Dear Mr Davies,

I am writing in response to your recently issued Regulation 28 Report dated the 7th of December 2023 concerning the sad death of Mr Ian Jacka. On behalf of University Hospitals Plymouth NHS Trust, We would like to begin by offering our sincere condolences to Mr Jacka’s family for their loss.

Thank you for highlighting the concerns regarding Mr Jacka’s death, we apologise that you have had to bring these concerns to our attention. We understand the severity of your concerns and are committed to making the necessary improvements that ensures the quality and safety of our services and prevents harm to future patients. A full investigation into each of your concerns has been undertaken and I have documented our response below. I hope that this response will satisfy you that we have robust processes in place and have taken the necessary action required to prevent a future death.

 There was an error of omission in record keeping and in handover from critical care to surgery, and that this error likely contributed to Ian’s death.

 There was no entry in Ian’s hospital notes to indicate the full extent of the critical incident of 5 June 2022.

 There was a lack of information on handover from critical care to the surgical team regarding the full extent of the critical incident of the 5 June 2022. There was a verbal handover which was brief and vague. There was no formal written handover process highlighting significant events.

 The error of omission was unexplained and has not been investigated by the NHS. The evidence regarding the error of omission came to light after the completion of the NHS investigation into Ian’s death. The Consultant Anaesthetist involved in Ian’s operation discovered the fact of the critical incident of 5 June 2022 on a later examination of ventilator data. The data indicated that Ian deteriorated significantly, that he was close to a cardiac arrest and the critical care team saved his life.

We have undertaken a full review of the record keeping and handover arrangements relating to this Mr Jacka’s care. A review of Mr Jacka’s clinical records demonstrated that the event that occurred in

the early hours of the 5th June 2022 was documented following the event at 04:24 in the intensive care Electronic Patient Record System (Innovian) by the medical team.

The documentation in relation to the critical incident is both comprehensive and appropriate. Mr Jacka deteriorated, requiring intubation and ventilation as a result of type 2 respiratory failure caused by his significant chest and spinal injuries. His blood oxygen saturations and blood pressure fell significantly but were rapidly restored to normal upon the arrival of the ICU registrar with simple interventions after a relatively short period of time. The lowest oxygen saturations and blood pressure values were recorded in the notes by the ICU nurse at the time. Mr Jacka was anaesthetised and intubated – this was technically challenging and represented a difficult airway, but Mr Jacka remained stable throughout this process with no further drop in oxygen levels. Following successful intubation, the Intensive Care Registrar documented a plan for ongoing sedation overnight, and for the Neurosurgeons to be informed. A plan for subsequent intubation was also documented which included appropriate recommendations for airway management; “For further intubations: Awake fibreoptic if situation permits, or CMAC D + bouguie + collar off”.

The airway technique used and the difficulties encountered during the intubation were both documented in Mr Jacka’s medical notes and verbalised to the anaesthetic team when they reviewed Mr Jacka pre-operatively on the 6th June 2022. The anaesthetic Pre-assessment Record completed by the Anesthetic Registrar pre-operatively documented the following in the ‘Intubation hazards’ section; “emergency intubation – V difficult. Size 7 ETT. Grade 4. CMAC D blade – epiglottis only. Able to ventilate with FM and Guedel. Size 7.0 ETT”. This is consistent with the details documented within the intensive care Electronic Patient Record System following the event on the 5th June 2022 and demonstrates that there was not an omission in record keeping or handover.

Investigation into events performed after Mr Jacka’s death did not identify missing information from the clinical record, or evidence that his deterioration was more significant than that documented in the contemporaneous record.

 The surgical and anaesthetic team had no reason to suspect a secondary brain injury. The team had no information on Ian’s neurological status. Ian is likely to have suffered a hypoxic brain injury during the critical incident of 5th June. This will have undermined his resilience and ability to physically withstand the rigors of spinal surgery and airway exchange.

A review of Mr Jacka’s clinical records identified that the Neurosurgical team reviewed him on the 5th June 2022 at 09:00 and Mr Jacka’s deterioration and the need for intubation and ventilation was acknowledged. The Neurosurgical team planned for surgery to be performed on the 6th June 2022, and a GCS assessment (an assessment to objectively describe the extent of impaired consciousness) was to be undertaken.

Mr Jacka was also reviewed by the Intensive Care Consultant on the 5th June 2022 at 11:13 and it was noted that he had been intubated in the early hours of the morning secondary to type 2 respiratory failure. A plan for a pause in sedation administration to facilitate a GCS assessment prior to surgery on the 6th June 2022 was documented.

