Re the MHRA's 2007-2008 investigation into a Gantry Hoist, Crossbar and Universal Sling

name removed 23 Oct 2012 (Account suspended)

4 March 2012

Dear Mr Peel, Medicines and Healthcare products Regulatory Agency, Department of Health, Mr Lansley Secretary of State for Health, Mr Turner MP for the Isle of Wight,

[complaint about non-FOI issue removed]

I am transposing the FOI Request that I originally made on 30 October to the COMMITTEE ON THE SAFETY OF DEVICES.

[request for requester’s own personal data removed]

Thank you very much for your help,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

Risk assessments of sling, crossbar and gantry hoist
[first name removed] [last name removed] made this Freedom of Information request to Committee on the Safety of Devices

Waiting for an internal review by Committee on the Safety of Devices of their handling of this request.

30 October 2011
Dear Committee on the Safety of Devices,

Risk assessments of sling, crossbar and gantry hoist

I would like to know if the Committee on the Safety of Devices has been given information regarding a very serious incident on 24 June 2006 which specifically involved a specific Gantry Hoist, a specific Crossbar Spreader Bar and a specific sling provided by a local authority, which risk-assessed the combination?

I have since been informed that the gantry hoist and this specific sling should have had a straight bar, NOT a crossbar.

I am concerned for public safety regarding the risk assessment of a "universal" sling. There is the potential risk that people will erroneously think that it can be used in any set of circumstances whereas it may not be appropriate in all circumstances and hence is not for universal use in all circumstances.

Thank you very much for your help in protecting people

Yours sincerely,

[first name removed] [last name removed]

[irrelevant quoted correspondence deleted]

11 November 2011
Dear Mr Peel, MHRA,

Thank you very much for this clarification.

I had no idea that the MANUFACTURERS had to inform you of incidents rather than the prescribers of the sling, crossbar and hoist.

In which case could you please confirm that the two manufacturers in this particular incident did inform you and when did they do so?

[irrelevant quoted correspondence removed]

Thank you so much

Yours sincerely,

[first name removed] [last name removed]

[irrelevant quoted correspondence removed]

21 November 2011
Dear Committee on the Safety of Devices,

[irrelevant quoted correspondence removed]

In 2007 I made request of the local authority who is their MEDICAL DEVICE LIAISON OFFICER but if the local authority does not have a regulatory duty to report incidents, then why should it be necessary for the local authority to have one at all?

[irrelevant quoted correspondence removed]

Could Mr Peel please explain fully what the role of the Medical Device Liaison Officer is, as clearly they do seem to play vital roles.

[irrelevant quoted correspondence removed]

Yours sincerely,

[first name removed] [last name removed]

[irrelevant quoted correspondence removed]

24 December 2011
Dear Committee on the Safety of Devices,MHRA,

[irrelevant quoted correspondence removed]

Is the Committee on the Safety of Devices part of the MHRA or not?

For if it is a separate body, why is the author of the two letters to me on MHRA-headed paper, and if the author is not part of the Committee on the Safety of Devices, then why has not the Committee on the Safety of Devices written to me in person using THEIR imprimatur, rather than that of the MHRA, unless they are all part of the MHRA itself?

[irrelevant quoted correspondence removed]

Thank you very much for your help

Happy New Year 2012

Yours sincerely,

[first name removed] [last name removed]

[irrelevant quoted correspondence removed]

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
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[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Regulation of medical devices:

[9]http://www.mhra.gov.uk/Howweregulate/Dev...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

Kind regards

Central Enquiry Point
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name removed 23 Oct 2012 (Account suspended)

13 March 2012

Dear Ms Jones MHRA, Mr Turner MP for the Isle of Wight, Mr Lansley Secretary of State for Health, Mr Pickles Secretary of State, Mr Cameron Prime Minister of Great Britain and Northern Ireland,

I thank you very much, Ms Jones, for your thoroughness in assessing this internal review of my Freedom of Information Request.

To me, the importance in all of this is health and safety for the public.

That to me is vital. My mother is no longer alive, but I know that she was very concerned lest other people might have similar traumatic experiences and asked me to lobby to make hoists safe. She was terrified of being hoisted - and with good reason.

A "universal" sling is NOT NECESSARILY actually able to be used in universal circumstances. This is what I have been campaigning about.

a] Why are "universal" slings on sale?

I was told by MHRA that one reason why they did not investigate further was that the MHRA had told the company in question NOT to use the word "universal" - but even in 2011 these slings were onsale. Why?

b] In 2008 why did MHRA accept that the universal sling could be used safely with the crossbar when in fact an email to the MHRA stated that so long as it was a straight bar it was all right to use on the gantry hoist?

To me this is at the heart of it all.

