Prevention of Future Deaths reports · 2021
Regulation 28 report to prevent future deaths, reference 2021-0322, written 29 Sep 2021. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 29 Sep 2021 |
|---|---|
| Reference | 2021-0322 |
| Deceased | Mary Land |
| Coroner | Kevin McLoughlin |
| Coroner area | West Yorkshire (East) |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths · Product related deaths |
| Organisation named | Mid Yorkshire Hospitals NHS Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 4 |
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.
ANNEX A REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. Philips Respironics 2. The Rt Hon Sajid Javid MP, Secretary of State for Health and Social Care 3. Mid Yorkshire Hospitals NHS Trust 1 | CORONER lam Kevin McLoughlin, Senior Coroner for the Coroner area of West Yorkshire (East). 2 | CORONER’S LEGAL POWERS | 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 22 February 2021 | commenced an investigation into the death of Mary Land, aged 76. The investigation concluded at the end of the Inquest on 27 September 2021. The conclusion of the Inquest was a narrative conclusion that Mrs Land died from: 1a Respiratory Failure 2 Obesity hypoventilation, atrial fibrillation, ischaemic heart disease on 5 February 2021, after the tubes connecting her BIPAP ventilator became detached from her facemask. 4 | CIRCUMSTANCES OF THE DEATH On 5 February 2021, Mary Land, aged 76, was a patient on an Acute Respiratory care unit ‘surge’ ward at Pinderfields Hospital, Wakefield. She was being treated for covid pneumonia against a background of comorbidities, including COPD. At 5am that morning, she was discovered in an unresponsive condition, with the tube connecting her facemask to a BIPAP ventilator detached at the connection point to the mask. The Inquest was unable to conclude, on the balance of probability, whether this malfunction contributed to her death, but it remains a possibility, and has the potential to do so in other cases unless a design solution is found. 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 will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTER OF CONCERN is as follows. — The Philips Respironics AF 541 mask connects to the tubing, linking it to the BIPAP ventilator by means of a ‘push on’ connection (rather than a fitting involving positive engagement). Evidence taken at the Inquest indicates this connection has come undone on other occasions as well. The introduction of a filter at the site of this union increases the potential for the joint to come apart. Consideration should be given to installing a more robust docking mechanism which is less vulnerable to working loose, or being inadvertently pulled apart, for example, by a patient suffering from delirium. ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and | believe you oryour 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 Monday 22 November 2021. |, 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 | have sent a copy of my report to the Chief Coroner and to the following Interested Persons: The family of Mary Land, deceased. | have also sent this report to the Medicines and Healthcare Products Regulatory Agency. | 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. 29th September 2021 ker. Ma CO
4 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.
From Maria Caulfield Parliamentary Under Secretary of State for Primary Care and Patient Safety 39 Victoria Street London SW1H 0EU Dear Mr McLoughlin, 26 January 2022 Thank you for your letter of 29 September 2021 to Sajid Javid about the death of Mary Land. I am replying as Minister with responsibility for Patient Safety, and am grateful for the additional time allowed. I would like to begin by expressing how saddened I was to read of the circumstances of Mary Land’s death, and I offer my sincere condolences to her family and loved ones. The circumstances your report describes are concerning and it is essential that these are carefully explored to ensure the continued safety of these medical devices. I have been made aware that the Medicine and Healthcare products Regulatory Agency (MHRA), the regulator of medical devices and medicinal products, has provided a response to your report explaining the actions it has taken in relation to this incident and the concerns raised. You will therefore be aware that following the outcome of the inquest into Mrs Land’s death, Phillips Respironics has extended its investigation to look at the connection tubing and facemask. Phillips has also been asked by the MHRA to investigate the potential impact on performance of the breathing circuit of using a filter in the facemask. A final report of the investigation has been requested by the MHRA, and the MHRA will ensure that the investigation has been conducted in line with the relevant regulations and that any corrective action identified is taken. In addition, MHRA will discuss with the British Thoracic Society and the National Institute