The GCS assessment was undertaken by the Intensive Care Consultant on the 5th June 2022 at 16:41. Mr Jacka was recorded to have been obeying commands whilst under sedation with a GCS score breakdown of Eyes-4 (eyes opening spontaneously), and Motor-6 (obeying commands).

In conclusion, based on the clinical information reviewed there is evidence that Mr Jacka did not suffer a hypoxic brain injury as a result of his deterioration in the early hours of the 5th June 2022. Mr Jacka

was opening his eyes spontaneously immediately after his acute deterioration, and a GCS assessment was undertaken which confirmed that Mr Jacka was able to open his eyes spontaneously and obey commands. This assessment is not consistent with a catastrophic brain injury and he appeared unchanged neurologically from his condition prior to being intubated overnight.

 Had the surgical and anaesthetic team known of the extent of the critical incident of 5 June, the operation would have been delayed and further tests and assessments undertaken. The anaesthetic team may have opted for elective tracheostomy if the full circumstances of the critical incident of 5 June 2022 had been known. An elective tracheostomy would have led to a different outcome because it would have avoided the complications that ensued from the attempted airway exchange.

The decision to progress to surgical fixation of Mr Jacka’s thoracic spinal injuries was made by the surgical team in consultation with the Intensive Care team and in the knowledge that he had been intubated for respiratory failure early on the 5th June. He had an appropriate clinical neurological assessment during the daytime on the 5th June and was demonstrated to be unchanged following intubation. No other investigations were deemed necessary pre-operatively by the surgical or Intensive Care teams.

Given the severity of Mr Jacka’s injuries, it is likely that a tracheostomy would have been performed at some stage during his treatment, however it was not indicated prior to his spinal surgery. Tracheostomy insertion carries significant risks, especially in the context of recent cervical spine injury, and a newly sited surgical tracheostomy would have represented a higher risk of airway displacement during prone spinal surgery than an oral endotracheal tube. These factors had been considered on the 5th June 2022 as part of the decision to proceed with spinal fixation surgery first.

 I note the NHS Investigator and the Investigatory Panel both recommended that action is required for the handover of complex patients. The panel recommended as follows: More robust and formalised handover of complex patients before transfer to theatre, to include review of airway management, cardiopulmonary status, potential avenues of deterioration and any significant events during admission.

 The Trust had chosen not to accept this recommendation but at the time the Trust made that decision it was not aware of the extent and significance of the error of omission.

A review of the current practice for reviewing and handing over patients who require transfer from the Intensive Care Unit to the operating theatre has been undertaken. Currently patients are reviewed by the surgical and anaesthetic teams pre-operatively and information is collected and documented by the anaesthetic team using a structured Pre-operative Anaesthetic Assessment chart in keeping with standard procedures across the Trust. The anaesthetic team assess the patient and examine/record relevant information relating to the patient’s history, airway assessment, cardiorespiratory system, and any diagnostic tests and results. The pre-operative assessment is undertaken to formulate a clear anaesthetic plan, but also provides an opportunity to seek additional information, optimise the patient if required, and consider if the surgery is safe to proceed. Members of the Intensive Care Medical team are present on the Intensive Care Unit 24 hours a day and can provide additional information as required. Once the patient has been reviewed by the anaesthetic and surgical team, information relating to the patient, as well as the surgical and anaesthetic plan is shared and discussed at the theatre brief prior to the start of the operating list.

The Trust has an existing process for the handover of postoperative patients to the intensive care Unit (appendix 1), and this has proved beneficial in promoting meaningful discussion between senior

decision makers, as well as improving the quality of information that is received. The Trust is committed to ensuring that the quality of handovers is as robust as possible given the well evidenced risks, and therefore the following actions have been agreed.

Action 1 (due to be completed by the 29th February 2024): The intensive care and anaesthetic department will work together to create a preoperative handover checklist (similar to the postoperative handover checklist in appendix 1) which will help ensure that the anaesthetic team collecting the patient has considered all things that are likely to be relevant to the patients ongoing care and treatment. This will include airway concerns, allergies, medications, clotting and blood products for example. This checklist would help support meaningful discussion between senior decision makers in complex patients.

I hope that this response provides some reassurance that we have fully explored the concerns raised, and that we are committed to taking the necessary steps to improve the safety of our services.

