FOI release

Freedom of Information request (FOI 22/1078)

Published 17 January 2024

1st December 2022

FOI 22/1078

Dear,

Thank you for your information request, dated 31 October 2022, where you asked for

the following information. Unfortunately, we do not hold some of the information that

you have requested. Where this is the case, we have provided further information

below which you might find useful.

1. Please confirm the registration dates of Electroconvulsive therapy devices

in use across the United Kingdom.

a. Date the Somatics, LLC ECT devices (Thymatron System IV, etc)

registered for sale in the UK

b. Date the MECTA ECT devices registered for sale in the UK prior to

the October 2021 registry.

Information on the registration of medical devices in the UK is publicly available at

the following link to PARD (Public Access Registration Database): https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200. The

MECTA electroconvulsive therapy (ECT) device appears to have been registered on

19.10.2021, but the Somatics Thymatron Systems IV device does not appear to be

registered.

1. Which company provided the safety certificate for the Somatics devices?

Please provide the research on which the company based their

certification.

1. Which company provided the safety certificate for the MECTA devices?

Please provide the research on which the company based their

certification.

MHRA does not hold this information. You may wish to contact Somatics LLC at

sales@thymatron.com and MECTA at mectasales@mectacorp.com as they may be

able to provide the information you requested.

1. How does the MHRA define adverse incidents?

2. Which adverse incidents must be reported to the MHRA, and which should

be referred to them?

Adverse incidents are defined as those which are statutorily reportable by

manufacturers (or their representatives) to the MHRA. The reporting of incidents by

other stakeholders, including members of the public and clinicians, is on a voluntary

basis. Further information can be found at https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

Reportable incidents are those occurring in the UK, involving the manufacturer’s

medical device, and are defined as follows (see https://ec.europa.eu/docsroom/documents/32305/attachments/1/translations)

“Any malfunction or deterioration in the characteristics and/or performance of a

device, as well as any inadequacy in the labelling or the instructions for use which,

directly or indirectly, might lead to or might have led to the death of a patient, or user

or of other persons or to a serious deterioration in their state of health.”

In practice manufacturers must therefore report incidents where a malfunction of

their device is suspected to have contributed to the cause of a death or serious injury

or could have done so if the incident were to occur again. A “malfunction” should be

understood to be the failure of the device to perform as intended by the

manufacturer, when used in accordance with the manufacturer’s instructions.

1. Please provide safety warnings which identify serious adverse effects sent

to users since 2012.

MHRA has not published any warnings or alerts relating to electroconvulsive therapy

(ECT) devices. Warnings, including potential side effects from ECT, are documented

in the instructions for use of the ECT device.

1. Were the three deaths caused by ECT since 2015 (reported in the media and

a public petition) reported to the MHRA?

1. How did the MHRA investigate these deaths?

Although a small number of adverse incidents involving these devices have been

reported to MHRA, from information available these deaths do not appear to have

been reported. MHRA investigates device related incidents by looking for adverse

trends in the data and identifying where concerns are linked to the safety or

performance of a medical device. An extensive adverse incident review was

conducted for ECT machines which did not identify any safety concerns relating to

the operation of these medical devices.

The safety of the provision of ECT in general falls within the remit of both the

National Institute for Health and Care excellence (NICE) and the Royal College of

Psychiatrists. NICE address this in their NICE guidance documents, and The Royal

College of Psychiatrists has published accreditation requirements concerning the

use of ECT.

Any member of the public who has experienced an adverse effect is encouraged to

report this to the MHRA using the Yellow Card scheme. If clinicians encounter

adverse events involving the use of the device, they can also report this to us

through the same route.

The Freedom of Information Act only entitles you access to information – the

information supplied is subject to Crown copyright, and there are some restrictions

on its re-use. For information on the reproduction or re-use of MHRA information,

please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000

with regards to your request, you can ask for the decision to be reviewed. The review

will be carried out by a senior member of the Agency who was not involved with the

original decision.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for

an internal review. Internal review requests should be submitted within two months of

the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future

communications.

If you were to remain dissatisfied with the outcome of the internal review, you would

have the right to apply directly to the Information Commissioner for a decision.

Please bear in mind that the Information Commissioner will not normally review our

handling of your request unless you have first contacted us to conduct an internal

review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

Safety and Surveillance