Dear Mr Irvine,

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The Resuscitation Council UK has reviewed and discussed the recommendation made in the Regulation 28 Report dated 12 March 2020.

Although defibrillators can be set to start up in either automatic or manual mode, the latter is preferred. This is because when used correctly, studies have shown that a manual mode results in greater chance of return of spontaneous circulation and subsequent survival to hospital discharge, compared with an automatic mode. Manual defibrillation is therefore recommended for advanced life support, as delivered by ambulance paramedics.

We are concerned, therefore, that recommending start-up in an automatic mode may actually worsen overall outcome. The resuscitation standards expected of ambulance paramedics are to deliver manual defibrillation and we would support the remedial actions taken by LAS in relation to local training, labelling and guidelines to ensure appropriate resuscitation practice is safely and effectively applied in future cardiac arrests.

We hope you find this information useful.

Dear Sir Regulation 28; Prevention of Future_ Deaths Report (PFDLarising_from the_inquest _into the death of _Mitica MARIN Thank vou for vour Regulation 28 Report dated 12th March 2020 setting out your recommendations for consideration: would like to begin by expressing my sincere condolences to the family of Mr Marin. will address the matters set out in the PFD report, as directed to the London Ambulance Service NHS Trust (LAS) as follows: Delay in defibrillation of Mr Marin It was accepted in evidence heard at the inquest that Paramedic A did not recognise, in a prompt manner, that Mr Marin was in ventricular fibrillation (VF) (a cardiac rhythm that may respond to defibrillation) and thus a defibrillation shock was not delivered immediately: A serious incident investigation was undertaken into the circumstances that gave rise to this incident The investigation found two causative factors were that Paramedic A, having attached Mr Marin to the Lifepak 15 defibrillator (LP1S defibrillator), did not then look at the screen of the LP1S defibrillator to observe the rhythm displaced and as such did not observer the VF and thus did not charge the LP1S defibrillator and deliver a shock in manual mode. Further, Paramedic A did not turn the LP1S defibrillator into automatic external defibrillator mode (AED) which would have initiated an audio and visual prompt to cease chest compressions and stand clear while the LP1S defibrillator analysed the rhythm and charged The investigation found the factors contributing to this omission were that this was Paramedic A's first shift as a solo responder and the significant stressors of managing a busy and emotionally charged environment, as the only clinician on scene in the initial stages. Paramedic A gave evidence that she focused on specifically coaching those present to assist with chest compressions and this caused her to become distracted from the LP15 defibrillator.

Paramedic A spoke in evidence of her immediate reflective practice and learning, which was supported by her clinical managers, and was able to demonstrate how that was able to it into action just a few later when managing another patient in cardiac arrest_ Paramedic A described how undergoing this reflection and further training has helped reinforce the importance of her training on the order of priorities when managing a patient in cardiac arrest, in a and emotional setting when working as a solo responder When asked what she would do differently going forward, Paramedic A cited the importance of putting the LP15 defibrillator into AED mode as priority and the focus on defibrillation, as the training for paramedics and ambulance crews sets out. Paramedic A cited the training actions the LAS had undertaken around the fundamental importance of prompt defibrillation, where clinically indicated. In addition to this, the LAS has produced clinical update material to mandate that on all cardiac arrests the LP1S defibrillator should initially be placed in AED mode_ comprehensive update bulletin 'Cardiac Care Guidance' dated 28th October 2019 was produced to this effect; attached for reference_ This has also been incorporated this into the core skills refresher (CSR) training which all clinical staff undergo in the LAS LAS thematic analysis of delayed defibrillation It was also recognised that the delay in defibrillation of Mr Marin was not an isolated incident for the Trust In order to address incidents of delayed defibrillation, the LAS undertook a review of similar cases and completed thematic analysis report in December 2019_ The updated Action Plan from this report is attached for your reference_ It is worth noting that the LAS aim to download data from defibrillators and analyse this to improve the care of patients in cardiac arrest: It is through this practice that the LAS have often been able to detect any delay in defibrillation. We would caution ay comparison of LAS practice against organisation who do not undertake such audits The thematic analysis found that a contributing factor to the circumstances where the LP1S defibrillator is not into AED mode was that the LP1S defibrillator model defaults to manual mode before use. It is therefore necessary for the user to deliberately the LP1S defibrillator into AED mode when the circumstances indicate_ You heard live evidence two LAS staff, the Clinical Practice Development Manager Critical Care, who provided a clinical opinion and also spoke in part to the thematic analysis. You also heard from Quality, Governance and Assurance Manager who provided evidence on the serious incident investigation, findings, individual reflection and learning and wider Trust learning as well as speaking on the details of the thematic analysis, action plan to continue work to mitigate the risks of not only the circumstances that gave rise to the delay when treating Mr Marin, but taking into account other contributory factors_