Dear Mr Davies, Re: Regulation 28: Report to Prevent Future Deaths in the Matter of the Inquest Touching the Death of Ian Jacka I am Head of Compliance for the National Trust and am writing in response to the Prevention of Future Death Report dated 27 December 2023 following the conclusion of the inquest touching upon the death of Ian Jacka. Thank you for agreeing to extend the time for the National Trust to respond.

The National Trust has considered your Report with care and taken expert advice from the Visitor Safety Group (VSG), who you will recall from the evidence produce the definitive guidance applicable to risk assessments at locations such as Chapel Porth, before reviewing its risk assessment and responding to your Report.

On 9 February 2024 four members of the VSG board visited the site, including the specific location where Ian fell. Those attending from the VSG included , VSG Chair and editor/co-author of ‘Managing Visitor Safety in the Countryside – principles & practice’. They were provided with the following context:

The National Trust car park has space for around 60 cars At busy times, a local landowner provides additional spaces in a field further up the lane. The lane is a dedicated highway, outside the ownership of the National Trust There are an estimated 160,000 annual visits, with a significant proportion being local. UNESCO World Heritage Site designation (mining history) SSSI and SAC designations The Southwest Coastal Path passes through the site, joining the lane a little way below the location of the accident The National Trust is not aware of any previous incidents in the area where Mr Jacka fell.

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Information Classification: CONTROLLED The VSG group was provided with a copy of the Prevention of Future Death Report prior to the visit and was aware of the circumstances surrounding the fall. So as to ensure they were uninfluenced by the risk assessments of others, the VSG were not provided with copies of the Cormac/Cornwall Council or the National Trust risk assessments prior to the visit.

reported that he and each VSG Board Member separately reached the conclusion that it would not be appropriate to introduce a ‘risk of fall sign’ or fencing. There was agreement that the hazard was reasonably obvious, with the likelihood of someone falling where the drop was greatest being remote. There was, in consequence, no reasonable requirement for signs or barriers at this location. The participants observed there were many other unguarded drops in the vicinity, and it would not be reasonably practicable to treat them in a similar manner, should a precedent be set at the accident site. Nor would signs and barriers be desirable interventions as they would detract from the landscape value and have an adverse effect on the special characteristics that underpin the designations listed above.

The VSG representatives were provided with copies of the National Trust’s and Cormac’s risk assessments after the site visit.

In summary, VSG participants were satisfied that the National Trust in its visitor risk management at Chapel Porth, had followed the VSG guiding principles. Two of particular relevance are:

1. Fundamentals

• Take account of conservation, heritage, recreation, cultural and landscape objectives.
• Do not take away people’s sense of freedom and adventure.
• Avoid restrictions on access.

4. Responsibility

• It is important to strike a balance between visitor self-reliance and management intervention.
• It is reasonable to expect parents, guardians and leaders to supervise people in their care.
• It is reasonable to expect visitors to exercise responsibility for themselves.
• It is reasonable to expect visitors not to put others at risk.

The VSG was concerned that you had found the National Trust’s Risk Assessment in place at the time of the accident, to be ‘flawed and unreliable.’ They advised that they do not agree with that view. They reviewed the risk assessment and concluded that it demonstrated a sensible, thorough process carried out by someone familiar with VSG principles. The hazard of fall from height is recognised and there is a listing under current precautions that ‘The highest point from the road to the car park is walled off so the edge is inaccessible and clearly visible’. The accompanying photographs demonstrate that the assessor looked at the site in the vicinity of the accident. The existing controls for falls from height are judged to be adequate.

A cause for concern set out in the PFD report was the absence of any discussion of control measures such as the signage and barriers that Cornwall Highways suggested following the accident. The VSG representatives recognised that the risk assessment might benefit from a statement explaining the need to avoid unnecessary and intrusive signs and barriers, but in

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Information Classification: CONTROLLED their view that would not have altered the conclusion that the residual risk on the site was acceptable without the need to introduce additional risk controls.

advised that he also reviewed the Cornwall Council risk assessment dated 20 March 2023. He commented as follows:

"It uses a risk matrix table of likelihood multiplied by severity of consequence to produce a score, where 15 or above is deemed unacceptable. Two hazards produced a score of 15. ‘Unprotected edge - Fall from height.’ And ‘Kerb at edge of carriage – trips, slips, falls when accessing adjacent private verge.’ Scoring is subjective. However, my judgement is that likelihood is scored too high. Few visitors seem likely to go near the edge, or indeed choose to walk onto the verge. The lack of incident reports over the past dozen or so years would appear to support this

The Cornwall Highways Risk Assessment applies the highest score (5, ‘catastrophic’) for the severity of consequence. However, a trip over the kerb would be most likely to result in no injury or a minor first aid case. The slope between the kerb and the drop is relatively gentle, so the risk of a fall from height following the trip is greatly diminished.

