PFD report

Archie Hames · Prevention of Future Deaths report

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Issued 5 Jun 2014•Surrey

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
3

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised1

  1. Failure to ensure the integrity of tracheostomy tube attachments when using Velcro straps
    Part of recurring concern: Unreliable tracheostomy tube management and safety controls
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. Action

    Initiate discussions with partner agencies to agree wider quality improvements reducing tracheostomy dislodgement risks, including methods of securing devices.

    Stated by Department of Health and Social CareStated plannedThe respondent said that this action was planned when they made their response on 5 June 2014.
  2. Action

    Issue a generic medical device alert to UK hospitals highlighting risks and relevant changes to instructions for use.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 5 June 2014.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    A ban on Velcro tracheostomy holders was not considered appropriate because either fastening system may create risks and unintended harms.

    Stated by Department of Health and Social CareNo action considered necessaryThe respondent said that no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to ensure the integrity of tracheostomy tube attachments when using Velcro straps

Wider context from the report

“• Independent expert testing of the tracheostomy tube (model AMFNF-49) manufactured by Arcadia Medical and its attaching Velcro strap (model Trachi-Hold mini, TR ACC) manufactured by Kapitex Healthcare, confirmed that their combined use compromised the integrity of the silicone eyelet to the tracheostomy tube and was more likely than not to have caused the detachment of Archie’s tube • The further implications of such continued use • The implications of using Velcro strap attachments with other like tracheostomy tubes. I would ask that you consider give further consideration to the appropriateness of using Velcro strap attachments with tracheostomy tubes. ”

Is this part of a recurring concern?

Yes — Unreliable tracheostomy tube management and safety controls.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Initiate discussions with partner agencies to agree wider quality improvements reducing tracheostomy dislodgement risks, including methods of securing devices.

Verbatim wording from the response

“NHS England therefore propose initiating discussions with partner agencies including NCEPOD and Patient Safety Expert Groups (PSEGs) to agree how all parties can take forward wider quality improvements to reduce the risk of tracheostomy dislodgment, including, but not limited to, the best methods of securing these devices. We would be happy to keep you updated with progress as this work goes forward.”

Source location

2014-0259-Response-by-Department-of-Health
Page 2 · response
Published 5 June 2014

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Issue a generic medical device alert to UK hospitals highlighting risks and relevant changes to instructions for use.

Verbatim wording from the response

“• The MHRA issued a Generic Medical Device Alert (MDA/2012/062) on 11th September 2012 to all UK Hospitals highlighting the risks and changes to instructions for use for some silicone tracheostomy tubes. A copy of MDA/2012/062 is attached.”

Source location

2014-0259-Response-by-Department-of-Health
Page 4 · response
Published 5 June 2014

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

A ban on Velcro tracheostomy holders was not considered appropriate because either fastening system may create risks and unintended harms.

Verbatim wording from the response

“NHS England has considered whether it is safe and realistic to ban the use of Velcro to secure tracheostomies. A wider review of NRLS data and clinical practice suggests there are risks as well as benefits in using either fastening system, and that a ban on Velcro might introduce new unintended risks. It might also not be considered acceptable by some patients and carers.”

Source location

2014-0259-Response-by-Department-of-Health
Page 2 · response
Published 5 June 2014

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. 1

    Continue surveying and monitoring incidents involving the products and ensuring their instructions for use support safe use.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 5 June 2014.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue surveying and monitoring incidents involving the products and ensuring their instructions for use support safe use.

Verbatim wording from the response

“MHRA will continue to survey and monitor any incidents with these products and ensure that instructions for their use result in safe use.”

Source location

2014-0259-Response-by-Department-of-Health
Page 2 · response
Published 5 June 2014

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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026