Medical Device Alert: Unilect (TM) ECG monitoring electrodes manufactured by Unomedical (MDA/2010/046)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/046 or 2010/003/010/291/001.

Technical aspects
Graham Nash / Catriona Blake
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Telephone: 020 7084 3125 / 3219
Fax: 020 7084 3209

Email: graham.nash@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Telephone: 020 7084 3128
Fax: 020 7084 3111

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 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

Telephone: 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

Telephone: 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

Telephone: 029 2082 3922

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

The gel on affected ECG monitoring electrodes may migrate from its normal position underneath the sponge to fill the position between the sensor and the snap connector.

If this happens, the ECG monitor may fail to display the patient's ECG, potentially leading to delayed diagnosis or treatment.

The manufacturer is recalling affected devices.

• Identify affected Unomedical Unilect ECG electrodes – refer to the manufacturer’s Field Safety Notice for the lot numbers.
• Do not use affected Unomedical Unilect ECG electrodes.
• Return them to your distributor or supplier for credit, as described in the Field Safety Notice.

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)
• Primary care trusts in England (chief executives)
• Social services in England (directors)

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:

• A&E consultants
• A&E departments
• Adult and paediatric intensive care units
• All clinical departments
• All wards
• Ambulance staff
• Cardiac laboratory technicians
• Cardiology departments
• Cardiothoracic departments
• Clinical governance leads
• Coronary care departments
• Day surgery units
• Medical directors
• Midwifery departments
• Nursing executive directors
• Obstetrics and gynaecology departments
• Outpatient clinics
• Outpatient theatre managers
• Resuscitation officers and trainers
• Special care baby units
• Supplies managers
• Theatres

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

• Care homes providing nursing care (adults)
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

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

• Community hospitals
• District nurses
• Equipment libraries and stores
• General practitioners
• Minor injury units
• Resuscitation officers
• Walk-in centres

Sara Collins
Customer Services Supervisor
Unomedical Ltd
First Floor
Unit 3 West Wing
Brooklands
Moons Moat Drive
Redditch
B98 9DW

Telephone: 01527 583 622
Fax: 01527 591 198

Email: sara.collins@convatec.com