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Can the LP1S defibrillator be set to AED mode as a default? You asked the question whether, if the LP1S defibrillator were to be set to automatic mode by default it would mitigate the risk of a delayed defibrillation, particularly in the circumstances that arose during the resuscitation of Mr Marin: Our Clinical Practice Development Manager gave evidence setting out that it was technically possible for the LP1S defibrillator to be set to AED mode as default; which would require the user to actively have to switch it off when managing a patient who did not require defibrillation: He went on to explain that this option has been considered by the Trust'$ medical directorate but the evidence gathered in consideration of the best option to mitigate against clinicians being distracted and/or overwhelmed managing multiple tasks at busy scene, indicates that to set the LP1S defibrillator to AED mode as default was not overtly practical for to use_ He cited the rationale that the LP1S defibrillator in the pre-hospital setting is used not only for defibrillation but as a multi parameter patient monitor including oxygen saturations, blood pressure and ECG and as such is used in this function many times per by ambulance crews. These functions cannot be used in the main when the LP1S defibrillator is in AED mode_ If the machine defaulted, when turned on, to AED mode it would issue verbal prompt to attach the defibrillation and analysis of the rhythm The LAS has sought the advice of colleagues worldwide as the benefit of this potential change it was felt given the numerous times a shift the monitor is used as a routine clinical assessment tool, it would simply become a matter of 'muscle memory' that the monitor is turned from AED mode to manual mode. It was felt that unintended consequences of such change would be in what are the comparably rare circumstances of a cardiac arrest we would find the ambulance clinicians turning the monitor to manual mode as this is what would do on other occasion it is used. Further to this the LAS is minded of the potential to heighten patient anxiety by the verbal prompts when the monitor is turned on in routine circumstances We would like to provide assurance that the LAS has considered this decision in some detail and assessed the potential benefits and consequences of such a change: Mitigating the risks of delayed defibrillation what are the LAS doing? Taking forward the actions identified in the Sl report for Mr Marin together with the Trust wide actions detailed in the thematic analysis, evidence was provided on the following: Continuing_to identify risks The Trust have taken significant steps in downloading our LP1S defibrillator data and this is one way that we are able to identify incidents of in defibrillation: The Trust set its own target of 20% which we exceeded and as such we increased it to 30%. We are currently on track at around 23%. We are attempting to lead the way with ambulance trusts in respect of these download figures and probably more importantly being able to review this data, but this is a work in progress that we are always seeking to improve. There is a further review planned to build on the finding of this thematic analysis and to monitor the effectiveness of actions that were identified and put into practice: We will be aiming to update our findings based on the continuing evidence we are collating: At this point in time we are unable to commit to a fixed timescale for this, in light of the severe pressures the Trust is currently managing due to the unprecedented demand, in relation to the COVID-19 pandemic response, which will certainly be ongoing for some time

