Prevention of Future Deaths reports · 2015
Regulation 28 report to prevent future deaths, reference 2015-0252, written 3 Jul 2015. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 Jul 2015 |
|---|---|
| Reference | 2015-0252 |
| Deceased | Davina Tavener |
| Coroner | Alan Walsh |
| Coroner area | Manchester (West) |
| Category | Other related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) NOTE: This form is to be used after an inquest. REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: + Dame Deirdre Hutton, Chief Executive, Civil Aviation Authority, 45-59 Kingsway, London, WC2B 6TE . Mr Patrick Ky, Executive Director, European Aviation Authority, Postfach 10 12 53, D-50452, Cologne, Germany « Mr Eamonn Brennan, Chief Executive, Irish Aviation Authority, The Times Building, 11-12 D’Olier Street, Dublin, Ireland 1 | CORONER T am Alan Peter Walsh Area Coroner, for the Coroner Area of Manchester West 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 On 11" November 2014 I commenced an Investigation into the death of Davina Tavener, 47 years, born on the 29" November 1966. The Investigation concluded at the end of the Inquest on the 15" June 2015. The medical cause of death was 1a) Unascertained The conclusion of the Inquest was Davina Tavener died as a consequence of naturally occurring diseases of unknown source. 4 | CIRCUMSTANCES OF THE DEATH 1. Davina Tavener died at San Bartolome, Arrecife Airport, Lanzarote on the 1 November 2014. 2. On the 1* November 2014 Mrs Tavener was travelling with her husband on Ryanair Flight FR2131 from Manchester to Lanzarote. During the final part of the journey, and approximately three hours into the flight, Mrs Tavener visited the toilet on the Aircraft and she was noted to be in the toilet for a prolonged period of time. When Hl and the Ryanair cabin crew became concerned the toilet door was opened and Mrs Tavener was found in a standing but collapsed condition in the toilet. Mrs Tavener was removed from the toilet and she || was laid on the floor of the Aircraft cabin for CPR, which was commenced immediately. A passenger announcement was made for a medically qualified person and a Nurse and a Consultant Surgeon responded. The Consultant Surgeon was EE, who is a Consultant Oncoplastic Breast Surgeon employed by the Royai Bolton Hospital NHS Foundation Trust. 3. RR began cardiopulmonary resuscitation using the pocket face mask provided by the cabin crew and chest compressions were given by the Nurse and the cabin crew. 4. camp asked the cabin crew for their medical equipment and she was told that the only relevant equipment on board the Aircraft was a pocket face mask. asked for an airway adjunct (a plastic tube that is inserted into the mouth or down the nose both of which prevent the tongue from occluding the airway and thereby allowing air to pass into the patient’s lungs). asked for suction equipment (equipment to remove blood/vomit from the patient’s mouth, enabling the airway to remain free of obstruction, so that air can pass into the patient's lungs). asked for a bag-valve-mask and oxygen (a bag-valve-mask is basic airway management equipment that allows for oxygenation and ventilation of patient to which oxygen can be attached). asked for a defibrillator (a machine that delivers electrical energy to the heart and may treat life threatening heart conditions). The cabin crew informed that they did not have any of the aforementioned equipment on the Aircraft. 5. The Aircraft continued to the nearest Airport which was the destination Airport at Lanzarote and resuscitation continued until the Aircraft landed at Arrecife Airport, Lanzarote. 6. After the Aircraft landed at Arrecife Airport paramedics came onto the Aircraft and confirmed that Mrs Tavener had died. RONER‘ ERN 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. The MATTERS OF CONCERN are as follows:- 1. During the Inquest evidence was heard that i, The Aircraft operated by Ryanair on Flight FR2131 carried six oxygen bottles, two pocket masks (resuscitation aids) and three first aid kits, the contents of which were approved by the Irish Aviation Authority. The equipment complied with the Regulations of the European Aviation Safety Authority. The European Aviation Safety Authority is responsible for the Regulations in relation