for Health and Care Excellence whether an update is required to guidance relating to the management of COVID-19 patients and, specifically, ensuring that guidance on the prescribing and setting up of breathing circuits and use of filters is in line with breathing system device manufacturer’s instructions. MHRA have also reviewed the current International Organisation for Standardization standards for connectors used within a breathing circuits and have conducted a stakeholder engagement with the Association of Respiratory Nurses in order to seek feedback on the use of breathing masks, tubing and filters and the means of connecting them to make a complete breathing circuit I am advised that the Mid Yorkshire Hospitals NHS Trust has taken learning from its own investigation of the circumstances around Mrs Land’s death. This includes actions relating to the response to the device alarm. I am further advised that the Care Quality Commission (CQC) is satisfied with the Trust’s action plan and will continue to monitor the Trust in line with its current regulatory approach. Finally, it is vitally important that local organisations and system-level leaders reflect carefully on, and take learnings from, the circumstances of deaths related to the Covid-19 pandemic, such as that of Mrs Land, and I am grateful to you for bringing these concerns to my attention. It is right that there is an active and continuous process of learning, adapting and responding to the challenges of the Covid-19 pandemic and you will know that the Prime Minister has announced that there will be a full statutory inquiry into the Government’s response to the Covid-19 pandemic, beginning in Spring 2022, to identify national learnings. I hope this response is helpful. MARIA CAULFIELD MP PARLIAMENTARY UNDER SECRETARY OF STATE FOR PATIENT SAFETY AND PRIMARY CARE
Mr Kevin McLoughlin Senior Coroner for the County of West Yorkshire (Eastern District) 71 Northgate Wakefield WF1 3BS Medicines & Healthcare products Regulatory Agency 10 South Colonnade Canary Wharf London E14 4PU United Kingdom gov.uk/mhra 18 November 2021 Dear Mr McLoughlin Regulation 28: Inquest to investigate the death of Mary Land We acknowledge your Regulation 28 prevention of future death report, received by MHRA on 29 September 2021 relating to the conclusions of the inquest investigating the death of Mary Land at Pinderfields Hospital, Wakefield and your concern included in report that consideration should be given to a design change for the devices and connectors within breathing circuits. You copied us into the report for information as the UK medical device regulator. I have taken the opportunity to provide you with some supporting information below, before providing comments to your matters of concern. As you may be aware, the Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care and is responsible for the regulation of medical devices and medicinal products. One of the MHRA’s responsibilities is to collect, analyse, monitor and act on information relating to safety concerns from a range of data sources including reports of adverse incidents involving medical devices. Patient safety is our highest priority and we encourage everyone to report safety concerns to the MHRA through our Yellow Card scheme. It is mandatory for manufacturers of medical devices to report incidents where the device is suspected or known to have contributed to the adverse event to MHRA. When an adverse incident occurs and is reported either to the manufacturer directly or via Yellow Card, the manufacturer is responsible for carrying out any investigation required and informing MHRA of their findings. We evaluate and view all incidents in the context of other reports and data sources to determine if there is a potential safety signal for investigation and whether further action is needed. Where necessary and when the Agency’s criteria have been demonstrated and agreed to have been met, we will issue safety messages to health and care organisations, patients, and the public. Manufacturers of medical devices considering a design change are expected to follow the principles set out in BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices. Each design feature should be methodically considered in terms of the hazards and risks it could introduce and then a process of analysis, evaluating and mitigation should be conducted to reduce any residual risk to be a low as reasonably practicable. This approach aims to ensure that any unintended new risks associated with the design of the device itself are appropriately managed and minimised, however it may not be possible to identify all potential unintended consequences in advance of the device being used in the intended use scenario. The risk management process is therefore an ongoing one throughout the product lifecycle. Manufacturers should demonstrate how their devices meet the relevant Designated/Harmonized Standards. If they have not applied these standards, then they must provide