The Cornwall Highways Risk Assessment recommends provision of a ‘pedestrian edge restraint to prevent falls from height and user accessing private verge’. To be effective, the barrier would need to have properties such as provided for fencing quarries. It would be visually intrusive and create a potential crush hazard for pedestrians on the road when encountering vehicles. None of the VSG Board Members judged this desirable.

We note that the Cornwall Highways Risk Assessment methodology does not appear to have any way to consider the site in context. In consequence, risk controls are proposed without any consideration of potential adverse effects on landscape designations or other benefits to the public."

In conclusion, The VSG was satisfied that VSG principles remain valid, and had been applied appropriately by the National Trust.

Following receipt of the VSG’s advice, the National Trust completed a further risk assessment at Chapel Porth focussing on the location of Mr Jacka`s fall. Based upon the finding of the risk assessment and applying VSG guidance, the Trust has decided not to install fencing at the location or a sign warning of the risk of falls for the following reasons:-

-The hazard is obvious. The likelihood of someone falling where the drop is greatest is remote. There are no reports of any incidents of falls prior to 3 June 2022 or after.

-A trip over the kerb would be most likely to result in no injury or a minor first aid case. The slope between the kerb and the drop is relatively gentle, so the risk of a fall from height following the trip is greatly diminished.

-There is no reasonable requirement for warning signs or barriers at this location. There are many other unguarded drops in the vicinity, and it would not be reasonably practicable to treat them in a similar manner, should a precedent be set at the accident site. Nor would signs and barriers be desirable interventions as they would detract from the landscape value and have an adverse effect on the special characteristics that underpin the designations listed above.

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Information Classification: CONTROLLED

-To be effective, any barrier would need to have properties such as provided for fencing quarries. It would be visually intrusive and create a potential crush hazard for pedestrians on the road when encountering vehicles.

The VSG suggested Cornwall Council should consider installing further signage on the road that might lesson the need for pedestrians to step off the road onto the verge. Cars exiting the car park, whose drivers have a clear view of any pedestrians on the road, are less of an issue than vehicles arriving. The view of the road ahead is more restricted for vehicles arriving at the site and their approach speed is likely to be higher. The VSG suggested discussions with Cornwall Council to consider use of further road signs to reduce speed and warn of pedestrians in the road. The VSG suggested the following signs be considered.

.

The National Trust will be contacting Cornwall Council to inform them of the suggestions made by the VSG. The National Trust will review the risk assessment at Chapel Porth on an annual basis in accordance with its risk assessment policy.

Dear Mr Davies,

Regulation 28 report relating to the death of Ian Jacka (DOD 15/06/2022)

Thank you for your Regulation 28 Report relating to the death of Ian Jack (DOD 15/06/2022) which was received on 2 January 2024. I would like to offer my sincere condolences to Mr Jacka’s family on their tragic loss.

Following receipt of the Regulation 28 Report we have considered the points of concern raised regarding the use of the Cook Airway Exchange (CAE) catheter, manufactured by Cook Medical, with the Manujet III manufactured by VMB.

Firstly, it may be helpful to provide background information relating to the Medicines and Healthcare products Regulatory Agency (MHRA) and the work we carry out. The MHRA is the executive Agency of the Department of Health and Social Care that acts on behalf of the Ministers to protect and promote public health and patient safety by ensuring that medicines and healthcare products can be used safely and meet appropriate standards of safety, quality, performance, and effectiveness. Medical devices such as these must comply with the medical device regulatory requirements and be CE or UKCA marked which is certified by notified bodies or approved bodies.

When an adverse incident involving a medical device is reported to the MHRA, we liaise with the manufacturer of the medical device(s) and request that they investigate and test the device(s). The MHRA assesses the balance of risks and benefits of devices, throughout their use in clinical practice, through the collection of information and assessment of any potential risks. This may be followed, when necessary, with communications and regulatory action to minimise those risks.

The Regulation 28 report concerns an incident that occurred on the 6 June 2022 at Derriford Hospital where a CAE catheter was used with a Manujet III, which is a manually controlled oxygen delivery system, to facilitate airway exchange in a complex polytrauma patient undergoing complex spinal surgery.

