Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Michael Trevor Walton who died on 13 July 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 4 July 2024 concerning the death of Michael Trevor Walton on 13 July 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Michael’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Michael’s care have been listened to and reflected upon.

Your Report raised the concern over the risk posed to patients by medical equipment shortages and the use of sub-optimal medical equipment. In Michael’s case, you raised that the operating surgeon’s preferred choice of cannula was not available due to supply issues, and this resulted in a cannula with a shorter tip being used, which ultimately contributed to its dislodgement and to Michael’s death. Nationally, NHS Resilience gets involved in supply disruptions where they receive an escalation. These come in from either NHS Trusts (via NHS England’s Emergency Preparedness, Resilience and Response (EPRR) Teams), the Department of Health and Social Care’s (DHSC’s) National Supply Disruption Response (NSDR) Team or, less frequently, from NHS Supply Chain or NHS England’s Patient Safety Team. Whilst defined triggers for our NHS Resilience involvement are in development and are not available to share, we consider (on a case-by-case basis) the potential risks to patients and the operational delivery of NHS services of a break in supply, how imminently supply disruption will occur, and the availability of alternative products, before potentially stepping up incident management arrangements – in the form of either a full Incident Management Team (IMT) or a working group approach. Where NHS Resilience lead meetings, clinical input is used to help devise guidance on the use of alternative devices, the preservation of existing stock through changes to practice, and to help coordinate national mutual aid, as required. Regarding this specific case and the Medtronic cannula product that was unavailable, NHS England does not believe (from a search dating back to 2021) that there was any escalation of a shortage to the national team, nor a referral from DHSC’s NSDR National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

28 August 2024

function stating that an inability to source this product was causing operational or patient safety risks. NHS Supply Chain colleagues have also been sighted on your Report. Many organisations order products through NHS Supply Chain, who aim to ensure adequate supply for demand and will link to alternative products where a product may be unavailable. Where there are shortages, these are communicated through an Important Customer Notice (ICN). All NHS Supply Chain shortages are tabled at a Supply Management Oversight Group (SMOG) which is chaired by DHSC. ICN 1832 was published on 26 October 2022, detailing transportation and logistical delays impacting availability across 56 Medtronic perfusion products. These impacted products were detailed in a product listing, with alternative products added for consideration. The ICN detailed that customers needed to undertake appropriate due diligence to determine the suitability of alternatives listed. The 71424 (NPC FXA418) cannula, the preferred cannula of the operating surgeon in this case, had the following alternative product codes listed - FXA413, FXA355, FXA206. The 72224 (NPC FXA572) which was used was not listed as an alternative product for FXA418 by NHS Supply Chain in the ICN. It is however noted that the two cannulas are very similar in size, design and intended use. NHS Supply Chain’s listing of alternative products is limited in scope and does not constitute advice. Decisions on the use of alternative products must be taken at local level. NHS England has engaged with Newcastle upon Tyne Hospitals NHS Foundation Trust on the concerns raised in your Report. We note that they state they were unable to determine the exact cause of the aortic cannula becoming dislodged, and that the default cannula choice was made for an operation of this nature. We note, however, that following Michael’s death, the Theatre Department have permanently suspended use of the cannula. I would also like to provide further assurances on the national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around events, such as the sad death of Michael, are shared across the NHS at both a national and regional level and helps us to pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Ms Nolan,

Thank you for the Regulation 28 Report of 4 July 2024 regarding the death of Michael Trevor Walton. I am replying as the Minister with responsibility for supply threats and disruption within the Department of Health and Social Care.

I would like to say how saddened I am to read of the circumstances of Mr Walton’s death, and I offer my sincere condolences to his family and loved ones. The circumstances your report describes are concerning and I am grateful to you for bringing these matters to my attention.

Matters of Concern

Your report outlines a number of matters of concern, including that the surgeon’s preferred choice of cannula was not available for the procedure due to supply issues; that the cannula type contributed to its dislodgement from the lumen of the aorta, and to Mr Walton’s death; and, that using sub-optimal medical equipment poses an avoidable risk to patients of significant harm including death.

Thank you for the additional time provided to the Department to provide a response to the concerns raised in the report. In preparing this response, Departmental officials have made enquiries with NHS England (NHSE), the Medicines and Healthcare products Regulatory Agency (MHRA) and the Care Quality Commission (CQC). I understand that you have also requested a response from NHS England, which will provide information on the specific actions taken by the Newcastle upon Tyne Hospitals NHS Foundation Trust following the concerns you have raised about Mr Walton’s death.

Minister of State for Health (Secondary Care)

39 Victoria Street London SW1H 0EU

Medical Supply

Medical supply chains are complex, global and highly regulated, making them vulnerable to a variety of shocks. Whilst we cannot always prevent supply disruption from occurring, there are a range of well-established processes and tools in place to help manage them when they do arise, and to help mitigate risks to patients.

Guidance1 published in June 2024 by NHS England and available to all NHS Trusts sets out how to report potential supply disruptions of medical equipment and includes the escalation processes that NHS Trusts can follow in the event of a disruption. This guidance outlines that, in the event that an NHS Trust is not able to resolve supply disruption via local activity, the Trust can report the disruption to the Department’s National Supply Disruption Response (NSDR)2.

The NSDR has been in place since December 2019 and acts as a single point of contact when an NHS Trust is experiencing supply disruption and has not been able to mitigate the disruption. Once a disruption has been reported to the NSDR, the Department will then work to help resolve the matter, including by:

• liaising with the manufacturer of the product in question for details of the disruption and any recovery plans;
• contacting NHS Supply Chain or other distributors/wholesalers that stock the product to determine whether any stock can be released to fulfil the NHS Trust’s immediate need; and,
• investigating alternative products and liaising with suppliers.

From a review of our records, we can confirm that supply disruption of the preferred choice of cannula for Mr Walton’s procedure was not escalated to the NSDR for support.

Product Safety: I understand from the MHRA that central arterial cannula are acceptably safe when used as intended. Unfortunately, rare complications do still occur during interventional procedures. The MHRA have analysed available data and past records up to and including 17 July 2024 and are not aware of any excess risk with the cannula used for Mr Walton’s procedure. For all devices on the UK market, the manufacturer must submit vigilance reports to the MHRA when reportable incidents that involve their device occur in the UK. The manufacturer must also take appropriate safety action when required and ensure their device meets appropriate standards of safety and performance for as long as it is in use.

1 NHS England » Reporting potential supply disruptions of medical equipment and consumables 2 Reporting to the National Supply Disruption Response (NSDR) - GOV.UK (www.gov.uk)

Minister of State for Health (Secondary Care)

39 Victoria Street London SW1H 0EU

Next Steps: The CQC have confirmed with my Department that they were made aware of Mr Walton’s death by the Trust and will be reviewing this information in line with their specific incident process. They are requesting further information from the Trust accordingly. The CQC inspected the cardiothoracic department at Freeman Hospital in September 2023 due to multiple concerns raised. The NHS Trust subsequently produced an action plan, and a quality improvement plan is now in place. As part of CQC’s ongoing regular engagement with the Trust, they will continue to monitor progress made. I hope this response is helpful. Thank you again for bringing these concerns to my attention.