a description of the solutions adopted to fulfil the requirements which apply to the devices. This information should be included within their technical documentation for the devices. Under the current UK medical device regulations manufacturers should inform and seek approval from their Notified Body of certain changes to the device or of the quality system. The requirements differ depending upon the route taken for conformity assessment however the guiding principle is that any change which could affect conformity with the essential requirements should be notified and approved prior to the updated device being placed on the market or put into service. An evidence base exists across a range of types of devices supporting a proposition that when users of devices are not familiar with the device or there is a change in design or handling technique this can also contribute to errors and lead to patient harm. Healthcare professionals operating and monitoring the use of devices need to be supported with training and clear protocols on correct and safe device use. Action undertaken by MHRA to date On receipt of the regulation 28 letter we conducted a search of our database of reported adverse incidents to confirm whether the incident had been reported by Philips Respironics in line with the requirements set out in UK MDR 2002. The incident had not been reported. We instructed Philips to report this incident to MHRA which they have now done. They informed us that the initial focus of investigation was on the BiPAP ventilator but following the inquest, the connection tubing and face masks are now being investigated. We requested they provide all available information established during their investigation to date. Their investigation has not been completed and a final investigation report has not yet been provided to MHRA. We have assessed the following facts may be relevant to future actions: - The Philips devices involved in this incident were a Trilogy EVO BiPAP machine and a AF541 face mask. The AF541 has been in the market since August 2016 and the Trilogy EVO was launched in the UK market in August 2019. - The elbow connection point of the AF541 and all masks manufactured by Philips conform to requirements of BS EN ISO 5356-1 2004 Conical Connectors. This is not the latest version of the standard. - A clear guard filter manufactured by Intersurgical was fitted between AF541 elbow and the tubing. The inclusion of a filter in the breathing circuit is not supported by Philips. MHRA has asked Phillips to investigate the potential impact on the performance of the breathing circuit of using the filter. - The hospital report to Philips stated that the filter was used in accordance with recommendations during the pandemic provided by the British Thoracic Society. We have confirmed with the Society that specific guidance regarding the use of filters was introduced during the COVID-19 pandemic response. This was in collaboration with NICE. - Philips has confirmed that the Trilogy EVO device has alarms to detect a disconnected circuit and the hospital has confirmed that the device alarm did sound during this incident. MHRA has requested more information about the incident from the hospital. We have reviewed the current versions of ISO standards for connectors used within breathing circuits: BS EN ISO 5356-1:2015 and BS EN ISO 5356-2:2012. BS EN ISO 5356-1:2015 defines the dimensions and test methods for cone and socket connections for breathing circuit components. The purpose of the standard is to ensure interchangeability between components from different manufacturers whilst maintaining a secure connection and at the same time enabling connection and disconnection by the operator. To minimise the risk of accidental disconnection the standard recommends a “latched” socket, also defined within the standard. BS EN ISO 5356-2:2012 defines “Screw-threaded weight-bearing connectors” which are intended for mounting heavy or fragile components of a breathing circuit. In October 2021 we conducted stakeholder engagement with the Association of Respiratory Nurses in order to seek qualitative feedback on the use of breathing masks, tubing and filters and the means of connecting them to make a complete breathing circuit. In summary they stated that, connections between masks and hoses are universal and all push-fit allowing for compatibility between the various manufacturer’s equipment. If the connection became a screw-thread style, then the ability to change the consumable components, when required and when in situ, would be more difficult. It could cause components to seize up, making quick changes difficult. This could put in place a further risk, when a patient is dependent on therapy, and a quick mask/hose change is needed. They also acknowledged that the risk of disconnection is no more than patients removing masks themselves. The hoses and masks fitting do not often come apart when fitted correctly. Further action to be undertaken by MHRA By the end