Medical Device Alert: Anaesthetic gas scavenging systems (AGSS) – all manufacturers (MDA/2010/021)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/021 or 2010/001/029/081/005.

Technical aspects
Douglas McIvor or 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
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: 028 9052 3704
Fax: 028 9052 3900

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

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).

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

Risk of serious harm to the patient from excessive pressure in anaesthetic breathing systems caused by blockage of AGSS hoses.

The AAGBI and representatives from the Technical Committee of the British Standards Institution (BSI) have identified that the European and International Standard EN ISO 8835-3 2009 Inhalational anaesthesia systems, Part 3 Transfer and receiving systems of active anaesthetic gas scavenging systems has failed to mandate that there is a means of pressure-relief at the inlet of all interchangeable AGSS transfer hoses. This standard defines the dimensional requirements of the inlet connectors of the AGSS transfer hoses to be a 30mm female connector, to ensure compatibility and interchangeability between anaesthetic breathing systems and AGSS from different manufacturers. Consequently this transfer hose can be attached to the exhaust valve of a breathing system or an anaesthetic ventilator that may not have integral over-pressure protection. Thus, any occlusion within the transfer hose would result in a build-up of excessive positive-pressure within the breathing system.

The technical specifications within this standard have been available to equipment manufactures since 2007; therefore these systems are now in use in the UK. Additionally some users have replaced the manufacturer’s non-interchangeable inlet connector with a 30 mm interchangeable type.

This latest version of the standard also mandates the use of a 30 mm male connector at the outlet of the AGSS receiving reservoir (which incorporates the air-break) thereby making it possible to fit the receiving system hose directly onto the exhaust valve of the breathing system by-passing the receiving reservoir and air-break altogether. This would create a high-flow negative pressure within the breathing system.

The MHRA, AAGBI, Royal College of Anaesthetists, British Anaesthetic and Respiratory Equipment Manufacturers Association and BSI are working to amend this European and International Standard. It is estimated this Standard will be amended approximately six months after publication of this Alert.

• Ensure all anaesthetic staff are aware of this problem.
• Have procedures in place to ensure that:
• • a means of over-pressure relief is provided at the entry to the AGSS transfer hose when it incorporates 30mm diameter connectors to attach to either the exhaust, or adjustable pressure limiting (APL) valves of anaesthetic breathing systems or ventilators
  • pre-use checks for the anaesthetic equipment are always followed, including the anaesthetic machine, ventilator, breathing systems and the AGSS, as recommended by the Association of Anaesthetists of Great Britain and Ireland (external link) in their guidelines 'Checking Anaesthetic Equipment 3 (2004)'.

These actions are endorsed by the Association of Anaesthetists of Great Britain and Ireland (AAGBI).

This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC)
• 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