Dear Ms Ridge,

Investigation into an Invacare Portugal Lda, Medley Ergo bed with an extension and its relation to the circumstances surrounding the death of Paul Rodney Batchelor (DOD 28/06/2023).

Thank you for your email of 16 September 2024 attaching the Regulation 28 letter following the inquest into the sad death of Mr Paul Rodney Batchelor. I would like to offer my sincere condolences to the family of Mr Batchelor on their loss.

In your letter, you requested that action should be taken to prevent similar events of this kind occurring in the future. I would like to take the opportunity to provide relevant background before responding to your matters of concern.

Introduction and regulation of medical devices in the UK

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, blood components for transfusion and medicinal products in the UK.

The MHRA takes all reasonable steps to protect the public’s health and safeguard the interests of patients, public and users. We ensure manufacturers of medical devices comply with the UK Medical Devices Regulations 2002 (as amended) to demonstrate that they meet appropriate standards of safety, quality, and performance for the expected lifetime of the device. Where possible, we work with a range of stakeholders, including patients and the public, to work towards the promotion of safer medical devices and their safe use.

Manufacturers must demonstrate compliance with the Regulations before a medical device can be UKCA or CE marked and placed on the UK market. Although not

mandatory, device manufacturers can use designated standards to demonstrate that they are compliant with relevant requirements of the Regulations.

One major area 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. An adverse incident is an event involving a medical device, which produces, or has the potential to produce, unwanted effects involving the safety of patients, users, and other persons. These effects may arise from shortcomings in the device, its operating instructions, user practice or conditions of use. Adverse incidents may also occur due to patient factors, as not all interventions are suitable for all patients and their condition may change over time, requiring a different approach.

Patient safety is our highest priority and we encourage everyone to report safety concerns to MHRA through our Yellow Card scheme. However, it is mandatory for manufacturers of medical devices to report certain incidents to MHRA.

In general, where an adverse incident occurs the manufacturer of a medical device is responsible for carrying out any investigation required and informing MHRA of their findings. We regularly review our database of incidents to detect safety signals and consider whether additional action is required. Where necessary we will issue safety messages to health and care organisations, patients, and the public. These types of actions help to reduce the risk of similar incidents happening again.

Synopsis of incident

The MHRA was initially informed of Mr Batchelor’s death involving a Medley Ergo bed by Invacare Portugal Lda on 14 February 2024. Invacare first became aware of the incident on 5 February 2024 and reported within the regulatory timeframes.

From the details within your report, Mr Batchelor was using a Medley Ergo bed with an extension frame manufactured by Invacare Portugal Lda. On 27 June 2023, Mr Batchelor was found trapped in the gap between the standard mattress and the footboard, after the extension section of the mattress fell through the gap. His death was formally recorded by paramedics on 28 June 2023. It was found that there was no deck in place to support the mattress extension.

Matters of concern

You expressed to the MHRA as a matter of concern that there may be a lack of awareness of the need to ensure adequate support for the mattress extension or bolster when using nursing care beds with an extension frame fitted.

Prevalence of the problem A search of the MHRA’s database over the last 5 years (20 September 2019 to 20 September 2024) yielded no similar incidents involving a patient becoming trapped between the mattress and footboard when a bed was extended, apart from this incident reported to the MHRA on 14 February 2024. This search was conducted for any bed, and not just the Medley Ergo.

Invacare Portugal Lda has searched their database of complaints and not found any similar complaints for the Medley Ergo bed.

The wider issue of entrapment with medical beds is well known. A search of the MHRA’s database over the last 5 years (20 September 2019 to 20 September 2024) yielded 32 reports of entrapment involving beds and associated devices such as mattresses, bed rails and bed grab handles. This includes reports of entrapment of caregivers as well as with bed occupants.