to equipment to be carried on Aircraft operating in Europe and from bases in Europe and the competent national authority, namely the Civil Aviation Authority for UK based Airlines and the Irish Aviation Authority for Irish based Airlines including Ryanair, are responsible for oversight of compliance with the Regulations. The Regulations do not require Aircraft to carry the equipment requested __ and the minimum requirement is to carry the equipment carried by Ryanair on Flight FR2131. It was accepted that Ryanair was operating within the Regulations in relation to medical equipment on Flight FR2131. The evidence at the Inquest confirmed that some Airlines do carry the equipment requested by |, even though there is no Regulation for such equipment to be carried. Evidence was given that the equipment is carried on some long haul flights as opposed to short haul flights but it was accepted that the differential is not relevant in view of the fact that a cardiac arrest can occur at any time whether the Aircraft is ten minutes into a flight or ten hours into a flight. WE gave evidence, supported by the Pathologist, that when someone has suffered a cardiac arrest, time is of the essence and the equipment requested by her could be critical in an attempt to save life. confirmed that a defibrillator would be critical to survival in cardiac events and a defibrillator would give someone the best chance of survival in a situation where there is a cardiac arrest. The evidence confirmed that for every one minute when activity in the heart has stopped the chance of survival reduces by ten percent and the availability of a defibrillator at the earliest time would increase the chance of survival. Both | the Pathologist gave evidence that an airway adjunct, suction equipment, bag-valve-mask and a defibrillator should be carried on all Aircraft as a mandatory provision of medical equipment to assist in the treatment and resuscitation of a passenger on an Aircraft and to give a passenger the best chance of survival until the Aircraft can reach the nearest destination. evidence and detailed The provision of the aforementioned equipment would be used for the reasons explained vs in paragraph 4.4 of this report. Evidence was given that all the above equipment is now available as relatively inexpensive portable equipment and, in particular, a defibrillator is very simple to operate in that the defibrillator will announce instructions in relation to use by the operator. It may be felt that cases of sudden cardiac arrest on Aircraft are very rare but Airlines carrying defibrillators have led to lives being saved and the saving of a single life would justify the availability of equipment on all Aircraft for use as and when a medical emergency arises, The Federal Aviation Authority has required US Airlines to carry a defibrillator on flights since 1994. vii. The evidence raised concerns that there is a risk that future deaths will occur unless action is taken to review the above issues. 2. I request you to consider the above concerns and to carry out a review with regard to the following:- i. The Regulations in relation to mandatory and compulsory medicai equipment to be carried on Aircraft operating both within Europe and out of bases in Europe. The medical equipment to be carried on Aircraft as a mandatory and compulsory provision with specific reference to airway adjuncts, suction equipment, bag-valve-mask equipment and a defibrillator. The compliance by Airlines under the control of the competent national authority, namely the Civil Aviation Authority in the United Kingdom and the Irish Aviation Authority in Ireland, to address any changes in the mandatory and compulsory provision of medical equipment to be carried on Aircraft. ACTION SHOULD BE TAKEN In my opinion urgent action should be taken to prevent future deaths and I believe you and your organisation 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 28" August 2015. 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:- 1. HE ors Tavener’s husband 2. Mr Michael O'Leary, Chief Executive, Ryanair Holdings PLC, Ryanair Corporate Head Office, Dublin Airport, County Dublin, Ireland 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. i Signed Alan P Wal
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.
