Latex reactions (allergies) and medical devices

In many countries, including the UK, there has been an increase in the general exposure to natural rubber latex (NRL) in both medical and non-medical devices. As NRL products have been used for longer periods and more frequently, latex sensitisation has become a problem for some people.

It can cause a variety of allergic reactions from urticaria to rare cases of anaphylactic shock. The introduction of universal precautions and the increased use of barriers against infection led to gloves being used as a primary method of protection. As most gloves are made of NRL and worn exclusively throughout health care establishments, both workers and patients have been identified as at high risk of sensitisation/allergy.

Healthcare establishments are advised to develop a policy to address the purchase and safe use of gloves within their establishments.

For enquiries contact:
Sally Mounter
Senior Medical Device Specialist
Tel: 020 3080 7168
Email: sally.mounter@mhra.gsi.gov.uk

See also:

Manufacturers of medical devices that contain NRL may find the European Commission guidelines on conformity assessment with the Medical Devices Drectives for medical devices useful: MEDDEV 2.5/9 rev.1 02-2004, which is on the MEDDEV guidelines website (external link).


Page last modified: 29 October 2010