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As a Trust we are proud of our instances of incident reporting, including self-reporting: This has improved significantly in recent years and the Trust has focused on providing supportive environment to identify lessons and learn, both individually (as evidenced by Paramedic A, who self-reported the incident) and as an organisation. Practical measures From August 2019 large vellow indicators (stickers) with 'push analyse for AED mode' were placed on LP1S defibrillators to act as an alert reminder to users to switch the machine into AED mode. This was communicated to staff via station management as well an update in our Routine Information Bulletin (RIB) which is emailed to all staff and also available on the intranet We have also sought to ensure that devices used in training reflect this change_ Training There is an ongoing focus on training and communications with staff: Paramedic A spoke to this effect in her evidence that bulletins, intranet communication, emails and clinical updates in our RIB are source of refresher training: This training has also been reiterated in our core skills refresher (mandatory) training program, which runs quarterly for all operational staff_ CSR 2019.2 and 2019.3 included refresher training on resuscitation including AED mode and order of priorities on scene: Our Quality, Governance & Assurance Manager explained in evidence that training now includes clear and unambiguous priorities to be undertaken at a cardiac arrest thus aiming to reduce the opportunity for errors in this first few minutes in managing a cardiac arrest: This has focused on ensuring that by having clear priorities the 'mental bandwidth' of the clinicians is maximised to ensure can more effectively deal with the challenges they are presented with on scene Human Factors Training Further to the evidence you heard in respect of training, in addition the LAS is continuing to progress 'human factors training' to focus on optimising staff performance through better understanding of behavioural interactions with each other and the environment: This is especially pertinent for operational staff who deal with chaotic, emotional scenes and where no two scenes are the same_ We have started to train clinical education and standard tutors to enable them to train front line staff through CSR program, to ensure human factors are included in the messages. To date, five members of staff have attended a 'Train the Trainer' program for human factors which involved them taking a lead role in being able to apply the principles to investigations and education programs In particular, at each of our 'Train the Trainer' sessions for the CSR program, we ensure human factors training is included in the messages so it is addressed by tutors at each session. We included a particular model to help with communications at scene which was included in our CSR 2017 module A further six staff are due to undertake the 'Train the Trainer' program: We also have a full of training in areas specific to human factors (communication, active listening, speaking Up as part of a team, and how bandwidth impacts decisions and communications) which we hope to be in a position to roll out in July/August

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2020 for all tutors and large number of clinical team managers and advanced paramedic practitioners This timescale will be kept under review, given the ongoing pressures that the Trust is currently facing: Procurement of defibrillators Your report also requests that address the matter of procurement decisions regarding the future supply of defibrillators: Efforts are being made to investigate devices which have in-built technology to potentially bypass the need for a clinician to have to remember to the device in AED mode (for example, a device that would automatically switch the device to AED mode when defibrillator pads were applied). At this point in time, we have not located specific device on the market with this functionality which is also sufficiently robust for the ambulance market; The available options for procurement of defibrillators will continue to be reviewed as part of the processes for tender for procurement of clinical equipment; Where we have such contacts as one of the world's largest users of defibrillators we have encouraged manufactures to consider such options in future development Finally, very much hope this response helps in setting out the ongoing work that the LAS are engaged with to ensure staff are fully up date and trained in the importance of AED mode and defibrillation as the priority and the ongoing work to further develop and monitor trust wide learning and communicate this to our staff We will continue to further our work following the thematic analysis in an ongoing effort to mitigate the risk of delayed defibrillation_ As always, we endeavour to contribute to national and international discussions to seek out the best available options for equipment and welcome the consideration of our stakeholders to this matter,

Dear Mr Irvine

REGULATION 28 REPORT – ACTION TO PREVENT FUTURE DEATHS: MITICA MARIN

I am writing in response to the Regulation 28 report to prevent future deaths following the inquest into the death of Mitica Marin which you issued on 12 March 2020 to , the Association of Ambulance Chief Executives (AACE).