I have emailed the MHRA with details of this.

c] I want it to be demonstrated to me specifically how the specific universal sling and the specific crossbar and the specific gantry hoist in use on 24 June 2006 can actually be risk-assessed as SAFE to use, in view of what was sent to the MHRA in 2008 stating that it had to be a straight bar.

d] It is very important because the local authority records have a record stating that it must have been the carer's mistake. I believe this to be wrong and mischievous as the person writing it was part of the assessment. I believe that the assessment was not
properly done, as can be seen in the correspondence you have.

I believe that slings which have holes in them are dangerous as simple as that.

I would be most grateful to have the MHRA's full report on this matter sent to me. You have my email address and home address.

I have been in contact with the South London Coroner's because my mother died 9 days after the adverse incident which specifically was NOT recorded by the local authority but their excuse was that they did not witness it and therefore they did not see any
requirement to let anyone know. To me, this is wrong.

I wish to have a proper report so that I may evaluate it as the Executrix of my late mother. It may be that the South London Coroner will want a copy if there are sufficient grounds to investigate further.

Thank you very much for your help.

I look forward to hearing from you in the near future.

Yours sincerely,

[first name removed] [last name removed]

Campaigner for liberty, truth and justice

Date 12 th March 2012
REVIEW OF FREEDOM OF INFORMATION ACT (FOIA) REQUEST FOI 12-046

1. INTRODUCTION
1.1 In an email dated 15/11/11 (sent via whatdotheyknow.com), Mrs [last name removed] requested a review of the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the request relating to the Committee on the Safety of Devices (CSD), again sent via whatdotheyknow.com, on 30/10/11.

“I would like to know if the Committee on the Safety of Devices has been given information regarding a very serious incident on 24 June 2006 which specifically involved a specific Gantry Hoist, a specific Crossbar Spreader Bar and a specific sling provided by alocal authority, which risk-assessed the combination?”

1.2 The MHRAs response was sent on 2 November 2011. Mrs [last name removed] also asked, in an email dated 4th March 2012 what is happening to her complaint in respect of this issue. I apologise for the delay in dealing with this review.

2. PURPOSE OF INTERNAL REVIEW
2.1 The purpose of this internal review is to determine whether the MHRA dealt properly with the applicant’s requests under the Freedom of Information Act (FOIA) in its response.
The terms of reference of this review are:
• To read all correspondence between the applicant and the Agency, and any other relevant correspondence;
• To form an opinion on the handling of the correspondence by the Agency;
• To advise whether the actions taken by the Agency in reaching their decisions is justified under the FOIA;
• To make recommendations for further action by the Agency if appropriate; and
• To prepare a report of the review for the Agency and Mrs [last name removed].

3. Background

3.1 The Agency’s response to Mrs [last name removed]’s request was as follows:

“The Committee members would not have been made aware of this particular incident, which I note happened some time ago. Committee members do not investigate specific incidents. Investigation of reported incidents is carried out by MHRA device specialists and all information is collated through our adverse incident centre. As I am sure you are aware hoists are covered by very specific safety regulations. Could you please confirm that the incident below was reported to us? If you can provide more information then I may be able to help further.”

3.2 This seems to me to be a clear and unequivocal response to the initial question asked, and should have concluded this FOI request. Had the MHRA acted correctly and logged this as an FOIA request
initially, this could have been done.

3.3 Instead, in a follow up email dated 02/11/11, Mrs [last name removed] asked: “I would like clarification whether it is or is not a requirement as of 24 June 2006 onwards for the local authority to inform the MHRA once they were informed of the incident.”
To which the Agency replied on 10/11/11

"Under the Medical device Regulations there is a mandatory requirement on medical device manufacturers to report adverse incidents involving their devices which resulted or had the potential to result in serious injury or death to users.

Although we encourage and welcome reports from users [healthcare professionals, patients, members of the public etc.]there is no legal requirement for this and reports are made on a voluntary basis."

3.4 This reply elicited yet a further question from Mrs [last name removed] on 11/11/11
“In which case could you please confirm that the two manufacturers in this particular incident did inform you and when did they do so?”

3.5 This question does not appear to have been answered, at least via the FOIA.

3.6 These emails effectively formed an ongoing discussion regarding Agency policy towards the safety of slings and hoists, e.g. requesting reviews and further investigations. Eventually, on 15 November, Mrs [last name removed] requested an internal review. This request was repeated on 21st November, 14th and 24th December, and 22nd January. These requests were all met by an automated answering service informing her that she would be answered when the recipient returned to work.

3.7 On 23rd December the situation was further confused when Mrs [last name removed] was notified that her request for an internal review had been referred and treated as a complaint. Understandably this served to confuse the matter and the requester. The complaints process should not have been employed to deal with the request for an internal review. Again, had the initial request been properly handled this would not have occurred.