Civil Aviation Authority Mr A P Walsh H M Area Coroner H M Coroner's Court Paderborn House Howell Croft North Bolton BL1 1QY 4 September 2015 Your ref: APW/CLW/03248-2014 Dear Mr Walsh DAVINA TAVENER DECEASED | refer to your letter of 3 July to Dame Deirdre Hutton, on whose behalf | am responding. | must apologise for missing your 28 August deadline, and the need for [EMFo chase this up. Your letter referred to your report to prevent future deaths under paragraph 7, schedule 5, of the Coroners and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. The report followed upon the conclusion of the Inquest, on 15 June, into the death of Davina Tavener. Your report raised a number of Matters of Concern from the Inquest evidence and you requested the CAA, the Irish Aviation Authority and the European Aviation Safety Authority (EASA) to consider those concerns and carry out a review with regard to the following: 1. The Regulations in relation to mandatory and compulsory medical equipment to be carried on aircraft operating both within Europe and out of bases in Europe; 2. The medical equipment to be carried on aircraft as a mandatory and compulsory provision with specific reference to airway adjuncts, suction equipment, bag-valve-mask equipment and a defibrillator; and 3. The compliance by airlines under the control of the competent national authority, namely the Civil Aviation Authority in the United Kingdom and the Irish Aviation Authority in Ireland, to address any changes in the mandatory and compulsory provision of medical equipment to be carried on aircraft. Under the heading “Action should be taken” at section 6 of the Report, you state your opinion that urgent action should be taken to prevent future deaths, and your belief that | and my organisation have the power to take such action. Our response is required to contain details of action taken or proposed to be taken, setting out the timetable for action, or otherwise explain why no action is proposed. Civil Aviation Authority CAA House K5 45-59 Kingsway London WC2B6TE www.caa.co.uk Direct Line 020 7453 6174 Fax 020 7453 6175 david.stoplar@caa.co.uk It should be noted, as recorded at section 5(1) of your report on the evidence given at the Inquest, that EASA is responsible for the regulations relating to equipment to be carried on aircraft operating in Europe, and that competent national authorities, such as the CAA and IAA, are responsible for oversight of compliance. Those regulations do not require aircraft to carry the equipment in question and the minimum requirement is to carry the equipment that Ryanair carried on the subject flight. It was accepted that Ryanair was operating within the regulations on that flight. The details of the regulatory framework were set out in a response of 10 March 2015 to your request for information for the Inquest, so will not be repeated here. In terms of possible changes to the current regulations on compulsory carriage of defibrillators, the CAA’s current view as set out on its Aviation Health Unit website, is that cases of sudden cardiac arrest are very rare when compared to the number of passengers carried. The evidence from those airlines that have been carrying them on a voluntary basis is that although a few lives are saved, in most cases the use of a defibrillator is not successful. This is partly because some of the cases are not due to ventricular fibrillation (the most common cause of cardiac arrest) and therefore a defibrillator will not be able to restore a normal rhythm. Also even if a normal heart rhythm can be restored, the cause of the abnormal rhythm — such as a heart attack — cannot be treated until the person gets to hospital and this can take several hours. Although defibrillators are now more commonly found in public places, they are not a legal requirement even in places where large numbers of people gather. There is no evidence that airline passengers are at increased risk of sudden cardiac arrest and most authorities do not consider that it would be justified to make it compulsory for all aircraft to carry defibrillators. Some airlines do carry defibrillators on a voluntary basis — particularly those operating on long haul sectors or mixed long haul and short haul sectors. The EASA regulations require operators to consider carrying them, depending on the type of their operations and other factors, such as passenger demographics (age etc). In the case of an airline operating only short haul routes, with flight durations of typically up to 3-4 hours (but often much shorter), the likelihood of a passenger who was well at the time of boarding having a significant medical event during the flight, let alone a cardiac arrest, is exceptionally small. Your report notes at Section 5(vi) that “the saving of a single life would justify the availability of equipment on all Aircraft for use as and when a medical emergency arises.” Tragic as this incident was, the mandating of any health or safety requirement will always be subject to some form of cost benefit