x.) xi.) i/ 2 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 9th May 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: Decathlon UK 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. Caroline Topping, 29th March 2023 9 3
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.
4 May 2023 Miss Caroline Topping Assistant Coroner South-Eastern England- London Coroners Group Dear Miss Topping Regulation 28 report Angela Kearn I am responding on behalf of Professor . I am deeply sorry to hear of the untimely and tragic circumstances of Angela Jean Kearns’ death. I extend my deepest condolences to Angela’s family and those impacted by her death. Following an incident in Egypt, your report has raised concerns about awareness of ‘Immersion Pulmonary Oedema’ in the medical profession and that this condition is not specifically addressed in medical training. Through our standards and quality assurance of medical education and training we ensure that doctors in the UK are equipped with professional behaviours, knowledge, and skills to competently assess complex and uncertain acute and emergency situations. In addition, through professional clinical reasoning doctors are able to consider relevant differential diagnoses and manage acute medical emergencies including identifying people at high risk due to underlying comorbidities (such as Angela’s age and her history with hypertension). I hope the information above assures you that clinical knowledge and training is being assessed in areas that may intersect with Immersion Pulmonary Oedema and therefore if a doctor in the UK was to encounter a patient with this rare condition, they should have the tools and knowledge to be able to diagnose the condition and proceed accordingly with treatment. Whilst it is not the role of the GMC to comment on specific clinical practice, Immersion Pulmonary Oedema is a rare condition and its emergency presentation may be similar to other medical emergencies. Its immediate management will also be similar and therefore we feel at this stage no further specific education and training intervention would be required. Institutions such as the Medical Royal Colleges may be able to provide you with information related to the details for a process to identify and develop areas where learning is needed and can be shared in postgraduate training across the relevant specialties and subspecialties. The GMC is a charity registered in England and Wales (1089278) and Scotland (SC037750). I note that this case happened in Egypt. We are not able to comment on the level of training or the medical education system in Egypt as that country is outside our jurisdiction. The GMC is committed to work with others in the health care sectors to improve training of the professionals we regulate so that doctors are better equipped with dealing with the variety of healthcare concerns and demands within the UK. To provide some context to medical education and training in the UK, I hope the attached annexe is helpful to you. Yours Sincerely Medical Director and Director of Education and Standards, GMC cc: • sarah.church@surreycoroner.gov.uk • officechairceo@gmc-uk.org gmc.uk.org 2 Our role as a medical regulator Our powers in medical education, as set out in the Medical Act 1983, are two-fold: to set the outcomes for graduates of UK medical schools leading to entry on to the medical register and to approve the curricula for postgraduate training of doctors. We quality assure both aspects of medical training against our standards for the management and delivery of medical education and training. The principle of patient safety drives our work. Undergraduate education Our powers don’t extend to mandating specific content in undergraduate curricula, but we determine and publish the high-level outcomes all medical students are required to demonstrate in order to graduate and be awarded a Primary Medical Qualification (PMQ). We updated our Outcomes for graduates in 2018 after extensive consultation. This is supplemented by a set of core Practical skills and procedures graduates must have achieved when they start work for the first time so they can practise safely. Foundation Programme All doctors enter the two-year Foundation Programme after graduating from a UK medical school. It provides new graduates with a range of essential interpersonal and clinical skills for managing acute and long-term conditions. The Academy of Medical Royal Colleges develops the Foundation Programme curriculum, which describes specific outcomes all Foundation doctors should demonstrate on completion of the programme. Our regulatory role is to approve the curriculum. The Foundation Programme curriculum requires first year trainees (FY1) to meet the outcomes we have set out in Outcomes for provisionally registered doctors with a license to practise, which includes fifteen core clinical and procedural skills. This enables the trainee to apply to the GMC for full registration and a license to practice, which is a requirement of entry to the second year of the Foundation Programme. Quality assurance of education and training We also have a duty to make sure medical education and training in the UK is meeting our standards. We expect organisations responsible for educating and training medical students and doctors in the UK to meet the standards set out in Promoting excellence: standards for medical education and training. We quality assure medical schools, postgraduate deaneries and local offices, and local education providers (such as NHS trusts and health boards) to check they are meeting our standards. Our quality activities are risk based, which means we look at our evidence and decide which areas are likely to be of concern. We provide feedback to organisations on how well we think they are meeting our standards. If we are concerned about something, we ask for more information to seek assurance that any issues are being dealt with appropriately, and if we're not satisfied with the response we can intervene. gmc.uk.org 3 We can place organisations providing postgraduate training under ‘enhanced monitoring’, which we do to promote and encourage local management of concerns about quality and safety. This involves more frequent progress updates and we can provide representation on a locally led visit to investigate a concern or check on progress. Where possible we work with all organisations to address the concern and develop a sustainable solution. Sometimes we need to work with other regulators to make improvements. We also approve new medical schools, which we subject to an extensive period of quality assurance to ensure their programmes will deliver the Outcomes for graduates and meet the Promoting Excellence standards. gmc.uk.org 4
National Trading Standards Sylvan Court, Sylvan Way Southfields Business Park Basildon Essex SS15 6TH Caroline Topping Surrey Coroners Service 10th April 2023 Dear Ms Topping, Regulation 28 Report – Angela Kearn We received the above report on 29/3/23. his behalf. Firstly we would like to express our condolences to the family of Ms Kearn. has asked me to respond on National Trading Standards (NTS) is not able to act on the issues raised in this report. NTS is a grant giving body that utilises Government grants to commission specified elements of Trading Standards related work from local authorities. Product safety does not fall within the scope of NTS. We do not receive any grants to commission work in this area. Issues surrounding product recalls and the Government lead for the safety of consumer products lies with the Office for Product Safety and Standards (part of the Department for Business and Trade). They work with local authorities on product recalls and we would recommend that, if it has not already been sent to them, that this report is sent to the Chief Executive of OPSS to respond. I am sorry that NTS is unable to assist directly. Yours Sincerely Director NTS ACTSO Ltd. A subsidiary company of the Trading Standards Institute. Registered in England and Wales. Register Number 8091348. Registered office: 1 Sylvan Court, Sylvan Way, Southfields Business Park, Basildon, Essex SS15 6TH VAT Reg. No GB 795 8626 60
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