Reusable laryngoscope handles - inquest found contaminated device caused patient's death

(All models and manufacturers) MHRA received a report of an inquest that found a patient died after a laryngoscope handle had not been decontaminated appropriately between each patient use. (MDA/2011/096)

Device

Reusable laryngoscope handle

Reusable laryngoscope handles

All models and all manufacturers.

Problem

The MHRA has received a coroner’s report of an inquest which found that a patient death was caused by a failure to decontaminate a laryngoscope handle appropriately between each patient use. This led to cross infection and subsequently septicaemia.

Action

  • Review, and if necessary update, local procedures to ensure that reusable laryngoscope handles are decontaminated appropriately between each patient use, in accordance with the manufacturer’s instructions.

  • Be aware of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) guidelines, Infection Control in Anaesthesia 2, 2008 .

Action by:

Healthcare professionals using these devices and staff responsible for reprocessing medical devices.

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 co-ordinators)
  • Local authorities in Scotland (equipment co-ordinators)
  • 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:

  • A&E departments
  • Adult intensive care units
  • All wards
  • Anaesthetists
  • Coronary care departments
  • Day surgery units
  • ENT departments 
  • Infection control departments
  • Intensive care units
  • Maternity units
  • Operating department practitioners
  • Paediatric ITU
  • Paramedics
  • Resuscitation officers and trainers
  • Risk managers
  • Special care baby units
  • Sterile services departments
  • Supplies managers
  • Theatres

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

  • Community hospitals
  • Infection control teams
  • Minor injury units
  • NHS walk-in centres
  • Resuscitation officers and trainers

Independent distribution

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

  • Hospitals in the independent sector
  • Independent treatment centres

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/2011/096 or 2011/009/006/291/003

Technical aspects

Douglas McIvor
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7193
Fax: 020 8754 3965

Email: douglas.mcivor@mhra.gsi.gov.uk

Decontamination aspects

Ian Smith
Medicines and Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7306
Fax: 020 8754 3965

Email: ian.smith@mhra.gsi.gov.uk

Clinical aspects

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

Tel: 020 3080 7128
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

http://www.dhsspsni.gov.uk/index/hea/niaic.htm

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

http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Wales

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

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

Download documents

Medical Device Alert: Reusable laryngoscope handles - all models and manufacturers (MDA/2011/096) (330Kb)

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