25 Oct 2012
MEDICAL DEVICE ALERT - Action
Ref: MDA/2012/075 and MDA/2012/075R
Anaphylactic reaction reports have been received by the Medicines and Healthcare products Regulatory Agency (MHRA) following the use of products containing chlorhexidine. Following an alert issued by the MHRA all healthcare professionals involved in patient care are advised to take steps to prevent further incidents.
A definitive list of products containing chlorhexidine is not held by the MHRA but a large number of medicinal products and medical devices do contain chlorhexidine.
Steps suggested by the MHRA to prevent further instances of anaphylactic reactions following the use of chlorhexidine products include:
- Awareness of the potential for an anaphylactic reaction to chlorhexidine
- Recording known allergies in patient notes
- Checking products do not contain chlorhexidine prior to supplying to patients with a known allergy
- Checking whether chlorhexidine was used or was impregnated in a medical device that was used when a patient experiences an unexplained reaction
- Reporting allergic reactions to products containing chlorhexidine to the MHRA
Further guidance on anaphylaxis is available from the MHRA, Resuscitation Council and NICE websites.
Healthcare professionals are asked by the MHRA to have action underway to deal with these issues by 22 November 2012 with action completed by 25 January 2013.