HCWH Europe Comments on the ECHA Annex XV Restriction Report on Mercury From June 15, 2010

Brussels — Health Care Without Harm Europe is pleased to have the opportunity to comment on the Annex XV restriction report by the European Chemical Agency (ECHA).

Mercury is a metal, which is toxic for humans and wildlife. High doses can be fatal; even low doses of mercury compounds can have serious neurodevelopmental effects, damaging the cardiovascular, immune and reproductive systems. Recent research indicates that, for some parts of the population, there is no such thing as a safe exposure level for mercury.

HCWH Europe welcomes the proposal for restrictions of mercury based measuring instruments. However we would like to make the following comments:

• Waste from mercury based measuring instruments already on the market needs to be addressed. The Commission and Member States should actively promote the collection and safe handling and storage of the waste;
• Derogations for long-term, epidemiological studies should only be for on-going studies at entry into force and not for studies, which start after entry into force;
• Derogations for reference standards in clinical validation studies of mercury-free sphygmomanometers should be limited to certified and specialised institutions only;
• Derogations should be time-limited;
• The Commission should take action to promote and develop alternative reference standards.

Scope of the restrictions

The report estimates that 3.5 to 7.6 tonnes of mercury are placed on the market containing mercury-measuring devices in 2010. At the same time there are low collection rate and resulting inadequate waste treatment. This presents high health and environmental risks and associated costs for health facilities due to leakage, breakage and cleaning costs.

The low collecting rate confirms the findings of our commissioned research in 2009 that mercury-based sphygmomanometers are still used and stored in hospitals and primary care centres in some Member States. The restriction will not address the mercury based measuring instruments already on the market. The report needs to clearly state and identify the lack collection and storage of mercury waste in the report. The Commission and Member States urgently need to take all necessary steps to address mercury waste from measuring devices and should set up collection and storage facilities.

Derogations

The SCENIHR report found that “mercury-free blood pressure measuring devices (when clinically validated) are generally reliable substitutes for mercury-containing sphygmomanometers in routine clinical practice.” It also concludes “there is no evidence of adverse effects on patients' health in clinical settings due to the replacement of mercury containing sphygmomanometers by validated mercury-free alternatives.” The report further finds that mercury-based sphygmomanometers are "not essential" for calibration.

Therefore, due to the acute toxic hazard to health care workers and chronic hazard to society, these devices have no place in clinical care. They may only be needed for validation of sphygmomanometers is specialised centres and long-term epidemiological studies that are on-going at entry into force.

It is important to set clear time limits for derogations.

Development alternative reference standards

The monograph ‘The accuracy of alternatives to mercury sphygmomanometers’ reviews the medical literature that evaluates the accuracy of mercury, aneroid, and oscillometric blood pressure devices.

It is important to note that the monograph states that mercury sphygmomanometers were not as unfailingly accurate as often expected. Failure rates using various validation, calibration and inspection protocols ranged from 1% to 28%.

The Commission should take action to promote and develop alternative reference standards. Although currently most professional organisations still require mercury for validation protocols, electronic pressure gauges offer superior accuracy and should be substituted for mercury manometers for calibration and validation.

We thank you for considering our comments and recommendations.

Health Care Without Harm is an international coalition of more than 500 organizations in 53 countries, working to transform the health care sector worldwide, without compromising patient safety or care, so that it is ecologically sustainable and no longer a source of harm to public health and the environment. Visit the HCWH website for more information.