It is understood that prior to surgery there were several unsuccessful attempts to intubate. However, an oral endotracheal tube (ETT) was successfully placed and subsequently replaced with an armoured ETT for the duration of the operation. At the end of the surgery the CAE Catheter was used to aid the replacement of the armoured ETT for a more flexible critical care ETT. There were several unsuccessful attempts to insert the replacement ETT resulting in the patient experiencing oxygen desaturation. Therefore, jet ventilation was performed with Manujet III using the CAE Catheter. Subsequently, the patient experienced subcutaneous emphysema and cardiac arrest. As result of this event and the additional time needed to establish an alternative secure airway (i.e. cricothyroidotomy), the patient experienced hypoxic brain damage and died several days later.

We were initially informed of this incident on 22 March 2023 through a Yellow Card report from a healthcare professional and also received a report from Cook Medical. However, no report was received directly from Derriford Hospital. Additionally, no product was returned to Cook Medical for evaluation. We informed Cook and requested they investigate the reported incident.

Cook Medical investigated and concluded that the cause of the failure could be associated with an unintended use error. They indicate the device was used in a patient with a difficult airway, the catheter was over-inserted, and jet ventilation may not have been used in a manner consistent with the instructions for use (IFU). We note the difference in opinion with the medical team around over insertion.

We have received no other incident reports within the last 10 years where an issue occurred with AEC and jet ventilation being used together during endotracheal intubation. Please see our response to the matters of concern raised below. (1) The Inquest found that the use of the ManuJet III Ventilator with Cook Airway Exchange Catheter (AEC) likely contributed to Ian’s death. This finding was based primarily on the evidence of the NHS investigation. It was found that the second use of the jet resulted in significantly increased airway pressure which caused tension pneumothoraxes and massive subcutaneous emphysema.

In this incident the CAE Catheter was initially being used with the Manujet III during an endotracheal tube (ETT) exchange. Endotracheal intubation involves a tube being placed through the mouth or nose into the windpipe. The incident describes multiple failed attempts at intubation indicating this was a difficult airway. However, the Cook airway exchange is intended for uncomplicated atraumatic endotracheal tube exchange where a ventilatory device may be used at any time during the procedure by using the Rapi-Fit Adaptor provided with the device. The IFUs provided with the device note that;

“Use of a high-pressure oxygen source should only be considered if the patient has a sufficient egression of the insufflated gas volume.”

This incident describes that; “.. having removed the armoured tube, the team were unable to insert the flexible tube despite repeated attempts. Ian then started to desaturate due to lack of oxygen. The Consultant Anaesthetist proceeded to jet ventilate Ian using a ManuJet III Ventilator with Cook Airway Exchange Catheter.”

The Manujet III can be used electively for microlaryngoscopy, rigid bronchoscopy, to assist a difficult fibreoptic intubation or during a predicted difficult extubation. However, the IFU states the intended use of the device is to provide transtracheal ventilation, in specific emergency situations. The IFUs specifies two types of emergency use with one including a lifesaving manoeuvre in the “cannot intubate – cannot ventilate “ situation for oxygenation to avoid severe desaturation of the patient. Transtracheal ventilation is achieved in conjunction with a transtracheal catheter, placed percutaneously into the trachea or using cricothyrotomy device inserted through the cricothyroid membrane. The second specified emergency use is for prehospital use if there is a partial obstruction of the upper airway. The IFUs indicate that in emergency situations the transtracheal jet ventilation (TTJV) has fewer complications and is faster and simpler as a surgical cricothyrotomy. The Manujet III is sold in a kit including Jet Ventilation Catheters.

The Manujet III is a manually operated device and the IFUs indicate the user must adjust the ventilation pressure and ventilation frequency properly to achieve balanced ventilation. Additionally, the IFUs have safety instructions which include that: “The user must ensure that expiration takes place via the upper airways. A total obstruction is a contra-indication for the use of Manujet III with Jet Ventilation Catheter. If another way of securing the airway is not possible and expiration is not assured, ventilation frequency should be reduced to 3 strokes per minute to avoid barotrauma. This can be sufficient as a life-saving manoeuvre in case of a total upper airway obstruction.”

(2) Had the ManuJet III not been used to provide oxygenation during airway exchange it is unlikely that the scenario would have deteriorated to cardiac arrest so rapidly.

