Medical Device Alert: Anaesthetic vaporizers - all manufacturers (MDA/2010/052)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/052 or 2008/012/011/401/021.

Technical aspects
Mr Douglas McIvor or Dr Louise Mulroy
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3193 / 3344
Fax: 020 7084 3209

Email: douglas.mcivor@mhra.gsi.gov.uk or louise.mulroy@mhra.gsi.gov.uk

Clinical aspects
Dr Tom Clutton-Brock
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3056
Fax: 020 7084 3111

Email: tom.clutton-brock@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 Central Alerting System website (external link).

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

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

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

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

The MHRA has received reports where the failure to correctly attach vaporizers to the anaesthetic machine backbar has led to anaesthetic gas leakage and patient awareness.

This may be more pronounced where:

• vaporizers are attached to anaesthetic machines from an alternative manufacturer
• vaporizers are attached to the backbar during anaesthsia.

• Ensure that vaporizers are correctly seated on the backbar before the induction of anaesthesia and that the machine has been tested for leaks in accordance with the manufacturer’s instructions and the Association of Anaesthetists of Great Britain and Ireland (AAGBI) Guidelines.
• If a new vaporizer is attached to the backbar during anaesthesia, the machine must be checked immediately in accordance with the manufacturer’s instructions and the AAGBI Guidelines (external link).

The AAGBI Guideline “Checking Anaesthesia Equipment” (external link) is under revision. The testing for leaks by occluding the Common Gas Outlet may not always be appropriate, therefore always consult the instructions for use of the vaporizer and the anaesthetic machine.

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Chief Executives)
• NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

• Anaesthetic nursing staff
• Anaesthetists
• Clinical perfusion scientists
• Day surgery units
• Operating department practitioners.
• Theatre managers
• Theatres

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

• Hospitals in the independent sector