analysis by whichever regulatory body seeks to introduce it. While defibrillators themselves are relatively cheap, there are significant additional costs associated with initial and continuation training for the crew in using them — reliance cannot be placed on there being a trained health professional or first aider on board at the time of the incident — and of specialist expertise in advising on the defibrillator programme, particularly the review of incidents where the defibrillator has been applied. With reference to the request at Section 5(2)(i) and (ii) of your report, we consider that a change in EASA regulations to mandate the general carriage of this equipment would currently be difficult to justify. We acknowledge however the importance of keeping the evidence of such incidents under review, and sharing such information and data as we receive with our EASA colleagues. We also recognise that there is scope, given current voluntary carriage by some airlines, and EASA requirements to consider carriage, to further look at the efficacy and success rate where this occurs and whether other airlines should be challenged to take action voluntarily. We would propose therefore to raise this issue at the CAA/industry forum for such discussions, the Flight Operations Liaison Group. Here we could obtain an industry view on the issue, and in particular whether operators should review their risk assessments with regard to medical kits and defibrillators. It would be for EASA to consider the need for any change in the Regulations which apply to EU operators and for ICAO to consider this in relation to non-European operators. In either case, this would require significant international agreement that a change should be mandated. While the UK cannot act alone in terms of legal change, if, through working with industry it could be shown that there was an evidence based case for a change in the legislation, the CAA would support this. With reference to Section 5(2)(iii) of your report, it would of course be CAA’s role in the UK to ensure regulatory compliance with any new legislative requirements. Yours sincerely ee Head Safety & Airspace Legal Team
» AEASA European Aviation Safety Agency Patrick KY Mr Alan P Walsh Executive Director H M Area Coroner H M Coroner’s Court Paderborn House 2015(D)53782 Howell Croft North SBl/mde/Flight Standards Directorate It Cologne, aL 1 TOY 26. AUS. 2015 ENGLAND e-mail: coroners@bolton.gov.uk Subject: Provision of emergency medical equipment on-board Reference: Your letter dated 03 July 2015 Ref APW/CLW/03248-2014 Dear Mr Walsh, Thank you for sharing your concerns with us about the provision of emergency medical equipment on-board passenger aircraft operating under EU legislation, in particular; airway adjuncts, suction equipment, bag-valve mask equipment and defibrillators. | would like to clarify the particular status of the European Aviation Safety Agency (EASA). As you may be aware, EASA is governed by Regulation (EC) 216/2008 which sets our tasks and responsibilities in the area of aviation safety. EASA’s legal status, as an Agency of the European Union, the latter being an international organisation, is further set out in Protocol (No 7) on the Privileges and Immunities of the European Union to the Treaty on the Functioning of the European Union. In light of this, the Agency is not subject to the national rules and procedures of a Member State, such as the Coroners and Justice Act 2009, the Corners (Investigations) Regulations 2013 and any ensuing instructions derived therefrom. Notwithstanding the above, | have given due consideration to your concerns, also taking into account the circumstances of the tragic event that triggered your request. The subject of defibrillators has been debated at length over recent years within the international aviation community, and the International Civil Aviation Organisation and the EU have so far concluded not to mandate their carriage. However, | do see a lot of merit in your proposal in support of the health and welfare of the travelling public. Technological advancements, with automated external defibrillators becoming smaller, lighter, more economic, and, more importantly, easier and safer to use; coupled with changing passenger demographics, reinforces the opportunity for the issue to be revisited. We will therefore engage with our Member States to reconsider the situation through analysis of available data. We will launch a first discussion on this matter at our next meeting with Member Postal! address: Postfach 10 12 53, Tel.: +49 221 89990 2000 Fax: 2500 50452 Cologne, Germany £-mail: patrick.ky@easa.europa.eu Visiting address: Ottoplatz 1 Web: www.easa.europa.eu ‘An agency of the European Union TE.GEN.00104-002, 50679 Cologne, Germany 1SO 9001 Certified Page 1 of 2 European Aviation Safety Agency BAEASA States’ representatives participating in the air operations thematic advisory group which is scheduled to take place on 9 September 2015. Yours sincerely, ie Postal address: Postfach 10 12 53, Tel.: +49 221 89990 2000 Fax: 2500 14 50452 Cologne, Germany E-mail: patrick.ky@easa.europa.eu teye® Visiting address: Ottoplatz 2, Web: www.easa.europa.eu ‘An agency of the European Union, TE.GEN.00104-002 50679 Cologne, Germany 1S0 9001 Certified Page 20f2
