Public Access Defibrillators

Ross Andrew made this Freedom of Information request to South East Coast Ambulance Service NHS Foundation Trust

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear South East Coast Ambulance Service NHS Foundation Trust,

My Freedom of Information request follows the recent installation of Public Access Defibrillators (PAD's) by South East Coast Ambulance Service NHS Foundation Trust (SECAmb) on Runnymede Borough Council (RBC) buildings and in other areas of Surrey, Sussex and Kent.

The unsecured storage cabinets that have been used outside for storing the defibrillators in Runnymede are designed and sold by the USA manufacturer Cardiac Science for indoor use in secure areas.

Given that improving access and outcomes to match international best practice and that this must be clinically and academically evidence based in the NHS I would like to know the following:

1/ What evidence was used in choosing the locations for these life saving medical devices?

2/ As the cabinets are unheated, how do you ensure that the PAD's are stored within their required operational temperature and humidity range?

3/ Who is tasked to check and ensure the ongoing operational capability of these PAD's?

4/ How often are these inspections carried out and how is this reported back to SECAmb and RBC who have vicarious responsibility for this equipment?

5/ What evidence was used to risk assess the locations of these PAD's to ensure their security, particularly since three had already been stolen in 2013 from Surrey and Kent, so denying public access to life saving equipment.

6/ Given the loss of public life saving equipment, the potential loss of life and the cost of replacing the equipment to the public, what evidence based reviews and measures were carried out following those thefts to prevent repeat occurrences?

7/ What evidence was used to support the statements by SECAmb staff to members of the public and RBC Councillors that the cabinets and storage methods were the same throughout the UK and that no PAD's had been stolen in the UK?

8/ What evidence was used to support the public statement by a SECAmb officer on Twitter, that secure PAD cabinets that are Keypad coded (code given by the 999 ambulance service operator) or electronically controlled by the ambulance service as commonly installed by charities, the public and ambulance services in the UK and Europe cause delays and reduces the chance of successful defibrillation?

9/ How many key coded and electronically secured PAD cabinets does SECAmb have in it's area and what delays have been caused by their operation of these cabinets?

10/ In Runnymede how many PAD public awareness and training events have been held, when and where were they held, how were they publicised and how many members of the public have been trained in their use?

Yours faithfully,

Mr Ross Andrew

Freedom of Information, South East Coast Ambulance Service NHS Foundation Trust

Dear Mr Andrew

Thank you for your enquiry under the Freedom of Information Act 2000 (FOIA) to which I have allocated the reference FOI/13/04/21.

We are handling your request and aim to provide a response within 20 working days of receipt.

Should you have any queries in the interim, please do not hesitate to contact me quoting the above reference.

Regards

Julie Rayner
Freedom of Information Coordinator – Lewes

Tel: 0300 123 0999

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Julie Rayner, South East Coast Ambulance Service NHS Foundation Trust

1 Attachment

Dear Mr Andrew

Please see attached our letter in response to your enquiry under the Freedom of Information Act 2000 (FOIA) reference number FOI/13/04/21.

Regards
Julie Rayner
Freedom of Information Coordinator (Lewes Office)

South East Coast Ambulance Service NHS Foundation Trust
Direct Dial: 01273 484772
Email: [email address]

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Dear Julie Rayner,

The South East Coast Ambulance Service NHS Foundation Trust (SECamb) response does raise serious cause for concern regarding your responsibility and attitude to the use and maintenance of expensive and complex medical devices, compliance with medical device directives, legislation and subsequent risk to public and patient safety. Also the blasé attitude of acceptable risk towards the theft of expensive life saving equipment, not only the financial cost to the tax payer or charity giver, but the fact that these devices are then unavailable to save lives for several weeks before replacement back in the same unlocked cabinets.

Public Access Defibrillators (PAD's) are a fantastic resource and an opportunity to raise awareness and save lives as they are doing around the world. But if not managed properly, as confirmed in the SECamb FOI response there is a high risk of failure of the medical device at the moment a member of the public attempts to save a life.

As an experienced clinician I have used defibrillators many times and fully advocate the responsible and wide spread use of (PAD's) as they do save lives. I teach resuscitation, use of Automated External Defibrillators (AED's), etc and support users of AED's in their locations, including those installed as PAD's.