MHRA response

The MHRA reviewed the manufacturer’s User Manual. The User Manual provides general warnings regarding the risk of entrapment. The User Manual also includes instructions on how to install the mattress support extension, which includes the step “Attach mattress deck extender to the mattress deck”. These instructions are also accompanied by diagrams. There are also instructions on the need for regular servicing and maintenance, and that these activities should only be conducted by “personnel who have received the necessary instructions or training”.

The MHRA carried out a review of deaths and serious injuries involving beds and bed rails in October 2022. In January 2023, the MHRA hosted a round table to discuss updating the Guidance on safe use and management of bed rails and how to raise awareness of the risks of death and serious injury with beds, bed rails, and other associated devices. As a result of these discussions, a National Patient Safety Alert on the risk of death from entrapment or falls with medical beds, trolleys, bed rails, bed grab handles and lateral turning devices was published in August 2023, two months after the sad death of Mr Batchelor.

The Alert requires that relevant staff receive device training suitable to their roles, organisations have an up-to-date medical device management system in place, and that regular servicing and maintenance of these medical devices is implemented in line with the manufacturer's instructions. It also requires regular risk assessments for patients using bed rails or handles, including entrapment risks.

This Alert was directed towards care home staff, among others, and was sent to relevant organisations via the MHRA’s Central Alerting System on 30 August 2023 and was also highlighted in the CQC’s Adult Social Care Bulletin on 28 September 2023. The MHRA attended meetings with Medical Device Safety Officer (MDSO) network on implementation of the Alert and provided input into the MDSO network’s FAQs for this Alert. The is available both on the MDSO network (restricted access) and also on the National Association of Medical Device Educators and Trainers (NAMDET) webpage (public access). The MHRA has also provided advice on the Alert wherever requested, including from various NHS organisations, local councils, care homes and manufacturers.

The MHRA also published in 2014 ‘Devices in Practice’ which is intended to provide a practical guide for health and social care professionals on using medical devices.

Ongoing Work

The MHRA has discussed with the NAMDET the possibility of producing training materials for users of beds and bed rails, and the risks relating to entrapment, and this is currently being drafted, with a view to be available in the coming months.

Conclusions

We suggest that the above list of actions detailed in the National Patient Safety Alert, published two months after Mr Batchelor’s death, are relevant to this case. Neither the MHRA nor the manufacturer have received any similar reports with the Medley Ergo bed, and the MHRA does not have any similar reports for other beds either, relating to the bed extension. The MHRA has published a National Patient Safety Alert with general requirements to prevent entrapment with beds and associated devices and based on the lack of similar reports relating to bed extensions, we believe these requirements are sufficient, and we therefore do not intend to take further action. The MHRA will continue to monitor reports of entrapments in beds and associated devices very carefully, and if any adverse signals are detected in the future, we will take further action.

Should you have any further questions, please do not hesitate to contact my office: .

Dear Madam The Inquest Touching the Death of Paul Rodney Batchelor Regulation 28 Report – Action to Prevent Future Deaths – The Red House Care Home dated 13 September 2024 (the “Report”) We refer to the above and write to provide our response to the Regulation 28 Report to Prevent Future Deaths, received on 16 October 2024. The covering email from the Coroner’s Officer confirms that the due date for our response is 56 days from the Report, so 8 November 2024. This response is made under paragraph 7(2) of Schedule 5 of the Coroners and Justice Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations 2013. We understand the response must contain detail of action taken or proposed to be taken, setting out a timetable for action. Otherwise, we must explain why no action is proposed. We have addressed the Second Concern in the Report as below: - The coroner notes that the care home has taken steps to ensure that any resident in distress and calling for help at night is heard. However, though the coroner has been shown minutes of briefings to care home staff conducted after Mr Batchelor’s death emphasising the need to conduct checks of residents by going into a resident’s room, she remains concerned that such briefings have not been formalised into care home policy and procedures. Nor do the minutes of those briefings explain what staff should do if they are frightened or concerned about entering a room on their own. There is the risk that rather than disturb a resident care home staff through, for example, fear or lack of time do not check a resident who may be in distress. We provide a list of actions taken and the relevant dates for each as follows: - Action Taken Date of Action Date Evidence Sent to Coroner Review of staffing levels 26/06/2023 ATTACHED 29/10/2024 Urgent Flash Reflective Debrief meeting 29/06/2023 26/01/2024 Staff meeting – flash 29/06/2023 30/08/2024