of November 2021: - Agree with Philips Respironics their investigation plan and a regular schedule for updates to be provided to MHRA, ensuring it is concluded in line with their regulatory obligations and any corrective actions identified are conducted. This includes ensuring they assess the impact of the connection design and the inclusion of the filter within the breathing circuit on the disconnection event and patient harm and measures to minimise this risk in the future - Engage with Philips Respironics regarding maintaining compliance to the latest version of relevant and Designated or Harmonised Standards - Contact the British Thoracic Society and NICE to agree a time to discuss updating the published guidance relating to the management of COVID-19 patients to ensure that health care professionals prescribing and setting up breathing circuits and the inclusion of filters are in accordance the breathing system device manufacturers’ instructions. Ongoing: - Continue to assess incoming data which identifies a new safety signal with these types of devices and take action when required. Conclusion Pending the conclusion of the actions detailed above, we will continue to monitor our reports and if further evidence should emerge we will review and take any necessary action. Yours sincerely Chief Safety Officer Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London, E14 4PU gov.uk/mhra Stay connected
Date: 22 November 2021 Mr Kevin McLoughlin HM Senior Coroner West Yorkshire (Eastern District) HM Coroner’s Service 71 Northgate Wakefield WF1 3BS Dr Medical Director Trust Headquarters and Medical Education Centre Aberford Road Wakefield WF1 4DG Dear Mr McLoughlin Re Inquest of Mary LAND (dcd) – 21.11.1944 to 05.02.2021 – I am responding on behalf of the Trust to the Regulation 28 Report to Prevent Future Deaths that you issued on 29 September 2021 jointly to Philips Respironics, The Rt Hon Sajid Javid MP, Secretary of State for Health and Social Care, and The Mid Yorkshire Hospitals NHS Trust (MYHT). The Matter of Concern raised in your report was: The Philips Respironics AF541 mask connects to the tubing, linking it to the BiPAP ventilator by means of a ‘push on’ connection (rather than a fitting involving positive engagement). Evidence taken at the Inquest indicates this connection has come undone on other occasions as well. The introduction of a filter at the site of this union increases the potential for the joint to come apart. Consideration should be given to installing a more robust docking mechanism which is less vulnerable to working loose, or being inadvertently pulled apart, for example, by a patient suffering from delirium. As you acknowledged during the Inquest, the Trust conducted a very open and candid significant event RCA investigation into this tragic incident and identified four actions in response to recommendations arising from the investigation. We subsequently undertook these actions and I am able to confirm that all four actions were completed by 4 August 2021 (refer Attachment 1). The following recommendation and its corresponding action are of specific relevance to the Matter of Concern. Recommendation 2: Scope and discuss with regional units if there can be an improvement on securing tubing circuit connections Action 2: To understand if manufacturer or other solution [is available] to provide greater tubing circuit connection stability. The inclusion of a filter to manage COVID-19 patients was recommended as part of the British Thoracic Society (BTS) Guidance issued in Wave 1 of the Pandemic (refer Attachment 2). At date, this advice remains current and is considered best practice for infection prevention and control purposes of COVID-19 patients on non-invasive ventilation. Unfortunately, the additional filter component inserted between the facemask and the ventilator tubing may have contributed to destabilisation of the circuit, although this cannot be clinically proven, and there is no current research/evidence to confirm or reject the theory that the additional filter caused/causes destabilisation of the circuit. Following the Inquest, the Trust has had further internal discussions with our Respiratory Team, including our lead for Non-invasive Ventilation (NIV), regarding the use of the filter. The presence of the filter is still considered beneficial in preventing the transmission of COVID-19 and as such, the Trust continues to use the filter in accordance with the BTS guidance. Of note, at the time when the incident was investigated and design solutions were researched, there was no all-in-one circuit available, i.e. where the filter was an integral constituent of the mask, rather than an optional add-on component. As such, the Trust thanks you for raising this issue directly with the manufacturer, Philips Respironics. I trust this advice is helpful and thank you again for raising this important matter with us. In closing, on behalf of The Mid Yorkshire Hospitals NHS Trust, I would also like to take this opportunity to once again offer our sincere condolences to Mrs Land’s family in relation to her sad death. Yours sincerely Dr Medical Director