As a clinician I have used and been responsible for medical devices and worked alongside the Medicines and Healthcare Regulatory Agency (MHRA) and their predecessors. In a lead NHS clinical post I was involved in investigating patient/staff safety incidents/failures where registered medical devices were poorly used and maintained outside the manufacturers standards, instructions and protocols and therefore related legislation.

I qualified my FOI questions with "Given that improving access and outcomes to match international best practice and that this must be clinically and academically evidence based in the NHS I would like to know the following".

However several of your answers completely ignored the requests for evidence and SECamb again repeated unsubstantiated, misleading statements that my FOI request was attempting to substantiate. It would be reasonable to speculate if proper evidence is used by SECamb in reaching clinical decisions.

My questions, comments and concerns about your response are completely evidence based and detailed below for clarification.

Locations of PAD's:
You stated that PAD placement is in areas of need, based on British Heart Foundation (BHF) criteria. If that is the case why in Runnymede and other areas have the PAD's not been placed in areas of higher risk "high foot-fall" as well as the relatively quiet locations you have used? For example there is no PAD in Egham town centre where there is the highest foot-fall in Runnymede of 1000's of people each day. Similarly in Staines High Street, although there is one inside the Elmsleigh shopping centre, besides having no Defibrillator signs as required by the BHF and Resuscitation Council UK (RCUK), this is unavailable when the centre is closed.

However I now understand that SECamb will be shortly correcting that and installing sufficient PAD's in both Egham and Staines town centres presumably working with local businesses to ensure correct installation and placement. It does seem strange not to locate them in these extremely busy areas in the first place.
Responsible Storage and maintenance of PAD's:
All the AED's and their cabinets installed by SECamb as PAD's are CE marked Registered Medical Devices, requiring legal compliance with manufacturers instructions to ensure they are fully operational when required to save lives.

I have rechecked your response with manufacturers and MHRA they confirm SECamb is not operating this life saving equipment within recommended registered parameters. There is a strong possibility that AED's would fail when needed to save a life if stored and managed as confirmed by your FOI response. This is considered a Medical Device Adverse Incident and should be formally reported by SECamb.

Just to be clear AED's must never be stored below freezing under any circumstance. SECamb have admitted storing them in unheated cabinets with a policy to check them if the temperature falls below -2°c for two days or more. Although it is unclear how they would check for the damage caused by freezing, as the AED's self checking and warning systems depend on operating under normal working parameters.

None of the manufacturers supply a "showerproof" cabinet as you state as there is no definition for this, they are either external/internal use or internal use only. The Cardiac Science cabinets installed this year in Runnymede by SECamb are all Internal use only, unheated cabinets and they have been installed outside, completely exposing these sensitive medical devices to all extremes of the weather. Therefore all these AED's have already been exposed beyond their safe working parameters and may not function to save lives when required as we would hope.

You state SECamb is checking the AED's 6 monthly, which again is way beyond what the Manufacturers and MHRA require, there is no assurance that they would work or even be there when required for a sudden cardiac arrest. Ideally daily or weekly, certainly no more than 2 weekly operational checks on these complex, sensitive medical devices are required.

As you know the two key coded PAD's in your area are fully checked by a representative of the charity AED Locator fortnightly and a full report sent to SECamb
Obviously SECamb have implemented a policy to take responsibility, operate and manage these medical devices against the manufacturers clear instructions, widely outside their safe working parameters and therefore against Medical Device legislation and directives.

Please provide a copy of that operational and maintenance policy, how this was decided and who by.
Are SECamb going to submit MHRA Adverse Incident reports regarding this serious matter?

Security of PAD's:
Your response about stolen AED's does not refer to any of the clinical and academic evidence required in the NHS to ensure best practice, public and staff safety. I'm unsure how your statement that only 3 defibrillators costing £1,000's have been stolen is reassuring and can be seen as a benefit.

There has been no review whatsoever of this policy following thefts, none of the evidence used by other NHS ambulance services or expert charities used, despite further thefts of AED's from unsecured PAD cabinets since the original freedom of information request.

Your response to the question what EVIDENCE was used by SECamb to support apparently false claims to local elected officials at RBC to their reasonable questions, that no PAD's had ever been stolen in the UK and that the cabinets and storage methods were the same throughout the UK. SECamb is fully aware this is not the case. As you know, the charity Arrhythmia Alliance who are experts in the correct installation of PAD's have written to RBC expressing their serious concerns about the PAD's installed by SECamb and the risk of their theft or failure to operate.