The Redhouse (Ashtead) Limited 43 Skinners Lane, Ashtead, Surrey, KT21 2NN Telephone: 01372 274552 | Email: redhouse@redhouseashtead.co.uk | Web: www.redhouseashtead.co.uk Company Registration No. 03187173 Individual supervision with DS (Carer) 29/06/2023 ATTACHED 29/10/2024 Lessons learnt session with DS (Carer) 29/06/2023 26/01/2024 Lessons learnt session with SM (RGN) 29/06/2023 26/01/2024 Lessons learnt session with DP (Carer) 29/06/2023 26/01/2024 Night allocation – reviewed 05/07/2023 In oral evidence
--monthly Bed Condition Reports instigated Dec 2023 In oral evidence Challenging Behaviour Support training 30/04/2024 ATTACHED 29/10/2024 Staff meeting – Flash 03/07/2024 30/08/2024 General staff meeting 09/08/2024 30/08/2024 General staff meeting 14/08/2024 ATTACHED 29/10/2024 Group supervision / lessons learnt 17/09/2024 ATTACHED 29/10/2024 Individual staff supervision – all staff 18/09/2024 ATTACHED 29/10/2024 Permanent staff Induction amended 19/09/2024 ATTACHED 29/10/2024 Agency staff Induction amended 19/09/2024 ATTACHED 29/10/2024 Bed Inspection report 19/09/2024 ATTACHED 29/10/2024 Night staff Meeting 20/09/2024 ATTACHED 29/10/2024 Staff Deployment and Retention policy updated 23/09/2024 ATTACHED 29/10/2024 Post Incident Training delivered by Legal Professionals 11/10/2024 29/10/2024 Reviewing the options for acoustic monitoring to be installed at the home Ongoing In oral evidence Group supervisions, staff meeting minutes are made available to all staff and form part of the procedures of the home. Challenging behaviour training was conducted by Elgee Training on 30 April 2024 and incorporated the following. The narrative from the trainer is as below: - The learning outcomes were:
• Understand what behaviour that challenges is and what person-centred values are, how to recognise triggers & report them
• Understand the needs of the people we support so their care is needs led
• How to keep you safe if a resident is violent or aggressive
• Produce a positive behavioural support plan My brief and, therefore, my narrative for the training was: Identify challenging behaviour theory and meaning, De-escalation techniques, principles of positive behavioural support, ABC process (to identify triggers to this behaviour),

The Redhouse (Ashtead) Limited 43 Skinners Lane, Ashtead, Surrey, KT21 2NN Telephone: 01372 274552 | Email: redhouse@redhouseashtead.co.uk | Web: www.redhouseashtead.co.uk Company Registration No. 03187173 Actions to avoid being restrained or attacked, post-incident actions, record keeping, de- briefing, Why do people challenge – often because of unmet needs (so what are they?). These unmet needs would have become a group exercise and would have included, not enough sleep, being disturbed, hungry, cold, thirsty, lonely, uncomfortable, too hot, too much noise, you not understanding me, in pain, need the toilet etc.

Know when to walk away (this is in the handouts too), and either hand the situation on to a colleague or get some help at that stage. Make sure incidents are recorded and the information passed on to the shift leader. Make sure that you have not placed yourself in a vulnerable position when entering a residents’ room or go in with a colleague. Don’t ignore these challenges. Record and report them otherwise they can become normalised (and then they don’t get seen)

During my discussions, I would have mentioned that if we can determine what triggers the behaviour that challenges, and then avoid the triggers by changing our behaviour, then the incidents won't happen.

To record this, we use the ABC method.

