Silicone tracheostomy tubes - eyelets of silicone tracheostomy tubes damaged by holder

(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)

CAS deadlines

Action underway: 25 September 2012, action complete: 9 October 2012

Note: These deadlines are for systems to be in place to take actions.

Device

Silicone tracheostomy tubes

Various manufacturers

Various models

Tracheostomy tubes are held in position using holders (also known as neck ties). The holders are attached by being threaded through the eyelets on the flanges of the tracheostomy tube.  

Problem

The MHRA is aware of several incidents where the eyelets of tracheostomy tubes appear to have been damaged by the holder. This led to dislodgement of the tube with the subsequent risk of airway loss.

Action

  • Check the instructions for use for both the tracheostomy tube and the holder to ensure that they are compatible.  
  • Be aware that some manufacturers have recently updated their instructions for use to include a warning to users not to use their tracheostomy tubes with sharp-edged holders, for example some types of Velcro or metal edged holders.
  • Ensure that the instructions for use are followed for both the tracheostomy tube and the holder.

Action by

All staff responsible for the care of patients with tracheostomy tubes.

Distribution

This MDA has been sent to:  

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (Headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (equipment coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • Primary care trusts in England (chief executives)

Onward distribution

Please bring this notice to the attention of relevant employees in your establishment.  Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Adult intensive care units
  • All clinical departments
  • All clinical staff
  • All wards
  • Ambulance services directors
  • Ambulance staff
  • Anaesthetists
  • Clinical governance leads
  • Day surgery units
  • Health and safety managers
  • Hospital at home units
  • Medical directors
  • Medical libraries
  • Nursing executive directors
  • Outpatient departments
  • Paediatric intensive care units
  • Purchasing managers
  • Risk managers
  • Supplies managers
  • Theatres

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Community children’s nurses
  • Community hospitals
  • Community nurses
  • District nurses
  • General practitioners
  • Health visitors
  • Minor injury units
  • NHS walk-in centres
  • Practice nurses
  • School nurses
  • Walk-in centres

Social services
Liaison officers for onward distribution to all relevant staff including::

  • In-house residential care homes

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Care homes providing nursing care
  • Care homes providing personal care
  • Hospices
  • Hospitals in the independent sector
  • Independent treatment centres
  • Private medical practitioners

Establishments registered with OFSTED
This alert should be read by:

  • Educational establishments with beds for children
  • Residential special schools

Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Feedback

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/062 or 2012/001/018/401/003

Technical aspects

Louise Mulroy and Gica Leclerc
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7344 and 6610
Fax: 020 8754 3965

Email: louise.mulroy@mhra.gsi.gov.uk or gica.leclerc@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 6648
Fax: 020 8754 3965

Email: jonathan.plumb@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices

Further information about CAS can be found on the CAS website

Northern Ireland

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the NIAIC website
Further information about SABS can be found on the SABS website

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)Health Facilities Scotland Incident Reporting and Investigation Centre (IRIC)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

Download documents

Medical Device Alert: Silicone tracheostomy tubes - various manufacturers (MDA/2012/062) (66Kb)

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