Again you have failed to answer the question about what EVIDENCE was used to support a misleading public statement by a SECamb clinician on Twitter.
Again you have produced no evidence or data supporting your claims of delays by using key coded cabinets or for advocating unsecure cabinets. In fact you have confirmed that there have been no delays in the use of the key coded cabinets that do operate in the SECamb area, therefore contradicting your own public statements.

Just to explain about Key Coded and remote opening cabinets. These are being installed in cooperation with NHS ambulance services throughout the UK by expert charities such as Arrhythmia Alliance, Community Heartbeat and AED Locator. As with the two already installed in Sussex, when a 999/112 call is made regarding possible cardiac arrest the ambulance service tells the caller where the nearest PAD is and opens the cabinet remotely, or gives them the simple 4 digit code.

There is no record of any delay accessing a PAD to any of the charities knowledge, but there is much less chance of AED's being stolen. The cabinets are heated and maintained as already explained, fully complying to manufacturers and MHRA standards, unlike the ones recently installed by SECamb in Runnymede.

In an ideal world we would have all unsecured cabinets, but there is a massive problem of stolen NHS equipment and each NHS trust is accountable and has a responsibility to reduce this risk as much as possible. Clearly from your response SECamb is not doing this, otherwise they would work together with the expert charities as many other NHS ambulance services are doing to install secure PAD's.

With the thefts in the SECamb area who paid for each replacement of these stolen medical devices?
How long did replacements take to install?
How long were the public left without an AED in each area?

What evidence was used to measure the acceptable risk you advocate?

Public awareness training:
The two dates for this were implemented after this FOI request in Runnymede, several months after installation, poorly attended and no one is aware of poster displays locally, not quite sure as to the value of Twitter to advertise this type of event. There appears to have been no Heartstart training locally, so this appears to be an ambition rather than actually happening on a regular, consistent basis.

The charities already referred to work with local communities when they install these life saving medical devices, as required by the MHRA (Devices in Practice - a guide for health and social care professionals). SECamb is required by the MHRA to ensure training is carried out before installing medical devices, obviously not everyone can be trained, but as much effort as possible should be made.

Given the constraints on budget and the well publicised difficulties SECamb is having in meeting the needs of the public does SECamb actually have the resources to properly install, operate and maintain these medical devices?

It has already been demonstrated that you are not meeting the evidence based requirements to operate and manage these PAD's, does SECamb have a policy not to work with the expert charities to ensure safe installation, management and training?

Is SECamb now committed to co-operating with local business, local people and expert charities such as the Fabrice Muamba supported Arrythmia Alliance campaign, as other NHS ambulance services are doing; to install PAD's responsibly in appropriate locations in the Runnymede and Spelthorne areas, rather than imposing them inappropriately with little public awareness?

Will SECamb now stop repeating unsubstantiated, misleading statements to the public and their representatives when reasonable questions about safe use, security and storage of AED's as Public Access Defibrillators are asked?

Yours sincerely,

Ross Andrew

Freedom of Information, South East Coast Ambulance Service NHS Foundation Trust

Dear Mr Andrew

Thank you for your email.

We are looking into the queries raised and will respond in due course.

Regards
Julie Rayner
Freedom of Information Coordinator (Lewes Office)

South East Coast Ambulance Service NHS Foundation Trust
Direct Dial: 0300 123 0999
Email: [South East Coast Ambulance Service NHS Foundation Trust request email]

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Freedom of Information, South East Coast Ambulance Service NHS Foundation Trust

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Dear Mr Andrew

Please see attached our letter in response to your recent email.

Regards
Julie Rayner
Freedom of Information Coordinator (Lewes Office)

South East Coast Ambulance Service NHS Foundation Trust
Direct Dial: 0300 123 0999
Email: [South East Coast Ambulance Service NHS Foundation Trust request email]

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Click on the logo and become a member today

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Dear Freedom of Information,

Unfortunately South East Coast Ambulance Service NHS Foundation Trust have refused to provide evidence to support their initial response to my FOI request and actually answer it properly.

