Adverse Incident Reports Involving ECT Machines

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

Could I please request the data of all adverse incidents reported for Electroconvulsive Therapy (ECT) or Electroshock machines?

Yours faithfully,
Nicholas Webb

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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Email: [8][MHRA request email]
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 19/003
       
Dear Mr Webb,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry attached and below which we received on 3rd January 2020.
       
I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt. 

If you need to contact us again about this request, please quote the reference number above.
        
Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 20/003

Dear Mr Webb,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry attached and below which we received on 3rd January 2020.

Please accept apologies the reference number for your FOI enquiry is FOI 20/003 not FOI 19/003.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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RE: FOI 20/003

Thanks MHRA Customer Services.

I am compiling data for an international research project using information on all electroconvulsive therapy device adverse event reports filed within the last five years (January 1, 2015 to December 31, 2019) for manufacturers MECTA, Somatics, LLC and Ectron.

Yours sincerely,

Nicholas Webb

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare products
Regulatory Agency. 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 requests within the Department of Health’s target response time
of 18 working days; or 20 working days if your request is a Freedom of
Information request; one month if you are making a request for access to
your personal data under the General Data Protection Regulation 2018.
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical trials of medicines and Clinical investigation for a medical
device:

[1]https://www.gov.uk/medicines-medical-dev...
       
Manufacturer’s and wholesale dealer’s licences:

[2]https://www.gov.uk/apply-for-manufacture...
 
Registration of medical devices, opticians and dental laboratories:

[3]https://www.gov.uk/register-as-a-manufac...
 
Reporting a problem with a medicine or medical device:

[4]https://www.gov.uk/report-problem-medici...
 
Deciding if your product is a medicine or a medical device:

[5]https://www.gov.uk/decide-if-your-produc...
 
Reporting a counterfeit medical product:
 
[6]https://yellowcard.mhra.gov.uk/counterfe...
 
We are continuously looking to make improvements to the service offered by
our Customer Services team, so if you have any feedback please don’t
hesitate to get in touch with us either on the number below or by
completing the form at the link below:
[7]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
Communications division
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [8][MHRA request email]
Stay connected: [9]mhra.gov.uk/stayconnected
 
All emails are retained by the Agency in a secure area together with the
Agency’s response, for eight years in accordance with our Retention and
Disposal Schedule. Our privacy notice can be found [10]here.
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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Queries, Devices, Medicines and Healthcare Products Regulatory Agency

MHRA reference: FOI 20/003

 

Dear Nicholas Webb

 

Thank you for your email of 03 January 2020 in which you asked for the
data of all adverse incidents reported for Electroconvulsive Therapy (ECT)
or Electroshock machines and your subsequent email of 07 January 2020
where you clarified that the data you required was all electroconvulsive
therapy device adverse event reports filed within the last five years
(January 1, 2015 to December 31, 2019) for manufacturers MECTA, Somatics,
LLC and Ectron.

 

MHRA received 4 adverse incident reports within this five year period.

I am unable to break these down per manufacturer because of the
confidentiality clause of the legislation that we work under. We can only
provide information about generic types of devices.

The information you have asked for is exempt from disclosure under section
44 (1)(b) of the Freedom of Information Act (FOIA) as detailed below.  

 

MHRA has not published any alerts on electro-convulsive therapy devices.

 

Section 44 (1)(b) of the Freedom of Information Act 2000 (FOIA provides an
exemption where disclosure of information would be incompatible with an EU
obligation.

 

All information provided to the MHRA in the course of its functions under
the Medical Devices Directive (93/42/EEC) is required to be treated as
confidential according to the confidentiality provisions in Article 20 of
the Directive. This Directive applies to the devices within your request.

 

Article 20(1) states:

 

'Without prejudice to the existing national provisions and practices on
medical confidentiality, Member States shall ensure that all the Parties
involved in the application of this Directive are bound to observe
confidentiality with regard to all information obtained in carrying out
their tasks.'

 

The MHRA is satisfied that disclosure of the information you have
requested would breach that obligation and the exemption in section
44(1)(b) is therefore engaged.

 

Section 44 of the FOIA is an absolute exemption and is not subject to the
public interest test.

 

If you have any questions about the information provided, please reply to
this email.

 

Yours sincerely

Enquiries Co-ordinator

Devices Division

Medicines and Healthcare Products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Email: [1][email address]   

 

 

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