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Device

All anaesthetic breathing systems, anaesthetic machines and anaesthetic ventilators.

Problem

The MHRA continues to receive reports of inadequate patient ventilation and oxygenation where harm could have been avoided if an alternative means of ventilation had been used earlier. These incidents occurred because of misconnection, entrapment or occlusion of the anaesthetic breathing systems, or because the anaesthetic machine or ventilator had failed.

In one particular incident an anaesthetic breathing system was wrongly connected to the auxiliary common gas outlet of an anaesthetic machine. The effects of this were wrongly interpreted as bronchospasm and the usual drug regimens were administered. The time taken to finally identify that this was a problem with the equipment meant that the patient was harmed.

Whilst such equipment issues are uncommon, they should be considered as a matter of course when problems with patient ventilation occur.

Action

• Prior to the induction of anaesthesia ensure that an alternative means of ventilation is immediately available eg self-inflating bag and an oxygen cylinder with suitable connections, as recommended by the 聽in their guidelines 鈥楥hecking Anaesthetic Equipment 3 (2004)鈥�. This publication is available from their website.
• When problems with patient ventilation occur, consider the immediate use of a self-inflating bag. This may identify the site of the problem, while maintaining ventilation and oxygenation.
• Ensure the self-inflating bag is directly attached to the endotracheal tube/airway device, removing all parts of the existing circuit including the catheter mount.

The AAGBI and the 聽endorse these actions.

Distribution

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters)
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (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:

• anaesthesia, directors of
• anaesthetic nursing staff
• anaesthetists
• operating department practitioners
• risk managers
• theatre managers

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

• hospitals in the independent sector
• independent treatment centres

Feedback

If you have any comments or feedback on this Medical Device Alert, please email us at: [email protected]

England

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/036 or 2009/012/014/401/004.

Technical aspects

Email: [email protected] 辞谤听[email protected]

Clinical aspects

Email: [email protected]

How to report adverse incidents

Please report via our website: .

Further information about CAS can be found on the .

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:

Email: [email protected]

How to report adverse incidents in Northern Ireland

Please report directly to NIAIC, further information can be found on the .

Further information about SABS can be found on the .

Scotland

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

Email: [email protected]

.

Wales

Enquiries in Wales should be addressed to:

Email: [email protected]

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