They have also stated in their latest response that they emailed me on several occasions for a meeting with their senior managers, we have thoroughly searched for these emails, but no such emails have been received. Although we have been receiving their normal foundation trust members newsletters by email with no problem.

Before my FOI request I had been repeatedly writing and trying to discuss this matter with this NHS Trust without success. They have now said that as far as they are concerned this FOI request is closed.

They appear to be trying to avoid answering the reasonable questions about their medical devices and patient/public safety and exactly what they have been telling the public. This week there have been the CQC concerns and the speech by Jeremy Hunt MP Secretary of State for Health about the terrible consequences of lax safety in the NHS, a culture of secrecy and the new Duty of Candour.

As a clinician I have always believed in and acted as Patient safety being my number one priority and have experienced many of the repercussions of directly raising concerns in the NHS about patient safety as a clinician.

I now have a professional and moral duty to pass these serious concerns onto the MHRA and CQC for them to investigate and hope that no one suffers as a result of this failure by the South East Coast Ambulance Service NHS Foundation Trust to store and use life saving medical devices correctly.

Yours sincerely,

Ross Andrew RN MASI FRSPH

Freedom of Information, South East Coast Ambulance Service NHS Foundation Trust

Dear Mr Andrew

Thank you for your email of 22nd June 2013, the contents of which have been noted.

I am sorry to learn that you feel this course of action is necessary especially as I am aware that my colleagues have tried to contact you using the following email address: [email address] on 9th May 2013 and other occasions and received an out of office email in response stating the following:' We are on Annual Leave and will respond to messages where required on our return.'

As previously mentioned this enquiry under the Freedom of Information Act is now considered closed.

Regards
Julie Rayner
Freedom of Information Coordinator (Lewes Office)

South East Coast Ambulance Service NHS Foundation Trust
Direct Dial: 0300 123 0999
Email: [South East Coast Ambulance Service NHS Foundation Trust request email]

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Dear Freedom of Information,

Not quite sure why South East Coast Ambulance Service NHS Foundation Trust felt the need to respond again without any additional information or fully answering the FOI request. My reply on 22 June 2013 remains the same - no emails have been received, including 09 May 2013.

However their very limited response to the FOI request exposed additional major public/patient safety issues with the failure by the South East Coast Ambulance Service NHS Foundation Trust to store, maintain and use these life saving medical devices - Automated External Defibrillators correctly and safely.

They clearly do not believe it is necessary to take any action to address this matter despite it being a legal requirement of an NHS Trust to protect public/patient safety within their area of responsibility.

As South East Coast Ambulance Service NHS Foundation Trust said "As previously mentioned this enquiry under the Freedom of Information Act is now considered closed." Therefore they closed that option to address this concern about public/patient safety and left this serious clinical problem unresolved.

When public/patient safety is at risk there is no option for responsible clinicians but to involve the CQC, MHRA and local MP (who has these devices in his constituency), to ensure public/patient safety is protected. This is why the CQC and MHRA have systems in place for such reports, it appears that this is what South East Coast Ambulance Service NHS Foundation Trust are really sorry about.

This matter was formally referred to both these external agencies on 22 June 2013, they have confirmed that they will be investigating and my MP has expressed his interest. It is no longer appropriate for this NHS Trust to be communicating with me about this matter.

Yours sincerely,

Ross Andrew RN MASI FRSPH

Dear Freedom of Information.

Final Update re Freedom of Information (FOI) request to South East Coast Ambulance Service NHS Foundation Trust (SECAmb) & Runnymede Borough Council (RBC) about their recently installed Public Access Defibrillators (PAD’s)and their related risk to Public Health.

As an experienced clinician, as well as using life saving equipment, I have been involved in fund raising for defibrillators since the 1980's for NHS ambulances in Surrey and more recently PAD's in other communities, along with CPR and defibrillator training. Most communities have enthusiastically welcomed properly installed PAD's along with the training, provided by expert charities and NHS ambulance services working together.

In my own community of Runnymede we attempted the same successful process, including Arrhythmia Alliance and British Heart Foundation charity stalls at a local community fair, but, RBC & SECAmb have been unwilling to support this charitable work. So instead of spending our time usefully, teaching people how to save lives, it has resulted in a lot of wasted time arguing with officials, who really should know better.