Irish Aviation Authority Udards Eitliochta na hEireann —_T: +353 1 603 1558 The Times Building Foirgneamh na hAmanna T: +353 1 603 1546 i 11~12 D’Olier Street 11-12 Sréid D’Olier F: +353 1 679 2935 Le Dublin 2, Ireland Baile Atha Cliath 2, Eire www. iaa.ie Directors’ Office Oitig Stidrthdiri | A A 17% July 2015 Mr. Alan P. Walsh, H M Area Coroner, Manchester West, H M Coroner’s Court, Paderborn House, Howell Croft North, Bolton BL1 1QY UK re ina Tavener Dear Mr. Walsh, I am writing to you in relation to your letter to a: ::<0 3r4 July 2015, regarding your Report concerning the death of Davina Travener on the ist November 2014. Thank you for sharing your Report with the IAA and we share your desire to prevent further deaths under any circumstance where it is feasible to do so. With regard to the carriage of defibrillators (AED) on passenger aircraft, | can confirm the following is the current situation with regard to Irish Air Operator Certificate (AOC) holders: INFORMATION REGARDING AED AND AIRCRAFT TYPES OPERATORS A330 aircraft (Predominantly longhaul ops) - AED carried A319/A320/A321 (shorthaul ops) — No AED carried currently but plans are in progress to fit all shorthaul aircraft with AEDs in the Aer Lingus near future. B757 (longhaul ops) - AED carried B737-300 (shorthaul ops) -AED carried B737-800 (shorthaul ops) — AED carried B737-800 (shorthaul ops) — No AED carried ATR 42 & ATR 72 (shorthaul ops) — No AED carried IRISH CAT Bord Stidrthdiri/Board of Directors Oitig Chiéraithe: Registered Office: Anne Nolan (Cathaoirleach/Chairman), Foirgneamh na hAmanna, 11-12 Srdid D’Olier The Times Building, 11-12 D'Olier Street Eamonn Brennan (Priomhfheidhmeannach/Chief Executive), Gaile Atha Cliath 2, Eire Dublin 2, Ireland Marie Bradley, Ernie Donnelly, Pascal Fitzgerald, Uimbir Chidraithe; 211082. Ait Chiéraithe: Eire Registered No, 241082. Registered in Ireland Basil Geoghegan, Michael Norton, Kevin O'Driscoll Cuideachla Diiteanais Theoranta A Limited Liability Company All AOC holders are in full compliance with the recommendations of European Aviation Safety Agency (EASA) and International Civil Aviation Organisation (ICAO). The following are observations from EASA and ICAO in regards to carrying defibrillators on board: 1. EASA; Regulation (EU) No 965/2012 on Air Operations, Annex IV (Part CAT) In the AMCs to the Regulation (EU) No 965/2012 on Air Operations (available here), it is recommended, for commercial air transport operations, to carry an automatic external defibrillator on aeroplanes required to carry an emergency medical kit (those having a passenger seating configuration of more than 30 seats when any point on the planned route is more than 60 minutes flying time at normal cruising speed from an aerodrome at which qualified medical assistance could be expected to be available) under certain conditions. Namely the acceptable means of compliance to the rule concerned (CAT.IDE.A.225), listing the content of the Emergency Medical Kit, recommend operators to determine through risk assessment the need to carry the defibrillator. So there is no strict requirement for operators, but only a recommendation based on the result of a risk assessment. 2. ICAO: The above is in line with the current ICAO Annex 6 recommendation, which reads as follows: ATTACHMENT B. MEDICAL SUPPLIES Supplementary to Chapter 6, 6.2.2 a) 1.2 Based on the limited available evidence, only a very small number of passengers are likely to benefit from the carriage of automated external defibrillators (AED) on aeroplanes. However, many operators carry them because they offer the only effective treatment for cardiac fibrillation. The likelihood of use, and therefore of potential benefit to a passenger, is greatest in aircraft carrying a large number of passengers, over long duration sector lengths. The carriage of AEDs should be determined by operators on the basis of a risk assessment taking into account the particular needs of the operation. Regarding the carriage of AED’s on short-haul aircraft, there may be very little impact on the actual overall statistics. Notwithstanding that, I can confirm that the Chief Executive of the IAA has written to the Chief Executive of Ryanair on the matter. Further to that correspondence, it is our understanding that Ryanair are now positively reviewing the carriage on their fleet and that they will make a decision shortly. If this were to come to pass, it would be on a voluntary basis and is beyond the current EASA / ICAO requirements. Finally, on behalf of the Irish Aviation Authority, I wish to extend my sympathies to the family of Ms. Tavener for the sad loss of their loved one. Yours sincerely, Head Corporate Affairs Irish Aviation Authority
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