Medical Device Alert: All medical devices and medicinal products containing chlorhexidine (MDA/2012/075)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2012/075 or 2012/010/003/081/016

Technical aspects
Sharon Knight or Louise Mulroy
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London SW1W 9SZ
Tel: 020 3080 7202 / 7344
Fax: 020 8754 3965
Email:  sharon.knight@mhra.gsi.gov.uk or louise.mulroy@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.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 CAS 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: 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 (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 (IRIC) (external link)

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

Risk of anaphylactic reaction due to chlorhexidine allergy.

The MHRA has received a number of reports of anaphylactic reactions following the use of products containing chlorhexidine. Two examples are given below:

• a patient had an anaphylactic reaction when a skin wipe that contained chlorhexidine gluconate was used prior to cannulation. The patient had previously had an anaphylactic reaction whilst under general anaesthetic but at the time the cause of the reaction was unknown.

• it was reported that a patient with a known chlorhexidine allergy, which was noted on his file and on his wristband, suffered a cardiac arrest shortly after a chlorhexidine impregnated central venous catheter was inserted whilst in the operating theatre. He was successfully resuscitated.

There are also other reports of allergic reactions to chlorhexidine published in journals.

• Be aware of the potential for an anaphylactic reaction to chlorhexidine.
• Ensure that known allergies are recorded in patient notes.
• Check the labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy.
• If a patient experiences an unexplained reaction, check whether chlorhexidine was used or was impregnated in a medical device that was used.
• Report allergic reactions to products containing chlorhexidine to the MHRA.
• Further guidance on anaphylaxis is available from NICE, the Resuscitation Council and the AAGBI.

Action by

All medical and nursing staff involved in the use of these devices and medicinal products.

This MDA has been sent to:

• NHS trusts in England (chief executives)
• Care Quality Commission (CQC) (headquarters) for information
• HSC trusts in Northern Ireland (chief executives)
• NHS boards in Scotland (equipment coordinators)
• Local authorities in Scotland (equipment coordinators)
• NHS boards and trusts in Wales (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 departments
• All clinical staff
• All departments
• All surgical units
• All wards
• Anaesthetists
• Clinical governance leads
• Dentists
• Haemodialysis units
• Immunologists
• Infection prevention & control directors
• Infection prevention & control teams
• Intensive care units
• IV nurse specialists
• Medical directors
• Medical oncologists
• Nursing executive directors
• Obstetrics and gynaecology departments
• Ophthalmology departments
• Paramedics
• Pharmacists
• Phlebotomists
• Renal medicine departments
• Resuscitation officers and trainers
• Risk managers
• Supplies managers
• Surgeons
• Theatre managers
• Urology departments

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

• Community dental practices
• Community hospitals
• Community midwives
• Community nurses
• Community pharmacists
• General dental practitioners
• General practitioners
• Minor injury units
• NHS walk-in centres
• Ophthalmic practices
• Optometrists
• Practice managers

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Care homes providing nursing care
• Clinics
• Hospitals in the independent sector
• Independent treatment centres
• Nursing agencies

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.

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk