Mercury in medical devices

Sale of medical devices containing mercury
Council Directive 2007/51/EC relating to restrictions on the marketing of certain measuring devices containing mercury amending Council Directive 76/769/EEC was transposed into UK Law by Statutory Instrument 2007 no.3438 Environment Protection. The European Commission has a dedicated web page on mercury (external link).

Mercury-in-glass fever thermometers
These cannot be placed on the market after 3 April 2009. They will no longer be available for purchase by members of the public and healthcare professionals. Devices in use and second-hand devices are not affected. However, new thermometers which are not in use but still in the distribution chain are covered by the restriction. Sale to the end-consumer after 3 April 2009 is not allowed and existing stocks must be withdrawn from the market.

Mercury sphygmomanometers
Since 3 April 2009 it has been prohibited to place these on the market for sale to the general public but they may still be available for healthcare sector. However, the European Commission was required to review this exemption by 3/10/2009. The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) published an opinion (external link), which the European Commission is now reviewing. The latest restrictions under consideration have been published by the European Chemicals Agency (external link).

Using mercury safely
The Health and Safety Executive (HSE) first issued the Regulations for the Control of Substances Hazardous to Health (COSHH) in 1988. This provides a comprehensive and systematic approach to the control of hazardous substances, such as mercury, substituting other less hazardous chemicals where possible. However, where it is not possible to substitute mercury, the above devices can still be used provided that members of staff are trained to ensure safe handling during normal use and in the event of a mercury spillage. There should be local procedures for dealing with mercury spillage and disposal. For more information see The Control of Substances Hazardous to Health Regulations 2002 (as amended)  (external link).

Using blood pressure measurement devices
We are aware of the many issues surrounding the use of mercury and the difficulty in obtaining accurate, reliable and cost effective alternative devices. Our publication ‘Blood Pressure Measurement Devices’ provides users and purchasers with information to enable them to decide whether to replace their mercury devices and to offer guidance on the selection process to ensure an appropriate product is obtained. We also issued a Medical Device Alert with an associated top tips leaflet on blood pressure monitors and sphygmomanometers (MDA/2006/037).

Committee on blood pressure monitoring in clinical practice
The remit of this group was to evaluate whether mercury sphygmomanometers should continue to be used or removed from the clinical environment; and to consider the alternatives to mercury devices and the evidence regarding their accuracy. The report was published in June 2005 and a summary was distributed via a Medical Device Alert (MDA/2005/069).

The Environment Agency has also issued guidance on ‘Mercury in measuring devices’, including restrictions under the REACH Regulation 2006 (external link).

For queries on sphygmomanometers and fever thermometers please contact: Catriona Blake, email: catriona.blake@mhra.gsi.gov.uk tel: 020 3080 7219

Using dental amalgam
At present, there are no plans to further restrict the addition of mercury to dental amalgam. Current advice is that it may be prudent not to remove or place fillings during pregnancy where clinically reasonable (although there is no evidence to suggest it is harmful). There are a few cases of allergy and hypersensitivity, and alternatives should then be used. At present, dental amalgam provides a high quality and effective restoration, with many of the alternatives not as effective.

The safety of dental amalgams has been reviewed extensively over the past 10 years, both nationally and internationally, concluding that dental amalgam is safe to use. Please see the summary of evidence (28Kb).

In the European Commission's communication ‘A Community Strategy concerning Mercury’ (external link), Action 6 states that ‘In the short term the Commission will ask the Medical Devices Expert Group to consider the use of mercury in dental amalgam, and will seek an opinion from the Scientific Committee on Health and Environmental Risks, with a view to considering whether additional regulatory measures are appropriate’. The MHRA and The Department of Health (UK) will continue to monitor the international literature for any reports that may indicate harmful side effects to health from dental mercury amalgam fillings. This information will be assessed against the benefit gained from the use of dental amalgam.

For queries on dental amalgam please contact: Ian Smith, 020 3080 7306, email ian.smith@mhra.gsi.gov.uk