4. CONSIDERATION OF THE ISSUES
Handling of the initial request:

4.1 Mrs [last name removed]’s initial request was never logged or dealt with as a request under the FOIA. It was only brought within the scope of the Act when a further request for internal review was sent on 23rd January and came to the attention of the Agency’s FOI officer. At this point the request was logged as an FOIA request in order that it could be internally reviewed as such.

4.2 The initial request dated 30th October should have been logged and processed as an FOIA request in the normal way, despite the question having apparently been answered. In the Agency’s defence the initial request was probably dealt with as a routine business enquiry as it was answered quickly and in full. Although all requests for information fall within the remit of the FOIA, it would be impractical to treat every request received as being an FOIA request given that the Agency processes many thousands of requests for various types of information every year in the course of normal business.

4.3 However, given that the request was submitted via the whatdotheyknow.com website, and Mrs. [last name removed] indicated clearly on 15th November that she considered her request to be an FOIA request, something should have been done much sooner than 23rd January.

4.4 This would also have allowed the Agency to deal with the request in a more focused way and to separate out the elements of her correspondence that were applicable to the FOIA, and those which were not.

4.5 What unfolded from the date of the first request is a somewhat confusing and ongoing dialogue mixing requests for information, with complaints, and requests for actions completely outside the remit of the Act.

The Freedom of Information Act (FOIA)
4.6 The FOIA confers two basic rights to a requester:
• To be informed if the information is held
• To receive that information (subject to any relevant exemptions)
These rights apply to information held by a public authority.

4.7 The initial request was answered and, had it been processed correctly, the subsequent answer would have closed the request. Subsequent questions would then have been dealt with as new FOIA requests, rather than parts of an ongoing dialogue.

4.8 As this was not done at the time, I have looked at those elements of the correspondence which are properly FOIA requests to determine what further action is required.
Request dated 30/10/11

4.9 “I would like to know if the Committee on the Safety of Devices has been given information regarding a very serious incident on 24 June 2006 which specifically involved a specific Gantry Hoist, a specific Crossbar Spreader Bar and a specific sling provided by a local authority, which risk-assessed the combination?”
• This request has been answered

Request dated 02/11/11
4.10 “I would like clarification whether it is or is not a requirement as of 24 June 2006 onwards for the local authority to inform the MHRA once they were informed of the incident.”
• This request has been answered

Request dated 02/11/11
4.11 “I had no idea that the MANUFACTURERS had to inform you of incidents rather than the prescribers of the sling, crossbar and hoist. In which case could you please confirm that the two manufacturers in this particular incident did inform you and when did they do so?”
• I can find no indication that this request has been answered and I have asked the relevant section to provide it within 20 days.

4.12 Anything within the correspondence, other than a request for information held, is outside the remit of the FOIA. Therefore I have confined my review to what I believe are relevant requests under the Act.

4.13 However, I feel it important to point out that while the FOIA can allow access to information, and the complaints process can oblige us to review whether we have correctly followed procedures, neither of them is really a mechanism for bringing about change as such. Consequently, other matters arising from the correspondence, such as a perceived need for the creation of national policies, investigations into local authority practices, reviews about incident reporting etc, are not within the remit of the FOIA or the complaints process to address, and are issues that should be pursued by other means.

5. SUMMARY
• The Agency was at fault in not having initially dealt with the request as an FOIA request, and in not taking relevant action on the numerous requests for an internal review which followed.

• The unanswered request of 02/02/11 will be processed (as part of the initial request) and the answer provided to Mrs [last name removed] within 20 working days.
For these errors, I would like to apologise to Mrs [last name removed]."

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
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time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
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Kind regards

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name removed 23 Oct 2012 (Account suspended)

7 APRIL 2012

Dear Medicines and Healthcare products Regulatory Agency, Mr Lansley Secretary of State for Health,
Mr Cameron Prime Minister of Great Britain and Northern Ireland, the Cabinet and Cabinet Office,
Mr Turner MP for the Isle of Wight, Information Commissioner,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'Re the MHRA's 2007-2008 investigation into a Gantry Hoist, Crossbar and Universal Sling'.