Kevin McLoughlin Senior Coroner, West Yorkshire (Eastern) Coroner’s Office and Court 71 Northgate Wakefield, WF1 3BS November 22, 2021 Dear Sir, (cid:53)(cid:40)(cid:54)(cid:51)(cid:50)(cid:49)(cid:54)(cid:40)(cid:3)(cid:55)(cid:50)(cid:3)(cid:53)(cid:40)(cid:42)(cid:56)(cid:47)(cid:36)(cid:55)(cid:44)(cid:50)(cid:49)(cid:3)(cid:21)(cid:27)(cid:3)(cid:53)(cid:40)(cid:51)(cid:50)(cid:53)(cid:55)(cid:3) Listed below is the concern described in the Regulation 28 report reference above, followed by the Philips response. (cid:38)(cid:82)(cid:81)(cid:70)(cid:72)(cid:85)(cid:81)(cid:29)(cid:3) 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 MATTER OF CONCERN is as follows. The Philips Respironics AF 541 mask connects to the tubing, linking it to the BiPAP ventilator by means of a ‘push on’ connection (rather than a fitting involving positive engagement). Evidence taken at the Inquest indicates this connection has come undone on other occasions as well. The introduction of a filter at the site of this union increases the potential for the joint to come apart. Consideration should be given to installing a more robust docking mechanism which is less vulnerable to working loose, or being inadvertently pulled apart, for example, by a patient suffering from delirium. (cid:51)(cid:75)(cid:76)(cid:79)(cid:76)(cid:83)(cid:86)(cid:3)(cid:53)(cid:72)(cid:86)(cid:83)(cid:76)(cid:85)(cid:82)(cid:81)(cid:76)(cid:70)(cid:86)(cid:3)(cid:85)(cid:72)(cid:86)(cid:83)(cid:82)(cid:81)(cid:86)(cid:72)(cid:29)(cid:3) The AF541 mask elbow design is a 22mm non-latching conical connection compliant with ISO 5356-1. This design is not intended to prevent accidental disconnection. The AF541 mask is contraindicated for use with patients requiring life support ventilation. During this incident, it is alleged that the AF541 mask was in use with a Trilogy EVO ventilator. The Trilogy EVO Clinical Manual states, “To prevent patient or ventilator contamination, you must use a Philips Respironics- approved main flow bacterial filter on the patient gas outlet port.” An Intersurgical clear guard filter (part number unknown) is reported to have been fitted between the AF541 mask elbow and the tubing. This configuration is not approved by the manufacturer. The Intersurgical clear guard filter is not approved by Philips, and Philips is unable to verify the safety or performance of a device using an unapproved filter in an altered configuration. The AF541 mask in use was not retained due to COVID-19 contamination. The manufacturer received the ventilator’s event logs. On the day of the event, 5 February 2021, the below alarms occurred between 03:14:44 and 04:26:24. (cid:36)(cid:79)(cid:68)(cid:85)(cid:80)(cid:3) Low Inlet Oxygen Pressure Circuit Disconnect Low Inlet Oxygen Pressure Circuit Disconnect Low Inlet Oxygen Pressure Circuit Disconnect Low Inlet Oxygen Pressure Circuit Disconnect Circuit Disconnect (cid:39)(cid:88)(cid:85)(cid:68)(cid:87)(cid:76)(cid:82)(cid:81)(cid:3) 114 seconds 45 seconds 2 seconds 45 seconds 27 seconds 37 seconds 14 seconds 853 seconds 820 seconds Page (cid:20) of (cid:21)(cid:3) The last two circuit disconnect alarms logged were not acknowledged for a total of more than 27 minutes. Shortly after 5:00:00, the ventilator was turned off. Based on the information reviewed by the manufacturer – specifically the greater than 30 minutes of active alarming of the device, hospital verification that the circuit disconnect alarm sounded, incorrect connection of an inline filter, and use of an unapproved inline filter, Philips Respironics concludes that the AF541 mask and Trilogy EVO ventilator operated as designed. The facility apparently failed to follow the manufacturer’s instructions and did not respond appropriately to ventilator alarms. In addition, the mask at issue meets the applicable standard for mask to circuit connection. Therefore, no action for the design of the AF541 22mm non-latching conical connection is proposed. Notwithstanding the Coroner’s duty to share a copy of this response with the Chief Coroner, Philips requests prior notification for the further release or publication of this response in a complete or redacted or summary form. Philips wishes to formally record that it was not requested to provide evidence to the Coroner prior to, or at, the inquest in respect of the functionality or use of the AF541 mask or Trilogy EVO ventilator – either generally, or specifically in relation to their use on the patient at Pinderfields Hospital. Such evidence would have been provided as set out above which, we assert, may have provided the opportunity for clarification of the matter of concern during the inquest. Best regards, Quality System Manager, Post Market Surveillance Philips Respironics - Sleep and Respiratory Care Page (cid:21) of (cid:21)(cid:3)
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