Umbilical cord clamps - close the clamp by squeezing it at the grips until you hear a click

(All) incorrect placement of the clamp on the umbilical cord has lead to improper seal and blood loss in a small number of cases, which can be fatal. (MDA/2010/094)

Device

Umbilical cord clamps

Umbilical cord clamp.

All makes and models.

Problem

Incorrect placement of the clamp on the umbilical cord has lead to an inadequate seal and blood loss in a small number of cases.

Such blood loss could prove fatal for some babies.

Examples of two umbilical cord clamps

Umbilical cord clamps are available in a variety of designs. The photograph above shows examples of two of the simpler single-use designs on the market. One design has an additional extension that acts as a ‘gate’ protecting the hinge (eye) of the device and prevents the cord from entering this area. Some users, unfamiliar with the ‘un-gated’ design, have failed to apply the clamp correctly.

Action

Ensure that all users:

  • are aware of design differences that have an impact on:
    • positioning – position the clamp correctly around the umbilical cord - it is important to centre the cord within the clamp body
      • closing the clamp – the clamp is closed by squeezing the clamp at the grips until a click is heard
  • are aware of the risks of inadequate sealing of the umbilical cord
  • check cord site regularly for signs of bleeding with all types of cord clamps.

Correct and incorrect positioning of an umbilical cord clamp

Ensure all users are aware of the differences in design and the correct positioning of the device as shown above.

Distribution

This MDA has been sent 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)
  • Local Supervising Authority Midwifery Officers

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:

  • Ambulance services directors
  • Ambulance staff
  • Health and safety managers
  • Maternity units
  • Midwifery departments
  • Midwifery staff
  • Neonatal nurses
  • Nursing executive directors
  • Obstetricians
  • Obstetrics departments
  • Obstetrics theatres
  • Obstetrics nurses
  • Paramedics
  • Purchasing managers
  • Risk managers
  • Supplies managers

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

  • Community midwives
  • General Practitioners

Local Supervisory Authority Midwifery Officers
LSAMOs for onward distribution to all relevant staff including:

  • Independent midwives

Independent distribution

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

This alert should be read by:

  • Hospitals in the independent sector

Please note: CQC and OFSTED do not distribute these alerts. 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 notice to the MHRA, quoting reference number MDA/2010/094 or 2010/007/001/401/016.

Technical aspects

Sara Vincent and Catriona Blake
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7169/7219

Email: sara.vincent@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 7128

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 .

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

Northern Ireland Adverse Incident Centre (NIAIC)

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 .

Wales

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

Download documents

Medical Device Alert: Umbilical cord clamps – all makes and models (MDA/2010/094) (291Kb)

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