Anaesthetic machines and associated devices - reports about what check failures cause

(All manufacturers) reports say that failure to check anaesthetic machines and or the breathing system is a major factor in many anaesthetic misadventures, including some that have resulted in hypoxic brain damage or death.(MDA/2012/031)

CAS deadlines

Action underway: 18 June 2012, action complete: 25 June 2012

Device

Anaesthetic machines and associated devices.

All manufacturers.

Problem

The Association of Anaesthetists of Great Britain and Ireland (AAGBI) report that ‘failure to check the anaesthetic machine and/or the breathing system features as a major contributory factor in many anaesthetic misadventures, including some that have resulted in hypoxic brain damage or death’.

Action

  • Be aware that the AAGBI has published an updated version of ‘Checking Anaesthetic Equipment’ endorsed by all UK Chief Medical Officers and the Royal College of Anaesthetists.  The new ‘Checklist for Anaesthetic Equipment 2012’ is attached to this alert, please see appendix.
  • Always follow the manufacturer’s instructions for use.
  • Check anaesthetic machines and all breathing system components before use.

Action by

Anaesthetists, operating department practitioners, anaesthetic nurses and all staff using anaesthetic machines and associated 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 coordinators)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (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
  • Anaesthetic nursing staff
  • Anaesthetists
  • Clinical governance leads
  • Day surgery units
  • Maternity units
  • Medical directors
  • Nursing executive directors
  • Operating department practitioners
  • Risk managers
  • Theatre recovery suite
  • Theatres

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

Appendix

Checklist for Anaesthetic Equipment 2012 (306Kb)

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/031 or 2012/005/022/291/017.

Technical aspects

Douglas McIvor or Elke Kerwick
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7193 / 6826
Fax: 020 8754 3965

Email: douglas.mcivor@mhra.gsi.gov.uk or elke.kerwick@mhra.gsi.gov.uk

Clinical aspects

Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965

Email: nicola.lennard@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:

Dr Chris Jones
Medical Director
Welsh Assembly Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

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

Download documents

Medical Device Alert: Anaesthetic machines and associated devices, all manufacturers (MDA/2012/031) (609Kb)

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