When PAD's were suddenly very badly installed by RBC and SECAmb away from population centres in Runnymede in 2013, without discussion with the expert charities that had already approached them we were concerned, which lead to this FOI request. The local MP Philip Hammond, also wrote to both organisations.

Following some of the information disclosed and the reluctance to fully disclose legitimate information about why these life saving medical devices were being installed & maintained completely against manufacturers instructions. The regulators MHRA and CQC were informed and both responded by contacting SECAmb to insist they comply fully with their legal requirements to manage medical devices properly and provide adequate training.

As a direct result the SECAmb CEO Paul Sutton has told the MP they are now going to comply with the regulators and address this, albeit in a very NHS way. They have started by directly employing someone to clarify the information on over 1600 possible PAD’s in the region, their aims, all at public expense:

1/ "Identifying an 'owner' for the PAD site who will be able to check the AED on a regular basis."
2/ "Planned programme of maintenance for all PAD sites (including financial implications)."
3/ "Assurance that PAD sites are correctly installed and functioning, which impacts on public safety and patient care."

However they have not said what they are going to do about their own installations this year of defibrillators onto the outside of buildings, into cabinets that are only designed for use inside buildings. Defibrillators are sensitive devices, there has been a recent report by the regulators in the USA about the failure of defibrillators, when used to try to save a life, as a result of poor installation and maintenance.

In recent rain showers, at least two of the new cabinets in Runnymede have leaked and allowed water in, one of these defibrillators was literally dripping with water and the cabinets steamed up with humidity. Only cabinets designed for external use as installed throughout the UK, Europe and worldwide should be used, they are required to be weatherproof, insulated and heated to ensure the battery, pads and other sensitive components don’t deteriorate.

SECAmb certainly should not continue to advise that PAD's should be installed outside in interior cabinets, not designed for the purpose.

SECAmb confirmed the vital public awareness training was left to RBC, their CEO insists these were publicised and held, although no one, including local businesses seem to have been aware of these and who was providing the training. RBC have also quoted British Heart Foundation (BHF) where it states that you don’t need to have training to use a PAD, nor do they have to be secure, which is the RBC rational for not providing any more training or improving security. Although the national and international evidence, including that from the BHF that has shown that there is a reluctance to use a defibrillator without training. Training is the key to success and even SECAmb admit the international evidence that there is no delay in using secure PAD's at least the Defibs aren't stolen.

Unfortunately Paul Turrell CEO of RBC states in his letter to our MP that RBC can do no more other than speak to SECAmb. He admits to being contacted by the international expert clinical charity Arrhythmia Alliance (he calls them 'Arismia Alliance'), he says it was only about security. They actually wrote concerned about the wrong cabinets being used and offered RBC help and support, which he dismissed by misquoting the BHF, although not using their support either, particularly as both charities do a lot of work together.

He also decided to make a dismissive personal remark about my clinical expertise, that he notes that this is the line of work I am "now in" as though this is new, rather than my clinical career of well over 35 years.

If only SECAmb and RBC had worked with one of the established charities Arrhythmia Alliance and AED Locator or Community Heartbeat and Defib Finder as most NHS ambulance services and many public authorities in the UK are.

The charities would have worked with the community groups and authorities to raise money, provide defibrillators in secure, properly installed, external, insulated, heated, internationally agreed marked cabinets with full instructions. They work together to provide all the publicity and ongoing community training and education.

All the PAD's are entered onto a publically accessible website database AED LOCATOR and/or DEFIB FINDER. Appointed local voluntary community PAD guardians check, maintain and provide a status report to the charities and the local Ambulance Service on every PAD every fortnight.

There is no cost to the NHS, no extra staff employed and reliable, working PAD's available when required to save a life, not difficult and is saving lives.

However this is how this part of the world wants to continue by doing their own thing instead of what has a proven track record, my hope as a clinician is that no one is harmed because of this. Obviously as the CEO's of SECAmb and RBC are now fully informed they are also fully accountable of any consequences. They can always choose to contact the charities (details above) for the freely offered support, should they have a change of heart.

Myself and colleagues will move on and continue to do what we do best to help people to save lives instead of arguing with public officials which is just exhausting.

Yours sincerely,

Ross Andrew

Dear FOI,

Just to be clear I would no longer be expecting, receiving or responding to any further responses as this particular FOI is now concluded.

Yours sincerely,

Ross Andrew