The Mental Capacity Act determines that if residents have capacity, then they have the right to say no, and to live their life the way they want it, if that is possible within the confines of a care home. Any changes would trigger a review of that resident’s care plan – your care plans and appropriate risk assessments are reviewed 4 weekly or sooner.

Post incident action The Red House has taken several steps immediately following the incident. The Manager met with care staff the following day and conducted reflective practice/lessons learnt with the staff present during the incident. The Manager then met with all staff, who were made aware of the risks of not responding to a call for assistance from a resident and the tragic consequences that can occur. All staff received individual supervision sessions and group supervision where this incident was discussed, and measures put in place to prevent a recurrence. Staff were instructed that if they felt unsure for any reason responding to a resident call for assistance, then they are to inform a colleague and enter in pairs, or the duty nurse. The individual supervision with DS (carer) clearly outlines what action to be taken if she felt unsure about entering a resident’s room.

The Redhouse (Ashtead) Limited 43 Skinners Lane, Ashtead, Surrey, KT21 2NN Telephone: 01372 274552 | Email: redhouse@redhouseashtead.co.uk | Web: www.redhouseashtead.co.uk Company Registration No. 03187173 The staffing levels in the home were reviewed on 26 June 2023 and a change to the allocation of night staff was made to ensure all floors had care support throughout the night. Since the inquest concluded, we have communicated to all staff the coroner’s concerns and whilst we believe this was an isolated and unforeseeable occurrence, the home has continued to reinforce the learnings to the present time, being 16 months following the incident. A policy was in place at the time of the incident (the Room Call Policy and Procedure) for care staff to respond to call bells and has been extended to include if a resident was verbally calling out for assistance. The policy is that there is to be no exceptions ever to physically checking on a resident. We will keep our policies under review to ensure that any positive changes to them will be made for the benefit, health, and safety of the residents. QR codes are now being placed in the residents’ bedrooms so that staff, when completing night checks, must enter the bedroom and scan the code using the handheld PCS device to record the check on the care system. The home had further post incident training on 11 October 2024 delivered by legal professionals versed in care matters. The home is also investigating options for acoustic monitoring to be installed. All staff training is maintained above 98% compliance and staff have competency assessments to ensure their knowledge and skills are current and up to date. As stated at the hearing, the carer involved is no longer working at The Red House and I would like to assure you their actions in no way reflect the high standard of care that staff at The Red House deliver. The staff team have been shocked and saddened by the events that led to the death of our resident PB and have embraced the changes that have been made to mitigate the risk of this happening again in the future. Mindful of the changes that we have implemented above, and which will be continuously monitored and reviewed going forward, we believe that all our residents are appropriately monitored, they are not left unattended and the environment that they live in is safe. We hope we have addressed and allayed the concerns of the Coroner in our response above.

Dear Coroner Ridge,

Prevention of future death report (PFD) following an inquest into the death of Paul Rodney Batchelor

Thank you for granting an extension to enable the Care Quality Commission (CQC) to respond to your report issued in regard to Mr Batchelor’s death at the Red House Care Home in Ashtead, Surrey. We offer our sincere condolences to the family of Mr Batchelor on their loss.

The report outlined two matters of concern; the first of which was addressed to the CQC and Medicines and Healthcare Products Regulatory Agency (MHRA) and the second to The Red House (Ashtead) Limited. We would like to take the opportunity to provide relevant background information before responding to your matters of concern.

Background: the role of the CQC

The CQC was established on 1 April 2009 by the Health and Social Care Act 2008 (‘the Act’). The CQC is the independent regulator of healthcare, adult social care, hospital and community trusts and primary care services in England. The CQC also protects the interests of vulnerable people, including those whose rights are restricted under the Mental Health Act.

Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA

Telephone: 03000 616161

The Act introduced a single registration system which applied to both healthcare and adult social services. Once registered with the CQC, providers such as The Red House (Ashtead) Limited were required to comply with conditions placed on their registration, as well as the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 (‘Regulated Activities Regulations 2010’) and the Care Quality CQC (Registration) Regulations 2009 (‘the Regulations’).