AACE is a private company owned by the English Ambulance NHS Trusts. It exists to provide ambulance services with a central organisation that supports, coordinates and implements nationally agreed policy. Our primary focus is the ongoing development of the English ambulance services and the improvement of patient care. We are a company owned by NHS organisations and possess the intellectual property rights of the JRCALC UK ambulance service clinical practice guidelines. AACE is not constituted to mandate or instruct ambulance service however we do have national influence via the regular meetings of ambulance Chief Executives and Trust Chairs along with a network of national specialist sub-groups.

I am responding as managing director of AACE on behalf of our chairman. I have read your report and considered the concerns you have raised. I can confirm that we are very aware of the need for prompt defibrillation if this is indicated for a patient in cardiac arrest.

Last year we undertook an extensive review of the resuscitation sections of our clinical practice guidelines. We considered the issue of using manual or automatic mode for delivering the first shock in a cardiac arrest situation and we issued our revised guidance to the UK ambulance services in June 2019. The section of our guidance pertaining to manual or automatic mode is detailed below:

Most manual defibrillators carried in ambulances can also be used in an AED mode where they analyse the ECG and recommend delivery of a shock when appropriate. There are advantages and disadvantages of each mode. Although AED mode may improve the time to first shock, manual mode may reduce pre- shock pauses and increase chest compression fraction which is associated with increased ROSC. Therefore, although manual defibrillation should be the preferred option for appropriately trained paramedics it should be recognised that solo responders are potentially in a stressful environment, and are attempting to manage multiple complex factors. Therefore, the initial use of the AED function is acceptable until additional help arrives.

Chairman: Managing Director:

In summary of the above extract, we are advocating that a defibrillator can be used in automatic mode if a solo responder arrives on scene first.

We are aware that there are a number of types of defibrillators in use in UK ambulance service, however, it is not our responsibility as a membership organisation to decide or recommend which device an ambulance service should purchase.

I hope that you will agree that we have responded to the concerns that you have raised. We can assure you that we are absolutely committed to learning from all adverse events and doing everything within our power to prevent them happening again in the future.

If we may be of further assistance, please do not hesitate to contact us.

We would like to extend our sincere condolences to the family of Mitica Marin.

Dear Mr Irvine

Thank you for your letter of 12 March 2020 to Matt Hancock about the death of Mitica Marin. I am replying as Minister with responsibility for patient safety and I am grateful for the additional time in which to do so.

Please extend my most sincere condolences to Mr Marin’s family and loved ones. I appreciate how distressing Mr Marin’s sudden death must be to those who knew and loved him and we must do all we can to take the learnings from his death to prevent future deaths.

Your report explains that in a review of cases of delayed defibrillation conducted by the London Ambulance Service, a contributing factor was that the LIFEPAK 15 monitor and defibrillator was defaulted to manual mode, requiring the user to select the automatic external defibrillator (AED) mode when desired. You ask if future deaths could be avoided if the LIFEPAK 15 device was defaulted to the AED setting.

In preparing this response, my officials have taken advice from NHS England and NHS Improvement (NHSEI), the Medicines and Healthcare products Regulatory Agency (MHRA), the Association of Ambulance Chief Executives (AACE) and the London Ambulance Service.

The MHRA advises that it has not received any similar reports regarding the default settings of this model of defibrillator. Factory default settings have to cover a wide range of applications and are not suitable for all purposes. The LIFEPAK 15, used in hospitals and by ambulance staff, may be set up with different default settings, based on the intended use, for example as a clinical monitoring tool or an AED. Information on different set up options is provided with the device.

Professional organisations are best placed to determine the appropriate default settings according to their local protocols and intended use, taking into account available guidance.

You will know from the AACE’s response to your report that in 2019, as part of a review of clinical practice guidelines, the advantages and disadvantages of manual and automatic modes for delivering the first shock to patients in cardiac arrest were considered. As a result, revised guidance was issued in June 2019 that acknowledged that while manual mode may be the preferred option for trained paramedics, the automatic mode may be preferable in other situations, for example, solo first responders in potentially stressful environments.

