Latex reactions (allergies) and medical devices

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. In April 1996, as part of the continuing evaluation of the potential hazards of latex, the Medical Devices Agency (now MHRA) produced a guidance document DB 9601 'Latex Sensitisation in the Health Care Setting - (Use of Latex Gloves)' . The Device Bulletin was distributed to all health authorities and NHS trusts in addition to our regular mailing list. Feedback has shown that the bulletin has proved useful and relevant in a variety of healthcare settings and we would like to encourage its extensive distribution. The Device Bulletin is designed to increase awareness of the potential problems of sensitisation. It also identifies:

• types of reactions
• high risk groups
• methods of diagnosis

Guidance on the management of sensitised individuals (patients and staff) centres on providing :

• information
• practical methods of avoiding or minimising latex contact
• suitable occupational health services
• glove selection
• extractable protein levels
• European standards

Healthcare establishments are advised to develop a policy to address the purchase and safe use of gloves within their establishments. For further information, please see Safety Notice SN 9825 'Latex Medical Gloves (Surgeons' and Examination) Powdered Latex Medical Gloves (Surgeons' and Examination)'.

To order a paper copy of DB 9601 contact: 
DTS Services
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3272
Fax: 020 7084 3124
E-mail : dts@mhra.gsi.gov.uk

For enquiries contact:
Sally Mounter
Senior Medical Device Specialist
Medicines and Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3168
Fax: 020 7084 3106
E-mail: sally.mounter@mhra.gsi.gov.uk

The Health & Safety Executive also provides latex information on their website that particularly applies to those in healthcare, concerning NRL allergies and how you can protect yourself and others against them.

Manufacturers of medical devices that contain NRL may find the European Commission guidelines on conformity assessment with the Medical Devices Drectives for medical devices containing NRL useful: MEDDEV 2.5/9 rev.1 02-2004.