The Regulations set out the essential standards of quality and safety that service users had a right to expect. The Regulated Activities Regulations 2010 were replaced by the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 which came into effect from 1 April 2015. The Act requires the CQC to publish guidance about compliance with the requirements of the Regulations.

Background: deaths and serious incidents reported to the CQC

The Act also requires providers to notify the CQC of certain events such as serious injury or the death of a service user. When this happens, we obtain information from the provider and other sources to help us determine if there is an on-going risk of harm to others and whether the information suggests there was a breach of the regulations. Important questions we must consider include whether there has been a failure on the part of a registered provider to provide safe care and treatment resulting in harm or a significant risk of exposure to avoidable harm.

Harm caused through acts or omissions by an individual are referred to the appropriate authority, such as the police. Our statutory powers do not allow us to impose or implement corrective measures directly onto a provider. We do, however, expect the provider to respond quickly and comprehensively to any incident to manage risk and provide safe care. We also expect any changes made to be imbedded into their usual practice and sustained.

CQC Enforcement Powers

1. If we find that a registered provider or registered manager is in breach of provisions within the Regulations or the Act, we can take action to make sure that they improve. The action we take should be proportionate to the impact that the breach has on the people who use the service, how serious it is and whether we can allow the provider time to meet the Regulations. Unless we are seeking to close a service, we aim always to follow up any enforcement action with another inspection to ensure that improvement has been made. If we find continued breaches of regulations, we may escalate our enforcement response. However, we always consider each case on its own merit.
2. We take enforcement action where there is a serious breach resulting in risk for people and where we cannot leave the registered provider to decide on the timescale for meeting the Regulations. Enforcement action can be undertaken using either our civil or criminal powers. Our civil enforcement powers include: a) Issuing a warning notice;

b) Impose, vary, restrict or remove a condition from the provider’s registration; c) Suspend registration; or d) Cancel registration. Where people are at immediate risk of significant harm, and we cannot be assured that unless we act people will come to serious harm we can use our 'urgent' powers. This means that in some cases we are able to take immediate action to suspend or cancel registration or impose, vary, restrict or remove a condition from the provider’s registration.

Background: the provider and brief chronology

Red House Care Home in Ashtead, Surrey, is a home with nursing for up to 26 people. The provider is registered for the following regulated activities:
• Accommodation for persons who require nursing or personal care
• Diagnostic and screening procedures
• Treatment of disease, disorder or injury

The location was inspected in 2014, 2016 and 2019. At the last full inspection in 2019 the location was rated as outstanding. We conducted a further inspection focussed on infection prevention and control (IPC) in 2022. Focussed inspections are unrated but in this instance we were assured that the provider was managing and mitigating IPC risks.

We learned from the provider of this tragic incident on 28 June 2023. Mr Batchelor died on 27th June having been admitted to the home on 26 May 2023. Following our serious incident protocol we gathered information from the provider about the circumstances of the death, their immediate actions and what measures they took to prevent further occurrence. Our initial contact with the provider commenced on 29 June 2023 and we were informed by them of the cause of death on 9 October 2023.

First matter of concern

“There may be a lack of awareness of the need to ensure adequate support for the mattress extension or bolster when using nursing care beds with an extension frame fitted. And that without adequate support there is a risk of death in that the mattress extension can fall through the bed frame creating a sufficient gap for a person to become wedged or stuck.

The lack of awareness of the risk may be compounded because when the mattress extension is fitted into the gap between the standard mattress and the footboard it may appear as though the bolster is adequately supported. Further that over time and use mattress deck extensions or other supporting framework can become detached or lost from the bed. Since this incident the court heard evidence that the care home and its sister care home have checked all existing extended profile beds and taken steps to ensure that they are fitted with the correct support.

However, the coroner is concerned that users of nursing care beds with extensions may need to be made aware of the circumstances of this death to prevent other deaths in similar circumstances”.