Please see answer to question 1

(3) It was found at Inquest that the outcome would have been different if the ventilator had incorporated an adjustable pressure limiting valve, allowing control of the flow pressure. This is not possible with the ManuJet. The ManuJet does not have automated pressure sensing capabilities to it which will reduce or cease delivery if it senses the pressure in the airway being too high.

The Manujet III is a manually operated device and the IFUs instruct the user to: “Adjust the desired ventilation pressure by turning the pressure regulator knob clockwise. Start with the lowest pressure (0 bar/psi) and afterwards increase this pressure slowly under ventilation and clinical control of chest movements. The adjusted ventilation pressure is displayed on the gauge. Push the pressure regulator knob for locking. To re- adjust the pressure, pull the pressure regulator knob and adjust to the desired pressure.”

The Manujet III IFU does indicate there is a maximum operation pressure of 4 bar (58 psi) and the pressure regulator and gauge ensure that the maximum operation pressure of 4 bar (58 psi) is not exceeded.

(4) The Inquest conclusion supported the finding in the NHS Investigation that the design of the Cook AEC is flawed and that it needs to be redesigned and in addition requires markings or a colour change at the maximal depth of 26cm. The Inquest found that there had been no over-insertion in Ian’s case, but the risk of over insertion was noted by clinicians.

The Cook AEC IFUs clearly indicate it is only intended for uncomplicated atraumatic endotracheal tube exchange. Additionally, Manujet III can be used electively for specified types of intubations, however the IFUs state its intended is for transtracheal ventilation for lifesaving manoeuvres e.g., “cannot intubate – cannot ventilate “ for oxygenation, to avoid severe desaturation of the patient.

It is also worth noting the IFU for the CAE Catheter warns to avoid barotrauma by ensuring the tip of the CAE Catheter is, “ always above the carina, preferably 2-3 cm”. It also instructs users to; “Properly position the CAE Catheter within the endotracheal tube by aligning the appropriate centimeter mark on the CAE Catheter with the corresponding centimeter mark on the endotracheal tube. This placement is determined by visualising the indicated centimeter length of the endotracheal tube, in place, as shown on the surface scale. (For example, an endotracheal tube that has been shortened to 24cm should have the 24cm marker of the CAE Catheter aligned at the 24cm mark of the endotracheal tube.)”

In response to the suggested colour changes at a maximal depth of 26cm, variation in patient anatomy would mean that a maximal depth marking of 26cm may not be suitable for every patient (i.e. to position the catheter 2-3 cm above the carina). Also producing colour on a plastic catheter may introduce other risks. Furthermore, it is widely accepted the use of colour can introduce confusion due to the potential diversity amongst manufacturers leading to errors in use, and therefore is not recommended.

(5) Following the NHS investigation into Ian’s death, Derriford Hospital have prohibited the use of jet ventilation via the Cook AEC outside of ENT and thoracic surgery without the use of a rigid bronchoscope. The hospital has removed ManuJet ventilators from theatres (apart from ENT and thoracic surgery).

Please see answer to question 1

In conclusion, this incident describes the use of the Cook Airway Exchange (CAE) Catheter, manufactured by Cook Medical, and Manujet III ventilator manufactured by VBM. However, the CAE Catheter is not intended for complicated airways. Additionally, the IFUs for the Manujet III ventilator indicate it can be used electively for specified types of intubations. However, it is intended to be used via transtracheal ventilation for lifesaving manoeuvres e.g., “cannot intubate – cannot ventilate “ for oxygenation, to avoid severe desaturation of the patient.

We keep the safe and effective use of medical devices, including airway exchange catheters and manual jet ventilators, under continual review. We will further consider the issues raised in the report and will raise them with the manufacturer of these devices.

We would request the manufacturers are provided with a copy of the Regulation 28 Report or agreement that we can provide them with a copy of the Regulation 28 report directly. Additionally, we will work with the manufacturers of these devices to explore if any further action including any further risk communication and/or provision of information is required to help prevent any future recurrence of this issue.

Our guidance on Managing Medical Devices is about the use and management of medical devices. This indicates that instructions may need to be written locally to cover whole systems where devices are used together with other devices. If healthcare organisations draft their own instructions to supplement the manufacturer’s instructions, consider consulting the manufacturer/supplier on their accuracy and suitability, before issue. Further information can be found in the Managing Medical Devices guidance available online at https://www.gov.uk/government/publications/managing-medical- devices.

Should you have any further questions, please do not hesitate to contact me.