Adverse Incident Reports Involving ECT Machines

Nicholas Webb made this Freedom of Information request to Therapeutic Goods Administration

The request was refused by Therapeutic Goods Administration.

From: Nicholas Webb

Delivered

Dear Therapeutic Goods Administration,

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

Yours faithfully,
Nicholas Webb

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From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Webb

 

I refer to your correspondence of 4 January 2020 to the Department of
Health (as below).

 

Section 15 of the FOI Act requires that a request for access meets certain
requirements. Your request, in its current form, does not constitute a
valid request as it is a request for information rather than documents.
The FOI Act provides for access to documents and not to 'information'.

 

In order for your request to be processed under the provisions of the FOI
Act we require further information to enable us to identify the document
or documents you are seeking.

 

I would greatly appreciate if you could provide us with more information
on the specific documents that you require. For example, it would be
helpful if you could clarify whether you require a particular type of
electroconvulsive therapy device, and/or a date range for the documents.
This will assist us to identify the documents you seek.

 

We would be grateful for your response by COB Tuesday 7 January 2020.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

 

 

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From: Nicholas Webb

Delivered

Dear TGA FOI,

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 (dates January 1, 2015 - December 31, 2019) for manufacturers MECTA, Somatics, LLC and Ectron.

Yours sincerely,

Nicholas Webb

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Webb

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

“…(request for) all electroconvulsive therapy device adverse event reports
filed within the last five years (dates January 1, 2015 - December 31,
2019) for manufacturers MECTA, Somatics, LLC and Ectron.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 7 February 2020.

However, where there is requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

1.       Personal Information

Documents containing personal information, (e.g. the names and contact
details of any individuals, or any information that could reasonably
identify an individual) may require the Department to consult with the
identified individuals or parties. This consultation is likely to add to
the time taken to process your request, and potentially increase the
charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         Commonwealth staff (please note that unless you advise
otherwise, we will assume that you do not seek access to personal
information of Commonwealth employees below Senior Executive Service
level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal information you require.

 

2.       Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Friday 17 January 2020, if
possible.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards

 

Freedom of Information

[2]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

 

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Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Mr Webb

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present. 

 

show quoted sections

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