Last year CQC contributed to a MHRA national patient safety alert (NPSA) on beds and bedrails and their guidance on safe use of bedrails. CQC promoted both publications through our provider bulletins in September 2023. These bulletins are sent to health and social care organisations registered with the CQC and are addressed for action by the registered manager or a senior manager identified to the commission beforehand (called the ‘nominated individual’). The CQC already signposted providers to the MHRA bedrails guidance on our website page ‘Regulations for service providers and managers: related guidance’

The MHRA guidance does not specifically address the risks of the device used in Mr Batchelor’s case. However, the NPSA, in conjunction with the MHRA guidance on medical devices and their medical device checklist are intended to support providers to understand risk areas more broadly concerning beds and associated equipment, the importance of correct use (in line with any manufacturer’s instructions), appropriate maintenance and training in their use.

As a result of this tragic event, CQC regulatory leadership and policy teams arranged for the specific NPSA to be highlighted as an example on our page: National Patient Safety Alerts in adult social care.

We have highlighted the MHRA NPSA on beds and bedrails; their guidance on bedrails, their medical device guidance and their medical device checklist in our November 2024 provider bulletin. The medical device checklist lists profiling or adjustable beds and we have made this link clearer for providers.

We have also included the MHRA medical device guidance and accompanying medical device checklist on our website page ‘Regulations for service providers and managers: related guidance’, which is shown in the link above.

In addition, our policy and regulatory leadership teams will be including references to the NPSA and relevant MHRA guidance into our new assessment framework, although we are currently developing our approach to this.

The NPSA itself was directed to care homes (among other organisations) and included requirements for adequate training on these devices, as well as requirements for regular servicing and maintenance.

Based on subsequent discussion with the MHRA, CQC learned that the instructions for use for the bed included clear diagrams on how to extend the bed correctly and the instructions for use also specified the requirements for regular servicing, carried out by an appropriately trained person.

This should have picked up the issue of the missing deck and the circumstances of how this happened in this case and what remedial actions have been undertaken since have been addressed with the provider by the CQC.

Second matter of concern

“The coroner notes that the care home has taken steps to ensure that any resident in distress and calling for help at night is heard. However, though the coroner has been shown minutes of briefings to care home staff conducted after Mr Batchelor’s death emphasising the need to conduct checks of residents by going into a resident’s room, she remains concerned that such briefings have not been formalised into care home policy and procedures. Nor do the minutes of those briefings explain what staff should do if they are frightened or concerned about entering a room on their own. There is the risk that rather than disturb a resident care home staff through, for example, fear or lack of time do not check a resident who may be in distress.”

Since receipt of your report, we contacted The Red House (Ashtead) Limited to obtain evidence to help us determine the results of any additional action they intend to take in response to the prevention of future death report.

We received 56 submissions from the provider, including records relating to additional staff training in respect of managing challenging behaviour; modified policy, training and competency records as well as other interventions such as the implementation of ‘QR codes’ placed in residents’ bedrooms so that staff, when completing night checks, need to enter the bedroom to scan the code on a handheld electronic device to record the check on the care monitoring system. The home management team explained they were investigating options for acoustic monitoring to be installed. We were informed that, as stated at the hearing, the staff member involved in the incident was no longer working at the care home.

Having reviewed the material the provider submitted, our view is that the changes made by the provider have now been established.

From a regulatory standpoint, there is always the risk that remedial plans put in place after an event of this nature might not stay embedded into normal practice or sustained. Therefore we will continue to monitor and assess the care home utilising information obtained from our insight data as well as other stakeholders such as the local authority. We do not exclude other assessment methodologies such as unannounced inspection visits, but for obvious reasons we would not wish to disclose details or intentions publicly.

In conclusion, we will continue to work with our MHRA colleagues in relation to any other notifications of incidents occurring in the care sector involving harm to service users through entrapments in beds and associated devices. We will take robust action as necessary.

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