On 4th April 2012 I wrote with my FOI Request:

"Re the MHRA's 2007-2008 investigation into a Gantry Hoist, Crossbar and Universal Sling"

Risk assessments of sling, crossbar and gantry hoist - a Freedom of...
Committee to be aware that the epithet "universal" sling does not mean that patients /people .... request as a complaint, not as an FOI request, and as such it has ...

www.whatdotheyknow.com/request/risk_asse...

http://www.whatdotheyknow.com/request/ri...
re London Borough of Bromley - a Freedom of Information request to ... 28 Oct 2011 ... 1] How many complaints overall you have received about London Borough of Bromley in ...... It is NOT a universal sling. It is only supposed to ...
www.whatdotheyknow.com/request/re_london...
http://www.whatdotheyknow.com/request/re...
[first name removed] [last name removed]'s Adverse Incident Report to the MHRA: Incident .... How many RIDDOR Reports/Complaints to the HSE by [first name removed] [last name removed] does ... 2007-2008 investigation into a Gantry Hoist, Crossbar and Universal Sling ...
www.whatdotheyknow.com/request/rosemary_...

I have made several enquiries about the use of "universal" as a word that encourages people - both professional healthcare providers and users alike - to believe that "universal" is meaning it can be used "universally" in all circumstances for all people of all conditions whereas in fact it is not like that at all.

What does "universal" actually mean?

1] SIZE:
"universal" can mean that one size fits all - but of course there are variations in size and you can get small, medium and large, for example. And adults and children.

This is therefore NOT universal in size.

2] MATERIAL:
"universal" can mean that just one specific type of material is used for a "universal" sling. But this is not so as various materials are used according to who the manufacturer is and for what specific purpose it is required.

This is therefore NOT universal in material.

3] STATUS OF PERSON USING "UNIVERSAL SLING"
Different types of patients need specialist types of slings. Amputees need "amputee" slings; some patients need to be transferred prone on a horizontal sling looking like a hammock / stretcher; some patients need adaptations to make a customised sling on account of swelling / oedema as my late mother required on account of illness.

This is therefore NOT universal in status of person using "universal sling" and in fact several people simply are NOT suited to use a "universal sling" and therefore it cannot be used in this manner.

4] TYPE OF HOIST AND SPREADER BAR
A "universal sling" cannot necessarily be used with each and every type of hoist. Some slings are specifically created for a "hanger type" spreader bar; some for "twin bar" spreader bars; some for "crossbar" spreader bars. If a "universal sling" is inappropriately used on a mismatched hoist and spreader bar, disaster can occur, as, I aver, happened with my late mother, for whom I am making this campaign to try and prevent any further catastrophes.

This therefore means that there is no such thing as "universal sling" because to be "universal" means de facto that it can be used universally on any and all hoists and spreader bars with any person regardless of clinical or social care status, but this simply is not the case. If only it were, my mother might still be alive today, for she fell not once but twice through the HOLE of a mismatched "universal sling" and gantry hoist and crossbar spreader bar.

Yet at no time have I been given the ENTIRE report on my mother by London Borough of Bromley who prescribed this contraption. They tell me that my mother's records have been destroyed in line with Council policy. Why?

My mother is dead, but her legacy should be the abolition of "universal" because it clearly is NOT a "universal" sling.

QED.

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/re...

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform,liberty, truth and justice

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the MHRA. This automated response confirms
that we have received your email and that it will be dealt with as quickly
as possible.

You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 20 working days. Further information on how we handle different
requests can be found on our website at the link below:

[1]http://www.mhra.gov.uk/Contactus/Central...

The MHRA website contains a wealth of information which may assist with
your enquiry. Some of our popular pages are:

Clinical Trials of medicines:
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:

[3]http://www.mhra.gov.uk/Howweregulate/Dev...

Manufacturer’s and wholesale dealer’s licences:
[4]http://www.mhra.gov.uk/Howweregulate/Med...

Registration of medical devices, opticians and dental laboratories:
[5]http://www.mhra.gov.uk/Howweregulate/Dev...

Reporting a side effect to a medicine:
[6]http://www.mhra.gov.uk/Safetyinformation...

Reporting an adverse incident involving a medical device:

[7]http://www.mhra.gov.uk/Safetyinformation...

Does my product need a licence?:
[8]http://www.mhra.gov.uk/Howweregulate/Med...

Reporting a counterfeit medical product:

[9]http://www.mhra.gov.uk/Safetyinformation...

Buying medicines over the internet:

[10]http://www.mhra.gov.uk/Safetyinformation...

If you have not heard from us after 20 working days then please contact us
on 020 3080 6000.

***Please note the MHRA will close for Easter at 13:00 on Thursday 5 April
2012, and will reopen at 09:00 on Tuesday 10 April 2012***

Kind regards

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency

Please note this is an automated reply; please do not respond to this
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show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
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References

Visible links
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2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
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5. http://www.mhra.gov.uk/Howweregulate/Dev...
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7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...

Ben Harris left an annotation ()

[name removed] has told us that she has referred this request to the Information Commissioner.

--
Ben Harris, WhatDoTheyKnow volunteer.

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