EU RETHINKING BAN ON MERCURY IN MEDICAL DEVICES
In a slight concession to the medical device industry, the European Parliament last month agreed to delay a proposed ban on mercury-containing sphygmomanometers (blood pressure monitors) while the European Commission conducts a review into safe and reliable alternatives.
The proposed directive gives the commission two years from the date the directive becomes effective to complete its investigation, at which time the commission must propose new legislation to extend the restrictions to blood pressure monitors and other measuring devices used in healthcare.
According to revised text of the proposed directive, "the commission should carry out a review of the availability of safer alternative solutions that are technically and economically feasible. In the case of sphygmomanometers in healthcare, medical experts should be consulted to ensure that the needs in terms of diagnosis and treatment of specific medical conditions are adequately addressed."
Manufacturers would have 18 months to seek exemption on a case-by-case basis if they "can prove that they have undertaken every effort to develop safer alternatives or alternative processes, and that safer alternatives or alternative processes are still not available," the directive says. Waivers would be for a limited time only.