Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - risk of inadequate external pacing

(All manufacturers and models) Can lead to potential periods of asystole, syncope and possible death. (MDA/2013/032)

CAS deadlines

Action underway: 24 May 2013, action complete: 7 June 2013
Note: These deadlines are for staff to be aware of the problem and to review settings.

Device

Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules.

All manufacturers and all models.

Transcutaneous pacing delivered by a defibrillator is also known as ‘external pacing’. It is the delivery of current via the external defibrillation pads. Successful delivery of this technique is reliant on sufficient current to stimulate the myocardium to contract (known as ‘capture’).

Transcutaneous pacing is sometimes used in the emergency setting to treat asystole or bradycardia. This is usually a temporary bridging measure prior to further treatment, such as temporary or permanent pacemaker implantation.

Problem

Risk of inadequate external pacing, leading to potential periods of asystole, syncope and possible death.

Factory default start-up pacing current and rate settings on transcutaneous pacemaker modules vary and may be too low to ensure pacing capture.

Users should be aware of this and ensure settings are configured to meet their local protocols.

Transcutaneous pacing modules have factory defaults that initiate pacing with a low current and rate.

The MHRA has received a report that highlights the importance of raising awareness that the factory defaults can be configured to user presets.

Further guidance on trancutaneous pacing is being considered by Heart Rhythm UK (HRUK) .

Action

Ensure that you:

  • are aware of the pacing current and rate settings
  • follow recommendations in the manufacturer’s instructions for use and local protocols within your trust.

Ensure those responsible for the devices:

  • are aware that factory default pacing settings (for current and rate) can be configured to user presets
  • review and evaluate appropriateness of the factory defaults for pacing mode (demand or fixed).

Action by

All medical, nursing and technical staff involved in the use and maintenance of these devices.

Distribution

This MDA has been sent to:

  • Care Quality Commission (CQC) (headquarters) for information
  • Clinical commissioning groups (CCGs)
  • HSC trusts in Northern Ireland (chief executives)
  • Local authorities in Scotland (equipment co-ordinators)
  • NHS boards and trusts in Wales (chief executives)
  • NHS boards in Scotland (equipment co-ordinators)
  • NHS England area teams
  • NHS England area teams (chief executives)
  • NHS England regional teams
  • NHS trusts in England (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 consultants
  • A&E departments
  • All clinical departments 
  • All staff
  • All wards
  • Ambulance services directors 
  • Ambulance staff
  • Anaesthesia, directors of 
  • Anaesthetic medical staff
  • Cardiac physiologists
  • Cardiologists
  • Cardiology departments 
  • Cardiothoracic departments 
  • Clinical governance leads
  • Community defibrillation officers 
  • EBME departments
  • Medical directors
  • Nursing executive directors
  • Outpatient theatre managers
  • Resuscitation officers and trainers 
  • Risk managers
  • Theatre managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only) 

This alert should be read by:

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

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

England

If you are in England, please send enquiries about this MDA/2013/032 or MHRA 2012/001/019/401/014.

Technical aspects 

Enitan Taiwo and Catriona Blake 
Medicines & Healthcare Products Regulatory Agency
Floor 4,
151 Buckingham Palace Road
London 
SW1W 9SZ 

Tel: 020 3080 7122/7219
Fax: 020 8754 3965

Email: enitan.taiwo@mhra.gsi.gov.uk or catriona.blake@mhra.gsi.gov.uk

Clinical aspects

Jonathan Plumb
Medicines & Healthcare Products Regulatory Agency
Floor 4,
151 Buckingham Palace Road
London 
SW1W 9SZ 

Tel: 020 3080 6648
Fax: 020 8754 3965

Email: jonathan.plum@mhrgsi.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)

Wales

Enquiries in Wales should be addressed to:

Improving Patient Safety Team
Medical Directorate
Welsh Government
Cathays Park
Cardiff CF10 3NQ

Tel: 029 2082 3922

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

Download documents

FAQs on MDA/2013/032 (12Kb) Medical Device Alert: Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules - all manufacturers and all models (MDA/2013/032) (68Kb)

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