I am advised that the London Ambulance Service provides training to clinical staff on the importance of prompt defibrillation and, in October 2019, issued updated cardiac care guidance for staff making clear that in all cases of cardiac arrest, the LIFEPAK 15 should initially be switched to AED mode.

I understand that the London Ambulance Service has considered if changing the default setting of the LIFEPAK 15 to AED mode could improve clinical outcomes. The London Ambulance Service has decided, for reasons set out in its response to your report, that this is not practical for every-day use given the device’s functionality as both a clinical monitoring tool and defibrillator.

In relation to future procurement of defibrillators, this is a matter for individual ambulance services. I am advised that the London Ambulance Service is looking to source devices that have in-built technology to negate the need for the user to actively select the mode of operation. I understand that such a device has not been located but that, where it can, the London Ambulance Service is encouraging manufacturers to consider this functional requirement for future models.

In the absence of such a design, it is of course important that ambulance services using devices such as the LIFEPAK 15 look to mitigate the risk of future incidents of delayed defibrillation and my officials have asked the AACE to make the concerns in your report known to ambulance services in England. I note the measures taken by the London Ambulance Service, including updated guidance to staff on managing cardiac arrest, human factors training and focused training for solo first responders.

Finally, my officials have drawn this matter to the attention of the MHRA and also Professor , the National Clinical Director for Heart Disease at NHSEI. Following discussion with clinical colleagues, Professor has advised that the current default mode of the device being manual, rather than automatic, is acceptable having considered the rationale of the London Ambulance Service deliberations on this matter. Professor has recommended that, if further monitoring and analysis of data shows continuing evidence of delays, consideration should be given to changing the default setting of the device and this advice has been shared with the London Ambulance Service.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

NADINE DORRIES

Dear Mr. Irvine, Regulation 28 Report, March 12, 2020, REF:

I write in relation to the Regulation 28 Report to Prevent Future Deaths dated March 12, 2020, REF: , issued by the Walthamstow Coroner’s Court (the “Report”). Please be advised that Physio-Control was acquired in 2016 by Stryker Corporation, and that the LP15 device is distributed in the UK by Stryker UK Ltd (“Stryker”). Accordingly, this response is made by Stryker on behalf of Physio-Control UK Ltd. A copy of the Report was sent to Stryker’s Newbury offices, however, it was not provided to me until after the response deadline of May 7, 2020. This delay was in part caused by reduced onsite staffing measures taken by Stryker to ensure the safety of its employees during the ongoing COVID-19 pandemic. We regret this delay, and the corresponding delay in our substantive response to the matters raised in the Report. In part, the Report concludes that “If the LP15 defaulted to automatic mode or on start-up required, the choice of manual or automatic mode it is possible that such delays could be avoided.” After consultation with the manufacturer of the LP15 device, I can advise that the LP15 monitor/defibrillator is designed with the ability to be configured to power on in either automatic or manual defibrillation mode based on the clinical protocols of the health system. Accordingly, I respectfully submit that the Coroner’s Concerns listed at Section 5 of the Report do not accurately reflect the capabilities of the LP15 device. Stryker requests that appropriate adjustments be made to both paragraph 4 (commencing “This is not an isolated incident,…”) and paragraph 7 (commencing “If the LP15…”) to accurately reflect that the LP15 device can be configured to power on in either automatic or manual defibrillation mode based on the clinical protocols of the health system using the device. Due to the existing capability of the LP15 to be configured to power on in either automatic or manual defibrillation mode, Stryker does not propose to take any action in relation to the Report. Finally, to date, Stryker has not received a copy of any responses from interested parties to the Report. Pursuant to r29 (6) of the Coroners (Investigations) Regulations 2013, I request that a copy of any responses received to the Report be provided to me using the contact details above (email preferred). Should you have any questions in relation to this letter, do not hesitate to contact me.